GRANISETRON HYDROCHLORIDE tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Bionpharma Inc.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 is contraindicated in patients with known hypersensitivity to the drug or any of its components.

Sommarju tal-prodott:

White to off-white film coated triangular shaped biconvex tablet debossed with “G1” on one side and plain on the other side. 1 mg Bottle of 20 Tablets: NDC 69452-350-11 1 mg Unit of Use 2s: NDC 69452-350-01 1 mg 20 (2 x 10) Unit Dose Tablets: NDC 69452-350-92 (intended for institutional use only) Storage Store between 20° and 25°C (68° and 77°F). [see USP Controlled Room Temperature]. Keep container closed tightly. Protect from light.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE TABLET, FILM
COATED
BIONPHARMA INC.
----------
GRANISETRON HYDROCHLORIDE TABLETS, USP
DESCRIPTION
Granisetron hydrochloride tablets USP contain granisetron
hydrochloride USP, 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 with a
molecular weight of
348.9 (312.4 free base). Its empirical formula is C
H
N O•HCl, while its chemical
structure is:
Granisetron hydrochloride USP is a white to off-white solid that is
readily soluble in water
and normal saline at 20ºC.
Each white to off-white film coated triangular shaped biconvex tablet
contains 1.12 mg
granisetron hydrochloride USP equivalent to granisetron, 1 mg.
Inactive ingredients are:
microcrystalline cellulose, sodium starch glycolate, lactose
monohydrate, hypromellose,
magnesium stearate and opadry white.
The components of opadry white are hypromellose, titanium dioxide,
polyethylene glycol
6000 and polysorbate 80.
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
α , α , or β-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, granis