ONDANSETRON- ondansetron tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Bryant Ranch Prepack

INN (Nama Antarabangsa):

ONDANSETRON HYDROCHLORIDE

Komposisi:

ONDANSETRON 4 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

Ondansetron tablets USP, 4 mg (ondansetron HCl USP dihydrate equivalent to 4 mg of ondansetron), are white, oval, standard convex, film-coated tablets with ‘4’ on one side and ‘G1’ logo on the other side in: Bottles of 30 tablets (NDC 68462-105-30). Carton containing 1 card with 3 unit of use blisters (NDC 68462-105-33). Ondansetron tablets USP, 8 mg (ondansetron HCl USP dihydrate equivalent to 8 mg of ondansetron), are yellow, oval, standard convex, film-coated tablets with ‘8’ on one side and ‘G1’ logo on the other side in: Bottles of 30 tablets (NDC 68462-106-30). Carton containing 1 card with 3 unit of use blisters (NDC 68462-106-33). Bottles: Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Cartons: Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from light. Store blister in carton. Ondansetron tablets USP, 24 mg (ondansetron HCl USP dihydrate equivalent to 24 mg of ondansetron), are pink, oval, standard convex, film-coated tablets with ‘24’ on one side and ‘G1’ logo on the other side in daily unit dose packs of 1 tablet (NDC 68462-107-40). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Ondansetron orally disintegrating tablets USP, 4 mg (as 4 mg ondansetron base) are white, circular, flat faced, uncoated tablets with ‘G’ engraved on one side and ‘4’ on the other side in unit dose packs of 30 tablets (NDC 68462-157-13). 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 unit dose packs of 10 tablets (NDC 68462-158-11) and 30 tablets (NDC 68462-158-13). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ONDANSETRON- ONDANSETRON TABLET, FILM COATED
BRYANT RANCH PREPACK
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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.
Each 4-mg ond