Ropinirole
Generic Name: ropinirole
Brand Names:
Ropinirole
11 DESCRIPTION Ropinirole Tablets, USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16 H 24 N 2 O•HCl. The molecular weight is 296.84 g/mol (260.38 as the free base).
Overview
11 DESCRIPTION Ropinirole Tablets, USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16 H 24 N 2 O•HCl. The molecular weight is 296.84 g/mol (260.38 as the free base).
Uses
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
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.
Side Effects
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-mornin...
Interactions
7 DRUG INTERACTIONS • Inhibitors or inducers of CYP1A2: May alter the clearance of ropinirole; dose adjustment of ropinirole may be required. ( 7.1 , 12.3) • Hormone replacement therapy (HRT): Starting or stopping HRT may require dose adjustment of ropinirole. ( 7.2 , 12.3 ) • Dopamine antagonists (e.g., neuroleptics, metoclopramide): May reduce efficacy of ropinirole. ( 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.
Warnings
5 WARNINGS AND PRECAUTIONS • Sudden onset of sleep and somnolence may occur ( 5.1 ) • Syncope may occur ( 5.2 ) • Hypotension, including orthostatic hypotension may occur ( 5.3 ) • May cause hallucinations and psychotic-like behaviors ( 5.4 ) • May cause or exacerbate dyskinesia ( 5.5 ) • May cause problems with impulse control or compulsive behaviors ( 5.6 ) 5.1 Falling Asleep during Activities of Daily Living and Somnolence Patients treated with ropinirole have reported falling asleep while engaged in activities of daily living, including driving or operating machinery, which sometimes resulted in accidents. 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 )
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole in pregnant women. In animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the MRHD for Parkinson’s disease. Ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-1822 NDC: 50090-1822-0 100 TABLET, FILM COATED in a BOTTLE Product: 50090-2068
Frequently Asked Questions
What is Ropinirole used for?▼
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).
What are the side effects of Ropinirole?▼
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-mornin...
Can I take Ropinirole during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole in pregnant women. In animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the MRHD for Parkinson’s disease. Ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity.
What are the important warnings for Ropinirole?▼
5 WARNINGS AND PRECAUTIONS • Sudden onset of sleep and somnolence may occur ( 5.1 ) • Syncope may occur ( 5.2 ) • Hypotension, including orthostatic hypotension may occur ( 5.3 ) • May cause hallucinations and psychotic-like behaviors ( 5.4 ) • May cause or exacerbate dyskinesia ( 5.5 ) • May cause problems with impulse control or compulsive behaviors ( 5.6 ) 5.1 Falling Asleep during Activities of Daily Living and Somnolence Patients treated with ropinirole have reported falling asleep while engaged in activities of daily living, including driving or operating machinery, which sometimes resulted in accidents. 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.