Schedule H

Oral

Formulation Type Strengths Available

Immediate-Release Tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg

Extended-Release (Prolonged-Release) Tablets 2 mg, 4 mg, 8 mg

Note: 5 mg immediate-release tablet availability in India is limited; verify local availability before prescribing.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Idiopathic Parkinson's Disease

Can be used as monotherapy in early disease or as adjunct to Levodopa in advanced disease with motor fluctuations.

Immediate-Release (IR) Tablets:

Parameter Dosing

Starting dose 0.25 mg three times daily

Titration Increase by 0.25 mg per dose weekly (i.e., 0.75 mg/day increments per week)

Usual maintenance dose 3–9 mg/day in three divided doses

Maximum dose 24 mg/day in divided doses

Titration Schedule (IR Tablets):

Week Dose per administration Total daily dose

1 0.25 mg TID 0.75 mg/day

2 0.5 mg TID 1.5 mg/day

3 0.75 mg TID 2.25 mg/day

4 1 mg TID 3 mg/day

Subsequent Increase by 0.5–1 mg TID weekly as needed Up to 24 mg/day

Extended-Release (ER) Tablets:

Parameter Dosing

Starting dose 2 mg once daily

Titration Increase by 2 mg/day at weekly intervals or longer

Usual maintenance dose 8–12 mg once daily

Maximum dose 24 mg once daily

Clinical Notes:

• Titrate slowly to minimise orthostatic hypotension, somnolence, and hallucinations

• When used as adjunct to Levodopa, consider reducing Levodopa dose by 20–30% as Ropinirole dose is optimised

• ER tablets must be swallowed whole — do not crush, chew, or divide

• May take with food to reduce nausea

• Taper gradually when discontinuing — do not stop abruptly (risk of dopamine agonist withdrawal syndrome)

Switching from IR to ER:

• Convert total daily IR dose to equivalent once-daily ER dose

• Adjust based on clinical response

1. Moderate to Severe Primary Restless Legs Syndrome (RLS)

Immediate-Release Tablets Only (ER tablets are NOT indicated for RLS):

Parameter Dosing

Starting dose 0.25 mg once daily, 1–3 hours before bedtime

Titration Increase to 0.5 mg/day after 2 days, then to 1 mg/day after 7 days if needed; further increase by 0.5 mg/week

Usual maintenance dose 0.5–2 mg once daily

Maximum dose 4 mg once daily

Clinical Notes:

• Administer 1–3 hours before bedtime for optimal effect

• Not effective for secondary (non-idiopathic) RLS

• Risk of augmentation (worsening of symptoms) with long-term use — reassess periodically

• If no adequate response after 3 months at adequate dose, consider discontinuation

Secondary Indications — Adults (Off-label)

Not applicable. No widely accepted off-label indications for Ropinirole in Indian practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Not applicable. Ropinirole is NOT approved for use in children and adolescents below 18 years of age for any indication.

Secondary Indications — Paediatric (Off-label)

Not applicable.

Clear Statement: Use in patients below 18 years of age is NOT RECOMMENDED. Safety and efficacy have not been established in the paediatric population. Any use in rare paediatric movement disorders is strictly OFF-LABEL and must be under specialist paediatric neurologist supervision only.

CrCl ≥30 mL/min No dose adjustment required

CrCl <30 mL/min (not on dialysis) Use with caution; start at lowest dose; slow titration; limited data available

Haemodialysis Not recommended — insufficient data; if essential, specialist supervision mandatory

Peritoneal dialysis Not recommended — insufficient data

Notes:

• Monitor closely for CNS adverse effects in patients with renal impairment

• Extended-release tablets should be used with caution in moderate renal impairment and avoided in severe impairment

• Known hypersensitivity to Ropinirole or any excipient

• Severe hepatic impairment (Child-Pugh C)

• History of or active psychiatric illness (psychosis, hallucinations, delusions, severe depression)

