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:

MedVantx, Inc.

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 30                                   NDC 65862-187-30             Bottles of 500                                 NDC 65862-187-05             Bottles of 1000                               NDC 65862-187-99             1 x 3 Unit-dose Tablets                 NDC 65862-187-03             10 x 10 Unit-dose Tablets             NDC 65862-187-10 Ondansetron Tablets USP, 8 mg are yellow colored, oval shaped, film-coated tablets debossed with ‘F’ on one side and ‘92’ on the other side.               Bottles of 30                                   NDC 65862-188-30             Bottles of 500                                 NDC 65862-188-05             Bottles of 1000                               NDC 65862-188-99             1 x 3 Unit-dose Tablets                 NDC 65862-188-03             10 x 10 Unit-dose Tablets             NDC 65862-188-10 Ondansetron Tablets USP, 24 mg are pink colored, oval shaped, film-coated tablets debossed with ‘C’ on one side and ‘71’ on the other side.               Unit-dose Packs of 1 Tablet            NDC 65862-189-11 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
MEDVANTX, INC.
----------
ONDANSETRON TABLETS, USP
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, 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-HIAA (5-
hydroxyindoleacetic acid) excretion increases after cisplatin
administration in parallel with the onset of
emesis. The released serotonin may stimulate the vagal afferents
through the 5