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Adults: APO-PRAMIPEXOLE (pramipexole dihydrochloride monohydrate) is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease. APO-PRAMIPEXOLE may be used both as early therapy, without concomitant levodopa, and as an adjunct to levodopa.
Geriatrics (>65 years of age): The majority of pramipexole (88%) is cleared via renal secretion. Due to age-related reduction in renal function, the elderly have a slower clearance of pramipexole (approximately 25-30% lower). The efficacy and safety appear to be unaffected, except the relative risk of hallucination is higher. (See Use in the Elderly under Precautions.)
Pediatrics: The safety and efficacy of pramipexole dihydrochloride has not been established in children less than 18 years of age, therefore APO-PRAMIPEXOLE is not recommended in this patient population.
