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:

i3 Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Selegiline Hydrochloride Tablets, USP 5 mg are available for oral administration as white, unscored, round tablets debossed with “i3” on one side and “6” on the other side. They are supplied as bottle of 60 (NDC 72319-006-02). Store at 20° to 25°C (68° to 77°F); excursions 15˚ to 30˚C (59˚ to 86˚F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP] with a child-resistant closure as required. i3 Pharmaceuticals, LLC SELEGILINE HYDROCHLORIDE TABLETS, USP 5 mg Manufactured by: i3 Pharmaceuticals, LLC 200 Park Ave Warminster, PA 18974 OS006-02 REV.1220 Revised: December 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SELEGILINE HYDROCHLORIDE- SELEGILINE HYDROCHLORIDE TABLET
I3 PHARMACEUTICALS, LLC
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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
1-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 223.74. The molecular formula
is C
H
N•HCl. The structural formula is as follows:
Each tablet, for oral administration, contains 5 mg selegiline
hydrochloride. Inactive
ingredients are corn starch, lactose monohydrate, microcrystalline
cellulose, povidone,
and stearic acid.
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
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