ROPINIROLE 1 mg/1
ROPINIROLE · TABLET, FILM COATED · Alembic Pharmaceuticals Limited
ROPINIROLE is a tablet, film coated containing ropinirole at 1 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Limited.
Key Facts
- Brand Name
- ROPINIROLE
- Generic Name
- ROPINIROLE
- NDC Code (Product)
46708-032- Manufacturer
- Alembic Pharmaceuticals Limited
- Strength
- 1 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090429
- Marketing Start
- 09/12/2013
Recall History
Mylan Pharmaceuticals Inc.
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
RemedyRepack Inc.
cGMP Deviations
Direct Rx
cGMP deviations
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Direct Rx
cGMP deviations
Sandoz, Inc
Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
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 Ropinirole Tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2). 1.1 Parkinson's Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION · Ropinirole tablets can be taken with or without food. (2.1) · Retitration of ropinirole tablets may be warranted if therapy is interrupted. (2.1) Parkinson’s Disease: · The recommended starting dose is 0.25 mg taken three times daily; titrate to a maximum daily dose of 24 mg. (2.2) · Renal Impairment: The maximum recommended dose is 18 mg/day in patients with end-stage renal disease on hemodialysis. (2.2) Restless Legs Syndrome: · The recommended starting dose is 0.25 mg once daily, 1 to 3 hours before bedtime, titrate to a maximum recommended dose of 4 mg daily. (2.3) · Renal Impairment: The maximum recommended dose is 3 mg/day in patients with end-stage renal disease on hemodialysis. (2.3) 2.1 General Dosing Recommendations Ropinirole tablets can be taken with or without food [see Clinical Pharmacology (12.3)] . If a significant interruption in therapy with ropinirole tablets have occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson's Disease Week Dosage Total Daily Dose 1 0.25 mg 3 times daily 0.75 mg 2 0.5 mg 3 times daily 1.5 mg 3 0.75 mg 3 times daily 2.25 mg 4 1 mg 3 times daily 3 mg Ropinirole tablets should be discontinu…
Contraindications
4 CONTRAINDICATIONS Ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. History of hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients (4)
Drug Interactions
7 DRUG INTERACTIONS · Inhibitors or inducers of CYP1A2: May alter the clearance of ropinirole tablets; dose adjustment of ropinirole tablets may be required (7.1, 12.3) · Hormone replacement therapy(HRT): Starting or stopping HRT may require dose adjustment of ropinirole tablets (7.2, 12.3) · Dopamine antagonists (e.g., neuroleptics, metoclopramide): May reduce efficacy of ropinirole tablets (7.3) 7.1 Cytochrome P450 1A2 Inhibitors and Inducers In vitro metabolism studies showed that CYP1A2 is the major enzyme responsible for the metabolism of ropinirole. There is thus the potential for inducers or inhibitors of this enzyme to alter the clearance of ropinirole. Therefore, if therapy with a drug known to be a potent inducer or inhibitor of CYP1A2 is stopped or started during treatment with ropinirole tablets, adjustment of the dose of ropinirole tablets may be required. Coadministration of ciprofloxacin, an inhibitor of CYP1A2, increases the AUC and C max of ropinirole [see Clinical Pharmacology (12.3)]. Cigarette smoking is expected to increase the clearance of ropinirole since CYP1A2 is known to be induced by smoking [see Clinical Pharmacology (12.3)]. 7.2 Estrogens Population pha…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the label: Hypersensitivity [see Contraindications (4)] Falling asleep during activities of daily living and somnolence [see Warnings and Precautions (5.1)] Syncope [see Warnings and Precautions (5.2)] Hypotension/orthostatic hypotension [see Warnings and Precautions (5.3)] Hallucinations/psychotic-like behavior [see Warnings and Precautions (5.4)] Dyskinesia [see Warnings and Precautions (5.5)] Impulse control/compulsive behaviors [see Warnings and Precautions (5.6)] Withdrawal-emergent hyperpyrexia and confusion [see Warnings and Precautions (5.7)] Withdrawal Symptoms [see Warnings and Precautions (5.8)] Augmentation and early-morning rebound in RLS [see Warnings and Precautions (5.9)] Fibrotic complications [see Warnings and Precautions (5.10)] Retinal pathology [see Warnings and Precautions (5.11)] Most common adverse reactions (incidence with ropinirole tablets at least 5% greater than placebo) in the respective indications were: Early PD: Nausea, somnolence, dizziness, syncope, asthenic condition, viral infection, leg edema, vomiting, and dyspepsia. (6.1) Advanced PD: Dyskine…
Frequently Asked Questions
What is ROPINIROLE used for?
ROPINIROLE contains ROPINIROLE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is ROPINIROLE a controlled substance?
ROPINIROLE is not classified as a controlled substance by the DEA.
What is the generic name for ROPINIROLE?
The generic name for ROPINIROLE is ROPINIROLE. There are 10 other brand versions of ROPINIROLE.
What is the NDC code for ROPINIROLE 1 mg/1?
The NDC (National Drug Code) for ROPINIROLE 1 mg/1 is 46708-032, listed by Alembic Pharmaceuticals Limited.