Olanzapine And Fluoxetine
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Uses
Olanzapine and fluoxetine HCl is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder in adults [see Clinical Studies (14.1)].
History
There is currently no drug history available for this drug.
Other Information
Olanzapine and fluoxetine capsules USP combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa ®*, and Zyprexa Zydis®*) and fluoxetine hydrochloride (the active ingredient in Prozac®*, Prozac Weekly™*, and Sarafem®*).
Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44.
Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3‑[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NO•HCl, which corresponds to a molecular weight of 345.79. The chemical structures are:
Olanzapine is a yellow crystalline solid, which is practically insoluble in water.
Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.
Olanzapine and fluoxetine capsules USP are available for oral administration in the following strength combinations:
| 3 mg/25 mg |
6 mg/25 mg |
6 mg/50 mg |
12 mg/25 mg |
12 mg/50 mg |
|
| Olanzapine equivalent |
3 |
6 |
6 |
12 |
12 |
| Fluoxetine base equivalent |
25 |
25 |
50 |
25 |
50 |
Each capsule consists of gelatin, magnesium stearate, partially pregelatinized starch, titanium dioxide, and yellow iron oxide. In addition, the 3 mg/25 mg capsule also contains red iron oxide; the 6 mg/50 mg capsule also contains FD&C blue No. 2, FD&C red No. 3, and FD&C yellow No. 6; the 12 mg/25 mg capsule also contains D&C red No. 28, FD&C blue No. 1, FD&C red No. 40, and red iron oxide; and the 12 mg/50 mg capsule also contains D&C red No. 28, FD&C blue No. 1 FD&C blue No. 2, FD&C red No. 3, FD&C red No. 40, and FD&C yellow No. 6. The capsules also have printing in edible black ink which contains the following ingredients: D&C yellow No. 10, ethanol, FD&C blue No. 1, FD&C blue No. 2, FD&C red No. 40, iron oxide black, methanol, n-Butyl alcohol, propylene glycol, and shellac glaze in alcohol.
Sources
Olanzapine And Fluoxetine Manufacturers
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Par Pharmaceutical, Inc
![Olanzapine And Fluoxetine (Olanzapine And Fuoxetine) Capsule [Par Pharmaceutical, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Olanzapine And Fluoxetine | Par Pharmaceutical, Inc
2.1 Depressive Episodes Associated with Bipolar I DisorderOlanzapine and Fluoxetine Capsules should be administered once daily in the evening, generally beginning with the 6 mg/25 mg capsule. While food has no appreciable effect on the absorption of olanzapine and fluoxetine given individually, the effect of food on the absorption of olanzapine and fluoxetine HCl has not been studied. Dosage adjustments, if indicated, can be made according to efficacy and tolerability. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine HCl in a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg [see Clinical Studies ( 14.1)]. The safety of doses above 18 mg per 75 mg has not been evaluated in clinical studies.
While there is no body of evidence to answer the question of how long a patient treated with olanzapine and fluoxetine HCl should remain on it, it is generally accepted that Bipolar I Disorder, including the depressive episodes associated with Bipolar I Disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.
2.3 Specific PopulationsThe starting dose of Olanzapine and Fluoxetine Capsules 3 mg/25 mg to 6 mg/25 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine and fluoxetine HCl (female gender, geriatric age, nonsmoking status) or those patients who may be pharmacodynamically sensitive to olanzapine. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Olanzapine and fluoxetine HCl has not been systematically studied in patients >65 years of age or in patients <18 years of age [see Warnings and Precautions (5.19), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3, 12.4)].
Treatment of Pregnant Women — When treating pregnant women with fluoxetine, a component of olanzapine and fluoxetine HCl, during the third trimester, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalizations, respiratory support, and tube feeding. The physician may consider tapering the dose of fluoxetine in the third trimester [see Use in Specific Populations (8.1)].
2.4 Switching a Patient To or From a Monamine 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 olanzapine and fluoxetine. Conversely, at least 5 weeks should be allowed after stopping olanzapine and fluoxetine before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.5 Use of Olanzapine and Fluoxetine Capsules with Other MAOIs such as Linezolid or Methylene BlueDo not start olanzapine and fluoxetine 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 (4.1)].
In some cases, a patient already receiving olanzapine and fluoxetine therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue are judged to outweigh the risks of serotonin syndrome in a particular patient, olanzapine and fluoxetine should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Olanzapine and Fluoxetine Capsules may be resumed 24 hours after the last dose of linezolid and intravenous methylene blue [see Warning and Precautions (5.7)].
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 1mg/kg with olanzapine and fluoxetine in unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.7).
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Sandoz Inc
Olanzapine And Fluoxetine | Rite Aid
do not take more than the recommended dose
(see overdose warning) adults and children 12 years and older: take 2 caplets with water repeat every 6 hours, as needed do not exceed 6 caplets per day children under 12 years: ask a doctor -
Avkare, Inc.
