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Ropinirole information from DrugsUpdate  

See Available Brands of Ropinirole in India

P - Caution when used during pregnancy
L - Contraindicated in lactation

Ropinirole (Requip, Ropark, Adartrel) is a non-ergoline dopamine agonist. It is manufactured by GlaxoSmithKline (GSK) and Sun Pharmaceutical. It is used in the treatment of Parkinson's disease. Ropinirole is also one of two medications in the United States (U.S.) with an Food and Drug Administration (FDA) approved indication for the treatment of restless legs syndrome (RLS), the other being pramipexole (Mirapex). The discovery of the drug's utility in RLS has been used as a successful example of drug repurposing.

Ropinirole's patent expired in May 2008, and the drug is now available in generic form.

Pharmacodynamics

Pharmacokinetics

Ropinirole is a non-ergot dopamine D2-agonist with similar actions to those of bromocriptine. It is used in the management of Parkinson's disease, either alone or as an adjunct to levodopa.

Absorption
Rapidly absorbed from the GI tract after oral admin. Bioavailability: about 50%.

Distribution
Widely distributed. Plasma protein binding: 10-40%.

Metabolism
Extensively metabolised in the liver by CYP1A2.

Excretion
Excreted in the urine as inactive metabolites; <10% of the oral dose is excreted unchanged. Elimination half-life: about 6 hours.

Ropinirole Indications / Ropinirole Uses

Information Not Available

Ropinirole Adverse Reactions / Ropinirole Side Effects

Sudden onset of sleep with or without any prior feeling of drowsiness. Nausea, abdominal pain; dizziness, somnolence, headache, hallucinations; dyskinesias.

Precautions

Dyskinesia
Ropinirole hydrochloride may potentiate the dopaminergic side effects of L-dopa and may cause and/or exacerbate preexisting dyskinesia in patients treated with L-dopa for Parkinson’s disease. Decreasing the dose of L-dopa may ameliorate this side effect.

Renal Impairment

No dosage adjustment is needed in patients with mild to moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The use of Ropinirole hydrochloride in patients with severe renal impairment has not been studied.

Hepatic Impairment
The pharmacokinetics of Ropinirole have not been studied in patients with hepatic impairment. Since patients with hepatic impairment may have higher plasma levels and lower clearance, Ropinirole hydrochloride should be titrated with caution in these patients.

Overdosage
Symptoms include nausea, vomiting, visual hallucinations, hyperhidrosis, asthenia and nightmares. General supportive measures and monitoring of vital signs are recommended. May consider gastric lavage.

Special Precautions

Pregnancy. May impair ability to drive or operate machinery. Withdrawal should be gradual. Hepatic or renal impairment. May cause daytime sleepiness or episodes of falling asleep during activities. May cause or worsen pre-existing dyskinesia.

Other Drug Interactions

Inhibitors of CYP1A2 e.g. cimetidine, ciprofloxacin, erythromycin, fluvoxamine, isoniazid, ritonavir and zileuton may increase serum concentrations of ropinirole. Oestrogens and tobacco smoking may decrease clearance of ropinirole. Efficacy may be reduced by dopamine antagonists such as phenothiazines and metoclopramide.

Other Interactions

Information Not Available

Dosage

Oral
As monotherapy in Parkinson's disease
Adult: Initially, 250 mcg tid, may increase by 750 mcg at weekly intervals for the first 4 weeks. Subsequent increments can be made in steps of 1.5 mg at weekly intervals up to 9 mg/day, then in steps of 3 mg at weekly intervals. Usual dose ranges from 3-9 mg daily. Max: 24 mg/day. Higher dose may be necessary if used in conjunction with levodopa. Gradual withdrawal is recommended.
Hepatic impairment: Dosing adjustments may be necessary.

Oral
Restless leg syndrome
Adult: Initially, 250 mcg daily for 2 days, taken 1-3 hours before bedtime. May increase to 500 mcg daily for the next few days. Subsequent increments may be made in steps of 500 mcg at weekly intervals until 3 mg daily is reached. Max: 4 mg daily.
Hepatic impairment: Dosing adjustments may be required.

Food(before/after)

Should be taken with food. (Swallow whole, do not chew/crush.)

List of Contraindications

Ropinirole and Pregnancy

Caution when used during pregnancy

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Ropinirole and Lactation

Contraindicated in lactation

Ropinirole and Children

Safety and effectiveness in the pediatric population have not been established

Ropinirole and Geriatic

Information Not Available

Ropinirole and Other Contraindications

Lactation.

Storage

Oral
Store at 20-25°C

Lab interference

Oral
Store at 20-25°C

Ropinirole brands in India:

Parkirop Ropark Ropark-XL Ropin Ropitor

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