ONDANSETRON HYDROCHLORIDE- 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:

Preferred Pharmaceuticals, Inc.

INN (International Name):

ONDANSETRON HYDROCHLORIDE

Composition:

ONDANSETRON 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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.

Product summary:

Ondansetron tablets USP, 4 mg (ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets debossed with "4" on one side and “NO” on the other side. They are supplied as follows: Bottle of 10 - 68788-9893-1 Bottle of 30 - 68788-9893-3 Ondansetron tablets USP, 8 mg (ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron), are yellow, oval, film-coated tablets, debossed with "8" on one side and "NO" on the other side They are supplied as follows: Bottle of 10 - 68788-9892-1 Bottle of 30 - 68788-9892-3 Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. 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
PREFERRED PHARMACEUTICALS, INC.
----------
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