GRANISETRON HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Ascend Laboratories, LLC

INN (국제 이름):

GRANISETRON HYDROCHLORIDE

구성:

GRANISETRON HYDROCHLORIDE 1 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

NDC 67877-184-20-20’s pack NDC 67877-184-02-2’s pack Montvale, NJ07645.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

GRANISETRON HYDROCHLORIDE - GRANISETRON HYDROCHLORIDE TABLET
ASCEND LABORATORIES, LLC
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GRANISETRON HYDROCHLORIDE TABLETS
RX ONLY
DESCRIPTION
Granisetron HCL tablets 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 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 is a white to off-white solid that is
readily soluble in water and normal
saline at 20°C.
TABLETS FOR ORAL ADMINISTRATION
Each white, triangular, biconvex, film-coated Granisetron HCl Tablet
contains 1.12 mg granisetron
hydrochloride equivalent to granisetron, 1 mg. Inactive ingredients
are: hyprmellose, 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
18
24
4
3
3
1
1A
1B/C
2
1
2
2
1
3
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