Pramipexole Dihydrochloride
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Questions & Answers
Side Effects & Adverse Reactions
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
taking sedatives or tranquilizers.
- do not exceed recommended dose
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have- high blood pressure
- heart disease
- thyroid disease
- diabetes
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
taking sedatives or tranquilizers.
Stop use and ask a doctor if- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- sinus congestion and pressure
- nasal congestion
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Pramipexole Dihydrochloride Manufacturers
-
Golden State Medical Supply, Inc
![Pramipexole Dihydrochloride Tablet [Golden State Medical Supply, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pramipexole Dihydrochloride | Meijer
adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use this product in children under 12 years of age -
Vensun Pharmaceuticals, Inc.
Pramipexole Dihydrochloride | L'oreal Usa Products Inc
For sunscreen use:
● apply generously 15 minutes before sun exposure
● apply to all skin exposed to the sun [this statement is optional]
● reapply:
● after 80 minutes of swimming or sweating
● immediately after towel drying
● at least every 2 hours
● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
● limit time in the sun, especially from 10 a.m. – 2 p.m.
● wear long-sleeved shirts, pants, hats, and sunglasses
● children under 6 months of age: Ask a doctor
-
Breckenridge Pharmaceutical, Inc.
Pramipexole Dihydrochloride | Breckenridge Pharmaceutical, Inc.
Parkinson's Disease
In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Dosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 3 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease Week Dosage (mg) Total Daily
Dose (mg) 1 0.125 TID 0.375 2 0.25 TID 0.75 3 0.5 TID 1.5 4 0.75 TID 2.25 5 1 TID 3 6 1.25 TID 3.75 7 1.5 TID 4.5Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 4 Pramipexole Dosage in Parkinson’s Disease Patients with Renal Impairment Renal Status Starting Dose
(mg) Maximum Dose
(mg) Normal to mild impairment
(creatinine Cl > 60 mL/min) 0.125 TID 1.5 TID Moderate impairment
(creatinine Cl = 35 to 59 mL/min) 0.125 BID 1.5 BID Severe impairment
(creatinine Cl = 15 to 34 mL/min) 0.125 QD 1.5 QD Very severe impairment
(creatinine Cl < 15 mL/min
and hemodialysis patients) The use of pramipexole dihydrochloride
tablets has not been adequately studied in this
group of patients.Discontinuation of Treatment
It is recommended that pramipexole dihydrochloride tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
-
Watson Pharma, Inc.
Pramipexole Dihydrochloride | Watson Pharma, Inc.
Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal FunctionInitial Treatment
Dosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 3 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson’s Disease Week Dosage (mg) Total Daily Dose (mg) 1 0.125 tid 0.375 2 0.25 tid 0.75 3 0.5 tid 1.50 4 0.75 tid 2.25 5 1 tid 3 6 1.25 tid 3.75 7 1.5 tid 4.50Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment Table 4 Pramipexole Dosage in Parkinson’s Disease Patients with Renal Impairment Renal Status Starting Dose (mg) Maximum Dose (mg) Normal to mild impairment (creatinine Cl > 60 mL/min) 0.125 tid 1.5 tid Moderate impairment (creatinine Cl = 35 to 59 mL/min) 0.125 bid 1.5 bid Severe impairment (creatinine Cl = 15 to 34 mL/min) 0.125 qd 1.5 qd Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients) The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients. Discontinuation of TreatmentIt is recommended that pramipexole dihydrochloride tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
-
Stat Rx Usa Llc
Pramipexole Dihydrochloride | Stat Rx Usa Llc
Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients With Normal Renal Function Initial TreatmentDosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 3: Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease Week Dosage (mg) Total Daily Dose (mg) 1 0.125 tid 0.375 2 0.25 tid 0.75 3 0.5 tid 1.50 4 0.75 tid 2.25 5 1 tid 3 6 1.25 tid 3.75 7 1.5 tid 4.50 Maintenance TreatmentPramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients With Renal Impairment Table 4: Pramipexole Dosage in Parkinson’s Disease Patients With Renal Impairment Renal StatusStarting Dose
(mg)Maximum Dose
(mg)Normal to mild impairment
