Quetiapine Fumarate
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Uses
Quetiapine fumarate tablet is an atypical antipsychotic indicated for the treatment of:
- Schizophrenia (1.1)
- Bipolar I disorder manic episodes (1.2)
- Bipolar disorder, depressive episodes (1.2)
Quetiapine fumarate tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES (14.1)].
Quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see CLINICAL STUDIES (14.2)].
Quetiapine fumarate tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see CLINICAL STUDIES (14.2)].
Quetiapine fumarate tablets are indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine fumarate tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see CLINICAL STUDIES (14.2)].
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
History
There is currently no drug history available for this drug.
Other Information
Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C42H50N6O4S2.C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:
Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water.
Quetiapine fumarate tablets are supplied for oral administration as 25 mg (quetiapine) round, pink tablets, 50 mg (quetiapine) round, white tablets, 100 mg (quetiapine) round, yellow tablets, 200 mg (quetiapine) round, white tablets, 300 mg (quetiapine) capsule-shaped, white tablets and 400 mg (quetiapine) capsule-shaped, yellow tablets.
Inactive ingredients are dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate and titanium dioxide.
The 25 mg tablets contain iron oxide red and iron oxide black; and the 100 mg and 400 mg tablets contain iron oxide yellow.
Sources
Quetiapine Fumarate Manufacturers
-
Remedyrepack Inc.
![Quetiapine Fumarate Tablet [Remedyrepack Inc. ]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food (2.1). Indication
Initial Dose
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.2) 25 mg twice daily
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years) (2.2) 25 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2) 25 mg twice daily
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults (2.2) 50 mg once daily at bedtime
300 mg/day
300 mg/day
GeriatricUse: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly (2.3, 8.5) HepaticImpairment: Lower starting dose (25 mg/day) and slower titration may be needed (2.4, 8.7, 12.3)Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see CLINICAL STUDIES (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg
divided two or three times on Days 2 and
3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day,
in intervals of not less than 2 days.
150 to 750
mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 800
mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to
800 mg/day by Day 6 should be in
increments of no greater than 200 mg/day.
400 to 800
mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 600
mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy-Adults
Administer twice daily totaling 400 to
800 mg/day as adjunct to lithium or
divalproex. Generally, in the maintenance
phase, patients continued on the same dose
on which they were stabilized.
400 to 800
mg/day
800 mg/day
1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment:
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see CLINICAL PHARMACOLOGY (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
Quetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John's wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7 to 14 days [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 N/A Not applicable -
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food (2.1). Indication
Initial Dose
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.2) 25 mg twice daily
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years) (2.2) 25 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2) 25 mg twice daily
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults (2.2) 50 mg once daily at bedtime
300 mg/day
300 mg/day
GeriatricUse: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly (2.3, 8.5) HepaticImpairment: Lower starting dose (25 mg/day) and slower titration may be needed (2.4, 8.7, 12.3)Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see CLINICAL STUDIES (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg
divided two or three times on Days 2 and
3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day,
in intervals of not less than 2 days.
150 to 750
mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 800
mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to
800 mg/day by Day 6 should be in
increments of no greater than 200 mg/day.
400 to 800
mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 600
mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy-Adults
Administer twice daily totaling 400 to
800 mg/day as adjunct to lithium or
divalproex. Generally, in the maintenance
phase, patients continued on the same dose
on which they were stabilized.
400 to 800
mg/day
800 mg/day
1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment:
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see CLINICAL PHARMACOLOGY (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
Quetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John's wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7 to 14 days [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 N/A Not applicable -
Direct Rx
Quetiapine Fumarate | Direct Rx
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1) and (14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended Dose Maximum DoseSchizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A 1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
1N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment — Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)] . When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)] .
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)] .
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food (2.1) Indication
Initial Dose
Recommended
Dose
Maximum
Dose
Schizophrenia-Aults (2.2)
25 mg twice daily
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years) (2.2)
25 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2)
50 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy (2.2)
25 mg twice daily
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults (2.2)
50 mg once daily at bedtime
300 mg/day
300 mg/day
Geriatric Use: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly (2.3, 8.5) Hepatic Impairment: Lower starting dose (25 mg/day) and slower titration may be needed (2.4, 8.7, 12.3)Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia- Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults
Monotherapy or as an
adjunct to lithium or
divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression- Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Quetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 N/A Not applicable -
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended
Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice daily.
Increase in increments of 25 mg-50 mg divided two or three times on Days 2 and 3 to range of 300-400 mg by Day 4.
Further adjustments can be made in increments of 25–50 mg twice a day, in intervals of not less than 2 days. 150-750 mg/day 750 mg/day Schizophrenia-Adolescents
(13-17 years) Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in incrementsno greater than 100 mg/day within therecommended dose range of 400-800 mg/day.
Based on response and tolerability, may beadministered three times daily. 400-800 mg/day 800 mg/day Schizophrenia-Maintenance N/A1 400-800 mg/day 800 mg/day Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400-800 mg/day 800 mg/day Bipolar Mania-Children and Adolescents
(10 to 17 years), Monotherapy Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-600 mg/day.
Based on response and tolerability, may be administered three times daily. 400-600 mg/day 600 mg/day Bipolar Depression-Adults Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy - Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400-800 mg/day 800 mg/day1N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Quetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Proficient Rx Lp
Quetiapine Fumarate | Proficient Rx Lp
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1) and (14.2) ].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended Dose Maximum DoseSchizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
1N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment — Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2) ].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3) ] . When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1) ].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1) ] .
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Cardinal Health
Quetiapine Fumarate | Apotheca Company
DIRECTIONS: 10 drops orally, 3 times a day or as directed by a health care professional. Consult a physician for use in children under 12 years of age.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended
Dose Maximum Dose Schizophrenia-Adults (2.1) Day 1: 25 mg twice daily.
Increase in increments of 25 mg-50 mg divided two or three times on Days 2 and 3 to range of 300-400 mg by Day 4.
Further adjustments can be made in increments of 25–50 mg twice a day, in intervals of not less than 2 days. 150-750 mg/day 750 mg/day Schizophrenia-Adolescents
(13-17 years) (2.1) Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in incrementsno greater than 100 mg/day within therecommended dose range of 400-800 mg/day.
Based on response and tolerability, may beadministered three times daily. 400-800 mg/day 800 mg/day Schizophrenia-Maintenance* N/A 400-800 mg/day 800 mg/day Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400-800 mg/day 800 mg/day Bipolar Mania-Children and Adolescents
(10 to 17 years), Monotherapy Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within therecommended dose range of 400-600 mg/day.
Based on response and tolerability, may be administered three times daily. 400-600 mg/day 600 mg/day Bipolar Depression-Adults Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy - Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400-800 mg/day 800 mg/day1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions 7.1)].
Quetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 N/A Not applicable -
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
•Quetiapine Fumarate Tablets can be taken with or without food (
2
.1)
Indication
Initial Dose
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.2)
25 mg twice daily
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents
(13 to 17 years) (2.2)25 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex (2.2)
50 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2)
25 mg twice daily
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults (2.2)
50 mg once daily at bedtime
300 mg/day
300 mg/day
•
Geriatric Use
: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly (
2.3
,
8.5
) •
Hepatic Impairment
: Lower starting dose (25 mg/day) and slower titration may be needed (
2.4
,
8.7
,
12.3
)
Quetiapine Fumarate Tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate TabletsIndication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made
in increments of 25 to 50 mg twice a day,
in intervals of not less than 2 days.150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of
no greater than 200 mg/day.400 to 800 mg/day
800 mg/day
Bipolar Mania-Children
and Adolescents
(10 to 17 years), MonotherapyDay 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg300 mg/day
300 mg/day
Bipolar I Disorder Maintenance
Therapy-AdultsAdults Administer twice daily totaling
400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same
dose on which they were stabilized.400 to 800 mg/day
800 mg/day
1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment:Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine fumarate dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate should be increased by 6 fold [see Clinical Pharmacology (12.3) and DrugInteractions 7.1)].
Quetiapine fumarate dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort, etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3)andDrug Interactions (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 N/A Not Applicable -
Northstar Rxllc
Quetiapine Fumarate | Northstar Rxllc
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1) and (14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended Dose Maximum DoseSchizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A 1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
1N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
MaintenanceTreatment — Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)] . When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)] .
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)] .
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Direct Rx
Quetiapine Fumarate | Direct Rx
2.1 Important Administration Instructions
Quetiapine fumarate tablets can be taken with or without food.
2.2 Recommended Dosing
The recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1) and (14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended Dose Maximum DoseSchizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
1N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment — Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly Patients
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)] . When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired Patients
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 Inhibitors
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 Inducers
Quetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously Discontinued
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from Antipsychotics
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Proficient Rx Lp
Quetiapine Fumarate | Air Source Industries Inc
There is currently no dosage information available for this product. We apologize for any inconvenience.
-
Alembic Pharmaceuticals Limited
Quetiapine Fumarate | Alembic Pharmaceuticals Limited
2.1 Important Administration InstructionsQuetiapine fumarate can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate
Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A1
400 to 800 mg/day
800 mg/day
Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy-Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
1 N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
2.3 Dose Modifications in Elderly Patients
Maintenance Treatment – Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Quetiapine Fumarate | Ncs Healthcare Of Ky, Inc Dba Vangard Labs
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets * N/A Not applicable Indication Initial Dose and TitrationRecommended
DoseMaximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.150 to 750
mg/day 750 mg/daySchizophrenia-
Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may be administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-
Maintenance
N/A*400 to 800
mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.400 to 800
mg/day
800 mg/dayBipolar Mania-Children and Adolescents
Monotherapy
(10 to 17 years),Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 600
mg/day
600 mg/dayBipolar Depression-
AdultsAdminister once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/dayBipolar I Disorder
Maintenance Therapy- AdultsAdminister twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex.
Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.400 to 800
mg/day 800 mg/dayMaintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions(7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Physicians Total Care, Inc.
Quetiapine Fumarate | Physicians Total Care, Inc.
Quetiapine fumarate tablets can be taken with or without food
2.1 SchizophreniaAdults
Dose Selection—quetiapine should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment—The effectiveness of quetiapine for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
2.2 Bipolar DisorderAdults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection—Quetiapine should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule
Day Day 1 Day 2 Day 3 Day 4 Quetiapine 50 mg 100 mg 200 mg 300 mgIn the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1-4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.3 Dosing in Special PopulationsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day - 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine, titration of quetiapine is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine for more than one week, the initial titration schedule should be followed.
2.5 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Stat Rx Usa Llc
Quetiapine Fumarate | Stat Rx Usa Llc
Quetiapine fumarate tablets can be taken with or without food.
2.1 SchizophreniaAdults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
2.2 Bipolar DisorderAdults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.3 Dosing in Special PopulationsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
2.5 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Golden State Medical Supply, Inc.
Quetiapine Fumarate | Golden State Medical Supply, Inc.
Quetiapine fumarate tablets can be taken with or without food.
2.1 SchizophreniaAdults
Dose Selection—Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment—The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13-17 years)
2.2 Bipolar Disorder
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection—Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine Fumarate Tablets
50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.3 Dosing in Special PopulationsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablets is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
2.5 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Major Pharmaceuticals
Quetiapine Fumarate | Major Pharmaceuticals
Quetiapine fumarate tablets can be taken with or without food
2.1 SchizophreniaAdults
Dose Selection—quetiapine should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment—The effectiveness of quetiapine for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
2.2 Bipolar DisorderAdults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection—Quetiapine should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule
Day Day 1 Day 2 Day 3 Day 4 Quetiapine 50 mg 100 mg 200 mg 300 mgIn the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1-4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.3 Dosing in Special PopulationsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day - 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine, titration of quetiapine is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine for more than one week, the initial titration schedule should be followed.
2.5 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Bryant Ranch Prepack
Quetiapine Fumarate | Bryant Ranch Prepack
Quetiapine fumarate tablets can be taken with or without food.
2.1 SchizophreniaAdults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
2.2 Bipolar DisorderAdults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.3 Dosing in Special PopulationsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
2.5 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Bryant Ranch Prepack
Quetiapine Fumarate | Bryant Ranch Prepack
Quetiapine fumarate tablets can be taken with or without food.
2.1 SchizophreniaAdults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
2.2 Bipolar DisorderAdults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.3 Dosing in Special PopulationsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
2.5 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection
— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment
—The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZenecaPharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection
—Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4 Quetiapine fumarate tablets
50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [
see Clinical Studies
(
14.2
)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [
see Clinical Pharmacology
(
12
)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablets is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Dosage & Administration SectionQuetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection
— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment
—The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZenecaPharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection
—Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4 Quetiapine fumarate tablets
50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [
see Clinical Studies
(
14.2
)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [
see Clinical Pharmacology
(
12
)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablets is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection
—Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment—The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection
—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection
—Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4 Quetiapine Fumarate Tablets
50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase
[see Clinical Studies (14.2)]
.
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions
[see Clinical Pharmacology (12)]
. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablets are not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection—Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment—The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 Years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP's quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP's marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection—Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4 Quetiapine Fumarate Tablets 50 mg 100 mg 200 mg 300 mgIn the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4, respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 Years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP's quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP's marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablets is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection—Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment—The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 Years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP's quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP's marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection—Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4 Quetiapine Fumarate Tablets 50 mg 100 mg 200 mg 300 mgIn the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4, respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 Years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP's quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP's marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablets is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection—Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment—The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 Years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP's quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP's marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection—Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4 Quetiapine Fumarate Tablets 50 mg 100 mg 200 mg 300 mgIn the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4, respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 Years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP's quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP's marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablets is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Teva Pharmaceuticals Usa Inc
Quetiapine Fumarate | Apotex Corp.
