Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Orion Corporation, Orionintie 1, FIN-02200, Espoo, Finland
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.
10 mg daily either alone or as an adjunct to levodopa or levodopa/peripheral decarboxylase inhibitor. 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.
Bottle: 36 months.
Blister: 36 months.
HDPE bottle: Do not store above 25°C. Keep the container tightly closed.
Blister Pack: Do not store above 25°C. Store in the original package.
a) White HDPE bottle with LDPE snap cap: 100 tablets.
b) AI/AI blister packs: 30, 50, 60 and 100 tablets.
c) White HDPE bottle with HDPE screw cap: 100 tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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