MIRAPEX ER Rx
Generic Name and Formulations:
Pramipexole dihydrochloride extended-release 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3mg, 3.75mg, 4.5mg; tabs.
Boehringer Ingelheim Pharmaceuticals
Indications for MIRAPEX ER:
Idiopathic Parkinson's disease.
Swallow whole. May take with food. Initially 0.375mg once daily; may increase gradually at intervals of 5–7 days, first to 0.75mg/day, then by 0.75mg increments up to max 4.5mg/day. Reevaluate response at intervals of ≥5 days after each dose increment. Switching overnight from immediate-release pramipexole: give same daily dose; monitor and adjust dose as needed. Renal impairment: CrCl 30–50mL/min: initially give every other day; reevaluate before increasing to daily dosing after 1 week and before titrating by 0.375mg increments up to 2.25mg/day. CrCl <30mL/min, hemodialysis: not recommended.
See full labeling. Consider discontinuing if excessive daytime sleepiness or if sudden onset of sleep during daily activities occurs. Monitor for drowsiness or sleepiness, orthostatic hypotension, or compulsive behaviors. Renal disease. Sleep disorders. Dyskinesia. Postural deformity; consider dose reduction or discontinuation if occurs. Avoid abrupt cessation (withdraw over 1 week). Elderly may have higher risk of hallucinations. Pregnancy. Nursing mothers: not recommended.
Dopamine agonist (non-ergot).
Consider reducing concomitant levodopa dose. Pramipexole levels increased by cimetidine, possibly other renally-excreted basic drugs (eg, ranitidine, diltiazem, triamterene, verapamil, quinidine, quinine). Caution with alcohol, other CNS depressants. May be antagonized by dopamine antagonists (eg, neuroleptics, metoclopramide).
Early disease: somnolence (including sudden sleep onset), nausea, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, peripheral edema, insomnia, asthenia, accidental injury, dyspepsia, others. Late disease: dyskinesia, nausea, constipation, hallucinations, headache, anorexia, postural hypotension, extrapyramidal syndrome, insomnia, dizziness, accidental injury, dream abnormalities, confusion, asthenia, somnolence (including sudden sleep onset), dystonia, abnormal gait, hypertonia, dry mouth, amnesia, urinary frequency, leg cramps, others; rhabdomyolysis.
Tabs 0.125mg, 0.25mg, 0.5mg, 1mg, 1.5mg (YES); 0.75mg (NO); ER tabs 0.375mg, 0.75mg, 1.5mg, 3mg, 4.5mg (YES); 2.25mg, 3.75mg (NO)
Tabs—90; ER tabs 0.375mg, 0.75mg, 1.5mg—7, 30; 2.25mg, 3mg, 3.75mg, 4.5mg—30