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.
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 daily dose: 1.5 mg. 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). Restless legs syndrome 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 onset of sleep & somnolence. Hallucinations, severe CV disease, dystonia. Behavioural changes may occur (reflecting symptoms of impulse control disorders & compulsive behaviours eg, binge eating, compulsive shopping, hypersexuality & pathological gambling). Melanoma; rhabdomyolysis. Consider dose reduction/taper discontinuation. Regular ophth & BP monitoring. Avoid abrupt w/drawal. Augmentation in RLS. Not recommended to co-administer w/ antipsychotics. May affect ability to drive & use machines. Renal impairment. Pregnancy. Not to be used during lactation. Childn & adolescents up to 18 yr.
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 onset of sleep, syncope; visual impairment eg, diplopia, blurred vision & reduced visual acuity; cardiac failure; hypotension; dyspnoea, hiccups; constipation, nausea, vomiting; hypersensitivity, pruritus, rash; fatigue, peripheral oedema; decreased & 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 sedating medications or alcohol.
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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