(creatinine Cl > 60 mL/min)0.125 tid
1.5 tid
Moderate impairment
(creatinine Cl = 35 to 59 mL/min)0.125 bid
1.5 bid
Severe impairment
(creatinine Cl = 15 to 34 mL/min)0.125 qd
1.5 qd
Very severe impairment (creatinine
Cl < 15 mL/min and hemodialysis patients) The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients. Discontinuation of TreatmentIt is recommended that pramipexole dihydrochloride tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
-
Kaiser Foundation Hospitals
Pramipexole Dihydrochloride | Kaiser Foundation Hospitals
Parkinson’s DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal FunctionInitial Treatment
Dosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 3 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets forParkinson’s Disease Week
Dosage (mg)
Total Daily
Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.50
4
0.75 TID
2.25
5
1 TID
3
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance TreatmentPramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson’s disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson’s disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment Table 4 Pramipexole Dosage in Parkinson's Disease Patients with Renal Impairment Renal Status
Starting Dose
Maximum Dose
(mg)
(mg)
Normal to mild impairment
(creatinine Cl > 60 mL/min)
0.125 TID
1.5 TID
Moderate impairment
(creatinine Cl = 35 to 59 mL/min)
0.125 BID
1.5 BID
Severe impairment
(creatinine Cl = 15 to 34 mL/min)
0.125 QD
1.5 QD
Very severe impairment (creatinine Cl < 15
mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride has not been adequately studied
in this group of patients.
Discontinuation of Treatment
It is recommended that pramipexole dihydrochloride tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
-
Endo Pharmaceuticals Inc. Dba Endo Generic Products
Pramipexole Dihydrochloride | Endo Pharmaceuticals Inc. Dba Endo Generic Products
Parkinson's Disease
In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Dosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 3 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.50
4
0.75 TID
2.25
5
1 TID
3
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets is used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 4 Pramipexole Dosage in Parkinson's Disease Patients with Renal Impairment
Renal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment
(creatinine Cl > 60 mL/min)
0.125 TID
1.5 TID
Moderate impairment
(creatinine Cl =35 to 59 mL/min)
0.125 BID
1.5 BID
Severe impairment
(creatinine Cl =15 to 34 mL/min)
0.125 QD
1.5 QD
Very severe impairment
(creatinine Cl < 15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride has not been adequately studied in this group of patients
Discontinuation of Treatment
It is recommended that pramipexole dihydrochloride tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful. -
Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Pramipexole Dihydrochloride | Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients With Normal Renal Function Initial TreatmentDosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 3: Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease Week Dosage (mg) Total Daily Dose (mg) 1 0.125 tid 0.375 2 0.25 tid 0.75 3 0.5 tid 1.50 4 0.75 tid 2.25 5 1 tid 3 6 1.25 tid 3.75 7 1.5 tid 4.50 Maintenance TreatmentPramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients With Renal Impairment Table 4: Pramipexole Dosage in Parkinson’s Disease Patients With Renal Impairment Renal StatusStarting Dose
(mg)Maximum Dose
(mg)Normal to mild impairment
(creatinine Cl > 60 mL/min)0.125 tid
1.5 tid
Moderate impairment
(creatinine Cl = 35 to 59 mL/min)0.125 bid
1.5 bid
Severe impairment
(creatinine Cl = 15 to 34 mL/min)0.125 qd
1.5 qd
Very severe impairment (creatinine
Cl < 15 mL/min and hemodialysis patients) The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients. Discontinuation of TreatmentIt is recommended that pramipexole dihydrochloride tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
-
Zydus Pharmaceuticals (Usa) Inc.
Pramipexole Dihydrochloride | Procter & Gamble Manufacturing Company
apply liberally 15 minutes before sun exposure reapply at least every 2 hours use water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: ask a doctorTreat skin morning and night by dispensing 2-4 pearl-sized drops of product into the palm of your hand and applying evenly on areas of discolorations such as sun spots and dark patches.
