SELEGILINE HYDROCHLORIDE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Carilion Materials Management

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Selegiline is indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. Selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of ‘off’ time, and patient self-rating of treatment success. Beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous

Produktbesonderheiten:

Product: 68151-2649 NDC: 68151-2649-0 1 CAPSULE in a PACKAGE

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

SELEGILINE HYDROCHLORIDE- SELEGILINE HYDROCHLORIDE CAPSULE
CARILION MATERIALS MANAGEMENT
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SELEGILINE HYDROCHLORIDE
CAPSULES
RX ONLY
DESCRIPTION:
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-propyny-phenethylamine
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 white opaque capsule is band printed with S 700. Each capsule
contains 5 mg selegiline
hydrochloride. Inactive ingredients are citric acid, lactose,
magnesium stearate and microcrystalline
cellulose. The capsule shells contain gelatin and titanium dioxide and
are imprinted with red ink. The ink
contains pharmaceutical glaze and synthetic red iron oxide.
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 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