ONDANSETRON- ondansetron tablet, orally disintegrating

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Cardinal Health

DCI (Denominação Comum Internacional):

ONDANSETRON

Composição:

ONDANSETRON 8 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. Ondansetron tablets and ondansetron orally disintegrating tablets are contraindicated for patients known to have hypersensitivity to the drug. Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

Resumo do produto:

Ondansetron orally disintegrating tablets USP, 8 mg (as 8 mg ondansetron base) are white, circular, flat faced, uncoated tablets with ‘G’ engraved on one side and ‘8’ on the other side in: Overbagged with 10 tablets per bag, NDC 55154-3683-0 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ONDANSETRON- ONDANSETRON TABLET, ORALLY DISINTEGRATING
CARDINAL HEALTH
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ONDANSETRON TABLETS USP, FOR ORAL USE
ONDANSETRON ORALLY DISINTEGRATING TABLETS USP, FOR ORAL USE
DESCRIPTION
The active ingredient in ondansetron tablets USP is ondansetron
hydrochloride (HCl) USP 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 empirical formula is C
H N O•HCl•2H O, representing a molecular weight of 365.85.
Ondansetron HCl USP dihydrate is a white to off-white powder that is
sparingly soluble in water and in
alcohol; soluble in methanol, slightly soluble in isopropyl alcohol,
and in dichloromethane; very
slightly soluble in acetone, in chloroform and in ethyl acetate.
The active ingredient in ondansetron orally disintegrating tablets USP
is ondansetron base, 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.
It has
the following structural formula:
The empirical formula is C
H N O representing a molecular weight of 293.4.
Each 4-mg ondansetron tablet USP for oral administration contains
ondansetron HCl USP (dihydrate)
equivalent to 4 mg of ondansetron. Each 8-mg ondansetron tablet USP
for oral administration contains
ondansetron HCl USP (dihydrate) equivalent to 8 mg of ondansetron.
Each 24-mg ondansetron tablet
USP for oral administration contains ondansetron HCl USP (dihydrate)
equivalent to 24 mg of
ondansetron. Each tablet also contains the inactive ingredients
colloidal silicon dioxide, hypromellose,
iron oxide yellow (8 mg tablet only), iron oxide red (24 mg tablet
only), lactose monohydrate,
magnesium stearate, microcrystalline cellulose, pregelatinized starch,
titanium dioxide and triacetin.
Ea