SELEGILINE HYDROCHLORIDE capsule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Rising Pharma Holdings, Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

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 60 capsules. (NDC 16571-659-06) Bottles of 500 capsules. (NDC 16571-659-50) 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       Rev. 03/20 554201 PIR65950-00

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

SELEGILINE HYDROCHLORIDE - SELEGILINE HYDROCHLORIDE CAPSULE
RISING PHARMA HOLDINGS, INC.
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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