Boehringer Ingelheim


Concise Prescribing Info
Pramipexole dihydrochloride monohydrate
Signs & symptoms of advanced idiopathic Parkinson's disease as monotherapy or in combination w/ levodopa. Symptomatic treatment of idiopathic restless legs syndrome (RLS).
Dosage/Direction for Use
Parkinson's disease Dose escalation: 0.125 mg tds on wk 1, followed by 0.25 mg tds on wk 2 then 0.5 mg tds on wk 3. If necessary, increased by 0.75 mg at wkly intervals to max: 4.5 mg daily. Maintenance: 0.375-4.5 mg daily. During dose escalation in pivotal studies, efficacy was observed starting at 1.5 mg daily dose. Patient on levodopa Reduce dose. Renal impairment CrCl 20-50 mL/min Initially 0.125 mg bd (max: 2.25 mg daily), <20 mL/min Initially 0.125 mg daily as single dose (max: 1.5 mg daily). RLS Initially 0.125 mg once daily 2-3 hr before bedtime, may be increased every 4-7 days to max: 0.75 mg daily.
May be taken with or without food.
Special Precautions
Sudden sleep onset & somnolence. Hallucinations, abnormal behaviour (reflecting symptoms of impulse control disorders & compulsive behaviours) eg, binge eating, compulsive shopping, hypersexuality & pathological gambling); psychotic disorders; severe CV disease; dystonia; melanoma; rhabdomyolysis. Closely monitor during & after discontinuation due to drug w/drawal syndrome. Regularly monitor ophth & BP during treatment. Avoid abrupt w/drawal. Augmentation in RLS. Not recommended to co-administer w/ antipsychotics. Concomitant use w/ other sedatives or alcohol. May affect ability to drive & use machines. Renal impairment. Pregnancy. Not to be used during lactation. Paed patients.
Adverse Reactions
Pneumonia; inappropriate antidiuretic hormone secretion; abnormal behaviour & dreams, confusion, delusion, hallucinations, hyperphagia, insomnia, libido disorders, paranoia, restlessness; amnesia, antecollis, dizziness, dyskinesia, headache, hyperkinesia, somnolence, sudden sleep onset, syncope; visual impairment eg, diplopia, blurred vision & reduced visual acuity; cardiac failure; hypotension; dyspnoea, hiccups; constipation, nausea, vomiting; hypersensitivity, pruritus, rash; fatigue, peripheral oedema, drug w/drawal syndrome; decreased wt & appetite, increased wt.
Drug Interactions
Reduced clearance w/ basic cationic drugs eg, cimetidine. Possible interaction w/ amantadine. Not recommended to co-administer w/ antipsychotics. Possible additive effects w/ other sedatives or alcohol.
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BC05 - pramipexole ; Belongs to the class of dopamine agonist. Used in the management of Parkinson's disease.
Sifrol tab 0.125 mg
Sifrol tab 1 mg
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