ONDANSETRON- ondansetron tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Lake Erie Medical DBA Quality Care Products LLC

INN (Algemene Internationale Benaming):

ONDANSETRON HYDROCHLORIDE

Samenstelling:

ONDANSETRON 8 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

- Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2 . - Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. - Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. - Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low. The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administ

Product samenvatting:

Ondansetron tablets, USP 4 mg (ondansetron hydrochloride, USP equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets debossed with "4" on one side and “NO” on the other side. They are supplied as follows: Ondansetron tablets, USP 8 mg (ondansetron hydrochloride, USP equivalent to 8 mg of ondansetron), are yellow, oval, film-coated tablets, debossed with "8" on one side and "NO" on the other side. They are supplied as follows: Store at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature). Dispense in a tight, light-resistant container as defined in the USP.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ONDANSETRON- ONDANSETRON TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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 empirical formula is C
H
N
O•HCl•2H
O, representing a molecular weight of 365.9.
Ondansetron HCl dihydrate is a white to off-white powder that is
soluble in water and normal saline.
Each 4 mg ondansetron tablet, USP for oral administration contains
ondansetron hydrochloride, USP
equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP
for oral administration contains
ondansetron hydrochloride, USP equivalent to 8 mg of ondansetron. Each
tablet also contains the
inactive ingredients croscarmellose sodium, hypromellose, lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, pregelatinized starch, titanium dioxide,
triacetin, and iron oxide yellow (8
mg tablet only).
Product meets USP Drug Release Test 3.
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 ma