ENTACAPONE tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

ENTACAPONE (UNII: 4975G9NM6T) (ENTACAPONE - UNII:4975G9NM6T)

Dostupné s:

Alembic Pharmaceuticals Inc.

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Entacapone tablets effectiveness has not been systematically evaluated in patients with Parkinson’s disease who do not experience end-of-dose “wearing-off”. Entacapone tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. Entacapone is not a controlled substance. Animal studies to evaluate the drug abuse and potential dependence have not been conducted. Although clinical studies have not revealed any evidence of the potential for abuse, tolerance or physical dependence, systematic studies in humans designed to evaluate these effects have not been performed.

Přehled produktů:

Entacapone Tablets USP, 200 mg are brownish-orange colored, oval-shaped unscored film coated tablets debossed with “L 633” on one side and plain on the other side. Tablets are provided in HDPE containers as follows: NDC 62332-478-31                bottle of 100 tablets NDC 62332-478-91                bottle of 1,000 tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature.] Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information call Alembic Pharmaceuticals Limited at 1-866-210-9797. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 09/2021

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

ENTACAPONE - ENTACAPONE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS INC.
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ENTACAPONE TABLETS, USP
_RX ONLY_
_PRESCRIBING INFORMATION_
DESCRIPTION
Entacapone is available as tablets containing 200 mg entacapone, USP.
Entacapone is an inhibitor of catechol-O-methyltransferase (COMT),
used in the
treatment of Parkinson’s disease as an adjunct to levodopa and
carbidopa therapy. It is
a nitrocatechol-structured compound with a relative molecular mass of
305.29. The
chemical name of entacapone is
(E)-2-cyano3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-
2-propenamide. Its empirical formula is C
H
N O and its structural formula is:
The inactive ingredients of the entacapone tablets, USP are
microcrystalline cellulose,
mannitol, croscarmellose sodium, colloidal silicon dioxide, magnesium
stearate,
hydrogenated vegetable oil, hypromellose, glycerin, titanium dioxide,
iron oxide yellow,
sucrose, polysorbate 80 and iron oxide red.
FDA approved dissolution testing specifications differ from USP.
CLINICAL PHARMACOLOGY
_MECHANISM OF ACTION_
Entacapone is a selective and reversible inhibitor of COMT.
In mammals, COMT is distributed throughout various organs with the
highest activities in
the liver and kidney. COMT also occurs in the heart, lung, smooth and
skeletal muscles,
intestinal tract, reproductive organs, various glands, adipose tissue,
skin, blood cells,
and neuronal tissues, especially in glial cells. COMT catalyzes the
transfer of the methyl
group of S-adenosyl-L-methionine to the phenolic group of substrates
that contain a
catechol structure. Physiological substrates of COMT include dopa,
catecholamines
(dopamine, norepinephrine, and epinephrine) and their hydroxylated
metabolites. The
function of COMT is the elimination of biologically active catechols
and some other
hydroxylated metabolites. In the presence of a decarboxylase
inhibitor, COMT becomes
the major metabolizing enzyme for levodopa, catalyzing the metabolism
to 3-methoxy-4-
hydroxy-L phenylalanine (3-OMD) in the brain and periphery.
The mechanis