• History of impulse control disorders — may worsen; counsel patient and caregivers

• Risk of sudden onset of sleep (sleep attacks) — caution patients about driving and operating machinery

• Cardiovascular disease — risk of orthostatic hypotension, especially during initiation and titration

• Elderly patients — increased susceptibility to CNS adverse effects

• Renal impairment — monitor closely

• Concurrent use with other sedating medications

• History of dyskinesias — may worsen when used with Levodopa

• Retinal pathology — periodic ophthalmological examination recommended

• Smoking status — tobacco induces CYP1A2 and may reduce Ropinirole efficacy

• Abrupt discontinuation — risk of dopamine agonist withdrawal syndrome and neuroleptic malignant syndrome-like symptoms

Parameter Details

Risk category Limited human data; animal studies show reproductive toxicity

Preferred alternatives Levodopa-Carbidopa is preferred for Parkinson's disease in pregnancy if treatment essential

When it may be used Only if maternal benefit clearly outweighs fetal risk; specialist neurologist and obstetrician supervision mandatory

Monitoring Fetal growth parameters, uteroplacental perfusion, maternal motor symptoms

Parameter Details

Compatibility Not recommended during breastfeeding

Drug levels in milk Unknown; Ropinirole inhibits prolactin secretion — likely to suppress lactation

Preferred alternatives Consider Levodopa-Carbidopa if antiparkinsonian therapy essential; or avoid breastfeeding

Monitoring in infant If inadvertent exposure: feeding adequacy, weight gain, sedation, irritability

Parameter Recommendation

Starting dose Same as younger adults (0.25 mg TID for IR; 2 mg once daily for ER)

Titration Slower than younger adults — increase at intervals of 7–14 days

Extra risks Orthostatic hypotension and falls, hallucinations, confusion, somnolence, delirium

Special considerations Reduced renal reserve may increase CNS effects; use lower maintenance doses if needed; regular cognitive and psychiatric assessment; educate caregivers about impulse control disorders and sleep attacks

Interacting Drug Effect Recommendation

Ciprofloxacin Strong CYP1A2 inhibitor — significantly increases Ropinirole plasma levels (up to 84%) Reduce Ropinirole dose by approximately 30–50%; monitor for adverse effects

Fluvoxamine Strong CYP1A2 inhibitor — increases Ropinirole exposure Avoid combination or significantly reduce Ropinirole dose

Antipsychotics (Haloperidol, Risperidone, Olanzapine) Dopamine receptor antagonism — reduces Ropinirole efficacy Avoid; if antipsychotic essential, consider Quetiapine or Clozapine under specialist care

Metoclopramide Central dopamine antagonist — reduces efficacy, may worsen Parkinsonism Avoid; use Domperidone as alternative antiemetic

Interacting Drug Effect Recommendation

Tobacco (Smoking) CYP1A2 induction — may reduce Ropinirole plasma levels Monitor efficacy; dose adjustment may be needed when starting or stopping smoking

Oestrogens (Oral contraceptives, HRT) CYP1A2 inhibition — may increase Ropinirole exposure Monitor for adverse effects

Levodopa Enhanced dopaminergic effects — increased dyskinesias May require 20–30% reduction in Levodopa dose

CNS depressants (Benzodiazepines, Opioids, Alcohol) Additive sedation; increased risk of sudden sleep episodes Use with caution; counsel about driving

Warfarin Potential for altered anticoagulation (mechanism unclear) Monitor INR closely when initiating or adjusting Ropinirole

Other Dopamine Agonists (Pramipexole, Rotigotine) Overlapping mechanism — no additional benefit Avoid combination

MAO-B Inhibitors (Selegiline, Rasagiline) Synergistic dopaminergic effects Can be combined; monitor for dyskinesias and psychiatric symptoms

Amantadine Combined dopaminergic effects Monitor for hallucinations and confusion

