ELDEPRYL selegiline hydrochloride capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

SELEGILINE HYDROCHLORIDE (UNII: 6W731X367Q) (SELEGILINE - UNII:2K1V7GP655)

제공처:

Mylan Specialty L.P.

INN (국제 이름):

SELEGILINE HYDROCHLORIDE

구성:

SELEGILINE HYDROCHLORIDE 5 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

New Drug Application

제품 특성 요약

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