ONDANSETRON HYDROCHLORIDE tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Proficient Rx LP

INN（国际名称）:

ONDANSETRON HYDROCHLORIDE

组成:

ONDANSETRON 4 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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.

產品總結:

Ondansetron Tablets USP, 4 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘F’ on one side and ‘91’ on the other side             Bottles of 01                                   NDC 63187-636-01             Bottles of 03                                   NDC 63187-636-03             Bottles of 12                                   NDC 63187-636-12             Bottles of 15                                   NDC 63187-636-15             Bottles of 20                                 NDC 63187-636-20             Bottles of 30                                NDC 63187-636-30             10 x 10 Unit-dose Tablets              NDC 63187-636-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.

授权状态:

Abbreviated New Drug Application

产品特点

ONDANSETRON HYDROCHLORIDE- ONDANSETRON HYDROCHLORIDE TABLET, FILM
COATED
PROFICIENT RX LP
----------
ONDANSETRON TABLETS,USP
RX ONLY
DESCRIPTION
The active ingredient in ondansetron tablets, USP 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 hydrochloride USP (dihydrate) is a white to
off-white powder that is
soluble in water and normal saline.
Ondansetron tablets, USP for oral administration contain ondansetron
hydrochloride
USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron.
Each film-coated
tablet also contains the inactive ingredients anhydrous lactose,
microcrystalline cellulose,
pregelatinized starch (maize), magnesium stearate, triacetin, titanium
dioxide and
hypromellose. In addition 8 mg tablet also contains iron oxide yellow
and 24 mg tablet
also contains iron oxide red.
Meets USP dissolution test 6.
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-
3
18
19
3
2
3
3
HIAA (5-hydroxyindoleacetic acid) excretion increases after cisplatin
administration in
parallel with the onset of emesis. The released serotonin may
stimulate