Monograph Details
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Central Nervous System
> Restless legs syndrome
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MIRAPEX |
| Manufacturer |
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Boehringer Ingelheim Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Dopamine agonist (non-ergot). |
| Generic Name |
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Pramipexole dihydrochloride 0.125mg, 0.25mg+, 0.5mg+, 0.75mg, 1mg+, 1.5mg+; tabs; +scored. |
| Indications |
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Moderate-to-severe primary restless legs syndrome. |
| Children |
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Not recommended. |
| Adults |
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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. |
| Precautions |
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See literature. Consider discontinuing if excessive daytime sleepiness or if sudden onset of sleep during daily activities occurs. Monitor for drowsiness or sleepiness, and for orthostatic hypotension. Renal disease. Sleep disorders. Dyskinesia. 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 (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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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 |
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GI upset, somnolence, pain, dizziness, influenza, nasal congestion, abnormal dreams. |
| How Supplied |
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Tabs—90 |
| Additional Resources |
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• Related Prescribing Note |
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