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:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Selegiline 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 walking and co

Product summary:

Selegiline Hydrochloride Capsules, USP 5 mg are available for oral administration as hard gelatin capsules with a white opaque body and blue opaque cap imprinted “P 659” in black ink on both cap and body. They are supplied as: Bottles of 30 capsules (NDC 71205-888-30) Bottles of 60 capsules (NDC 71205-888-60) Bottles of 90 capsules (NDC 71205-888-90) Bottles of 100 capsules (NDC 71205-888-00) Bottles of 500 capsules (NDC 71205-888-55) Bottles of 1000 capsules (NDC 71205-888-11) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep this medication and all medications out of reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in USA Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Rev. 03/20 554201 PIR65950-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SELEGILINE HYDROCHLORIDE- SELEGILINE HYDROCHLORIDE CAPSULE
PROFICIENT RX LP
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SELEGILINE HYDROCHLORIDE CAPSULES, 5MG
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 α-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
N·HCl
and the structural formula is as follows:
Each capsule, for oral administration contains 5 mg of selegiline
hydrochloride. In
addition, each capsules contains the following inactive ingredients:
anhydrous citric acid,
anhydrous lactose, colloidal silicon dioxide, microcrystalline
cellulose, and magnesium
stearate. The capsule shell contains gelatin, D&C Red # 28, FD&C Blue
# 1, FD&C Yellow
#6 and titanium dioxide and are imprinted with black ink. The ink
contains the inactive
ingredients: ammonium hydroxide, n-butyl alcohol, isopropyl alcohol,
iron oxide black,
propylene glycol and shellac.
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 se