Ropinirole

What it is and how it works

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 D 2 receptors within the caudate-putamen in the brain. The precise mechanism of action of ropinirole as a treatment for RLS is unknown, although it is thought to be related to its ability to stimulate dopamine receptors.

Indications

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 ) Parkinson's Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease. Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

Dosage and administration (summary)

• Ropinirole tablets can be taken with or without food. • Retitration of ropinirole tablets may be warranted if therapy is interrupted. Parkinson’s Disease: • The recommended starting dose is 0.25 mg taken three times daily; titrate to a maximum daily dose of 24 mg. • Renal Impairment: The maximum recommended dose is 18 mg/day in patients with end-stage renal disease on hemodialysis. 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. • Renal Impairment: The maximum recommended dose is 3 mg/day in patients with end-stage renal disease on hemodialysis.

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. ()

Warnings and precautions

• Sudden onset of sleep and somnolence may occur • Syncope may occur • Hypotension, including orthostatic hypotension may occur • May cause hallucinations and psychotic-like behaviors • May cause or exacerbate dyskinesia • May cause problems with impulse control or compulsive behaviors 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.

Pregnancy

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) th…

Storage and supply

Each circular, beveled edged, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to the labeled amount of ropinirole as follows: • 2 mg: pale pink to pink tablets with ‘2’ over ‘56’ debossed on one side and ‘G’ on the other side NDC 68788-4138-3 Bottles of 30 with child-resistant closure Storage Store at 20°C to 25°C (68°…

Source: Ropinirole (Ropinirole) — US FDA prescribing information, 2026-07-06, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.