SELEGILINE HYDROCHLORIDE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Selegiline Hydrochloride (UNII: 6W731X367Q) (Selegiline - UNII:2K1V7GP655)

Disponibil de la:

Apotex Corp.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Selegiline Hydrochloride Tablets USP are 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 state). Selegiline hydrochloride is contraindicated in patients with a known hypersensitivity to this drug. Selegiline is contraindicated for use with meperidine. This contraindication is often extended to other opioids. (See Drug Interactions .)

Rezumat produs:

Selegiline Hydrochloride Tablets USP 5 mg are available for oral administration as white or slightly mottled, round, unscored tablets imprinted with  on one side and “3438” on the other side. They are supplied as bottles of 60 (NDC 60505-3438-3) and bottles of 500 (NDC 60505-3438-8). Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP] with a child-resistant closure as required. APOTEX INC. SELEGILINE HYDROCHLORIDE TABLETS USP 5 mg Manufactured by:           Manufactured for: Apotex Inc.                   Apotex Corp. Toronto, Ontario           Weston, Florida Canada M9L 1T9          33326 Revised: June 2009 Rev. 1

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

SELEGILINE HYDROCHLORIDE- SELEGILINE HYDROCHLORIDE TABLET
APOTEX CORP.
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SELEGILINE HYDROCHLORIDE TABLETS USP 5 MG
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-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 molecular formula
is C
H
•HCl.
The structural formula is as follows:
Each tablet, for oral administration, contains 5 mg selegiline
hydrochloride. Inactive
ingredients are citric acid, anhydrous 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 is predomina