Pramipexole


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Parkinson's disease As adjunct to levodopa therapy: As HCl: Initial: 125 mcg tid on the 1st wk, increase to 250 mcg tid on the 2nd wk and 500 mcg tid on the 3rd wk according to response. Dose may further increase if needed. Max: 4.5 mg/day. Restless leg syndrome As HCl: 125 mcg/day, increase if needed. Max: 750 mcg/day.
Dosage Details
Oral
Parkinson's disease
Adult: As an adjunct to levodopa therapy: As HCl: Initially, 125 mcg tid on the 1st wk, increased to 250 mcg tid on the 2nd wk and 500 mcg tid on the 3rd wk according to response. Daily dose may be increased by 750 mcg at wkly intervals. Max: 4.5 mg/day.
Elderly: No dosage adjustment needed.

Oral
Restless leg syndrome
Adult: As HCl: 125 mcg once daily 2-3 hr before bedtime. May increase, if necessary by 250 mcg every 4-7 days. Max: 750 mcg/day.
Elderly: No dosage adjustment needed.
Renal Impairment
Oral:
Restless leg syndrome:
CrCl Dosage
20-60 Increase titration interval to 14 days.
Parkinson's disease:
CrCl Dosage
<20 125 mcg once daily. Max: 1.5 mg/day.
20-50 125 mcg bid. Max: 2.25 mg/day.
Hepatic Impairment
No dosage adjustment needed.
Administration
May be taken with or without food. May be taken w/ meals to minimise GI side effects such as nausea.
Special Precautions
Psychotic disorder, severe CV disease, augmentation (earlier onset, increase and spread of symptoms). Risk of neuroleptic malignant syndrome w/ abrupt withdrawal. Taper dose at 750 mcg/day for a wk, then reduce by 375 mcg/day thereafter. Renal impairment. Pregnancy and lactation.
Adverse Reactions
Dyskinesia, sudden onset of sleep and somnolence, hallucinations, abnormal dreams, insomnia, confusion, headache, nausea, dizziness, vomiting, fatigue, constipation, peripheral oedema, visual impairment, decreased appetite.
Patient Counseling Information
Patients should be informed to refrain from activities involving mental alertness and physical coordination after drug intake.
MonitoringParameters
Monitor BP, signs and symptoms of fibrosis and orthostatic hypotension, development of impulse control disorder, behavioural changes. Perform periodic skin examinations. Regular ophthalmological testing due to risk of visual disorders.
Overdosage
Symptoms: Nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension. Management: Symptomatic and supportive treatment accompanied w/ gastric lavage, IV fluids, activated charcoal admin and ECG monitoring.
Drug Interactions
Antagonism of effects occur w/ concomitant use w/ antipsychotics or methyldopa. Increased plasma concentration w/ cimetidine. Additive sedative effect w/ CNS depressants. May increase orthostatic hypotensive effect w/ MAOI.
Food Interaction
Avoid concomitant use w/ valerian, St John's wort. May increase sedative effect w/ alcohol.
Action
Description: Pramipexole is a nonergot-derivative dopamine receptor agonist which alleviates Parkinsonian motor deficits by directly stimulating postsynaptic dopamine activity on the striatum and substantia nigra It is used as an adjunct to levodopa for the symptomatic management of parkinsonian syndrome in patients w/ advanced disease. It is also used as monotherapy for the initial symptomatic management of parkinsonian syndrome.
Pharmacokinetics:
Absorption: Readily absorbed. Oral bioavailability: Approx 90%. Time to peak plasma concentration: Fasted state: 2 hr; w/ food: 3 hr.
Distribution: Volume of distribution: Approx 500 L. Plasma protein binding: <20%.
Metabolism: Minimal metabolism.
Excretion: Via renal tubular secretion into the urine >90% (unchanged). Elimination half-life: 8-12 hr.
Storage
Do not store above 25°C. Protect from light and moisture.
Disclaimer: This information is independently developed by MIMS based on Pramipexole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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