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:

Novitium Pharma LLC

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

Product summary:

Selegiline Hydrochloride Capsules, USP are available containing 5 mg of selegiline hydrochloride, USP. Each hard gelatin capsule with white opaque cap and white opaque body imprinted “Novitium 5 mg” on the body and “504” on the cap in red ink containing white to off-white powder.     They are available as: NDC 70954-504-10   bottles of 60 capsules NDC   70954-504-20 bottles of 1000 capsules  Store at 20º to 25 ºC (68º to 77ºF ) [see USP Controlled Room Temperature]. All trademarks are the property of their respective owners.  Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520  LB4312-00 Issued: 01/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SELEGILINE HYDROCHLORIDE - SELEGILINE HYDROCHLORIDE CAPSULE
NOVITIUM PHARMA LLC
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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 molecular formula
is C
H
N.HCI
and the structural formula is as follows:
Each hard gelatin capsule with white opaque cap and white opaque body
imprinted
"Novitium 5 mg" on the body and "504" on the cap in red ink containing
white to off-
white powder. Each capsule contains 5 mg selegiline hydrochloride,
USP. Inactive
ingredients are citric acid anhydrous, lactose monohydrate, magnesium
stearate and
microcrystalline cellulose. The capsule shells contain gelatin and
titanium dioxide and are
imprinted with red ink. The imprinting ink contains shellac, alcohol,
isopropyl alcohol,
butyl alcohol, propylene glycol, sodium hydroxide, titanium dioxide,
povidone and FD&C
Red #40 Aluminum Lake.
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.
13
17
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