ONDANSETRON 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:

Cardinal Health

INN (International Name):

ONDANSETRON HYDROCHLORIDE

Composition:

ONDANSETRON 4 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ONDANSETRON- ONDANSETRON TABLET, FILM COATED
CARDINAL HEALTH
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ONDANSETRON TABLETS, USP
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 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 4 mg ondansetron tablet, USP for oral administration contains
ondansetron hydrochloride, USP
equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP
for oral administration contains
ondansetron hydrochloride, USP 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).
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 may stimulate the vag