Pramipexole dihydrochloride .5 mg/1
Pramipexole dihydrochloride · TABLET · Glenmark Pharmaceuticals Inc., USA
Pramipexole dihydrochloride is a tablet containing pramipexole dihydrochloride at .5 mg/1, taken oral. Manufactured by Glenmark Pharmaceuticals Inc., USA.
Key Facts
- Brand Name
- Pramipexole dihydrochloride
- Generic Name
- Pramipexole dihydrochloride
- NDC Code (Product)
68462-332- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Strength
- .5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090781
- Marketing Start
- 10/08/2010
Recall History
Macleods Pharma Usa Inc
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
American Health Packaging
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Boehringer Ingelheim Pharmaceuticals, Inc.
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
American Health Packaging
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Sandoz Incorporated
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Zydus Pharmaceuticals USA Inc
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
American Health Packaging
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Par Pharmaceutical
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease. Pramipexole dihydrochloride extended-release tablet is a non-ergot dopamine agonist indicated for the treatment of Parkinson’s disease (PD) (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Pramipexole dihydrochloride extended-release tablets are taken once daily, with or without food (2.1) Tablets must be swallowed whole and must not be chewed, crushed, or divided (2.1) Starting dose is 0.375 mg given once daily (2.2) Dose may be increased gradually, not more frequently than every 5 to 7 days, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day. Assess therapeutic response and tolerability at a minimal interval of 5 days or longer after each dose increment. (2.2) Patients may be switched overnight from immediate-release pramipexole tablets to extended-release pramipexole tablets at the same daily dose. Dose adjustment may be needed in some patients (2.3) Pramipexole dihydrochloride extended-release tablets should be discontinued gradually. (2.2) 2.1 General Dosing Considerations Pramipexole dihydrochloride extended-release tablets are taken orally once daily, with or without food. Pramipexole dihydrochloride extended-release tablets must be swallowed whole and must not be chewed, crushed, or divided. If a significant interruption in therapy with pramipexole dihydrochloride extended-rel…
Contraindications
4 CONTRAINDICATIONS None. None (4)
Drug Interactions
7 DRUG INTERACTIONS Dopamine antagonists: May diminish the effectiveness of pramipexole (7.1). 7.1 Dopamine Antagonists Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of pramipexole dihydrochloride extended-release tablets.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1) ] Symptomatic Orthostatic Hypotension [see Warnings and Precautions (5.2) ] Impulse Control / Compulsive Behaviors [see Warnings and Precautions (5.3) ] Hallucinations and Psychotic-like Behavior [see Warnings and Precautions (5.4) ] Dyskinesia [see Warnings and Precautions (5.5) ] Postural Deformity [see Warnings and Precautions ( 5.6 ) ] Rhabdomyolysis [see Warnings and Precautions (5.8) ] Retinal Pathology [see Warnings and Precautions (5.9) ] Events Reported with Dopaminergic Therapy [see Warnings and Precautions (5.10) ] Withdrawal Symptoms [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (incidence ≥5% and greater than placebo) : Early PD without levodopa: somnolence, nausea, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and peripheral edema (6.1) Advanced PD with levodopa: dyskinesia, nausea, constipation, hallucinations, headache, and anorexia (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s L…
Frequently Asked Questions
What is Pramipexole dihydrochloride used for?
Pramipexole dihydrochloride contains Pramipexole dihydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Pramipexole dihydrochloride a controlled substance?
Pramipexole dihydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Pramipexole dihydrochloride?
The generic name for Pramipexole dihydrochloride is Pramipexole dihydrochloride. There are 8 other brand versions of Pramipexole dihydrochloride.
What is the NDC code for Pramipexole dihydrochloride .5 mg/1?
The NDC (National Drug Code) for Pramipexole dihydrochloride .5 mg/1 is 68462-332, listed by Glenmark Pharmaceuticals Inc., USA.
Other Pramipexole Brands
See all →- Pramipexole Dihydrochloride.75 mg/113668-184
- Pramipexole Dihydrochloride.375 mg/116714-916
- pramipexole dihydrochloride1 mg/129300-210
- Pramipexole Dihydrochloride4.5 mg/133342-214
- Pramipexole Dihydrochloride1.5 mg/146708-007
- Pramipexole Dihydrochloride3.75 mg/146708-579
- Pramipexole Dihydrochloride1.5 mg/150090-7816
- Pramipexole Dihydrochloride.125 mg/150228-126
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)