Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
ONDANSETRON (UNII: 4AF302ESOS) (ONDANSETRON - UNII:4AF302ESOS)
NuCare Pharmaceutical, Inc.
ONDANSETRON
ONDANSETRON 4 mg
ORAL
PRESCRIPTION DRUG
- Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m 2 . - 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 orally disintegrating tablets 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 apomor
Ondansetron orally disintegrating tablets, 4 mg (as 4 mg ondansetron base) are white to off white, oval, uncoated tablets debossed with “240” on one side, plain on the other side. Bottles of 2 NDC 68071-1968-2 Bottles of 3 NDC 68071-1968-3 Bottles of 4 NDC 68071-1968-4 Bottles of 6 NDC 68071-1968-6 Bottles of 10 NDC 68071-1968-1 NDC 62756-356-66) Store between 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]
Abbreviated New Drug Application
ONDANSETRON- ONDANSETRON TABLET, ORALLY DISINTEGRATING NUCARE PHARMACEUTICAL, INC. ---------- ONDANSETRON ORALLY DISINTEGRATING TABLETS DESCRIPTION The active ingredient in ondansetron orally disintegrating tablets 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-1H-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. Each 4 mg ondansetron orally disintegrating tablet for oral administration contains 4 mg ondansetron, USP. Each 8 mg ondansetron orally disintegrating tablet for oral administration contains 8 mg ondansetron, USP. Each ondansetron orally disintegrating tablet also contains the inactive ingredients aspartame, colloidal silicon dioxide, croscarmellose sodium, glycerol distearate, magnesium stearate, mannitol, talc and strawberry flavor. Ondansetron orally disintegrating tablets are orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. Does not meet USP Disintegration Time. This product disintegrates in approximately 60 seconds. 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 ons Lestu allt skjalið