General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Ropinirole Hydrochloride
ROPINIROLE HYDROCHLORIDE
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).
Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians ·
Brand names:ROPINIROLE HYDROCHLORIDE
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- ROPINIROLE HYDROCHLORIDE
- Medicine class
- General Medicine
- Brand names
- ROPINIROLE HYDROCHLORIDE
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life is approximately 6 hours
- FDA approved
- Yes
What Is Ropinirole Hydrochloride?
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).
Ropinirole Hydrochloride (ROPINIROLE HYDROCHLORIDE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Ropinirole Hydrochloride. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Ropinirole Hydrochloride with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Ropinirole Hydrochloride is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
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 Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult 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. (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 Parkinso
Available Forms
Available Strengths
Side Effects
Common
- 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: 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 Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice.
- Parkinson’s Disease During the premarketing development of ropinirole tablets, patients received ropinirole tablets either without L-dopa (early Parkinson’s disease trials) or as concomitant therapy with L-dopa (advanced Parkinson’s disease trials).
- Because these two populations may have differential risks for various adverse reactions, this section will in general present adverse reaction data for these two populations separately.
Serious
- 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.
- Although many of these patients reported somnolence while on ropinirole tablets, some perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event.
- Some have reported these events more than 1 year after initiation of treatment.
- In controlled clinical trials, somnolence was commonly reported in patients receiving ropinirole tablets and was more frequent in Parkinson's disease (up to 40% ropinirole tablets, 6% placebo) than in Restless Legs Syndrome (12% ropinirole tablets, 6% placebo) [see Adverse Reactions (6.1)] .
- It has been reported that falling asleep while engaged in activities of daily living usually occurs in a setting of pre-existing somnolence, although patients may not give such a history.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
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 Livi
How Ropinirole Hydrochloride Works
12.1 Mechanism of Action Ropinirole is a non-ergoline dopamine agonist. The precise mechanism of action of ropinirole as a treatment for Parkinson’s disease is unknown, although it is thought to be related to its ability to stimulate dopamine D2 receptors within the caudate-putamen in the brain. The precise mechanism of action of ropinirole as a treatment for Restless Legs Syndrome is unknown, although it is thought to be related to its ability to stimulate dopamine receptors.
Pharmacokinetics
Absorption
Absorption Ropinirole is rapidly absorbed after oral administration, reaching peak concentration in approximately 1 to 2 hours
Half-Life
half-life is approximately 6 hours
Metabolism
Metabolism Ropinirole is extensively metabolized by the liver
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Ropinirole Hydrochloridewhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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- Detail
Ropinirole Hydrochloride dosage guide
Adult, pediatric, renal, and hepatic dosing for Ropinirole Hydrochloride
- Detail
Ropinirole Hydrochloride side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Ropinirole Hydrochloride
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.