Intensely hydrate and renew skin's surface at night with Brightening Renewal Cream by smoothing over entire face and neck.
-
Cadila Healthcare Limited
Pramipexole Dihydrochloride | Cadila Healthcare Limited
Parkinson’s DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal FunctionInitial Treatment
Dosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 3 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets forParkinson’s Disease Week
Dosage (mg)
Total Daily
Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.50
4
0.75 TID
2.25
5
1 TID
3
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance TreatmentPramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson’s disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson’s disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment Table 4 Pramipexole Dosage in Parkinson's Disease Patients with Renal Impairment Renal Status
Starting Dose
Maximum Dose
(mg)
(mg)
Normal to mild impairment
(creatinine Cl > 60 mL/min)
0.125 TID
1.5 TID
Moderate impairment
(creatinine Cl = 35 to 59 mL/min)
0.125 BID
1.5 BID
Severe impairment
(creatinine Cl = 15 to 34 mL/min)
0.125 QD
1.5 QD
Very severe impairment (creatinine Cl < 15
mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride has not been adequately studied
in this group of patients.
Discontinuation of Treatment
It is recommended that pramipexole dihydrochloride tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
-
Cardinal Health
Pramipexole Dihydrochloride | Cardinal Health
Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function Initial TreatmentDosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 3: Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease Week Dosage (mg) Total Daily
Dose (mg) 1 0.125 TID 0.375 2 0.25 TID 0.75 3 0.5 TID 1.50 4 0.75 TID 2.25 5 1 TID 3 6 1.25 TID 3.75 7 1.5 TID 4.50 Maintenance TreatmentPramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses 3 times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment Table 4: Pramipexole Dosage in Parkinson's Disease Patients with Renal Impairment Renal Status Starting Dose
(mg) Maximum Dose
(mg) Normal to mild impairment
(creatinine Cl > 60 mL/min) 0.125 TID 1.5 TID Moderate impairment
(creatinine Cl = 35 to 59 mL/min) 0.125 BID 1.5 BID Severe impairment
(creatinine Cl = 15 to 34 mL/min) 0.125 QD 1.5 QD Very severe impairment
(creatinine Cl < 15 mL/min
and hemodialysis patients) The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients. Discontinuation of TreatmentIt is recommended that pramipexole dihydrochloride tablets be discontinued over a period of one week; in some studies, however, abrupt discontinuation was uneventful.
-
Northstar Rx Llc
Pramipexole Dihydrochloride | Northstar Rx Llc
Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function Initial TreatmentDosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 3 Ascending Dosage Schedule of Pramipexole Dihydrochloride tablets for Parkinson's Disease Week Dosage (mg) Total Daily Dose (mg) 1 0.125 TID 0.375 2 0.25 TID 0.75 3 0.5 TID 1.50 4 0.75 TID 2.25 5 1 TID 3 6 1.25 TID 3.75 7 1.5 TID 4.50 Maintenance TreatmentPramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment Table 4 Pramipexole Dosage in Parkinson's Disease Patients with Renal Impairment Renal Status Starting Dose (mg) Maximum Dose (mg) Normal to mild impairment
(creatinine Cl > 60 mL/min)
0.125 TID
1.5 TID Moderate impairment
(creatinine Cl = 35 to 59 mL/min)
0.125 BID
1.5 BID Severe impairment
(creatinine Cl = 15 to 34 mL/min)
0.125 QD
1.5 QD Very severe impairment
(creatinine Cl < 15 mL/min
and hemodialysis patients)
The use of pramipexole dihydrochloride has not been adequately studied in this group of patients. Discontinuation of TreatmentIt is recommended that pramipexole dihydrochloride tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
-
Physicians Total Care, Inc.
Pramipexole Dihydrochloride | Physicians Total Care, Inc.
Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients With Normal Renal Function Initial TreatmentDosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 3: Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease Week Dosage (mg) Total Daily Dose (mg) 1 0.125 tid 0.375 2 0.25 tid 0.75 3 0.5 tid 1.50 4 0.75 tid 2.25 5 1 tid 3 6 1.25 tid 3.75 7 1.5 tid 4.50 Maintenance TreatmentPramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients With Renal Impairment Table 4: Pramipexole Dosage in Parkinson’s Disease Patients With Renal Impairment Renal StatusStarting Dose
(mg)Maximum Dose
(mg)Normal to mild impairment
(creatinine Cl greater than 60 mL/min)0.125 tid
1.5 tid
Moderate impairment
(creatinine Cl = 35 to 59 mL/min)0.125 bid
1.5 bid
Severe impairment
(creatinine Cl = 15 to 34 mL/min)0.125 qd
1.5 qd
Very severe impairment (creatinine
Cl less than 15 mL/min and hemodialysis patients) The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients. Discontinuation of TreatmentIt is recommended that pramipexole dihydrochloride tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
-
Torrent Pharmaceuticals Limited
Pramipexole Dihydrochloride | Torrent Pharmaceuticals Limited
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets have occurred, re-titration of therapy may be warranted.
2.2 Dosing for Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in Table 1:
Table 1 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson’s Disease Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 three times a day
0.375
2
0.25 three times a day
0.75
3
0.5 three times a day
1.50
4
0.75 three times a day
2.25
5
1 three times a day
3.0
6
1.25 three times a day
3.75
7
1.5 three times a day
4.50
Maintenance Treatment
Pramipexole Dihydrochloride Tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
The recommended dosing of pramipexole dihydrochloride tablets in Parkinson's disease patients with renal impairment is provided in Table 2.
Table 2 Dosing of Pramipexole Dihydrochloride Tablets in Parkinson’s Disease Patients with Renal Impairment Renal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment
(creatinine Cl > 50 mL/min)
0.125 three times a day
1.5 three times a day
Moderate impairment
(creatinine Cl = 30 to 50 mL/min)
0.125 twice a day
0.75 three times a day
Severe impairment
(creatinine Cl = 15 to <30 mL/min)
0.125 once a day
1.5 once a day
Very severe impairment
(creatinine Cl < 15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride tablets may be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose may be reduced by 0.375 mg per day.
-
Glenmark Generics Inc., Usa
Pramipexole Dihydrochloride | Glenmark Pharmaceuticals Inc., Usa
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted.
2.2 Dosing for Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in Table 1:
Table 1 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease
Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 three times a day
0.375
2
0.25 three times a day
0.75
3
0.5 three times a day
1.5
4
0.75 three times a day
2.25
5
1 three times a day
3
6
1.25 three times a day
3.75
7
1.5 three times a day
4.5
Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
The recommended dosing of pramipexole dihydrochloride tablets in Parkinson’s disease patients with renal impairment is provided in Table 2.
Table 2 Dosing of Pramipexole Dihydrochloride Tablets in Parkinson’s Disease Patients with Renal Impairment
Renal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment (creatinine Cl >50 mL/min)
0.125 three times a day
1.5 three times a day
Moderate impairment (creatinine Cl =30 to 50 mL/min)
0.125 twice a day
0.75 three times a day
Severe impairment (creatinine Cl =15 to <30 mL/min)
0.125 once a day
1.5 once a day
Very severe impairment (creatinine Cl <15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride tablets may be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose may be reduced by 0.375 mg per day.
-
Aurobindo Pharma Limited
Pramipexole Dihydrochloride | Aurobindo Pharma Limited
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
2.2 Dosing for Parkinson's Disease
If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted.In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in Table 1:
Table 1 Ascending Dosage Schedule of Pramipexole Dihydrochloride tablets for Parkinson's Disease Week Dosage (mg) Total Daily Dose (mg) 1
0.125 three times a day
0.375
2
0.25 three times a day
0.75
3
0.5 three times a day
1.5
4
0.75 three times a day
2.25
5
1 three times a day
3
6
1.25 three times a day
3.75
7
1.5 three times a day
4.5
Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
The recommended dosing of pramipexole dihydrochloride tablets in Parkinson's disease patients with renal impairment is provided in Table 2.
