ONDANSETRON tablet orally disintegrating

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Clinical Solutions Wholesale

INN（国際名）:

ONDANSETRON

構図:

ONDANSETRON 4 mg

処方タイプ:

PRESCRIPTION DRUG

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ONDANSETRON- ONDANSETRON TABLET, ORALLY DISINTEGRATING
CLINICAL SOLUTIONS WHOLESALE
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ONDANSETRON ORALLY DISINTEGRATING TABLETS, USP
DESCRIPTION
The active ingredient in ondansetron orally disintegrating tablets,
USP is ondansetron base, 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-1 H-imidazol-
1-yl)methyl]-4H-carbazol-4-one. It
has the following structural formula:
The molecular formula is C
H
N
O representing a molecular weight of 293.4.
USP disintegration test pending.
Each ondansetron orally disintegrating tablet, USP intended for oral
administration contains 4 mg or 8
mg of ondansetron base. In addition, each ondansetron orally
disintegrating tablet, USP contains the
following inactive ingredients: aspartame, calcium stearate, colloidal
silicon dioxide, mannitol,
microcrystalline cellulose, polacrilin potassium, sodium starch
glycolate, strawberry flavor and talc.
Ondansetron orally disintegrating tablets, USP are a orally
administered formulation of ondansetron
which rapidly disintegrates on the tongue and does not require water
to aid dissolution or swallowing.
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