Country: Afrika Selatan
Bahasa: Inggeris
Sumber: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
PARKILYNE (Tablets) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): PARKILYNE (Tablets) COMPOSITION: Each tablet contains 5 mg selegiline hydrochloride: ((R)-(-)-N, alpha-dimethyl-N-2-propynyl-phenethylamine hydrochloride). PHARMACOLOGICAL CLASSIFICATION: A 5.4.1. Anti-Parkinsonism preparations. PHARMACOLOGICAL ACTION: Selegiline is a selective MAO-B (monoamine oxidase type B) inhibitor which prevents the breakdown of dopamine in the brain. It also inhibits the re-uptake of dopamine at pre-synaptic dopamine receptors. These effects potentiate dopaminergic function in the brain. Thus selegiline acts in Parkinsonism by potentiating and prolonging the effect of levodopa. Pharmacokinetics: Selegiline is rapidly absorbed from the gastro-intestinal tract. It crosses the blood-brain barrier. It is rapidly and completely metabolized to N-desmethyldeprenyl, L-methamphetamine and L-amphetamine. The mean half-lives of the 3 active metabolites that were found in serum and urine following a single dose of selegiline are as follows: N-desmethyldeprenyl 2 hours L-methamphetamine 17.7 hours L-amphetamine 20.5 hours Selegiline is 94% bound to plasma proteins at therapeutic concentrations. INDICATIONS: PARKILYNE is indicated in the management of early morning akinesia and nocturnal akinesia in patients with Parkinson’s disease being treated with levodopa alone or levodopa and a peripheral decarboxylase inhibitor. At the end- stage of Parkinson’s disease, response may be markedly reduced. CONTRA-INDICATIONS: PARKILYNE is contra-indicated in patients with a known hypersensitivity to any of the ingredients. PARKILYNE should be avoided in patients with active ulceration. PARKILYNE is contra-indicated in patients receiving serotonin receptor agonists such as sumatriptan Baca dokumen lengkap