GRANISETRON HYDROCHLORIDE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Breckenridge Pharmaceutical, Inc.

INN (Kansainvälinen yleisnimi):

GRANISETRON HYDROCHLORIDE

Koostumus:

GRANISETRON 1 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Granisetron hydrochloride tablets USP 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.

Tuoteyhteenveto:

Granisetron hydrochloride tablets USP are available as: White colored, triangular shaped, biconvex, film-coated tablets with debossing of '1GN' on one side and plain surface on the other side. Granisetron HCl tablets, USP are available as 20 Unit Dose tablets and 2's pack. NDC 51991-735-20-20'S Pack NDC 51991-735-32 - 2'S Pack Store between 20° and 25°C (68° and 77°F) [see USP Controlled Room Temperature]. Keep container closed tightly. Protect from light. Retain in carton until time of use.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE TABLET
BRECKENRIDGE PHARMACEUTICAL, INC.
----------
GRANISETRON HYDROCHLORIDE TABLETS, USP
RX ONLY
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.
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, triangular, biconvex, film-coated granisetron
hydrochloride tablet USP
contains 1.12 mg granisetron hydrochloride equivalent to granisetron,
1 mg. Inactive
ingredients are: hypromellose, lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, polyethylene glycol, 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
18 24 4
3
3
1
1A
1B/C
2
1-
2-
2
1
3
3
3
due to high-dose cisplatin or arrested vomiting within 5 to 30
seconds.
In most human studies, granisetron has had little effect on bloo