Granisetron Injection is indicated for: The prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including therapy with high dose cisplatin. The prevention and treatment of postoperative nausea and vomiting.

Granisetron Tablet is indicated for: 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 is a potent, selective antagonist of 5-HT₃ receptors. The antiemetic activity of the drug is brought about through the inhibition of 5-HT₃ receptors present both centrally (medullary chemoreceptor zone) and peripherally (GI tract). This inhibition of 5-HT₃ receptors in turn inhibits the visceral afferent stimulation of the vomiting center, likely indirectly at the level of the area postrema, as well as through direct inhibition of serotonin activity within the area postrema and the chemoreceptor trigger zone.

Granisetron Injection:

Chemotherapy-induced nausea and vomiting:

• Adults: The recommended dosage for Granisetron Injection is 10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy and only on the day(s) chemotherapy is given. Granisetron Injection may be administered intravenously either undiluted over 30 seconds or diluted with 0.9% Sodium Chloride or 5% Dextrose and infused over 5 minutes. As a general precaution, Granisetron Injection should not be mixed in solution with other drugs.
• Pediatric Patients: The recommended dose in pediatric patients 2 to 16 years of age is 10 mcg/kg.
• Pediatric patients under 2 years of age: Have not been studied.
• Geriatric Patients, Renal Failure Patients or Hepatically Impaired Patients: No dosage adjustment is required.

Treatment of postoperative nausea and vomiting:

• Adults: The recommended dosage for prevention of postoperative nausea and vomiting is a single dose of 1 mg of Granisetron should be diluted to 5 ml and administered as a slow intravenous injection (over 30 seconds). Administration should be completed prior to induction of anesthesia. The recommended dosage for the treatment of nausea and vomiting after surgery is 1 mg of Granisetron undiluted, administered intravenously over 30 seconds.
• Paediatric Patients: The safety and effectiveness of Granisetron Injection have not been established in paediatric patients for the prevention or treatment of postoperative nausea or vomiting.
• Geriatric patients, Renal Failure Patients or Hepatically Impaired Patients: No dosage adjustment is required.

Granisetron Tablet:

• Emetogenic chemotherapy: The recommended adult dosage of oral Granisetron 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.
• Use in the Elderly, Renal Failure Patients or Hepatically Impaired Patients: No dosage adjustment is required.
• Radiation (either total body irradiation or fractionated abdominal radiation): The recommended adult dosage of oral Granisetron is 2 mg once daily. Two 1 mg tablets are taken within one hour of irradiation.
• Pediatric use: There is no experience with oral Granisetron in the prevention of radiation-induced nausea and vomiting in pediatric patients.

Granisetron does not induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system. As Granisetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes, inducers or inhibitors of these enzymes may change the clearance and the half-life of granisetron.

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

Headache, constipation, asthenia, diarrhea, abdominal pain, dyspepsia, nausea and vomiting, dizziness, insomnia, and anxiety.

Pregnancy category B. No evidence of impaired fertility or harm to the animal fetus has been found. However, this drug may be used in pregnancy only if clearly needed. It is not known whether Granisetron is excreted in human milk. So caution should be exercised when granisetron is administered to a nursing mother.

Patients with cardiac co-morbidities, on cardiotoxic chemotherapy and/or with concomitant electrolyte abnormalities. May mask progressive ileus and/or gastric distention. Children. Pregnancy and lactation.

Pediatric Uses: The safety and effectiveness of granisetron in pediatric patients under 2 years have not been established.
Geriatric use: Efficacy and safety were maintained with increasing age.

Anti-emetic drugs, Supportive Care Therapy

Injection: Store below 25°C. Protect from light.Tablet: Store below 30°C. Protect from light.