GRANISETRON HYDROCHLORIDE- granisetron hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GRANISETRON HYDROCHLORIDE (UNII: 318F6L70J8) (GRANISETRON - UNII:WZG3J2MCOL)

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

GRANISETRON HYDROCHLORIDE

Composition:

GRANISETRON 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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