Ropinirole is a nonergot dopamine agonist sold in the U.S. under 3 brand and generic names, for parkinson disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Requip (application NDA020658). Other ropinirole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 has occurred, retitration of therapy may be warranted. 2.2 Dosing for Parkinson’s Disease The recommended starting dose of ropinirole tablets for Parkinson's disease is 0.25 mg 3 times daily. Based on individual patient therapeutic response and tolerability, if necessary, the dose should then be titrated with weekly increments as described in Table 1. After Week 4, if necessary, the daily dose may be increased by 1.5 mg/day on a weekly basis up to a dose of 9…
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: Dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, sweating, and headache. ( 6.1 ) • RLS: Nausea, vomiting, somnolence, dizziness, and asthenic condition. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare U. S., LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $2 | View → | |
| 2 | 70/100 | Prescription | Tablet | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 972;HH | 0.25 mg | white | round | — |
| 972;HH | 0.25 mg | white | round | — |
| 973;HH | 0.5 mg | yellow | round | — |
| 974;HH | 1 mg | green | round | — |
| 975;HH | 2 mg | pink | round | — |
| 976;HH | 3 mg | purple |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
History of hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. ( 4 ) 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.
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 cytochrome P450 1A2 (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 pharmacokinetic analysis revealed that higher doses of estrogens (usually associated with hormone replacement therapy) reduced the clearance of ropinirole. Starting…
| $2 |
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| 3 | Not yet rated | Prescription | Tablet | Generic | $2 | View → |
| round |
| — |
| 977;HH | 4 mg | brown | round | — |
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| 978;HH | 5 mg | blue | round | — |
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| 595;S | 0.25 mg | white | round | — |
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| 596;S | 0.5 mg | yellow | round | — |
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| 597;S | 1 mg | green | round | — |
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| 598;S | 2 mg | pink | round | — |
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