2.1 Treatment of Postmenopausal Osteoporosis[see Indications and Usage (1.1)]
The recommended regimen is:
one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each monthor
one 150 mg tablet orally, taken once-a-month 2.2 Prevention of Postmenopausal Osteoporosis[see Indications and Usage (1.1)]
The recommended regimen is:
• one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be considered
or
• alternatively, one 150 mg tablet orally, taken once-a-month may be considered
2.6 Important Administration InstructionsInstruct patients to do the following:
Take risedronate sodium tablets at least 30 minutes before the first food or drink of the day other than water, and before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, [see Drug Interactions (7.1)]. Avoid the use of water with supplements, including mineral water, because they may have a higher concentration of calcium. Swallow risedronate sodium tablets whole with a full glass of plain water (6 to 8 ounces). Avoid lying down for 30 minutes after taking the medication [see Warnings and Precautions (5.1)]. Do not chew or suck the tablet because of a potential for oropharyngeal ulceration. Do not eat or drink anything except plain water, or take other medications for at least 30 minutes after taking risedronate sodium tablets. 2.7 Recommendations for Calcium and Vitamin D SupplementationInstruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate; and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of risedronate sodium tablets.
2.8 Administration Instructions for Missed DosesInstruct patients about missing risedronate sodium tablets doses as follows:
If one or both tablets of risedronate sodium tablets 75 mg on two consecutive days per month are missed, and the next month’s scheduled doses are more than 7 days away: If both tablets are missed, take one risedronate sodium 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning. If only one risedronate sodium 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered Return to taking their risedronate sodium 75 mg tablets on two consecutive days per month as originally scheduled. Do not take more than two 75 mg tablets within 7 days. If one or both tablets of risedronate sodium 75 mg tablets on two consecutive days per month are missed, and the next month's scheduled doses are within 7 days: Wait until their next month’s scheduled doses and then continue taking risedronate sodium 75 mg tablets on two consecutive days per month as originally scheduled. If the dose of risedronate sodium tablets 150 mg once-a-month is missed, and the next month’s scheduled dose is more than 7 days away: Take the missed tablet in the morning after the day it is remembered and then return to taking their risedronate sodium tablet 150 mg once-a-month as originally scheduled. Do not take more than one 150 mg tablet within 7 days. If the dose of risedronate sodium 150 mg tablet once-a-month is missed, and the next month's scheduled dose is within 7 days: Wait until their next month’s scheduled dose and then continue taking risedronate sodium 150 mg tablets once-a-month as originally scheduled. -
Sandoz Inc
Quetiapine Fumarate | Sandoz Inc
2.1 Important Administration InstructionQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see CLINICAL STUDIES (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets
* N/A Not applicable.Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia- Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults
Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years),
Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression- Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment – Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets, 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Adults
Dose Selection
— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment
—The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZenecaPharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection
—Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4 Quetiapine fumarate tablets
50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [
see Clinical Studies
(
14.2
)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [
see Clinical Pharmacology
(
12
)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Although there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablets is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Unit Dose Services
Quetiapine Fumarate | Unit Dose Services
Quetiapine fumarate tablets can be taken with or without food.
2.1 SchizophreniaAdults
— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective. Dose Selection
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment. Maintenance Treatment—
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
2.2 Bipolar DisorderAdults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4. Dose Selection
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine fumarate tablets
50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [ ( )]. see Clinical Studies14.2
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.3 Dosing in Special PopulationsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [ ( )]. When indicated, dose escalation should be performed with caution in these patients. see Clinical Pharmacology12
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
2.5 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Apotex Corp.
Quetiapine Fumarate | Apotex Corp.
Quetiapine fumarate tablets can be taken with or without food.
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended
Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice daily.
Increase in increments of 25 mg-50 mg divided two or three times on Days 2 and 3 to range of 300-400 mg by Day 4.
Further adjustments can be made in increments of 25–50 mg twice a day, in intervals of not less than 2 days. 150-750 mg/day 750 mg/day Schizophrenia-Adolescents
(13-17 years) Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in incrementsno greater than 100 mg/day within therecommended dose range of 400-800 mg/day.
Based on response and tolerability, may beadministered three times daily. 400-800 mg/day 800 mg/day Schizophrenia-Maintenance N/A1 400-800 mg/day 800 mg/day Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400-800 mg/day 800 mg/day Bipolar Mania-Children and Adolescents
(10 to 17 years), Monotherapy Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-600 mg/day.
Based on response and tolerability, may be administered three times daily. 400-600 mg/day 600 mg/day Bipolar Depression-Adults Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy - Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400-800 mg/day 800 mg/day1N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Aurobindo Pharma Limited
Quetiapine Fumarate | Aurobindo Pharma Limited
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for quetiapine fumarate tablets 1. N/A Not applicable Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-
Adolescents (13 to 17
years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be
in increments no greater than
100 mg/day within the
recommended dose range of
400 to 800 mg/day.
Based on response and
tolerability, may be
administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-
Maintenance
N/A1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults
Monotherapy or as an
adjunct to lithium or
divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17
years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-
Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder
Maintenance Therapy-
Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I DisorderMaintenance Treatment-Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
2.4 Dose Modifications in Hepatically Impaired Patients
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Jubilant Cadista Pharmaceuticals Inc.
Quetiapine Fumarate | Jubilant Cadista Pharmaceuticals Inc.
2.1 Important Administration InstructionsQuetiapine can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice daily.
Table 1: Recommended Dosing for Quetiapine
Increase in increments of 25 mg-50 mg divided two or three times on Days 2 and 3 to range of 300-400 mg by Day 4.
Further adjustments can be made in increments of 25–50 mg twice a day, in intervals of not less than 2 days. 150-750 mg/day 750 mg/day Schizophrenia- Adolescents (13-17 years) Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-800 mg/day.
Based on response and tolerability, may be administered three times daily. 400-800 mg/day 800 mg/day Schizophrenia-Maintenance N/A 400– 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400– 800 mg/day 800 mg/day Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-600 mg/day.
Based on response and tolerability, may be administered three times daily. 400-600 mg/day 600 mg/day Bipolar Depression- Adults Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy- Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400-800 mg/day 800 mg/day1. N/A Not applicable
2.3 Dose Modifications in Elderly Patients
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment – Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
2.4 Dose Modifications in Hepatically Impaired Patients
Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day - 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7-14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7-14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Dr.reddy’s Laboratories Limited
Quetiapine Fumarate | Dr.reddy's Laboratories Limited
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets
Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days. 150 to 750 mg/day 750 mg/day Schizophrenia- Adolescents (13 to 17 years) Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily. 400 to 800 mg/day 800 mg/day Schizophrenia-Maintenance N/A1 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400 to 800 mg/day 800 mg/day Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily. 400 to 600 mg/day 600 mg/day Bipolar Depression- Adults Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy- Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400 to 800 mg/day 800 mg/day1 N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need formaintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions(7.1)].
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Sun Pharma Global Fze
Quetiapine Fumarate | Teva Pharmaceuticals Usa Inc
Citalopram tablets should be administered once daily, in the morning or evening, with or without food.
Initial TreatmentCitalopram tablets should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg/day at an interval of no less than one week. Doses above 40 mg/day are not recommended due to the risk of QT prolongation. Additionally, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose.