Table 2 Dosing of Pramipexole Dihydrochloride tablets in Parkinson’s Disease Patients with Renal Impairment Renal Status Starting Dose (mg) Maximum Dose (mg) Normal to mild impairment (creatinine Cl > 50 mL/min)
0.125 three times a day
1.5 three times a day
Moderate impairment (creatinine Cl = 30 to 50 mL/min)
0.125 twice a day
0.75 three times a day
Severe impairment (creatinine Cl = 15 to <30 mL/min)
0.125 once a day
1.5 once a day
Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride tablets may be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose may be reduced by 0.375 mg per day. -
Lake Erie Medical Dba Quality Care Products Llc
Pramipexole Dihydrochloride | Lake Erie Medical Dba Quality Care Products Llc
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted.
2.2 Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
InitialTreatment
Table 1 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.50
4
0.75 TID
2.25
5
1 TID
3
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 2 Dosing of Pramipexole Dihydrochloride Tablets in Parkinson’s Disease Patients with Renal ImpairmentRenal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment
(creatinine Cl >50 mL/min)0.125 TID
1.5 TID
Moderate impairment
(creatinine Cl =30 to 50 mL/min)0.125 BID
0.75 TID
Severe impairment
(creatinine Cl =15 to <30 mL/min)0.125 QD
1.5 QD
Very severe impairment
(creatinine Cl <15 mL/min
and hemodialysis patients)The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride tablets should be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose should be reduced by 0.375 mg per day. In some studies, however, abrupt discontinuation was uneventful. -
Macleods Pharmaceuticals Limited
Pramipexole Dihydrochloride | Macleods Pharmaceuticals Limited
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted.
2.2 Dosing for Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following Table 1:
Table 1 Ascending Dosage Schedule of Pramipexole dihydrochloride tablets for Parkinson's Disease
Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 three times a day
0.375
2
0.25 three times a day
0.75
3
0.5 three times a day
1.50
4
0.75 three times a day
2.25
5
1 three times a day
3.0
6
1.25 three times a day
3.75
7
1.5 three times a day
4.50Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
The recommended dosing of pramipexole dihydrochloride tablets in Parkinson's disease patients with renal impairment is provided in Table 2.
Table 2 Dosing of Pramipexole Dihydrochloride Tablets in Parkinson's Disease Patients with Renal Impairment
Renal Status Starting Dose (mg) Maximum Dose (mg) Normal to mild impairment (creatinine Cl >50 mL/min) 0.125 TID 1.5 TID Moderate impairment (creatinine Cl =30 to 50 mL/min) 0.125 BID 0.75 TID Severe impairment (creatinine Cl =15 to <30 mL/min) 0.125 QD 1.5 QD Very severe impairment (creatinine Cl <15 mL/min and hemodialysis patients) The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
Renal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment (creatinine Cl >50 mL/min)
0.125 three times a day
1.5 three times a day
Moderate impairment (creatinine Cl =30 to 50 mL/min)
0.125 twice a day
0.75 three times a day
Severe impairment (creatinine Cl =15 to <30 mL/min)
0.125 once a day
1.5 once a day
Very severe impairment (creatinine Cl <15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride tablets may be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose should be reduced by 0.375 mg per day.
-
Avkare, Inc.
Pramipexole Dihydrochloride | Avkare, Inc.
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted.
2.2 Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Table 1 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease Week Dosage (mg) Total Daily Dose (mg) 1 0.125 TID 0.375 2 0.25 TID 0.75 3 0.5 TID 1.50 4 0.75 TID 2.25 5 1 TID 3.0 6 1.25 TID 3.75 7 1.5 TID 4.50
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 2 Dosing of Pramipexole Dihydrochloride Tablets in Parkinson’s Disease Patients with Renal Impairment Renal Status Starting Dose (mg) Maximum Dose (mg) Normal to mild impairment
(creatinine Cl > 50 mL/min) 0.125 TID 1.5 TID Moderate impairment
(creatinine Cl = 30 to 50 mL/min) 0.125 BID 0.75 TID Severe impairment
(creatinine Cl = 15 to <30 mL/min) 0.125 QD 1.5 QD Very severe impairment
(creatinine Cl < 15 mL/min
and hemodialysis patients) The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.Discontinuation of Treatment
Pramipexole dihydrochloride tablets should be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose should be reduced by 0.375 mg per day. In some studies, however, abrupt discontinuation was uneventful.
