Drug Catalog - Product Detail
GRANISETRON HCI TB 1MG 2X10
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-1003-94 | MYLAN | 20EA | 1MG | NA |
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Description
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 with a molecular weight of 348.9 (312.4 free base). Its molecular formula is C 18 H 24 N 4 O•HCl, while its chemical structure is: granisetron hydrochloride Granisetron hydrochloride, USP is a white to off-white powder that is freely soluble in water and slightly soluble in methanol. Tablets for Oral Administration Each white film-coated, round, granisetron hydrochloride tablet contains 1.12 mg granisetron hydrochloride, USP equivalent to granisetron, 1 mg. Inactive ingredients are: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin. Structural Formula
How Supplied
HOW SUPPLIED Granisetron Hydrochloride Tablets, USP are available containing 1.12 mg of granisetron hydrochloride, USP equivalent to 1 mg of granisetron. The 1 mg tablets are a white film-coated, round, unscored tablet debossed with M on one side of the tablet and G3 on the other side. They are available as follows: NDC 0378-1003-94 bottles of 20 tablets (Intended for Institutional Use Only) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep container closed tightly. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED FEBRUARY 2010 GRTN:R2
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Emetogenic Chemotherapy The recommended adult dosage of granisetron hydrochloride tablets is 2 mg once daily or 1 mg twice daily. In the 2 mg once daily regimen, two 1 mg tablets are given up to one hour before chemotherapy. In the 1 mg twice daily regimen, the first 1 mg tablet is given up to one hour before chemotherapy, and the second tablet, 12 hours after the first. Either regimen is administered only on the day(s) chemotherapy is given. Continued treatment, while not on chemotherapy, has not been found to be useful. Use in the Elderly, Renal Failure Patients or Hepatically Impaired Patients No dosage adjustment is recommended (see CLINICAL PHARMACOLOGY: Pharmacokinetics ). Pediatric Use Safety and effectiveness in pediatric patients have not been established. Radiation (Either Total Body Irradiation or Fractionated Abdominal Radiation) The recommended adult dosage of oral granisetron hydrochloride tablets is 2 mg once daily. Two 1 mg tablets are taken within 1 hour of radiation. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Use in the Elderly No dosage adjustment is recommended.