Gratiril Injection (Granisetron Hydrochloride)

Adult administration

Adults Nausea and vomiting induced by chemotherapy or radiotherapy To prepare an intravenous infusion solution, withdraw 3 mL (3 mg) of granisetron from the ampoule and dilute in one of the infusion solutions listed below to a total volume of 20 ∼ 50 mL or 15 mL. Do not use any other diluent. For dilution to 20 ∼ 50 mL: Normal Saline Injection, 0.18 % w/v Sodium Chloride + 4.0 % w/v Glucose Injection, 5 % w/v Glucose Injection, Hartmann's Injection, Sodium Lactate Injection, 10 % w/v Mannitol Injection For dilution to 15 mL: Normal Saline Injection Administer granisetron 40 μg/kg (usually 3 mg), diluted in 20 ∼ 50 mL of infusion solution, over at least 5 minutes, or dilute in 15 mL of infusion solution and administer intravenously (over at least 30 seconds). A single dose of this medicine controls nausea and vomiting, but up to 2 additional doses of 3 mg may be administered at intervals of at least 10 minutes within 24 hours. Maximum daily dose: Up to 3 doses of 3 mg of this medicine may be administered within 24 hours. The total dose must not exceed 9 mg in 24 hours. Postoperative nausea and vomiting Dilute 1 mL (1 mg) of this medicine in Normal Saline Injection to a total volume of 5 mL (do not use any other diluent), then administer slowly intravenously (over at least 30 seconds). Maximum daily dose: Up to 2 mL (2 mg) of this medicine may be administered within 24 hours. Elderly patients No specific dosage adjustment is required. Patients with renal or hepatic impairment No specific dosage adjustment is required.

Child administration

Children (2 years and older) — Chemotherapy-induced nausea and vomiting: Dilute a dose of 40 μg/kg of this medicine in infusion solution (see Adult Dosage and Administration) to a total volume of 10 ∼ 30 mL. Dilute 40 μg/kg (maximum 3 mg) of this medicine in 10 ∼ 30 mL of infusion solution and administer over at least 5 minutes. A single dose of this medicine controls nausea and vomiting, but 1 additional dose of 40 μg/kg (maximum 3 mg) may be administered within 24 hours at an interval of at least 10 minutes. Children — Postoperative nausea and vomiting: 2) Since there is no experience with the use of this medicine for postoperative nausea and vomiting in children, it is preferable not to administer it.

Care should be taken to avoid glass fragments when using glass ampules, especially in children or the elderly. This medication should not be administered to patients allergic to this medication or its ingredients. This medication can inhibit bowel motility, so patients with bowel obstruction symptoms must be closely monitored after administration. Patients with heart problems or arrhythmias may experience changes in electrocardiograms upon administration of this medication, necessitating caution. In clinical trials, headaches and constipation were the most common side effects, and most were mild to moderate. This medication can temporarily increase liver function test results, but this is generally not serious. Allergic reactions such as rash or anaphylaxis can occur, so any unusual symptoms should be reported to medical personnel immediately. When used with other serotonergic medications, there is a risk of serious neurological side effects known as serotonin syndrome, so patients should be closely monitored when taken together. Caution is advised during driving or operating machinery, as somnolence has been reported, and activity should be restricted if symptoms arise. This medication may mask symptoms of progressive bowel obstruction or gastric distension, so patients with these conditions should be careful. This medication is known to be safe when used with certain anesthetics or analgesics, but it should be used after consultation with a physician. During pregnancy, it is preferable not to use unless in special cases, and during breastfeeding, it is recommended to stop nursing. Safety in children, especially premature or newborn infants, has not been adequately verified, so it should be used cautiously. In case of overdose, as there is no specific antidote, treatment should be tailored to the symptoms, and serious aftereffects are rare. This medication should not be mixed with other drugs, and opened ampules should be stored away from direct sunlight, with diluted solutions used as soon as possible. Store in a safe place out of reach of children, and avoid transferring to other containers.

• Hypersensitivity
• urticaria
• headache
• serotonin syndrome
• QT prolongation
• constipation
• increased liver aminotransferases
• rash
• diarrhea
• nausea

This medication should be stored in a sealed container to prevent air ingress and kept in a dark place to avoid direct light exposure. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance

Colorless, transparent injection solution contained in colorless, transparent ampules

Package unit

1 mL × 5 ampules, 3 mL × 5 ampules