Piritan

Pramipexole diHCl monohydrate

Signs & symptoms of idiopathic Parkinson's disease in adults as monotherapy or in combination w/ levodopa (ie, over course of disease) through to late stages when effect of levodopa wears off or becomes inconsistent & fluctuations of the therapeutic effect occur (end of dose or "on-off" fluctuations). Symptomatic treatment of moderate to severe idiopathic restless legs syndrome in adults in doses up to 0.54 mg of base (0.75 mg of salt).

Parkinson's disease Ascending dose schedule: Wk 1: 0.125 mg tid. Wk 2: 0.25 mg tid. Wk 3: 0.5 mg tid. If necessary, increase daily dose by 0.75 mg at wkly intervals up to max: 4.5 mg daily. Maintenance: 0.375-4.5 mg daily. 1.5 mg daily can be useful in patient where reduction of levodopa therapy is intended. Discontinuation: Taper off at rate of 0.75 mg daily until daily dose has been reduced to 0.75 mg. Thereafter, reduce dose by 0.375 mg daily. Renal impairment CrCl 20-50 mL/min Initially 0.125 mg bid. Max: 2.25 mg daily, <20 mL/min Initially 0.125 mg daily as single dose. Max: 1.5 mg daily. If renal function declines during maintenance, reduce daily dose by same % as decline in CrCl (ie, if CrCl declines by 30%, reduce daily dose by 30%). Restless legs syndrome Initially 0.125 mg once daily 2-3 hr before bedtime. May be increased every 4-7 days to 0.25 mg once daily (2nd titration step), then 0.5 mg once daily (3rd titration step), then max: 0.75 mg once daily (4th titration step) if needed.

May be taken with or without food.

Hypersensitivity.

Dopamine agonist w/drawal syndrome. Regularly monitor patients for development of impulse control disorders; mania & delirium. Ophth monitoring is recommended at regular intervals or if vision abnormalities occur. Monitor BP especially at the beginning of treatment. Symptoms suggestive of neuroleptic malignant syndrome w/ abrupt w/drawal of therapy. Hallucinations & dyskinesia (in advanced Parkinson's disease) in combination w/ levodopa. Avoid co-administration w/ antipsychotic medicinal products. Concomitant use w/ other sedating medicinal products or alcohol. Major influence on ability to drive & use machines. Not to be used during pregnancy & lactation. Not to be used in childn or adolescents w/ Tourette disorder. Parkinson's disease: Axial dystonia including antecollis, camptocormia & pleurothotonus (Pisa syndrome); somnolence & episodes of sudden sleep onset. No relevant use in childn <18 yr. Restless legs syndrome: Augmentation. Not recommended in childn & adolescents <18 yr.

Nausea. Insomnia, abnormal dreams; headache; constipation, vomiting; fatigue. Parkinson's disease: Somnolence, dizziness, dyskinesia. Hallucinations, confusion, behavioural symptoms of impulse control disorders & compulsions; visual impairment including diplopia, blurred vision, reduced visual acuity; hypotension; peripheral oedema; wt decrease including decreased appetite. Restless legs syndrome: Dizziness, somnolence.

Clearance may be reduced w/ medicinal products that are inhibitors of the cationic secretory transport system of the renal tubules or are eliminated by this pathway eg, cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine & procainamide. Reduce dose of concomitant levodopa & keep dose of other anti-parkinsonian medicinal products constant while increasing dose of pramipexole. Possible additive effects w/ other sedating medicinal products or alcohol. Avoid co-administration w/ antipsychotic medicinal products if antagonistic effects can be expected.

Antiparkinsonian Drugs

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

Rx