Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
SELEGILINE HYDROCHLORIDE (UNII: 6W731X367Q) (SELEGILINE - UNII:2K1V7GP655)
Mylan Specialty L.P.
SELEGILINE HYDROCHLORIDE
SELEGILINE HYDROCHLORIDE 5 mg
PRESCRIPTION DRUG
New Drug Application
ELDEPRYL- SELEGILINE HYDROCHLORIDE CAPSULE MYLAN SPECIALTY L.P. ---------- DESCRIPTION ELDEPRYL (selegiline hydrochloride) is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl. The chemical name is: (R)-(-)-_N_,2-dimethyl-_N_-2-propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.75. The structural formula is as follows: Each aqua blue capsule is band imprinted with the Somerset logo on the cap and "Eldepryl 5 mg" on the body. Each capsule contains 5 mg selegiline hydrochloride, USP. Inactive ingredients are anhydrous citric acid, lactose, magnesium stearate, and microcrystalline cellulose. CLINICAL PHARMACOLOGY The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of Parkinson's disease are not fully understood. Inhibition of monoamine oxidase, type B, activity is generally considered to be of primary importance; in addition, there is evidence that selegiline may act through other mechanisms to increase dopaminergic activity. Selegiline is best known as an irreversible inhibitor of monoamine oxidase (MAO), an intracellular enzyme associated with the outer membrane of mitochondria. Selegiline inhibits MAO by acting as a 'suicide' substrate for the enzyme; that is, it is converted by MAO to an active moiety which combines irreversibly with the active site and/or the enzyme's essential FAD cofactor. Because selegiline has greater affinity for type B rather than for type A active sites, it can serve as a selective inhibitor of MAO type B if it is administered at the recommended dose. MAOs are widely distributed throughout the body; their concentration is especially high in liver, kidney, stomach, intestinal wall, and brain. MAOs are currently subclassified into two types, A and B, which differ in their substrate specificity and tissue distribution. In humans, intestinal MAO Olvassa el a teljes dokumentumot