Special Populations20 mg/day is the maximum recommended dose for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers or those patients taking cimetidine or another CYP2C19 inhibitor (see WARNINGS).
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram Tablets should be used with caution in patients with severe renal impairment.
Treatment of Pregnant Women During the Third TrimesterNeonates exposed to citalopram tablets and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with citalopram tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Maintenance TreatmentIt is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of Citalopram Tablets in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of Citalopram Tablets (20 to 60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of Citalopram Tablets 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see CLINICAL PHARMACOLOGY, Clinical Efficacy Trials). Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.
Discontinuation of Treatment With Citalopram TabletsSymptoms associated with discontinuation of citalopram tablets and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with citalopram tablets. Conversely, at least 14 days should be allowed after stopping citalopram tablets before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).
Use of Citalopram Tablets with Other MAOIs, Such as Linezolid or Methylene Blue
Do not start citalopram tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).
In some cases, a patient already receiving citalopram tablets therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, citalopram tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with citalopram tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with citalopram tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
-
Teva Pharmaceuticals Usa Inc
Quetiapine Fumarate | Meds Direct Rx Of Ny Llc
There is currently no dosage information available for this product. We apologize for any inconvenience.
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American Health Packaging
Quetiapine Fumarate | American Health Packaging
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets 1 N/A Not applicableIndication
Schizophrenia-Adults
Initial Dose and Titration
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
Recommended Dose
150 to 750 mg/day
Maximum Dose
750 mg/day
Schizophrenia- Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.400 to 600 mg/day
600 mg/day
Bipolar Depression- Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need formaintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Northstar Rx Llc
Quetiapine Fumarate | Northstar Rx Llc
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for quetiapine fumarate tablets 1. N/A Not applicable Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-
Adolescents (13 to 17
years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be
in increments no greater than
100 mg/day within the
recommended dose range of
400 to 800 mg/day.
Based on response and
tolerability, may be
administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-
Maintenance
N/A1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults
Monotherapy or as an
adjunct to lithium or
divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17
years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-
Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder
Maintenance Therapy-
Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I DisorderMaintenance Treatment-Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
2.4 Dose Modifications in Hepatically Impaired Patients
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Avkare, Inc.
Quetiapine Fumarate | Avkare, Inc.
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets *N/A Not applicable Indication Initial Dose and TitrationRecommended
DoseMaximum Dose
Schizophrenia-Adults
(2.1)Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.150 to 750
mg/day 750 mg/daySchizophrenia-
Adolescents (13 to 17 years) (2.1)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may be administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-
Maintenance
N/A*400 to 800
mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2)
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.400 to 800
mg/day
800 mg/dayBipolar Mania-Children and Adolescents
Monotherapy
(10 to 17 years),Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be
administered three times daily.400 to 600
mg/day
600 mg/dayBipolar Depression-
AdultsAdminister once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/dayBipolar I Disorder
Maintenance Therapy- AdultsAdminister twice daily totaling 400 to 800
mg/day as adjunct to lithium or divalproex.
Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.400 to 800
mg/day 800 mg/dayMaintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and TitrationRecommended
DoseMaximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.150 to 750
mg/day 750 mg/daySchizophrenia-
Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may be administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-
Maintenance
N/A*400 to 800
mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.400 to 800
mg/day
800 mg/dayBipolar Mania-Children and Adolescents
Monotherapy
(10 to 17 years),Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 600
mg/day
600 mg/dayBipolar Depression-
AdultsAdminister once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/dayBipolar I Disorder
Maintenance Therapy- AdultsAdminister twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex.
Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.400 to 800
mg/day 800 mg/day
1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions(7.1)].
Quetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 N/A Not applicable -
Preferred Pharmaceuticals, Inc.
Quetiapine Fumarate | Preferred Pharmaceuticals, Inc.
Quetiapine tablets can be taken with or without food.
2.1 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for quetiapine
Indication
Initial Dose and Titration
Recommended
DoseMaximum Dose
Schizophrenia-Adults
(2.1)Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.150 to 750
mg/day750 mg/day
Schizophrenia-
Adolescents (13 to 17 years) (2.1)Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-
MaintenanceN/A
400 to 800
mg/day800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2)
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg. Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.400 to 800
mg/day800 mg/day
Bipolar Mania-
Children and Adolescents (10 to 17 years),
MonotherapyDay 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg. Day 3: Twice daily dosing totaling 200 mg. Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.400 to 600 mg/day
600 mg/day
Bipolar Depression-
AdultsAdminister once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg300 mg/day
300 mg/day
Bipolar I Disorder
Maintenance Therapy- AdultsAdminister twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800
mg/day800 mg/day
N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.2 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.3 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day - 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions 7.1)].
2.5 Dose Modifications when used with CYP3A4 InducersQuetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7-14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7-14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.7 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Preferred Pharmaceuticals, Inc.
Quetiapine Fumarate | Preferred Pharmaceuticals, Inc.
Quetiapine fumarate tablets can be taken with or without food.
2.1 SchizophreniaAdults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
2.2 Bipolar DisorderAdults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.3 Dosing in Special PopulationsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
2.5 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Aphena Pharma Solutions – Tennessee, Llc
Quetiapine Fumarate | Aphena Pharma Solutions - Tennessee, Llc
Quetiapine fumarate tablets can be taken with or without food.
2.1 SchizophreniaAdults
Dose Selection—Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment—The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13-17 years)
2.2 Bipolar Disorder
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.Adults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection—Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine Fumarate Tablets
50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.3 Dosing in Special PopulationsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablets is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
2.5 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Aphena Pharma Solutions – Tennessee, Llc
Quetiapine Fumarate | Aphena Pharma Solutions - Tennessee, Llc
2.1 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate TabletsIndication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.1)
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years) (2.1)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A
400 to 800 mg/day
800 mg/day
Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex (2.2)
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.400 to 800 mg/day
800 mg/day
Bipolar Mania-Children
and Adolescents
(10 to 17 years), MonotherapyDay 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg300 mg/day
300 mg/day
Bipolar I Disorder Maintenance
Therapy-AdultsAdults Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex.
Generally, in the maintenance phase,
patients continued on the same dose on which they were stabilized.400 to 800 mg/day
800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment:Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.2 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.3 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Dose Modifications When Used with CYP3A4 InhibitorsQuetiapine fumarate dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions 7.1)].
2.5 Dose Modifications When Used with CYP3A4 InducersQuetiapine fumarate dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort, etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3)andDrug Interactions (7.1)].
2.6 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.7 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Bryant Ranch Prepack
Quetiapine Fumarate | Bryant Ranch Prepack
Quetiapine fumarate tablets can be taken with or without food.
2.1 SchizophreniaAdults
Dose Selection— Quetiapine fumarate tablets should generally be administered with an initial dose of 25 mg twice daily, with increases in total daily dose of 25 mg to 50 mg divided in two or three doses on the second and third day, as tolerated, to a total dose range of 300 mg to 400 mg daily by the fourth day. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state for quetiapine fumarate tablets would not be achieved for approximately 1 to 2 days in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 25 mg to 50 mg divided twice daily are recommended. Most efficacy data with quetiapine fumarate tablets were obtained using three times daily dosing regimens, but in one controlled trial 225 mg given twice per day was also effective.
