ONDANSETRON HYDROCHLORIDE tablet film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS)

Disponible desde:

Cardinal Health

Designación común internacional (DCI):

ONDANSETRON HYDROCHLORIDE

Composición:

ONDANSETRON 4 mg

tipo de receta:

PRESCRIPTION DRUG

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ONDANSETRON HYDROCHLORIDE- ONDANSETRON HYDROCHLORIDE TABLET, FILM
COATED
CARDINAL HEALTH
----------
ONDANSETRON TABLETS USP
DESCRIPTION
The active ingredient in ondansetron tablets is ondansetron
hydrochloride (HCl) as the dihydrate, the
racemic form of ondansetron and a selective blocking agent of the
serotonin 5-HT receptor type.
Chemically it is (±) 1, 2, 3,
9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-
4-one, monohydrochloride, dihydrate. It has the following structural
formula:
The molecular formula is C
H N O•HCl•2H O, representing a molecular weight of 365.86.
Ondansetron HCl dihydrate USP is a white to off-white powder that is
soluble in water and normal
saline.
Each 4 mg ondansetron tablet USP for oral administration contains
ondansetron HCl dihydrate USP
equivalent to 4 mg of ondansetron. Each 8 mg ondansetrone tablet USP
for oral administration contains
ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each
16 mg ondansetron tablet USP
for oral administration contains ondansetron HCl dihydrate USP
equivalent to 16 mg of ondansetron.
Each 24 mg ondansetron tablet USP for oral administration contains
ondansetron HCl dihydrate USP
equivalent to 24 mg of ondansetron.
Each tablet also contains the inactive ingredients colloidal silicon
dioxide, hypromellose 2910(5cP)
(for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for
the 8 mg and 24 mg tablets
only), iron oxide red and iron oxide black (for the 24 mg tablet
only), iron oxide yellow (for the 8 mg
and 24 mg tablets only), lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, pregelatinized starch, sodium starch glycolate,
and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Ondansetron is a selective 5-HT receptor antagonist. While its
mechanism of action has not been fully
characterized, ondansetron is not a dopamine-receptor antagonist.
Serotonin receptors of the 5-HT type
are present both peripherally on vagal nerve terminals and centrally
in the