• Nausea, vomiting

• Dizziness, lightheadedness

• Somnolence, fatigue

• Headache

• Orthostatic hypotension

• Dyskinesias (when used with Levodopa)

• Peripheral oedema

• Constipation

• Abdominal pain

• Hallucinations (especially in elderly)

• Sudden onset of sleep (sleep attacks) — may occur without warning; driving hazard — counsel patients; immediate dose reduction required

• Impulse control disorders — pathological gambling, hypersexuality, compulsive shopping, binge eating; requires dose reduction or discontinuation; family counselling essential

• Psychosis, severe hallucinations, delusions — may require dose reduction or discontinuation; consider Quetiapine or Clozapine if antipsychotic needed

• Severe orthostatic hypotension — risk of syncope and falls

• Dopamine agonist withdrawal syndrome — anxiety, panic attacks, depression, irritability, sweating, pain; taper gradually

• Neuroleptic malignant syndrome-like symptoms — on abrupt withdrawal; requires immediate medical attention

• Retroperitoneal fibrosis, pulmonary fibrosis, pericardial effusion — rare; more common with ergot-derived agonists but reported with non-ergot agents; requires discontinuation

Phase Parameters to Monitor

Baseline Blood pressure (lying and standing), hepatic function (in liver disease), renal function, psychiatric history, cognitive assessment, ophthalmological examination (if prolonged use anticipated)

After initiation / dose change Blood pressure (lying and standing) at each visit during titration, motor response, emergence of somnolence/sleep attacks, hallucinations, dyskinesias

Long-term Impulse control disorder screening (actively ask patient and caregivers), psychiatric status, cognitive function, periodic ophthalmological examination, motor fluctuations

Brand Name Manufacturer Formulations Available

Ropark Sun Pharma IR: 0.25 mg, 0.5 mg, 1 mg, 2 mg

Ropitor Lupin IR: 0.25 mg, 0.5 mg, 1 mg, 2 mg

Ropizee USV IR: 0.25 mg, 0.5 mg, 1 mg

Ropicon Intas IR: 0.25 mg, 0.5 mg, 1 mg, 2 mg

Requip GSK (limited availability) IR and ER formulations

Note: Extended-release formulations have limited availability in India; verify local availability before prescribing. No major FDCs with Levodopa are commercially marketed in India.

Note: Ropinirole is NOT included in NLEM India 2022; prices are not NPPA-controlled. Prices are market-based and vary across brands and regions.

• “Start low, go slow": Slow titration over weeks minimises hallucinations, orthostatic hypotension, and somnolence — especially important in elderly.

• RLS timing is critical: For Restless Legs Syndrome, administer 1–3 hours before bedtime for optimal effect; ER formulation is NOT indicated for RLS.

• CYP1A2 matters: Be aware of CYP1A2 inhibitors (Ciprofloxacin, Fluvoxamine) and inducers (smoking) — dose adjustments are often necessary.

• Screen for impulse control disorders: Actively ask patients and caregivers about gambling, hypersexuality, compulsive shopping at every visit — patients often do not volunteer this information.

• Warn about sleep attacks: Document counselling about sudden onset of sleep and advise against driving/operating machinery until stable on dose for at least 2 weeks.

• Taper, never stop abruptly: Dopamine agonist withdrawal syndrome can be severe; always taper over 1–2 weeks minimum.

Ropinirole; Parkinson's disease; dopamine agonist; non-ergot; Restless Legs Syndrome; RLS; impulse control disorders; sleep attacks; CYP1A2; Schedule H; elderly-caution; Neurology

RxIndia v1.0 — 11 Jun 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia 2022 / National Formulary of India

• API Textbook of Medicine — Movement Disorders chapter

• AIIMS Delhi Parkinson's Disease Treatment Protocols

• Harrison's Principles of Internal Medicine, 21st edition

• Goodman & Gilman's The Pharmacological Basis of Therapeutics, 13th edition

• NLEM 2022 (confirmation of exclusion)