-
Mylan Pharmaceuticals Inc.
Pramipexole Dihydrochloride | 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.
-
Sandoz Inc
Pramipexole Dihydrochloride | Sandoz Inc
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted.
2.2 Dosing for Parkinson's DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
InitialTreatment
Table 1 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson's Disease
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in Table 1Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 three times a day
0.375
2
0.25 three times a day
0.75
3
0.5 three times a day
1.50
4
0.75 three times a day
2.25
5
1 three times a day
3
6
1.25 three times a day
3.75
7
1.5 three times a day
4.50
Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
The recommended dosing of pramipexole dihydrochloride tablets in Parkinson's disease patients with renal impairment is provided in Table 2.
Table 2 Dosing of Pramipexole Dihydrochloride Tablets in Parkinson’s Disease Patients with Renal ImpairmentRenal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment
(creatinine Cl >50 mL/min)0.125 three times a day
1.5 three times a day
Moderate impairment
(creatinine Cl =30 to 50 mL/min)0.125 twice a day
0.75 three times a day
Severe impairment
(creatinine Cl =15 to <30 mL/min)0.125 once a day
1.5 once a day
Very severe impairment
(creatinine Cl <15 mL/min
and hemodialysis patients)The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride tablets may be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose may be reduced by 0.375 mg per day. -
Bryant Ranch Prepack
Pramipexole Dihydrochloride | Bryant Ranch Prepack
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets have occurred, re-titration of therapy may be warranted.
2.2 Parkinson’s DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 1 Ascending Dosage Schedule of pramipexole dihydrochloride tablets for Parkinson’s Disease Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.50
4
0.75 TID
2.25
5
1 TID
3.0
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance Treatment
Pramipexole Dihydrochloride Tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 2 Dosing of pramipexole dihydrochloride tablets in Parkinson’s Disease Patients with Renal Impairment Renal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment
(creatinine Cl > 50 mL/min)
0.125 TID
1.5 TID
Moderate impairment
(creatinine Cl = 30 to 50 mL/min)
0.125 BID
0.75 TID
Severe impairment
(creatinine Cl = 15 to <30 mL/min)
0.125 QD
1.5 QD
Very severe impairment
(creatinine Cl < 15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride Tablets should be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose should be reduced by 0.375 mg per day. In some studies, however, abrupt discontinuation was uneventful.
-
Bryant Ranch Prepack
Pramipexole Dihydrochloride | Bryant Ranch Prepack
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets have occurred, re-titration of therapy may be warranted.
2.2 Parkinson’s DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 1 Ascending Dosage Schedule of pramipexole dihydrochloride tablets for Parkinson’s Disease Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.50
4
0.75 TID
2.25
5
1 TID
3.0
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance Treatment
Pramipexole Dihydrochloride Tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 2 Dosing of pramipexole dihydrochloride tablets in Parkinson’s Disease Patients with Renal Impairment Renal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment
(creatinine Cl > 50 mL/min)
0.125 TID
1.5 TID
Moderate impairment
(creatinine Cl = 30 to 50 mL/min)
0.125 BID
0.75 TID
Severe impairment
(creatinine Cl = 15 to <30 mL/min)
0.125 QD
1.5 QD
Very severe impairment
(creatinine Cl < 15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride Tablets should be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose should be reduced by 0.375 mg per day. In some studies, however, abrupt discontinuation was uneventful.
