ONDANSETRON- ondansetron tablet, orally disintegrating

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Lake Erie Medical DBA Quality Care Products LLC

INN (nume internaţional):

ONDANSETRON

Compoziție:

ONDANSETRON 4 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2 . 2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3. 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. 4. 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 hydrochloride tablets, ondansetron orally disintegrating tablets, and ondansetron hydrochloride oral solution are recommended even where the incidence of postoperative nausea and/or vomiting is low. The concomitant use of apomorphine with ondansetron is contraindic

Rezumat produs:

Ondansetron orally disintegrating tablets USP, equivalent to 4 mg of (ondansetron base), are white to off white, round, flat, beveled edged tablets, debossed with “SZ” on one side and “342” on the other side, and are supplied as follows: NDC 0781-5238-01 in bottles of 100 tablets with child-resistant closure NDC 0781-5238-64 in unit dose package of 30 tablets Ondansetron orally disintegrating tablets USP, equivalent to 8 mg of (ondansetron base), are white to off white, round, flat, beveled edged tablets, debossed with “SZ” on one side and “343” on the other side, and are supplied as follows: NDC 0781-5239-01 in bottles of 100 tablets with child-resistant closure NDC 0781-5239-80 in unit dose package of 10 tablets NDC 0781-5239-64 in unit dose package of 30 tablets Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from light and moisture REFERENCES 1. Britto MR, Hussey EK, Mydlow P, et al. Effect of enzyme inducers on ondansetron (OND) metabolism in humans. Clin Pharmacol Ther. 1997;61:228. 2. Pugh RNH, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Brit J Surg. 1973; 60:646-649. 3. Villikka K, Kivisto KT, Neuvonen PJ. The effect of rifampin on the pharmacokinetics of oral and intravenous ondansetron. Clin Pharmacol Ther. 1999;65:377-381. 4. De Witte JL, Schoenmaekers B, Sessler DI, et al. Anesth Analg. 2001;92:1319-1321. 5. Arcioni R, della Rocca M, Romanò R, et al. Anesth Analg. 2002;94:1553-1557. Manufactured in India by Sandoz Private Limited For Sandoz Inc. Princeton, NJ 08540 Rev. November 2011

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ONDANSETRON- ONDANSETRON TABLET, ORALLY DISINTEGRATING
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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