Sifrol

Pramipexole diHCl monohydrate

Signs & symptoms of idiopathic Parkinson's disease as monotherapy or in combination w/ levodopa. Symptomatic treatment of moderate to severe idiopathic restless legs syndrome (RLS).

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. Increase by 0.75 mg at wkly intervals to a max of 4.5 mg daily if necessary. Maintenance: 0.375-4.5 mg daily. Concomitant levodopa therapy Reduce levodopa dose during dose escalation & maintenance treatment. 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 a 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 a max of 0.75 mg daily.

May be taken with or without food.

Hypersensitivity.

Possible hallucinations & confusion. Abnormal behaviour may occur (reflecting symptoms of impulse control disorders & compulsive behaviours eg, binge eating, compulsive shopping, hypersexuality & pathological gambling); consider dose reduction/tapered discontinuation. Ophthalmological monitoring is recommended at regular interval or if visual abnormalities occur. Severe CV disease. Monitor BP especially at the beginning of treatment due to general risk of postural hypotension. Patients w/ Parkinson's disease may present w/ axial dystonia (eg, antecollis, camptocormia or pleurothotonus). Symptoms suggestive of NMS w/ abrupt w/drawal of therapy. Drug w/drawal syndrome during or after discontinuation. Monitor for melanoma. Patient w/ psychotic disorder. Augmentation in RLS. Sudden onset of sleep & somnolence. Hallucinations can occur & may adversely affect ability to drive & use machines. Dose reduction for patient w/ renal impairment. Pregnancy. Not to be used during breast-feeding. Childn & adolescent up to 18 yr.

Somnolence, dizziness, dyskinesia, augmentation in RLS; nausea. Insomnia, hallucinations, abnormal dreams, confusion, behavioural symptoms of impulse control disorders & compulsions; headache; visual impairment including diplopia, blurred vision, reduced visual acuity; hypotension; constipation, vomiting; fatigue, peripheral oedema; decreased wt including decreased appetite.

Reduced clearance w/ basic cationic drugs (eg, cimetidine). Potential dopamine overstimulation eg, dyskinesias, agitation or hallucinations w/ amantadine. Not recommended to be co-administered w/ antipsychotics. Possible additive effects in concomitant administration w/ other sedating medication or alcohol.

Antiparkinsonian Drugs

N04BC05 - pramipexole ; Belongs to the class of dopamine agonist. Used in the management of Parkinson's disease.

POM