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.
MIRAPEX ER Warnings/Precautions:
See full labeling. Consider discontinuing if excessive daytime sleepiness or falling asleep during activities occurs. Monitor for drowsiness or sleepiness, orthostatic hypotension, or compulsive behaviors. Consider dose reduction or discontinuation if urges/compulsive behaviors develop. Sleep disorder. Psychotic disorder. Dyskinesia. Postural deformity; consider dose reduction or discontinuation if occurs. Avoid abrupt cessation (withdraw over 1 week). Renal impairment. Elderly may have higher risk of hallucinations. Pregnancy. Nursing mothers: not recommended.
MIRAPEX ER Classification:
Dopamine agonist (non-ergot).
MIRAPEX ER Interactions:
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, dystonia, abnormal gait, hypertonia, dry mouth, amnesia, urinary frequency, leg cramps, others; rhabdomyolysis.
Generic Drug Availability:
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