Efficacy in schizophrenia was demonstrated in a dose range of 150 mg/day to 750 mg/day in the clinical trials supporting the effectiveness of quetiapine fumarate tablets. In a dose response study, doses above 300 mg/day were not demonstrated to be more efficacious than the 300 mg/day dose. In other studies, however, doses in the range of 400 mg/day to 500 mg/day appeared to be needed. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Maintenance Treatment— The effectiveness of quetiapine fumarate tablets for longer than 6 weeks has not been evaluated in controlled clinical trials. While there is no body of evidence available to answer the question of how long the patient treated with quetiapine fumarate tablets should be maintained, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents (13 to 17 years)
Pediatric dosing information in patients (13 to 17 years of age) with schizophrenia is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those adolescent patients.
2.2 Bipolar DisorderAdults
Acute Treatment of Manic Episodes in Bipolar I Disorder
Dose Selection—When used as monotherapy or adjunct therapy (with lithium or divalproex), quetiapine fumarate tablets should be initiated in twice daily doses totaling 100 mg/day on Day 1, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in twice daily divided doses. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. Data indicate that the majority of patients responded between 400 mg/day to 800 mg/day. The safety of doses above 800 mg/day has not been evaluated in clinical trials.
Acute Treatment of Depressive Episodes in Bipolar Disorder
Dose Selection— Quetiapine fumarate tablets should be administered once daily at bedtime to reach 300 mg/day by Day 4.
Recommended Dosing Schedule Day Day 1 Day 2 Day 3 Day 4Quetiapine
fumarate tablets50 mg
100 mg
200 mg
300 mg
In the clinical trials supporting effectiveness, the dosing schedule was 50 mg, 100 mg, 200 mg and 300 mg/day for Days 1 to 4 respectively. Patients receiving 600 mg increased to 400 mg on Day 5 and 600 mg on Day 8 (Week 1). Antidepressant efficacy was demonstrated with quetiapine fumarate tablets at both 300 mg and 600 mg; however, no additional benefit was seen in the 600 mg group.
Maintenance Treatment of Bipolar I Disorder
Maintenance of efficacy in bipolar I disorder was demonstrated with quetiapine fumarate tablets (administered twice daily totaling 400 to 800 mg per day) as adjunct therapy to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase [see Clinical Studies (14.2)].
Children and Adolescents (10 to 17 years)
Pediatric dosing information in patients (10 to 17 years of age) with bipolar mania is approved for AstraZeneca Pharmaceuticals LP’s quetiapine fumarate drug product labeling. However, due to AstraZeneca Pharmaceuticals LP’s marketing exclusivity rights; this drug product is not labeled for such use in those pediatric patients.
2.3 Dosing in Special PopulationsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12)]. When indicated, dose escalation should be performed with caution in these patients.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address reinitiation of treatment, it is recommended that when restarting patients who have had an interval of less than one week off quetiapine fumarate tablets, titration of quetiapine fumarate tablet is not required and the maintenance dose may be reinitiated. When restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial titration schedule should be followed.
2.5 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Accord Healthcare Inc.
Quetiapine Fumarate | International Medication Systems, Limited
EPINEPHRINE 1:10,000
As Cardiac Stimulant:
Intravenous or Intracardiac Injection
Administer by I.V. injection and/or in cardiac arrest, by intracardiac injection into the left ventricular chamber. Intracardiac injection should only be administered by personnel well trained in the technique, if there has not been sufficient time to establish an intravenous route.
Adult Dosage: 1-10 mL (0.1 - 1 mg of epinephrine), repeated every five minutes, if necessary.Pediatric Dosage: 0.05 - 0.1 mL/ kg of body weight (0.005 - 0.01 mg/ kg) e.g., 2 kg infant would receive 0.1 - 0.2 mL of epinephrine 1:10,000.
NOTE: Do not inject if fibrillation is occurring.
As Vasopressor (Anaphylaxis):
Intravenous InjectionAdult Dosage: 1-2.5 mL (0.1 - 0.25 mg of epinephrine), administered slowly. May be repeated every 5 to 15 minutes as needed.
Pediatric Dosage: 3 mL (0.3 mg of epinephrine), repeated every 15 minutes for 3 or 4 doses, if necessary.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
-
Bryant Ranch Prepack
Quetiapine Fumarate | Bryant Ranch Prepack
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1) and (14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended Dose Maximum DoseSchizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
1N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment — Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)] . When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Major Pharmaceuticals
Quetiapine Fumarate | Major Pharmaceuticals
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets
Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days. 150 to 750 mg/day 750 mg/day Schizophrenia- Adolescents (13 to 17 years) Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily. 400 to 800 mg/day 800 mg/day Schizophrenia-Maintenance N/A1 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400 to 800 mg/day 800 mg/day Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily. 400 to 600 mg/day 600 mg/day Bipolar Depression- Adults Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy- Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400 to 800 mg/day 800 mg/day1 N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need formaintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions(7.1)].
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Quetiapine Fumarate | Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Quetiapine fumarate tablets can be taken with or without food.
2.1 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see CLINICAL STUDIES (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets
* N/A Not applicable.Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.1)
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia- Adolescents (13 to 17 years) (2.1)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults
Monotherapy or as an adjunct to lithium or divalproex (2.2)
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years),
Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression- Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment – Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].
2.2 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets, 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.3 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
2.5 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
2.6 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.7 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Bluepoint Laboratories
Quetiapine Fumarate | Ostl, Inc.
• Clean effected area
• Apply small amount of this product on the area 1-3 times daily
• May be covered with a sterile bandage
• If bandaged, let dry first
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and TitrationRecommended
DoseMaximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.150 to 750
mg/day 750 mg/daySchizophrenia-
Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may be administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-
Maintenance
N/A*400 to 800
mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.400 to 800
mg/day
800 mg/dayBipolar Mania-Children and Adolescents
Monotherapy
(10 to 17 years),Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 600
mg/day
600 mg/dayBipolar Depression-
AdultsAdminister once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/dayBipolar I Disorder
Maintenance Therapy- AdultsAdminister twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex.
Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.400 to 800
mg/day 800 mg/day
1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions(7.1)].
Quetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 N/A Not applicable -
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food
The recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets
Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days. 150 to 750 mg/day 750 mg/day Schizophrenia- Adolescents (13 to 17 years) Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily. 400 to 800 mg/day 800 mg/day Schizophrenia-Maintenance N/A1 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400 to 800 mg/day 800 mg/day Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily. 400 to 600 mg/day 600 mg/day Bipolar Depression- Adults Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy- Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400 to 800 mg/day 800 mg/day1 N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need formaintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions(7.1)].
