ONDANSETRON HYDROCHLORIDE tablet film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (Jina la Kimataifa):

ONDANSETRON HYDROCHLORIDE

Tungo:

ONDANSETRON 8 mg

Dawa ya aina:

PRESCRIPTION DRUG

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

ONDANSETRON HYDROCHLORIDE - ONDANSETRON HYDROCHLORIDE TABLET, FILM
COATED
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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ONDANSETRON HYDROCHLORIDE TABLETS
0233
7236
RX ONLY
DESCRIPTION
The active ingredient in this product is ondansetron hydrochloride 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-1_H_-imidazol-1-yl)methyl]-4_H_-carbazol-4-one,
monohydrochloride, dihydrate. It has the following structural formula:
C
H N O•HCl•2H O M.W. 365.9
Ondansetron hydrochloride dihydrate is a white to off-white powder
that is soluble in water and normal
saline.
Each 4 mg ondansetron hydrochloride tablet for oral administration
contains ondansetron hydrochloride
dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron
hydrochloride tablet for oral
administration contains ondansetron hydrochloride dihydrate equivalent
to 8 mg of ondansetron. Each
tablet also contains the inactive ingredients hypromellose, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, pregelatinized starch, polyethylene
glycol, sodium starch glycolate, and
titanium dioxide. In addition, the 8 mg strength contains iron oxide
yellow.
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