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:

Apotex Corp.

INN (International Name):

SELEGILINE HYDROCHLORIDE

Composition:

SELEGILINE HYDROCHLORIDE 5 mg

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 comparison to previous state).  Selegiline is contraindicated in patients with a known hypersensitivity to this drug. Selegiline is contraindicated for use with meperidine (DEMEROL & other trade names). This contraindication is often extended to other opioids. (See Drug Interactions .)

Product summary:

Selegiline Hydrochloride Capsules, USP 5 mg are available for oral administration as hard gelatin capsules with a white opaque body and an aqua blue opaque cap.  “APO 055” is imprinted on each capsule in black ink. They are supplied as bottles of 60 (NDC 60505-0055-1), bottles of 500 (NDC 60505-0055-3) and bottles of 1000 (NDC 60505-0055-2). Storage Store at 20º to 25ºC (68º to 77Fº) [see USP Controlled Room Temperature]. APOTEX INC. SELEGILINE HYDROCHLORIDE CAPSULES, USP 5 MG Revised: June 2014 Rev. 5

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SELEGILINE HYDROCHLORIDE- SELEGILINE HYDROCHLORIDE CAPSULE
APOTEX CORP.
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SELEGILINE HYDROCHLORIDE CAPSULES, 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_,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 HCI
and the structural formula is as follows:
Each capsule, for oral administration contains 5 mg of selegiline
hydrochloride. In
addition, each capsule contains the following inactive ingredients:
Anhydrous Lactose
NF, Citric Acid Anhydrous USP, Microcrystalline Cellulose NF PH102,
Stearic Acid NF and
Talc USP. The capsule shell contains Gelatin NF, FD & C Blue #1 and
Titanium Dioxide.
The capsule logo ink Black SW-9008/SW-9009 contains the following
inactive
ingredients: Ammonium Hydroxide; Black Iron Oxide, Bacteria Controlled
EEC No. 172;
n-Butyl NF; Ethyl Alcohol, Anhydrous, 200 Proof; Isopropyl Alcohol
USP; Potassium
Hydroxide NF; Propylene Glycol USP; Purified Water USP and Shellac NF.
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