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Indications:

MIRAPEX ER and Mirapex® (pramipexole dihydrochloride) tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease (PD).

Important Safety Information:

MIRAPEX ER and MIRAPEX may cause patients to fall asleep without warning signs during activities of daily living, including driving, which sometimes resulted in accidents. Some events may occur well after the start of treatment. Advise patients that, until they know how MIRAPEX ER or MIRAPEX affects them, or if they experience increased somnolence or episodes of falling asleep, they should not engage in potentially dangerous activities.

There have been reports of patients experiencing intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone and that are generally used for the treatment of PD, including MIRAPEX ER and MIRAPEX. Consider dose reduction or stopping MIRAPEX ER or MIRAPEX if a patient develops such urges.

As patients may not recognize or acknowledge increased drowsiness, sleepiness, or behavioral changes, prescribers should continually reassess patients.

Symptomatic orthostatic hypotension may occur, especially during initial treatment or dose escalation. Hallucinations may occur at any time during treatment.
MIRAPEX ER and MIRAPEX may potentiate the dopaminergic side effects of levodopa and may cause and/or exacerbate dyskinesia.

In a clinical trial for early PD, the most commonly reported adverse events with MIRAPEX ER that were more frequent than with placebo are somnolence, nausea, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and peripheral edema. In a clinical trial for advanced PD, the most commonly reported adverse events with MIRAPEX ER that were more frequent than with placebo are dyskinesia, nausea, constipation, hallucinations, headache, and anorexia.

In clinical trials for early PD, the most commonly reported side effects of MIRAPEX that were more frequent than with placebo are nausea, dizziness, somnolence, insomnia, asthenia, and constipation. In clinical trials for advanced PD, the most commonly reported side effects of MIRAPEX that were more frequent than with placebo are postural hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, accidental injury, hallucinations, and dream abnormalities.

MIRAPEX ER is not recommended for patients with severe renal impairment (creatinine clearance [CrCl] <30 mL/min) or patients on hemodialysis. For patients with moderate renal impairment (CrCl between 30 and 50 mL/min), refer to full prescribing information for special dosing instructions. Patients with mild renal impairment (creatinine clearance [CrCl] >50 mL/min) require no reduction in daily dose.

MIRAPEX ER tablets are taken orally once daily and must not be chewed, crushed, or divided, and should be discontinued gradually over a period of one week.

Please see full Prescribing Information for MIRAPEX ER and MIRAPEX.