ONDANSETRON- ondansetron tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Cardinal Health

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

Ondansetron Tablets, USP are available containing ondansetron hydrochloride, USP equivalent to 4 mg or 8 mg of ondansetron. The 4 mg tablets are white film-coated, round, unscored tablets debossed with 315 on one side of the tablet and M on the other side. They are available overbagged with 10 tablets per bag, NDC 55154-5369-0. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

ONDANSETRON- ONDANSETRON TABLET, FILM COATED
CARDINAL HEALTH
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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
4_H_-Carbazol-4-one,1,2,3,9-tetrahydro-9-methyl-3-(2-methyl-1_H_-
imidazol-1-yl)methyl-,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 hydrochloride dihydrate is a white to off-white powder
that is soluble in water and normal
saline.
Each 4 mg ondansetron tablet for oral administration contains
ondansetron hydrochloride dihydrate
equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet for
oral administration contains
ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron.
Each tablet also contains the
following inactive ingredients: anhydrous lactose, colloidal silicon
dioxide, croscarmellose sodium,
hypromellose, magnesium stearate, microcrystalline cellulose,
polydextrose, polyethylene glycol,
pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide
and triacetin. In addition, the 8 mg
tablet contains FD&C Yellow No. 6 Aluminum Lake.
_Meets USP Dissolution Test 4._
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 increa