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Quetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Bryant Ranch Prepack
Quetiapine Fumarate | Bryant Ranch Prepack
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1) and (14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended Dose Maximum DoseSchizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
1N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment — Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)] . When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
•Quetiapine Fumarate Tablets can be taken with or without food (
2
.1)
Indication
Initial Dose
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.2)
25 mg twice daily
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents
(13 to 17 years) (2.2)25 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex (2.2)
50 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2)
25 mg twice daily
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults (2.2)
50 mg once daily at bedtime
300 mg/day
300 mg/day
•
Geriatric Use
: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly (
2.3
,
8.5
) •
Hepatic Impairment
: Lower starting dose (25 mg/day) and slower titration may be needed (
2.4
,
8.7
,
12.3
)
Quetiapine Fumarate Tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate TabletsIndication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made
in increments of 25 to 50 mg twice a day,
in intervals of not less than 2 days.150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of
no greater than 200 mg/day.400 to 800 mg/day
800 mg/day
Bipolar Mania-Children
and Adolescents
(10 to 17 years), MonotherapyDay 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg300 mg/day
300 mg/day
Bipolar I Disorder Maintenance
Therapy-AdultsAdults Administer twice daily totaling
400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same
dose on which they were stabilized.400 to 800 mg/day
800 mg/day
1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment:Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine fumarate dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate should be increased by 6 fold [see Clinical Pharmacology (12.3) and DrugInteractions 7.1)].
Quetiapine fumarate dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort, etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3)andDrug Interactions (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 N/A Not Applicable -
Ascend Laboratories, Llc
Quetiapine Fumarate | Ascend Laboratories, Llc
Quetiapine tablets can be taken with or without food.
2.1 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for quetiapine
Indication
Initial Dose and Titration
Recommended
Dose
Maximum Dose
Schizophrenia-Adults
(2.1)
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750
mg/day
750 mg/day
Schizophrenia-
Adolescents (13 to 17 years) (2.1)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-
Maintenance
N/A
400 to 800
mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2)
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg. Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800
mg/day
800 mg/day
Bipolar Mania-
Children and Adolescents (10 to 17 years),
Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg. Day 3: Twice daily dosing totaling 200 mg. Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-
Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder
Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800
mg/day
800 mg/day
N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I DisorderMaintenance Treatment—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.2 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.3 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day - 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions 7.1)].
2.5 Dose Modifications when used with CYP3A4 InducersQuetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7-14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7-14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.7 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Clinical Solutions Wholesale
Quetiapine Fumarate | Clinical Solutions Wholesale
Quetiapine fumarate tablets can be taken with or without food.
2.1 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate TabletsIndication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.1)
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.150 to 750 mg/day
750 mg/day
Schizophrenia- Adolescents (13 to 17 years) (2.1)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults
Monotherapy or as an
adjunct to lithium or
divalproex (2.2)Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.400 to 600 mg/day
600 mg/day
Bipolar Depression- Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.2 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.3 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.4 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.5 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.7 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Lupin Pharmaceuticals, Inc.
Quetiapine Fumarate | Lupin Pharmaceuticals, Inc.
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see CLINICAL STUDIES (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets * N/A Not applicable Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg
divided two or three times on Days 2 and
3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day,
in intervals of not less than 2 days.
150 to 750
mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 800
mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to
800 mg/day by Day 6 should be in
increments of no greater than 200 mg/day.
400 to 800
mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 600
mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy-Adults
Administer twice daily totaling 400 to
800 mg/day as adjunct to lithium or
divalproex. Generally, in the maintenance
phase, patients continued on the same dose
on which they were stabilized.
400 to 800
mg/day
800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment:
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see CLINICAL PHARMACOLOGY (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John's wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7 to 14 days [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Cardinal Health
Quetiapine Fumarate | Cardinal Health
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets
Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia- Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.400 to 600 mg/day
600 mg/day
Bipolar Depression- Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
1 N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need formaintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions(7.1)].
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Citron Pharma Llc
Quetiapine Fumarate | Citron Pharma Llc
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for quetiapine fumarate tablets 1. N/A Not applicable Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-
Adolescents (13 to 17
years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be
in increments no greater than
100 mg/day within the
recommended dose range of
400 to 800 mg/day.
Based on response and
tolerability, may be
administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-
Maintenance
N/A1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults
Monotherapy or as an
adjunct to lithium or
divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17
years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-
Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder
Maintenance Therapy-
Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I DisorderMaintenance Treatment-Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
2.4 Dose Modifications in Hepatically Impaired Patients
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Tya Pharmaceuticals
Quetiapine Fumarate | Tya Pharmaceuticals
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see and ]. Clinical Studies(14.1)(14.2)
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended Dose Maximum DoseSchizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A 1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
N/A Not applicable 1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance — Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment Treatment[see ]. Clinical Studies (14.2)
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions . When indicated, dose escalation should be performed with caution in these patients. [see ] Clinical Pharmacology (12.3)
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold . [see and ] Clinical Pharmacology (12.3)Drug Interactions (7.1)
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days . [see and ] Clinical Pharmacology (12.3)Drug Interactions (7.1)
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Roxane Laboratories, Inc.
Quetiapine Fumarate | Roxane Laboratories, Inc.
2.1 Important Administration InstructionsQuetiapine Fumarate Tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets * N/A Not ApplicableIndication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made
in increments of 25 to 50 mg twice a day,
in intervals of not less than 2 days.150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of
no greater than 200 mg/day.400 to 800 mg/day
800 mg/day
Bipolar Mania-Children
and Adolescents
(10 to 17 years), MonotherapyDay 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg300 mg/day
300 mg/day
Bipolar I Disorder Maintenance
Therapy-AdultsAdults Administer twice daily totaling
400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same
dose on which they were stabilized.400 to 800 mg/day
800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment:Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications When Used with CYP3A4 InhibitorsQuetiapine fumarate dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate should be increased by 6 fold [see Clinical Pharmacology (12.3) and DrugInteractions 7.1)].
2.6 Dose Modifications When Used with CYP3A4 InducersQuetiapine fumarate dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort, etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3)andDrug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Cardinal Health
Quetiapine Fumarate | Hygenesis
Wash hands Rub in 2 to 4 drops For Healthcare, repeat process every 4 hours -
Torrent Pharmaceuticals Limited
Quetiapine Fumarate | Torrent Pharmaceuticals Limited
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for quetiapine fumarate tablets1. N/A Not applicable
Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg-50 mg divided two or three times on Days 2 and 3 to range of 300-400 mg by Day 4.
Further adjustments can be made in increments of 25-50 mg twice a day, in intervals of not less than 2 days.
150-750 mg/day
750 mg/day
Schizophrenia- Adolescents (13-17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-800 mg/day.
Based on response and tolerability, may be administered three times daily.
400-800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A1
400-800 mg/day
800 mg/day
Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400-800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-600 mg/day.
Based on response and tolerability, may be administered three times daily.
