Pramipexole is indicated for:
- The treatment of Parkinson's diseases, used alone or as an adjunct to levodopa with dopa decarboxylase inhibitor
- Moderate to severe restless legs syndrome
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 with advanced disease. It is also used as monotherapy for the initial symptomatic management of parkinsonian syndrome.
Dosage & Administration
The recommended dose of Pramipexole is as following-
- Initial dose: 88 micrograms 3 times daily, dose doubled every 5-7 days if tolerated to 350 micrograms 3 times daily; further increased if necessary by 180 micrograms 3 times daily at weekly intervals
- Maximum dose: 3.3 mg daily in 3 divided doses. During pramipexole dose titration and maintenance Levodopa dose should be reduced.
Restless legs syndrome:
- Initial dose: 88 micrograms once daily 2-3 hours before bedtime, dose doubled every 4-7 days if necessary to 350 micrograms daily.
- Maximum dose: 540 micrograms daily
Pramipexole is the only dopamine agonist not appreciably metabolized by the P450 system which minimizes about possible drug-drug interactions. Cimetidine and amantadine may reduce the renal clearance of pramipexole. Sedating medicinal products or alcohol in combination with pramipexole may cause additive effects.
Pramipexole is contraindicated in patients with known Hypersensitivity to the active substance or to any of the excipients.
The common side effects are dizziness, dyskinesia, nausea, hypotension, abnormal dreams, confusion, constipation, delusion, hallucinations, headache, hyperkinesia, increased eating (binge eating, hyperphagia), insomnia, libido disorders, nausea, peripheral oedema, paranoia, pathological gambling, hypersexuality and other abnormal behaviour, somnolence, weight increase, sudden onset of sleep, pruritus and rash and other hypersensitivity.
Pregnancy & Lactation
The effect of pramipexole on pregnancy and lactation has not been investigated in humans so it should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Pramipexole inhibits secretion of prolactin in humans. The excretion of pramipexole into breast milk has not been studied in women so it should not be used during breast-feeding. However, if its use is unavoidable then breast-feeding should be discontinued.
Precautions & Warnings
Caution should be taken in patients with psychotic disorder, ophthalmologic monitoring is recommended at regular intervals, severe cardiovascular disease and renal impairment.
Use in Special Populations
Restless leg syndrome:
- CrCl 20-60: Increase titration interval to 14 days.
- CrCl <20: 125 mcg once daily. Max: 1.5 mg/day.
- CrCl 20-50: 125 mcg bid. Max: 2.25 mg/day.
Hepatic Impairment: No dosage adjustment needed.
Use in children: Pramipexole is not recommended for children below 18 years of age
There is no clinical experience with massive overdose. Symptoms of overdose are nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension. There is no established antidote. If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated. Management of the overdose may require general supportive measures, along with gastric lavage, intravenous fluids, administration of activated charcoal and electrocardiogram monitoring.
Store in a cool and dry place. Protect from light.
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