Only for the use of Medical Professionals
Parixol®
Pramipexole
Description
Parixol® is a preparation pramipexole. Pramipexole is a non-ergot dopamine agonist. It has
high affinity for dopamine D2-like receptors with highest affinity at dopamine D3 and D2
receptors. Pramipexole s affinity to D3 receptors might be responsible for its antidepressant
activity.
Indication and usage
Parixol® is indicated for the treatment of
Parkinson s disease, used alone or as an adjunct to levodopa with dopa-decarboxylase
inhibitor
Moderate to severe restless legs syndrome
Dose and administration
The recommended dose of Parixol® is as following.
Parkinson s disease: Initially 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: Initially 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
Use in children
Pramipexole is not recommended for children below 18 years of age.
Use in pregnancy and 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
Caution should be taken in patients with psychotic disorder, ophthalmologic monitoring is
recommended at regular intervals, severe cardiovascular disease and renal impairment.
Side effects
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.
Drug interactions
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.
Contraindications
Pramipexole is contraindicated in patients with known Hypersensitivity to the active
substance or to any of the excipients.
Overdose
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.
Pharmaceutical precautions
Store in a cool and dry place. Protect from light.
Presentation
Parixol® 88 tablet : Each tablet contains Pramipexole 88mcg as hydrochloride.
Parixol® 180 tablet : Each tablet contains Pramipexole 180mcg as hydrochloride.
Packaging quantities
Parixol® 88 tablet : Each box contains 3 blister strips of 10 tablets.
Parixol® 180 tablet : Each box contains 3 blister strips of 10 tablets.
® Registered Trade Mark
ACI Limited
Narayanganj,
Bangladesh
Brand: ACI Limited
