País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
GRANISETRON HYDROCHLORIDE (UNII: 318F6L70J8) (GRANISETRON - UNII:WZG3J2MCOL)
Teva Pharmaceuticals USA, Inc.
GRANISETRON HYDROCHLORIDE
GRANISETRON 1 mg
ORAL
PRESCRIPTION DRUG
Granisetron hydrochloride tablets are indicated for the prevention of: - Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. - Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. Granisetron hydrochloride tablets are contraindicated in patients with known hypersensitivity to the drug or any of its components. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. F 2/2016
Granisetron hydrochloride tablets USP are available as: 1 mg, white to off-white, film-coated, capsule-shaped tablet, debossed with the number “93” on one side and “7485” on the other. They are available in blister cards of 2 (1 card of 2 unit dose tablets) NDC 0093-7485-12 and blister cards of 20 (4 cards of 5 unit dose tablets each) NDC 0093-7485-20. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container closed tightly. Protect from light.
Abbreviated New Drug Application
GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- GRANISETRON HYDROCHLORIDE TABLETS USP 7485 RX ONLY DESCRIPTION Granisetron hydrochloride tablets USP contain granisetron hydrochloride, an antinauseant and antiemetic agent. Chemically it is _endo_-N-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-1-methyl-1H-indazole-3- carboxamide hydrochloride. C H N O•HCl M.W. 348.9 (312.4 free base) Granisetron hydrochloride is a white to off-white crystalline powder that is freely soluble in water and slightly soluble in methanol. TABLETS FOR ORAL ADMINISTRATION Each white to off-white, film-coated, capsule-shaped, granisetron hydrochloride tablet USP contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg. Inactive ingredients are: hypromellose, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, polysorbate 80, sodium starch glycolate, and titanium dioxide. CLINICAL PHARMACOLOGY Granisetron is a selective 5-hydroxytryptamine (5-HT ) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT ; 5-HT ; 5-HT ; 5-HT ; for alpha , alpha , or beta- adrenoreceptors; for dopamine-D ; or for histamine-H ; benzodiazepine; picrotoxin or opioid receptors. Serotonin receptors of the 5-HT type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy that induces vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT receptors. This evokes vagal afferent discharge, inducing vomiting. Animal studies demonstrate that, in binding to 5-HT receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds. In most human studies, granisetron has had little effect on blood pressure, heart rate or ECG. No Leia o documento completo