ONDANSETRON HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

ONDANSETRON HYDROCHLORIDE

Composition:

ONDANSETRON 4 mg

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 hydrochloride tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low. Ondansetron hydrochloride tablets are contraindicated for patients known to have hypersensitivity to the drug. Animal studies have shown that ondansetron is no

Product summary:

Ondansetron hydrochloride tablets, for oral administration, are available as: 4 mg: Equivalent to 4 mg of ondansetron base, round, white, film-coated tablets, debossed GG on one side and 927 on the reverse side. They are supplied as follows: NDC 0781-1679-31 in bottles of 30 NDC 0781-1679-01 in bottles of 100 NDC 0781-1679-33 in unit of use package of 3 NDC 0781-1679-13 in unit-dose package of 100 8 mg: Equivalent to 8 mg of ondansetron base, round, yellow, film-coated tablets, debossed GG on one side and 928 on the reverse side. They are supplied as follows: NDC 0781-1681-31 in bottles of 30 NDC 0781-1681-01 in bottles of 100 NDC 0781-1681-33 in unit of use package of 3 NDC 0781-1681-13 in unit-dose package of 100 24 mg: Equivalent to 24 mg of ondansetron base, round, pink, film-coated tablets, debossed GG on one side and 305 on the reverse side. They are supplied as follows: NDC 0781-1879-13 in unit-dose package of 100 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ONDANSETRON HYDROCHLORIDE - ONDANSETRON HYDROCHLORIDE TABLET, FILM
COATED
H.J. HARKINS COMPANY, INC.
----------
ONDANSETRON HYDROCHLORIDE TABLETS
DESCRIPTION
The active ingredient in ondansetron hydrochloride 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-1Himidazol-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 dihydrate is a white to off-white powder that is
soluble in water and normal saline.
Each ondansetron hydrochloride tablet, intended for oral
administration, contains ondansetron
hydrochloride equivalent to 4 mg or 8 mg or 24 mg of ondansetron. In
addition, each tablet contains the
following inactive ingredients: hypromellose, lactose anhydrous,
magnesium stearate, microcrystalline
cellulose, pregelatinized starch, polyethylene glycol and titanium
dioxide.
Additionally, each 4 mg and 8 mg tablet contains polysorbate 80 while
the 24 mg tablet contains
polyvinyl alcohol and talc, respectively.
Additionally, 8 mg and 24 mg strength tablets contain the following
colorants:
8 mg strength: Iron oxide yellow, Iron oxide red
24 mg strength: FD&C Red No. 40 aluminum lake, FD&C Yellow No. 6
aluminum lake
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 chemoreceptor trigger zone
of the area postrema. It is not certain whether ondansetron’s
antiemetic action is mediated centrally,
peripherally, or in both sites. However, cytotoxic chemotherapy
appears to be associated with release
of serotonin from the enterochro