-
Bryant Ranch Prepack
Pramipexole Dihydrochloride | Bryant Ranch Prepack
Parkinson’s DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal FunctionInitial Treatment
Dosages should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 3 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets forParkinson’s Disease Week
Dosage (mg)
Total Daily
Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.50
4
0.75 TID
2.25
5
1 TID
3
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance TreatmentPramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson’s disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson’s disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment Table 4 Pramipexole Dosage in Parkinson's Disease Patients with Renal Impairment Renal Status
Starting Dose
Maximum Dose
(mg)
(mg)
Normal to mild impairment
(creatinine Cl > 60 mL/min)
0.125 TID
1.5 TID
Moderate impairment
(creatinine Cl = 35 to 59 mL/min)
0.125 BID
1.5 BID
Severe impairment
(creatinine Cl = 15 to 34 mL/min)
0.125 QD
1.5 QD
Very severe impairment (creatinine Cl < 15
mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride has not been adequately studied
in this group of patients.
Discontinuation of Treatment
It is recommended that pramipexole dihydrochloride tablets be discontinued over a period of 1 week; in some studies, however, abrupt discontinuation was uneventful.
-
Strides Arcolab Limited
Pramipexole Dihydrochloride | Strides Arcolab Limited
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets s are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted.
2.2 Parkinson’s diseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table
Table 1 Ascending Dosage Schedule of Pramipexole dihydrochloride tablets for Parkinson's Disease Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.5
4
0.75 TID
2.25
5
1 TID
3
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related - postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 2 Dosing of Pramipexole dihydrochloride tablets in Parkinson's Disease Patients with Renal Impairment Renal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment
0.125 TID
1.5 TID
(creatinine Cl >50 mL/min)
Moderate impairment
0.125 BID
0.75 TID
(creatinine Cl =30 to 50 mL/min)
Severe impairment
0.125 QD
1.5 QD
(creatinine Cl =15 to <30 mL/min)
Very severe impairment (creatinine Cl <15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride tablets should be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose should be reduced by 0.375 mg per day. In some studies, however, abrupt discontinuation was uneventful.
-
Carilion Materials Management
Pramipexole Dihydrochloride | Carilion Materials Management
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets have occurred, re-titration of therapy may be warranted.
2.2 Parkinson’s DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 1 Ascending Dosage Schedule of pramipexole dihydrochloride tablets for Parkinson’s Disease Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.50
4
0.75 TID
2.25
5
1 TID
3.0
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance Treatment
Pramipexole Dihydrochloride Tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 2 Dosing of pramipexole dihydrochloride tablets in Parkinson’s Disease Patients with Renal Impairment Renal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment (creatinine Cl > 50 mL/min)
0.125 TID
1.5 TID
Moderate impairment (creatinine Cl = 30 to 50 mL/min)
0.125 BID
0.75 TID
Severe impairment (creatinine Cl = 15 to <30 mL/min)
0.125 QD
1.5 QD
Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride Tablets should be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose should be reduced by 0.375 mg per day. In some studies, however, abrupt discontinuation was uneventful.
-
Carilion Materials Management
Pramipexole Dihydrochloride | Carilion Materials Management
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets have occurred, re-titration of therapy may be warranted.
2.2 Parkinson’s DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 1 Ascending Dosage Schedule of pramipexole dihydrochloride tablets for Parkinson’s Disease Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.50
4
0.75 TID
2.25
5
1 TID
3.0
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance Treatment
Pramipexole Dihydrochloride Tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 2 Dosing of pramipexole dihydrochloride tablets in Parkinson’s Disease Patients with Renal Impairment Renal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment (creatinine Cl > 50 mL/min)
0.125 TID
1.5 TID
Moderate impairment (creatinine Cl = 30 to 50 mL/min)
0.125 BID
0.75 TID
Severe impairment (creatinine Cl = 15 to <30 mL/min)
0.125 QD
1.5 QD
Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride Tablets should be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose should be reduced by 0.375 mg per day. In some studies, however, abrupt discontinuation was uneventful.
