Apo-Pramipexole

Apo-Pramipexole

pramipexole

Manufacturer:

Apotex

Distributor:

Hind Wing
Concise Prescribing Info
Contents
Pramipexole diHCl monohydrate
Indications/Uses
Treatment of signs & symptoms of idiopathic Parkinson's disease as early therapy, w/o concomitant levodopa, or as an adjunct to levodopa.
Dosage/Direction for Use
Initially 0.375 mg daily in 3 divided doses, increase gradually every 5-7 days. Maintenance: 1.5-4.5 mg daily in 3 equally divided doses. Patient w/ mild renal impairment (CrCl >60 mL/min) Initially 0.125 mg tds. Max: 1.5 mg tds; moderate renal impairment (CrCl 35-59 mL/min) Initially 0.125 mg bd. Max: 1.5 mg bd; severe renal impairment (CrCl 15-34 mL/min) Initially 0.125 mg once daily. Max: 1.5 mg once daily.
Administration
May be taken with or without food: May be taken w/ meals to minimise GI side effects such as nausea.
Special Precautions
Reports of sudden onset of sleep (w/ or w/o warning signs); orthostatic hypotension; neuroleptic malignant syndrome; behavioural changes, hallucinations, confusion. Caution in patients w/ severe CV disease. Perform ophthalmological monitoring for retinal pathologic changes in people who suffer from albinismus oculi. Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis, & cardiac valvulopathy in some patients treated w/ ergot-derived dopaminergic agents. May potentiate dopaminergic side effects of levodopa & cause or exacerbate pre-existing dyskinesia. Frequently monitor patients for melanomas during treatment. Discontinue treatment over a period of 1 wk. May impair ability to drive or use machines. Patient w/ renal impairment. Pregnancy. Do not administer to women who wish to breast-feed infants. Not recommended in ped patients. Elderly >65 yr.
Adverse Reactions
Early Parkinson's disease: Nausea, dizziness, somnolence, insomnia, asthenia, constipation. Advanced Parkinson's disease: Orthostatic hypotension, dyskinesia, insomnia, dizziness, hallucinations, accidental injury, dream abnormalities, constipation, confusion.
Drug Interactions
Increased Cmax of levodopa. Reduced renal clearance w/ drugs eliminated via the renal cationic transport system (eg, amantadine, cimetidine, ranitidine, diltiazem, triamterene, verapamil, quinidine, quinine). Reduced therapeutic effects w/ dopamine antagonists eg, neuroleptics (eg, phenothiazines, butyrophenones, thioxanthines); metoclopramide. Possible additive effects w/ sedating medications 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.
Presentation/Packing
Form
Apo-Pramipexole tab 0.25 mg
Packing/Price
100's
Form
Apo-Pramipexole tab 1 mg
Packing/Price
100's
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