Olanzapine And Fluoxetine | Avkare, Inc.
2.1 Depressive Episodes Associated With Bipolar I DisorderAdults - Olanzapine and fluoxetine capsules USP should be administered once daily in the evening, generally beginning with the 6 mg/25 mg capsule (mg equivalent olanzapine/mg equivalent fluoxetine) capsule. While food has no appreciable effect on the absorption of olanzapine and fluoxetine given individually, the effect of food on the absorption of olanzapine and fluoxetine capsules USP has not been studied. Dosage adjustments, if indicated, can be made according to efficacy and tolerability. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine capsules USP in a dose range of olanzapine 6 mg to 12 mg and fluoxetine 25 mg to 50 mg [see Clinical Studies (14.1)]. The safety of doses above 18 mg of olanzapine and 75 mg of fluoxetine has not been evaluated in adult clinical studies.
There is no body of evidence to answer the question of how long a patient treated with olanzapine and fluoxetine capsules USP should remain on them beyond 8 weeks. It is generally accepted that Bipolar I Disorder, including the depressive episodes associated with Bipolar I Disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.
2.3 Specific PopulationsThe starting dose of olanzapine and fluoxetine capsules USP, 3 mg/25 mg to 6 mg/25 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine and fluoxetine capsules USP (female gender, geriatric age, nonsmoking status) or those patients who may be pharmacodynamically sensitive to olanzapine. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Olanzapine and fluoxetine capsules USP have not been systematically studied in patients > 65 years of age or in patients < 10 years of age [see Warnings and Precautions (5.19), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3, 12.4)].
Treatment of Pregnant Women — When treating pregnant women with fluoxetine, a component of olanzapine and fluoxetine capsules USP, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalizations, respiratory support, and tube feeding [see Use in Specific Populations (8.1)].
2.4 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 olanzapine and fluoxetine capsules USP. Conversely, at least 5 weeks should be allowed after stopping olanzapine and fluoxetine capsules USP before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.5 Use of Olanzapine and Fluoxetine Capsules USP With Other MAOIs Such as Linezolid or Methylene BlueDo not start olanzapine and fluoxetine capsules USP 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 (4.1)].
In some cases, a patient already receiving olanzapine and fluoxetine capsule 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 are judged to outweigh the risks of serotonin syndrome in a particular patient, olanzapine and fluoxetine capsules USP should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with olanzapine and fluoxetine capsules USP may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.7)].
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 olanzapine and fluoxetine capsules USP is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.7)].
2.6 Discontinuation of Treatment With Olanzapine and Fluoxetine Capsules USPSymptoms associated with discontinuation of fluoxetine, a component of olanzapine and fluoxetine capsules USP, SNRIs, and SSRIs, have been reported [see Warnings and Precautions (5.24)].
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Teva Pharmaceuticals Usa Inc
Olanzapine And Fluoxetine | Cardinal Health
Dosage must be adjusted according to each patient’s needs. Therapy for either hypertension or angina should be initiated with 30 mg or 60 mg once daily. Nifedipine extended-release tablets should be swallowed whole and should not be bitten or divided. In general, titration should proceed over a 7 to 14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. Since steady-state plasma levels are achieved on the second day of dosing, titration may proceed more rapidly, if symptoms so warrant, provided the patient is assessed frequently. Titration to doses above 120 mg are not recommended.
Angina patients controlled on nifedipine immediate-release capsules alone or in combination with other antianginal medications may be safely switched to nifedipine extended-release tablets at the nearest equivalent total daily dose (e.g., 30 mg t.i.d. of nifedipine immediate-release capsules may be changed to 90 mg once daily of nifedipine extended-release tablets). Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patients with angina is limited. Therefore, doses greater than 90 mg should be used with caution and only when clinically warranted.
Avoid coadministration of nifedipine with grapefruit juice (see CLINICAL PHARMACOLOGY and PRECAUTIONS: Other Interactions).
No “rebound effect” has been observed upon discontinuation of nifedipine extended-release tablets. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.
Care should be taken when dispensing nifedipine extended-release tablets to assure that the extended-release dosage form has been prescribed.
Coadministration with Other Antianginal DrugsSublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during nifedipine titration. See PRECAUTIONS: Drug Interactions, for information on coadministration of nifedipine with beta-blockers or long-acting nitrates.
![Olanzapine And Fluoxetine Capsule [Sandoz Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=69bda7d7-8660-4e8d-b8ac-892a3b1f2124&name=menstrual-complete-1.jpg)
![Olanzapine And Fluoxetine (Olanzapine And Fluoxetine) Capsule [Avkare, Inc.]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Olanzapine And Fluoxetine Capsule [Teva Pharmaceuticals Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3dc7ea33-2b6f-4835-92e2-87a5ca77502b&name=image-01.jpg)
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