Ropinirole Hydrochloride
Generic Name: ropinirole hydrochloride
Brand Names:
Ropinirole Hydrochloride
11 DESCRIPTION Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride 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 (260.38 as the free base). The structural formula is: Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243 o C to 250°C and a solubility of 133 mg/mL in water.
Overview
11 DESCRIPTION Ropinirole tablets contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride 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 (260.38 as the free base). The structural formula is: Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243 o C to 250°C and a solubility of 133 mg/mL in water.
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 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 US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 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 tablets have reported falling asleep while engaged in activities of daily living, including driving or operating machinery, which sometimes resulted in accidents. 4 CONTRAINDICATIONS 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.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole tablets 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 Each round biconvex film-coated ropinirole tablet, USP contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows: 0.25 mg: White color coated, round, biconvex tablets debossed with "972" on one side and "HH" on the other side Bottles of 90 – NDC 51655-360-26 Storage Store at room temperature between 20°C and 25°C (68°F and 77°F...
Frequently Asked Questions
What is Ropinirole Hydrochloride 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 Hydrochloride?▼
6 ADVERSE REACTIONS 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 US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Ropinirole Hydrochloride during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole tablets 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 Hydrochloride?▼
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 tablets have reported falling asleep while engaged in activities of daily living, including driving or operating machinery, which sometimes resulted in accidents. 4 CONTRAINDICATIONS 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.
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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.