ONDANSETRON tablet orally disintegrating

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Preferred Pharmaceuticals Inc.

INN (International Nazwa):

ONDANSETRON

Skład:

ONDANSETRON 8 mg

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

ONDANSETRON- ONDANSETRON TABLET, ORALLY DISINTEGRATING
PREFERRED PHARMACEUTICALS INC.
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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
throug