SELEGILINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

SELEGILINE HYDROCHLORIDE

Composition:

SELEGILINE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Selegiline hydrochloride capsules, 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 walki

Product summary:

Selegiline Hydrochloride Capsules, USP are available containing 5 mg of selegiline hydrochloride. Each opaque white capsule is printed with S 700. They are available as: NDC 60429-019-60 bottles of 60 capsules. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] All brand names listed are registered trademarks of their respective owners and are not trademarks of Par Pharmaceutical. Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528 USA Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 Revised: 03/17 Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012 300 172 990 140

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SELEGILINE HYDROCHLORIDE- SELEGILINE HYDROCHLORIDE CAPSULE
GOLDEN STATE MEDICAL SUPPLY, INC.
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SELEGILINE HYDROCHLORIDE CAPSULES, USP
RX ONLY
DESCRIPTION:
Selegiline hydrochloride, USP 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 white opaque capsule is band printed with S 700. Each capsule
contains 5 mg selegiline
hydrochloride, USP. 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 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, intes