Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS)
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
ONDANSETRON HYDROCHLORIDE
ONDANSETRON 8 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ONDANSETRON HYDROCHLORIDE - ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC ---------- 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 Lestu allt skjalið