Pramipexole Dihydrochloride Extended-Release .75 mg/1
Pramipexole Dihydrochloride · TABLET, EXTENDED RELEASE · Xiamen LP Pharmaceutical Co., Ltd.
Pramipexole Dihydrochloride Extended-Release is a prescription tablet, extended release containing pramipexole dihydrochloride at .75 mg/1, taken oral. Manufactured by Xiamen LP Pharmaceutical Co., Ltd..
Key Facts
- Brand Name
- Pramipexole Dihydrochloride Extended-Release
- Generic Name
- Pramipexole Dihydrochloride
- NDC Code (Product)
71034-003- Manufacturer
- Xiamen LP Pharmaceutical Co., Ltd.
- Strength
- .75 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA212797
- Drug Class
- Dopamine Agonists [MoA]; Nonergot Dopamine Agonist [EPC]
- Marketing Start
- 06/11/2021
Recall History
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.
Par Pharmaceutical, Inc.
Failed impurities/degradation specifications: Finished product contain a known product impurity about current 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 tablets are 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 andtolerability 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 pramipexole dihydrochloride extended-release 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 dih…
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 ) ] 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 Xiamen LP Pharmaceutical Co., Ltd. at 1-415-516-…
Frequently Asked Questions
What is Pramipexole Dihydrochloride Extended-Release used for?
Pramipexole Dihydrochloride Extended-Release contains Pramipexole Dihydrochloride. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Pramipexole Dihydrochloride Extended-Release a controlled substance?
Pramipexole Dihydrochloride Extended-Release is not classified as a controlled substance by the DEA.
What is the generic name for Pramipexole Dihydrochloride Extended-Release?
The generic name for Pramipexole Dihydrochloride Extended-Release is Pramipexole Dihydrochloride. There are 12 other brand versions of Pramipexole Dihydrochloride.
What is the NDC code for Pramipexole Dihydrochloride Extended-Release .75 mg/1?
The NDC (National Drug Code) for Pramipexole Dihydrochloride Extended-Release .75 mg/1 is 71034-003, listed by Xiamen LP Pharmaceutical Co., Ltd..
Other Pramipexole Brands
See all →- Pramipexole dihydrochloride.5 mg/10615-8552
- Pramipexole Dihydrochloride.75 mg/113668-184
- Pramipexole Dihydrochloride.375 mg/116714-916
- pramipexole dihydrochloride1 mg/129300-210
- Pramipexole dihydrochloride.5 mg/133342-033
- 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)