Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Selegiline is indicated for the treatment of Parkinson’s disease or symptomatic parkinsonism.
It may be used alone in early Parkinson’s disease for symptomatic relief to delay the need for levodopa (with or without decarboxylase inhibitor) or as an adjunct to levodopa (with or without decarboxylase inhibitor). Selegiline in combination with maximal levodopa therapy is indicated particularly in patients who experience fluctuations in their condition such as ‘end-dose’ type fluctuations, ‘on-off’ symptoms or other dyskinesias.
10mg daily, either alone or as an adjunct to levodopa/peripheral decarboxylase therapy.
When selegiline is added to a levodopa regimen it is possible to reduce the levodopa dosage by an average of 10-30%. Reduction of the levodopa dose should be gradual in steps of 10% every 3 to 4 days.
No dosage adjustment is required for patients with renal or hepatic impairment.
Selegiline may be administered either as a single dose in the morning or in two divided doses of 5 mg, taken at breakfast and lunch.
Selegiline is rapidly metabolised and the metabolites rapidly excreted. In cases of suspected overdosage the patient should be kept under observation for 24 to 48 hours.
No overdosage cases are known. Since the selective inhibition of MAO-B by selegiline is achieved only at doses recommended for the treatment of Parkinson’s disease (5 to 10 mg/day). However, experience gained during selegiline’s development reveals that some individuals exposed to doses of 600 mg/day selegiline suffered severe hypotension and psychomotor agitation.
Theoretically, overdosage causes significant inhibition of both MAO-A and MAO-B and thus, symptoms of overdosage may resemble those observed with non-selective MAO-inhibitors which can progress over 24 hours to include, different central nervous and cardiovascular system disorders. These include agitation, irritability, hyperactivity, drowsiness, tremor, severe headache, hallucination, alternating low and high blood pressure dizziness, faintness, vascular collapse, rapid and irregular pulse, precordial pain, respiratory depression and failure, severe muscle spasms, hyperpyrexia, diaphoresis coma and convulsions.
There is no specific antidote and the treatment is symptomatic.
3 years.
Store below 25°C, in the original package, in order to protect from light and moisture.
Selegos tablets are packed in the following: PVC/PCTFE film-aluminium foil blisters of ten tablets, in packs of 10, 50, 100, 500 and 1000 tablets.
Dispensing packs of either screw cap or securitainer type made of polyvinylchloride (PVC) containing 100, 500 or 1000 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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