Mirapex ER

Monotherapy or in combination w/ levodopa for the treatment of signs & symptoms of idiopathic Parkinson's disease in adults.

Initially 0.375 mg/day, then increase every 5-7 days. If further dose increase is necessary, increase by 0.75 mg at wkly intervals up to max dose of 4.5 mg/day. Patient w/ CrCl 30-50 mL/min Initially 0.375 mg every other day. If further dose increase is necessary, increase by 0.375 mg at wkly intervals up to max dose of 2.25 mg/day.

May be taken with or without food: Swallow whole w/ water. Do not chew/divide/crush.

Hypersensitivity.

Risk of hallucinations; dyskinesia; somnolence & episodes of sudden sleep onset; impulse control disorders (eg, pathological gambling, increased libido, hypersexuality, compulsive spending, buying or eating, & binge eating); mania & delirium. Reports of axial dystonia including antecollis, camptocormia & pleurothotonus (Pisa syndrome). Patients w/ psychotic disorders should only be treated w/ dopamine agonists if potential benefits outweigh risks. Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur. Monitor BP, especially at the beginning of treatment, in patients w/ severe CV disease due to the risk of postural hypotension. Abrupt discontinuation can lead to development of NMS or dopamine agonist w/drawal syndrome. Reassess patient's response to therapy if remnants, which may resemble intact tab, are observed in the stool. Major influence on the ability to drive & use machines. Not recommended in patients w/ CrCl <30 mL/min. Potential influence of hepatic insufficiency on pharmacokinetics has not been investigated. Do not use during pregnancy unless clearly necessary. Discontinue breast-feeding during use. No relevant use in the paed population for the indication of Parkinson's disease.

Somnolence, dizziness, dyskinesia; nausea. Insomnia, hallucinations, abnormal dreams, confusion, behavioral 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 renal clearance w/ medicinal products that are inhibitors of active renal elimination pathway or are eliminated by this pathway eg, cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, & procainamide. Possible additive effects w/ other sedating medicinal products or alcohol. Avoid co-administration w/ antipsychotic medicinal products eg, if antagonistic effects can be expected. When co-administered w/ levodopa, reduce dose of levodopa & keep dose of other anti-parkinsonian medicinal products constant while increasing dose of Mirapex ER.

Antiparkinsonian Drugs

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

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