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Pramipexole Generic Name & Formulations
Legal Class
Rx
General Description
Pramipexole dihydrochloride 0.125mg, 0.25mg+, 0.5mg+, 0.75mg, 1mg+, 1.5mg+; tabs; +scored.
Pharmacological Class
Dopamine agonist (non-ergot).
See Also
How Supplied
Tabs—contact supplier; ER tabs 0.375mg, 0.75mg, 1.5mg—7, 30; 2.25mg, 3mg, 3.75mg, 4.5mg—30
Manufacturer
Pramipexole Indications
Indications
Idiopathic Parkinson's disease.
Pramipexole Dosage and Administration
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.
Pramipexole Contraindications
Not Applicable
Pramipexole Boxed Warnings
Not Applicable
Pramipexole Warnings/Precautions
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. Potential withdrawal symptoms; monitor during and after discontinuation. Avoid abrupt cessation (withdraw over 1 week). Renal impairment. Elderly may have higher risk of hallucinations. Pregnancy. Nursing mothers: not recommended.
Pramipexole Pharmacokinetics
Elimination
Renal.
Pramipexole Interactions
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).
Pramipexole Adverse Reactions
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, dystonia, abnormal gait, hypertonia, dry mouth, amnesia, urinary frequency, leg cramps, others; rhabdomyolysis.
Pramipexole Clinical Trials
See Literature
Pramipexole Note
Notes
Formerly known under the brand name Mirapex.
Pramipexole Patient Counseling
See Literature
Pramipexole Generic Name & Formulations
Legal Class
Rx
General Description
Pramipexole dihydrochloride 0.125mg, 0.25mg+, 0.5mg+, 0.75mg, 1mg+, 1.5mg+; tabs; +scored.
Pharmacological Class
Dopamine agonist (non-ergot).
See Also
How Supplied
Tabs—contact supplier; ER tabs 0.375mg, 0.75mg, 1.5mg—7, 30; 2.25mg, 3mg, 3.75mg, 4.5mg—30
Manufacturer
Pramipexole Indications
Indications
Moderate to severe primary restless legs syndrome.
Pramipexole Dosage and Administration
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.
Pramipexole Contraindications
Not Applicable
Pramipexole Boxed Warnings
Not Applicable
Pramipexole Warnings/Precautions
Warnings/Precautions
See full labeling. Consider discontinuing if excessive daytime sleepiness or falling asleep during daily activities occurs. Monitor for drowsiness or sleepiness, orthostatic hypotension, or compulsive behaviors. Consider dose reduction or discontinuation if compulsive behaviors develop. Sleep disorder. Psychotic disorder. 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). Renal impairment. Elderly may have higher risk of hallucinations. Pregnancy. Nursing mothers: not recommended.
Pramipexole Pharmacokinetics
Elimination
Renal.
Pramipexole Interactions
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).
Pramipexole Adverse Reactions
Adverse Reactions
GI upset, somnolence, fatigue, headache, pain, dizziness, influenza, nasal congestion, abnormal dreams; rhabdomyolysis.
Pramipexole Clinical Trials
See Literature
Pramipexole Note
Notes
Formerly known under the brand name Mirapex.
Pramipexole Patient Counseling
See Literature
