Cabigranisetron Injection (Granisetron Hydrochloride)

Adult administration

1. Adults 1) Nausea and vomiting caused by chemotherapy or radiotherapy <Directions for use> To prepare the solution for intravenous infusion, withdraw 3 mL (3 mg) of granisetron from the ampoule and dilute it in one of the infusion solutions below to a total volume of 20 ∼ 50 mL or 15 mL. Do not use any other diluent. - When diluting to 20 ∼ 50 mL: normal saline injection, 0.18 % w/v sodium chloride + 4.0 % w/v dextrose injection, 5 % w/v dextrose injection, Hartmann's injection, sodium lactate injection, 10 % w.v mannitol injection - When diluting to 15 mL: normal saline injection <Dose> Dilute 40 μg/kg (usually 3 mg) of granisetron in 20 ∼ 50 mL of infusion solution and administer over at least 5 minutes, or dilute it in 15 mL of infusion solution and administer intravenously (over at least 30 seconds). Although one dose of this medicine controls nausea and vomiting, up to 2 additional doses of 3 mg may be administered within 24 hours, at intervals of at least 10 minutes. Maximum daily dose: Up to 3 doses of 3 mg of this medicine may be administered within 24 hours. The total dose administered over 24 hours should not exceed 9 mg. 2) 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 by intravenous injection (over at least 30 seconds). Maximum daily dose: Up to 2 mL (2 mg) of this medicine may be administered within 24 hours. 3. Elderly patients No special dosage adjustment is necessary. 4. Patients with renal or hepatic impairment No special dosage adjustment is necessary.

Child administration

2. Children (2 years of age and older) 1) Nausea and vomiting induced by chemotherapy <Directions for use> Dilute a dose of 40 μg/kg of this medicine in infusion solution (see the adult directions for use) to a total volume of 10 ∼ 30 mL. <Dose> Dilute 40 μg/kg (maximum 3 mg) of this medicine in 10 ∼ 30 mL of infusion solution and administer over at least 5 minutes. Although one dose of this medicine controls nausea and vomiting, one additional dose of 40 μg/kg (maximum 3 mg) may be administered within 24 hours, at an interval of at least 10 minutes. 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 cut the container carefully to avoid glass fragments when using this injectable drug. Extra caution is required when used in children or the elderly. Patients with allergies to this medication or its components should not use it. This medication may reduce bowel movements, and patients with bowel obstruction symptoms should be carefully monitored after administration. Patients with heart-related issues or abnormal ECG findings may experience changes in heart rhythm upon administration, requiring caution. Common side effects include headaches and constipation, mostly mild to moderate in severity. Liver enzyme levels may temporarily rise, but this is less related to serious liver damage. Allergic reactions such as rashes or anaphylaxis may occur, and any unusual symptoms should be reported to healthcare professionals immediately. Careful monitoring is necessary when this medication is used with other serotonergic drugs, as a condition known as serotonin syndrome may lead to neurological abnormalities. There is no data regarding its effects on driving or operating machinery; however, caution is advised as drowsiness may occur during use. It is recommended not to use this medication during pregnancy unless absolutely necessary, and it is safer to discontinue breastfeeding while using this medication. The safety of this medication in children, especially premature infants or newborns, has not been sufficiently established, thus it should be used with caution. In the event of an overdose, there is no specific antidote, and symptomatic treatment should be initiated; caution should be exercised to avoid exceeding the recommended dosage. This medication should not be mixed with other medications, and once diluted, it should be used as soon as possible while avoiding exposure to direct sunlight and keeping it out of reach of children.

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

This drug should be stored in a sealed container to protect it from air and light, ideally at room temperature between 1°C and 30°C. This storage method helps maintain the medication's effectiveness for a longer period.

Appearance

Colorless and transparent injection solution in a colorless and transparent ampule

Package unit

1ml/ampule X 5, 3ml/ampule X 5