-
Carilion Materials Management
Pramipexole Dihydrochloride | Carilion Materials Management
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets have occurred, re-titration of therapy may be warranted.
2.2 Parkinson’s DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 1 Ascending Dosage Schedule of pramipexole dihydrochloride tablets for Parkinson’s Disease Week
Dosage (mg)
Total Daily Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.50
4
0.75 TID
2.25
5
1 TID
3.0
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance Treatment
Pramipexole Dihydrochloride Tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 2 Dosing of pramipexole dihydrochloride tablets in Parkinson’s Disease Patients with Renal Impairment Renal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment (creatinine Cl > 50 mL/min)
0.125 TID
1.5 TID
Moderate impairment (creatinine Cl = 30 to 50 mL/min)
0.125 BID
0.75 TID
Severe impairment (creatinine Cl = 15 to <30 mL/min)
0.125 QD
1.5 QD
Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride Tablets should be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose should be reduced by 0.375 mg per day. In some studies, however, abrupt discontinuation was uneventful.
-
Cardinal Health
Pramipexole Dihydrochloride | Cardinal Health
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted.
2.2 Parkinson’s DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial TreatmentDoses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in the following table:
Table 1 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson’s DiseaseWeek
Dosage (mg)
Total Daily Dose (mg)
1
0.125 TID
0.375
2
0.25 TID
0.75
3
0.5 TID
1.50
4
0.75 TID
2.25
5
1 TID
3
6
1.25 TID
3.75
7
1.5 TID
4.50
Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson’s disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson’s disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
Table 2 Dosing of Pramipexole Dihydrochloride Tablets in Parkinson’s Disease Patients with Renal ImpairmentRenal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment (creatinine Cl > 50 mL/min)
0.125 TID
1.5 TID
Moderate impairment (creatinine Cl = 30 to 50 mL/min)
0.125 BID
0.75 TID
Severe impairment (creatinine Cl = 15 to < 30 mL/min)
0.125 QD
1.5 QD
Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride tablets should be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose should be reduced by 0.375 mg per day. In some studies, however, abrupt discontinuation was uneventful.
-
American Health Packaging
Pramipexole Dihydrochloride | Trifecta Pharmaceuticals Usa Llc
Wash the affected area and dry thoroughly.● Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor.
● Supervise children in the use of this product.
● For athlete’s foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.
● For athlete’s foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
● If conditions persists longer, consult a doctor.
● This product is not effective on the scalp or nails.
-
American Health Packaging
Pramipexole Dihydrochloride | American Health Packaging
2.1 General Dosing ConsiderationsPramipexole dihydrochloride tablets are taken orally, with or without food.
If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted.
2.2 Dosing for Parkinson’s DiseaseIn all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.
Dosing in Patients with Normal Renal Function
Initial Treatment
Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in Table 1:
Table 1 Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson’s DiseaseWeek
Dosage (mg)
Total Daily Dose (mg)
1
0.125 three times a day
0.375
2
0.25 three times a day
0.75
3
0.5 three times a day
1.50
4
0.75 three times a day
2.25
5
1 three times a day
3
6
1.25 three times a day
3.75
7
1.5 three times a day
4.50
Maintenance Treatment
Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).
In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.
When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.
Dosing in Patients with Renal Impairment
The recommended dosing of pramipexole dihydrochloride tablets in Parkinson's disease patients with renal impairment is provided in Table 2.
Table 2 Dosing of Pramipexole Dihydrochloride Tablets in Parkinson’s Disease Patients with Renal ImpairmentRenal Status
Starting Dose (mg)
Maximum Dose (mg)
Normal to mild impairment (creatinine Cl > 50 mL/min)
0.125 TID
1.5 TID
Moderate impairment (creatinine Cl = 30 to 50 mL/min)
0.125 BID
0.75 TID
Severe impairment (creatinine Cl = 15 to < 30 mL/min)
0.125 QD
1.5 QD
Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients)
The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
Discontinuation of Treatment
Pramipexole dihydrochloride tablets may be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose may be reduced by 0.375 mg per day.
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