MIRAPEX Rx

Indications for MIRAPEX:

Idiopathic Parkinson's disease.

Adult:

May take with food. Gradually increase from initial dose at intervals of 5–7 days. Initially 0.125mg three times daily; max 1.5mg three times daily. Renal impairment: CrCl 30–50mL/min: initially 0.125mg twice daily; max 0.75mg three times daily. CrCl 15–<30mL/min: initially 0.125mg once daily; max 1.5mg once daily. CrCl <15mL/min, hemodialysis: not recommended.

Children:

Not established.

Warnings/Precautions:

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.

See Also:

MIRAPEX ER

Pharmacological Class:

Dopamine agonist (non-ergot).

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).

Adverse Reactions:

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.

Elimination:

Renal.

Generic 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)

How Supplied:

Tabs—90; ER tabs 0.375mg, 0.75mg, 1.5mg—7, 30; 2.25mg, 3mg, 3.75mg, 4.5mg—30

Indications for MIRAPEX:

Moderate-to-severe primary restless legs syndrome.

Adult:

Initially 0.125mg once daily 2–3 hrs before bedtime. If needed, may double dose every 4–7 days. Max 0.5mg/day (doses of 0.75mg/day have been used). Renal impairment: CrCl: 20–60min/mL: increase titration interval to every 14 days if needed.

Children:

Not established.

Warnings/Precautions:

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). Symptoms may shift to early morning hours (rebound) or have an earlier onset (afternoon or evening). Elderly may have higher risk of hallucinations. Pregnancy. Nursing mothers: not recommended.

Pharmacological Class:

Dopamine agonist (non-ergot).

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).

Adverse Reactions:

GI upset, somnolence, fatigue, headache, pain, dizziness, influenza, nasal congestion, abnormal dreams; rhabdomyolysis.

Elimination:

Renal.

Generic 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)

How Supplied:

Tabs—90; ER tabs 0.375mg, 0.75mg, 1.5mg—7, 30; 2.25mg, 3mg, 3.75mg, 4.5mg—30