400-600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy-
Adults
Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400-800 mg/day
800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment-Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day -50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7-14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John's wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7-14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Tya Pharmaceuticals
Quetiapine Fumarate | Tya Pharmaceuticals
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see and ]. Clinical Studies(14.1)(14.2)
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended Dose Maximum DoseSchizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A 1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
N/A Not applicable 1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance — Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment Treatment[see ]. Clinical Studies (14.2)
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions . When indicated, dose escalation should be performed with caution in these patients. [see ] Clinical Pharmacology (12.3)
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold . [see and ] Clinical Pharmacology (12.3)Drug Interactions (7.1)
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days . [see and ] Clinical Pharmacology (12.3)Drug Interactions (7.1)
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Tya Pharmaceuticals
Quetiapine Fumarate | Tya Pharmaceuticals
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in . After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient Table 1[see Clinical Studies ( and )]. 14.114.2
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets * N/A Not applicable Indication Initial Dose and Titration DoseRecommended
Maximum Dose
Schizophrenia-Adults
increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
mg/day150 to 750
750 mg/daySchizophrenia-
Adolescents (13 to 17 years)
Based on response and tolerability, may be administered three times daily.Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day.
400 to 800 mg/day
800 mg/day
Schizophrenia-
Maintenance
N/A *400 to 800
mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
400 to 800
mg/day
800 mg/day MonotherapyBipolar Mania-Children and Adolescents (10 to 17 years),
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.
400 to 600
mg/day
600 mg/day AdultsBipolar Depression-
Day 4: 300 mgAdminister once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
300 mg/day 300 mg/day Maintenance Therapy- AdultsBipolar I Disorder
Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex.
mg/day400 to 800
800 mg/dayMaintenance Treatment for Schizophrenia and Bipolar I Disorder
—Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment Maintenance Treatment[see Clinical Studies ( )]. 14.2
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions . When indicated, dose escalation should be performed with caution in these patients. [see Clinical Pharmacology( ) 12.3]
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient .
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold . [see Clinical Pharmacology ( ) and Drug Interactions 12.3)] (7.1
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days . [see Clinical Pharmacology ( ) and Drug Interactions 12.3( )] 7.1
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1) and (14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended Dose Maximum DoseSchizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 800 mg/day
800 mg/day
Schizophrenia-Maintenance
N/A1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy- Adults
Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
1N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment — Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)] . When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Quetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food
The recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets
Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days. 150 to 750 mg/day 750 mg/day Schizophrenia- Adolescents (13 to 17 years) Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily. 400 to 800 mg/day 800 mg/day Schizophrenia-Maintenance N/A1 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400 to 800 mg/day 800 mg/day Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily. 400 to 600 mg/day 600 mg/day Bipolar Depression- Adults Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy- Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400 to 800 mg/day 800 mg/day1 N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment—Patients should be periodically reassessed to determine the need formaintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions(7.1)].
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Quetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food (2.1). Indication
Initial Dose
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.2) 25 mg twice daily
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years) (2.2) 25 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2) 25 mg twice daily
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults (2.2) 50 mg once daily at bedtime
300 mg/day
300 mg/day
GeriatricUse: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly (2.3, 8.5) HepaticImpairment: Lower starting dose (25 mg/day) and slower titration may be needed (2.4, 8.7, 12.3)Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see CLINICAL STUDIES (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg
divided two or three times on Days 2 and
3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day,
in intervals of not less than 2 days.
150 to 750
mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 800
mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to
800 mg/day by Day 6 should be in
increments of no greater than 200 mg/day.
400 to 800
mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 600
mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy-Adults
Administer twice daily totaling 400 to
800 mg/day as adjunct to lithium or
divalproex. Generally, in the maintenance
phase, patients continued on the same dose
on which they were stabilized.
400 to 800
mg/day
800 mg/day
1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment:
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see CLINICAL PHARMACOLOGY (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
Quetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John's wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7 to 14 days [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 N/A Not applicable -
Safecor Health, Llc
Quetiapine Fumarate | Safecor Health, Llc
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for quetiapine fumarate tablets 1. N/A Not applicableIndication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days.150 to 750 mg/day
750 mg/day
Schizophrenia-
Adolescents (13 to 17
years)Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be
in increments no greater than
100 mg/day within the
recommended dose range of
400 to 800 mg/day.
Based on response and
tolerability, may be
administered three times daily.400 to 800 mg/day
800 mg/day
Schizophrenia-
MaintenanceN/A1
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults
Monotherapy or as an
adjunct to lithium or
divalproexDay 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.400 to 800 mg/day
800 mg/day
Bipolar Mania- Children and Adolescents (10 to 17
years), MonotherapyDay 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may be administered three times daily.400 to 600 mg/day
600 mg/day
Bipolar Depression-
AdultsAdminister once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg300 mg/day
300 mg/day
Bipolar I Disorder
Maintenance Therapy-
AdultsAdminister twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.
400 to 800 mg/day
800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I DisorderMaintenance Treatment-Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
2.4 Dose Modifications in Hepatically Impaired Patients
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food (2.1). Indication
Initial Dose
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.2) 25 mg twice daily
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years) (2.2) 25 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2) 25 mg twice daily
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults (2.2) 50 mg once daily at bedtime
300 mg/day
300 mg/day
GeriatricUse: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly (2.3, 8.5) HepaticImpairment: Lower starting dose (25 mg/day) and slower titration may be needed (2.4, 8.7, 12.3)Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see CLINICAL STUDIES (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg
divided two or three times on Days 2 and
3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day,
in intervals of not less than 2 days.
150 to 750
mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 800
mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to
800 mg/day by Day 6 should be in
increments of no greater than 200 mg/day.
400 to 800
mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 600
mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy-Adults
Administer twice daily totaling 400 to
800 mg/day as adjunct to lithium or
divalproex. Generally, in the maintenance
phase, patients continued on the same dose
on which they were stabilized.
400 to 800
mg/day
800 mg/day
1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment:
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see CLINICAL PHARMACOLOGY (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
Quetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John's wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7 to 14 days [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 N/A Not applicable -
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food.
Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine fumarate tablets dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication Initial Dose and Titration Recommended
Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice daily.
Increase in increments of 25 mg-50 mg divided two or three times on Days 2 and 3 to range of 300-400 mg by Day 4.
Further adjustments can be made in increments of 25–50 mg twice a day, in intervals of not less than 2 days. 150-750 mg/day 750 mg/day Schizophrenia-Adolescents
(13-17 years) Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in incrementsno greater than 100 mg/day within therecommended dose range of 400-800 mg/day.
Based on response and tolerability, may beadministered three times daily. 400-800 mg/day 800 mg/day Schizophrenia-Maintenance N/A1 400-800 mg/day 800 mg/day Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400-800 mg/day 800 mg/day Bipolar Mania-Children and Adolescents
(10 to 17 years), Monotherapy Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400-600 mg/day.
