GRANISETRON HYDROCHLORIDE tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Natco Pharma Limited

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

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 (Intended for institutional use only) and 2’s pack. NDC 63850-0005-1-20’S Pack  NDC No. 63850-0005-2 – 2’S Pack Store between 20º to 25ºC (68º and 77ºF) [see USP Controlled Room Temperature]. Keep container closed tightly. Protect from light. Retain in carton until time of use.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE TABLET, FILM
COATED
NATCO PHARMA LIMITED
----------
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.
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 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
evidence of an effect on plasma prolactin or aldosterone
concentrations has been fou