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Granisteron Hcl 1Mg 20 Unit Dose Tabs By Teva Pharma

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Granisteron Hcl 1Mg 20 Unit Dose Tabs By Teva Pharma

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Granisteron Hcl 1Mg 20 Unit Dose Tabs By Teva Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXB10049961/RXD4041968
Size : 20
Selling UoM : EA
NDC: 00093-7485-20
UPC Barcode : 300937485209
Supplier: 0050001899 TEVA PARENTERAL MEDICINES
Supplier Material : 748520
Generic Code : 021592 GRANISETRON HCL ORAL TABLET 1 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

93, 7485
tablet , film-coated , white , oblong oblong
White to off-whiteDebossed

KYTRIL Tablets and KYTRIL Oral Solution 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).

Tablets for Oral Administration

Each white, triangular, biconvex, film-coated KYTRIL Tablet contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg. Inactive ingredients are: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.
Oral Solution

Each 10 mL of clear, orange-colored, orange-flavored KYTRIL Oral Solution contains 2.24 mg of granisetron hydrochloride equivalent to 2 mg granisetron. Inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, orange flavor, purified water, sodium benzoate, and sorbitol.

INDICATIONS

KYTRIL (granisetron hydrochloride) 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.

SIDE EFFECTS

QT prolongation has been reported with KYTRIL (see PRECAUTIONS and DRUG INTERACTIONS).
Chemotherapy-Induced Nausea and Vomiting

Over 3700 patients have received KYTRIL Tablets in clinical trials with emetogenic cancer therapies consisting primarily of cyclophosphamide or cisplatin regimens.

DRUG INTERACTIONS

Granisetron does not induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system in vitro. There have been no definitive drug-drug interaction studies to examine pharmacokinetic or pharmacodynamic interaction with other drugs however, in humans, KYTRIL Injection has been safely administered with drugs representing benzodiazepines, neuroleptics, and anti-ulcer medications commonly prescribed with antiemetic treatments. KYTRIL Injection also does not appear to interact with emetogenic cancer chemotherapies. Because granisetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of granisetron. No specific interaction studies have been conducted in anesthetized patients. In addition, the activity of the cytochrome P-450 subfamily 3A4 (involved in the metabolism of some of the main narcotic analgesic agents) is not modified by KYTRIL in vitro.

In in vitro human microsomal studies, ketoconazole inhibited ring oxidation of KYTRIL. However, the clinical significance of in vivo pharmacokinetic interactions with ketoconazole is not known. In a human pharmacokinetic study, hepatic enzyme induction with phenobarbital resulted in a 25% increase in total plasma clearance of intravenous KYTRIL. The clinical significance of this change is not known.

QT prolongation has been reported with KYTRIL. Use of Kytril in patients concurrently treated with drugs known to prolong the QT interval and/or are arrhythmogenic, this may result in clinical consequences.