ONDANSETRON- 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:

KAISER FOUNDATION HOSPITALS

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/m 2 . - 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 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 loss of consciousness when apomorphine was administered

Product summary:

Ondansetron Hydrochloride tablets, 4 mg (ondansetron HCl dihydrate equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets engraved with “4” on one side and “NO” on the other side, bottles of 1440 tablets. Ondansetron Hydrochloride tablets, 8 mg (ondansetron HCl dihydrate equivalent to 8 mg of ondansetron), are yellow, oval, film-coated tablets engraved with “8” on one side and “NO” on the other side, bottles of 1440 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled room temperature] Dispense in tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ONDANSETRON- ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED
KAISER FOUNDATION HOSPITALS
----------
RX ONLY
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 365.9.
Ondansetron HCl dihydrate 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 hydrochloride dihydrate
equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP
for oral administration contains
ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron.
Each tablet also contains the
inactive ingredients croscarmellose sodium, hypromellose, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, pregelatinized starch, titanium dioxide,
triacetin, and iron oxide yellow (8
mg tablet only).
This product meets USP Dissolution Test 3.
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 enterochromaffin cells of the small intestine.
In humans, urinary 5-HIAA (5-
hydroxyindoleacetic acid) excretion increases after cisplatin
administration in parallel with the onset of
emesis. The released serotonin