SIFROL 0.18 MG 0.25MG 30TAB

Indications

Approved Uses

Treatment of the signs and symptoms of idiopathic Parkinson's disease, Symptomatic treatment of moderate to severe primary Restless Legs Syndrome (RLS).

Dosage & Administration

Dosing by Condition

Parkinson’s disease (immediate‑release): start 0.088 mg base three times daily (equivalent to 0.125 mg salt TID) and titrate at ~5-7 day intervals to effect/tolerability; usual max is 1.1 mg base TID (3.3 mg/day base). RLS (immediate‑release): start 0.088 mg base once daily 2-3 hours before bedtime (equivalent to 0.125 mg salt), increase every 4-7 days if needed; max 0.54 mg/day base (equivalent to 0.75 mg salt).

Initial Dose

Parkinson's disease: 0.125 mg (salt) three times daily; RLS: 0.125 mg (salt) once daily 2-3 hours before bedtime

Maximum Dose

Parkinson’s disease (immediate-release): 4.5 mg/day (salt). RLS: 0.5 mg/day (salt

Children's Dosage

Safety and effectiveness in pediatric patients have not been established.

Dose Adjustment Notes

Titrate gradually; reduce dose in renal impairment (pramipexole is renally cleared); when used with levodopa, levodopa dose may need reduction; when discontinuing (especially in Parkinson’s disease), taper gradually rather than stopping abruptly.

How to Take

Oral: swallow tablet with water; may be taken with or without food (taking with food can reduce nausea). Immediate‑release pramipexole is typically given three times daily for Parkinson’s disease and once daily 2-3 hours before bedtime for restless legs syndrome (RLS), per prescriber directions.

Side Effects

Common Side Effects

Common: nausea, dizziness, somnolence/drowsiness, insomnia, constipation, fatigue, headache; also common/clinically important especially in Parkinson’s disease: hallucinations/confusion, peripheral edema, and dyskinesia (particularly with concomitant levodopa).

Safety & Warnings

Contraindications

Hypersensitivity to pramipexole or any excipients

Warnings & Precautions

Warn/monitor for: somnolence and sudden sleep (avoid driving until effects known), hallucinations/psychotic behavior (higher risk in elderly), orthostatic hypotension (monitor BP during initiation/titration), impulse-control disorders (monitor and reduce/stop if occurs), dyskinesia with levodopa (may need levodopa reduction), renal impairment (dose adjust), and avoid abrupt discontinuation (taper to prevent severe withdrawal/NMS-like syndrome); in RLS monitor for augmentation.

Age Restriction

Not approved/recommended for patients <18 years

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Key interactions: dopamine antagonists (e.g., antipsychotics, metoclopramide) may reduce effect; CNS depressants/alcohol increase sedation; cimetidine and other OCT2/renal cation-transport inhibitors (e.g., ranitidine, verapamil, quinidine/quinine, triamterene) can increase pramipexole exposure; with levodopa may increase dyskinesia/hallucinations (often requires levodopa dose reduction).

Interaction Severity

MAJOR: dopamine antagonists (e.g., antipsychotics, metoclopramide) may reduce pramipexole efficacy. MODERATE: CNS depressants/alcohol (additive sedation/sleep attacks), cimetidine (may increase pramipexole levels via reduced renal tubular secretion), levodopa (increased dyskinesia/hallucinations-often requires levodopa dose reduction).

Food Interaction

No clinically significant food restriction; may be taken with or without food, and taking with food can lessen nausea.

Alcohol Interaction

Avoid

Special Populations

Breastfeeding

Weigh the potential benefits against the potential risks before taking this medication while breastfeeding

Children

Safety and effectiveness in pediatric patients have not been established.

Elderly

Start at lowest dose and titrate slowly; increased risk of hallucinations, confusion, and orthostatic hypotension; monitor renal function as clearance is reduced with age

Storage & Patient Advice

Missed Dose

Parkinson’s disease (TID): take as soon as remembered unless it is close to the next dose; if close, skip-do not double. RLS (once daily evening): skip the missed dose and take the next dose at the usual time the next evening; do not take extra doses to make up.

Stopping the Medicine

Parkinson’s disease: do not stop abruptly-taper gradually (typically over ≥1 week). RLS: may be discontinued without taper in many patients, but tapering can be considered to reduce rebound/withdrawal risk.

Patient Counseling

Counsel on: risk of somnolence and sudden sleep attacks (avoid driving/machinery until effects known), orthostatic dizziness (rise slowly), nausea (may take with food), hallucinations/confusion (especially older PD patients), impulse control disorders (gambling/shopping/sexual urges/binge eating), edema; avoid alcohol/CNS depressants if possible; do not stop abruptly-taper under prescriber guidance; follow renal-dose instructions and attend monitoring follow-up.

Monitoring Requirements

Monitor: blood pressure (orthostatic hypotension), somnolence/sudden sleep episodes, neuropsychiatric effects (hallucinations, confusion), impulse control disorders, peripheral edema; assess renal function for dosing; in Parkinson’s disease, periodic skin examination for melanoma risk is advised.

Pharmacology

Mechanism of Action

Non‑ergot dopamine agonist that stimulates dopamine D2/D3 receptors in the CNS (notably striatal pathways), improving dopaminergic signaling in Parkinson’s disease and relieving symptoms in RLS.

Product Information

Available Dosage Forms

Immediate-release tablet, extended-release tablet

OTC Alternatives

No OTC alternative

Psych Class

Anti-Parkinson Drugs

Controlled Substance

No

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