GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE

Pharmacokinetics In healthy volunteers and adult cancer patients undergoing chemotherapy, administration of Kytril tablets produced mean pharmacokinetic data shown in Table 1 .

Table 1Pharmacokinetic Parameters (Median [range]) Following Kytril Tablets 1 Not determined after oral administration; following a single intravenous dose of 40 mcg/kg, terminal phase half-life was determined to be 8.95 hours. N.D. Not determined. Peak Plasma Concentration (ng/mL) Terminal Phase Half-Life (h) Volume of ...

ADVERSE REACTIONS QT prolongation has been reported with granisetron (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. In patients receiving Kytril tablets 1 mg bid for 1, 7 or 14 days, or 2 mg daily for 1 day, adverse experiences reported in more than 5% of the patients with comparator and placebo inc...

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

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 medicati...