SELEGILINE HYDROCHLORIDE- selegiline hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

SELEGILINE HYDROCHLORIDE

Composition:

SELEGILINE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Selegiline hydrochloride tablets 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 hydrochloride tablets have 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 hydrochloride tablets or placebo in patients receiving levodopa/carbidopa. Selegiline hydrochloride tablets were 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 dressin

Product summary:

Selegiline Hydrochloride Tablets, USP are available containing 5 mg of selegiline hydrochloride, USP. Each white, round, unscored tablet is debossed with G on one side and SE over 5 on the other side. They are available as follows: NDC 0378-9290-91 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The brand names mentioned are registered trademarks of their respective manufacturers. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia Revised: 3/2017 ALP:SELG:R2

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SELEGILINE HYDROCHLORIDE- SELEGILINE HYDROCHLORIDE TABLET
MYLAN PHARMACEUTICALS INC.
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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-dimethylpropynylphenethylamine
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:
C H N · HCL
Each tablet, for oral administration, contains 5 mg selegiline
hydrochloride, USP. In addition, each
tablet contains the following inactive ingredients: citric acid,
lactose monohydrate, maize starch,
magnesium stearate, povidone and talc.
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
predomi