ONDANSETRON tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dispensing Solutions, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2 . - Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. - Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. - Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets USP and ondansetron orally disintegrating tablets USP are recommended even where the incidence of postoperative nausea and/or vomiting is low. The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and los

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ONDANSETRON - ONDANSETRON TABLET, ORALLY DISINTEGRATING
DISPENSING SOLUTIONS, INC.
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ONDANSETRON TABLETS USP
ONDANSETRON ORALLY DISINTEGRATING TABLETS USP
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 365.9.
Ondansetron HCl USP dihydrate is a white to off-white powder that is
soluble in water and normal
saline.
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 ondansetron orally disintegrating tablet USP for oral
administration contains 4 mg
ondansetron base. Each 8-mg ondansetron orally disintegrating tablet
USP for oral administrat