SELEGILINE HYDROCHLORIDE capsule

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ixtrih issa

Ingredjent attiv:

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

Disponibbli minn:

Lake Erie Medical DBA Quality Care Products LLC

INN (Isem Internazzjonali):

SELEGILINE HYDROCHLORIDE

Kompożizzjoni:

SELEGILINE HYDROCHLORIDE 5 mg

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

                                SELEGILINE HYDROCHLORIDE- SELEGILINE HYDROCHLORIDE CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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 F
                                
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