Based on response and tolerability, may be administered three times daily. 400-600 mg/day 600 mg/day Bipolar Depression-Adults Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy - Adults Administer twice daily totaling 400-800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized. 400-800 mg/day 800 mg/day1N/A Not applicable
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine fumarate tablets 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine fumarate tablets dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine fumarate tablets should be increased by 6 fold [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Quetiapine fumarate tablets dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate tablets should be reduced to the original level within 7 to 14 days [see Clinical Pharmacology (12.3) and Drug Interactions (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine fumarate tablets for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine fumarate tablets for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine fumarate tablets, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine fumarate tablets therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Clinical Solutions Wholesale, Llc
Quetiapine Fumarate | Clinical Solutions Wholesale, Llc
2.1 Important Administration InstructionsQuetiapine fumarate tablets can be taken with or without food.
2.2 Recommended DosingThe recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see CLINICAL STUDIES ( 14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets * N/A Not applicableIndication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg
divided two or three times on Days 2 and
3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day,
in intervals of not less than 2 days.150 to 750
mg/day750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may
be administered three times daily.400 to 800
mg/day800 mg/day
Schizophrenia-Maintenance
N/A *
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to
800 mg/day by Day 6 should be in
increments of no greater than 200 mg/day.400 to 800
mg/day800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may
be administered three times daily.400 to 600
mg/day600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy-Adults
Administer twice daily totaling 400 to
800 mg/day as adjunct to lithium or
divalproex. Generally, in the maintenance
phase, patients continued on the same dose
on which they were stabilized.400 to 800
mg/day800 mg/day
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment:
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES ( 14.2)].
2.3 Dose Modifications in Elderly PatientsConsideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see CLINICAL PHARMACOLOGY ( 12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
2.4 Dose Modifications in Hepatically Impaired PatientsPatients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
2.5 Dose Modifications when used with CYP3A4 InhibitorsQuetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see CLINICAL PHARMACOLOGY ( 12.3) and DRUG INTERACTIONS ( 7.1)].
2.6 Dose Modifications when used with CYP3A4 InducersQuetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John's wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7 to 14 days [see CLINICAL PHARMACOLOGY ( 12.3) and DRUG INTERACTIONS ( 7.1)].
2.7 Reinitiation of Treatment in Patients Previously DiscontinuedAlthough there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
2.8 Switching from AntipsychoticsThere are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
-
Remedyrepack Inc.
Quetiapine Fumarate | Remedyrepack Inc.
Quetiapine fumarate tablets can be taken with or without food (2.1). Indication
Initial Dose
Recommended Dose
Maximum Dose
Schizophrenia-Adults (2.2) 25 mg twice daily
150 to 750 mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years) (2.2) 25 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily
400 to 800 mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2) 25 mg twice daily
400 to 600 mg/day
600 mg/day
Bipolar Depression-Adults (2.2) 50 mg once daily at bedtime
300 mg/day
300 mg/day
GeriatricUse: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly (2.3, 8.5) HepaticImpairment: Lower starting dose (25 mg/day) and slower titration may be needed (2.4, 8.7, 12.3)Quetiapine fumarate tablets can be taken with or without food.
The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see CLINICAL STUDIES (14.1 and 14.2)].
Table 1: Recommended Dosing for Quetiapine Fumarate Tablets Indication
Initial Dose and Titration
Recommended Dose
Maximum Dose
Schizophrenia-Adults
Day 1: 25 mg twice daily.
Increase in increments of 25 mg to 50 mg
divided two or three times on Days 2 and
3 to range of 300 to 400 mg by Day 4.
Further adjustments can be made in
increments of 25 to 50 mg twice a day,
in intervals of not less than 2 days.
150 to 750
mg/day
750 mg/day
Schizophrenia-Adolescents (13 to 17 years)
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 800 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 800
mg/day
800 mg/day
Schizophrenia-Maintenance
N/A*
400 to 800 mg/day
800 mg/day
Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex
Day 1: Twice daily dosing totaling 100 mg.
Day 2: Twice daily dosing totaling 200 mg.
Day 3: Twice daily dosing totaling 300 mg.
Day 4: Twice daily dosing totaling 400 mg.
Further dosage adjustments up to
800 mg/day by Day 6 should be in
increments of no greater than 200 mg/day.
400 to 800
mg/day
800 mg/day
Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy
Day 1: 25 mg twice daily.
Day 2: Twice daily dosing totaling 100 mg.
Day 3: Twice daily dosing totaling 200 mg.
Day 4: Twice daily dosing totaling 300 mg.
Day 5: Twice daily dosing totaling 400 mg.
Further adjustments should be in increments
no greater than 100 mg/day within
the recommended dose range of 400 to 600 mg/day.
Based on response and tolerability, may
be administered three times daily.
400 to 600
mg/day
600 mg/day
Bipolar Depression-Adults
Administer once daily at bedtime.
Day 1: 50 mg
Day 2: 100 mg
Day 3: 200 mg
Day 4: 300 mg
300 mg/day
300 mg/day
Bipolar I Disorder Maintenance Therapy-Adults
Administer twice daily totaling 400 to
800 mg/day as adjunct to lithium or
divalproex. Generally, in the maintenance
phase, patients continued on the same dose
on which they were stabilized.
400 to 800
mg/day
800 mg/day
1
Maintenance Treatment for Schizophrenia and Bipolar I Disorder
Maintenance Treatment:
Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see CLINICAL STUDIES (14.2)].
Consideration should be given to a slower rate of dose titration and a lower target dose in the elderly and in patients who are debilitated or who have a predisposition to hypotensive reactions [see CLINICAL PHARMACOLOGY (12.3)]. When indicated, dose escalation should be performed with caution in these patients.
Elderly patients should be started on quetiapine 50 mg/day and the dose can be increased in increments of 50 mg/day depending on the clinical response and tolerability of the individual patient.
Patients with hepatic impairment should be started on 25 mg/day. The dose should be increased daily in increments of 25 mg/day to 50 mg/day to an effective dose, depending on the clinical response and tolerability of the patient.
Quetiapine dose should be reduced to one sixth of original dose when co-medicated with a potent CYP3A4 inhibitor (e.g. ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.). When the CYP3A4 inhibitor is discontinued, the dose of quetiapine should be increased by 6 fold [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
Quetiapine dose should be increased up to 5 fold of the original dose when used in combination with a chronic treatment (e.g., greater than 7 to 14 days) of a potent CYP3A4 inducer (e.g. phenytoin, carbamazepine, rifampin, avasimibe, St. John's wort etc.). The dose should be titrated based on the clinical response and tolerability of the individual patient. When the CYP3A4 inducer is discontinued, the dose of quetiapine should be reduced to the original level within 7 to 14 days [see CLINICAL PHARMACOLOGY (12.3) and DRUG INTERACTIONS (7.1)].
Although there are no data to specifically address re-initiation of treatment, it is recommended that when restarting therapy of patients who have been off quetiapine for more than one week, the initial dosing schedule should be followed. When restarting patients who have been off quetiapine for less than one week, gradual dose escalation may not be required and the maintenance dose may be reinitiated.
There are no systematically collected data to specifically address switching patients with schizophrenia from antipsychotics to quetiapine, or concerning concomitant administration with antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized. When switching patients with schizophrenia from depot antipsychotics, if medically appropriate, initiate quetiapine therapy in place of the next scheduled injection. The need for continuing existing EPS medication should be re-evaluated periodically.
1 N/A Not applicable
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