Ondansetron Injection (Vial) (Ondansetron Hydrochloride Monohydrate)

Adult dosage

1. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy 1) Adults The emetogenic potential of cancer treatment varies depending on the dose of chemotherapy agents, concomitant medications, and type of radiotherapy. The route and dose may be selected as appropriate within a range of 8∼32mg of ondansetron per day, administered orally, intravenously, or intramuscularly. (1) For chemotherapy agents and radiotherapy with relatively low emetogenic potential ① Immediately before chemotherapy or radiotherapy, slowly administer 8mg of ondansetron by intravenous injection (over at least 30 seconds) or intramuscular injection, or administer 8mg orally 1∼2 hours before treatment, followed by 8mg orally 12 hours later. ② To prevent delayed vomiting, administer 8mg orally twice daily for up to 5 days after treatment. (2) When administering chemotherapy agents with high emetogenic potential (e.g., high-dose cisplatin) ① Immediately before chemotherapy, slowly administer 8mg of ondansetron by intravenous injection (over at least 30 seconds) or intramuscular injection, then administer two additional doses of 8mg at 4-hour intervals by intravenous injection (over at least 30 seconds) or intramuscular injection, or administer by intravenous infusion at a rate of 1mg per hour for up to 24 hours. ② Alternatively, dilute 16mg of ondansetron in 50∼100mL of normal saline or another compatible injection solution and administer by intravenous infusion over at least 15 minutes immediately before chemotherapy. ③ As the risk of QT prolongation increases in a dose-dependent manner, do not exceed a single dose of 16mg (for injection only). ④ The effect of this drug may be enhanced by slowly administering 20mg of dexamethasone sodium phosphate intravenously before chemotherapy (for injection only). ⑤ Oral dexamethasone sodium phosphate 12mg may be administered together with a single oral dose of up to 24mg of ondansetron 1~2 hours before chemotherapy (for oral formulations only). ⑥ To prevent delayed vomiting, administer 8mg orally twice daily for up to 5 days after treatment. 3) Older adults ⦁Oral administration: Follow the recommended adult dose. ⦁Intravenous administration: For patients aged 65 to 74 years, follow the recommended adult dose. For all intravenous doses, dilute in 50∼100mL of normal saline or another compatible injection solution and administer by intravenous infusion over at least 15 minutes. For patients aged 75 years or older, the initial intravenous dose must not exceed 8mg. For all intravenous doses, dilute in 50∼100mL of normal saline or another compatible injection solution and administer by intravenous infusion over at least 15 minutes. 4) Patients with renal impairment No special dosage adjustment is required. 5) Patients with hepatic impairment In patients with moderate to severe hepatic impairment, the clearance of this drug is substantially reduced and the serum half-life is markedly prolonged; therefore, do not exceed 8mg per day. 2. Postoperative nausea and vomiting 1) Adults (1) Prevention of postoperative nausea and vomiting ① Administer 16mg orally as a single dose 1 hour before induction of anesthesia. ② Slowly administer 4mg as a single dose by intravenous or intramuscular injection at induction of anesthesia. (2) Treatment of postoperative nausea and vomiting Slowly administer 4mg as a single dose by intravenous or intramuscular injection. 3) Older adults Experience with use in patients aged 65 years or older is limited; however, tolerability was good in patients receiving chemotherapy. 4) Patients with renal impairment No special dosage adjustment is required. 5) Patients with hepatic impairment In patients with moderate to severe hepatic impairment, the clearance of this drug is substantially reduced and the serum half-life is markedly prolonged; therefore, do not exceed 8mg per day. 6) Patients with impaired sparteine/debrisoquine metabolism The elimination half-life of this drug is unchanged in patients with impaired sparteine/debrisoquine metabolism. Repeated administration in these patients does not result in drug exposure different from that in the general population; therefore, no adjustment of the daily dose, dosing frequency, or route of administration is required.

Children's dosage

1. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy 2) Children (6 months and older) The dose may be calculated based on body surface area or body weight. The total daily dose calculated based on body weight is higher than that calculated based on body surface area. Ondansetron hydrochloride (hydrate) injection should be diluted with 5% dextrose injection, 0.9% sodium chloride injection, or another compatible injection solution and administered by intravenous infusion over at least 15 minutes. In pediatric clinical studies, ondansetron was diluted in 25~50mL of normal saline or another compatible injection solution and administered by intravenous infusion over at least 15 minutes. (1) Immediately before chemotherapy, administer 5mg/㎡ (body surface area) of ondansetron intravenously. Oral doses are given 12 hours after the intravenous dose and may be continued for up to 5 days. (Table 1) Table 1. Dosage based on body surface area (6 months and older) < 0.6 ㎡: Day 1 (a, b) 5mg/㎡ intravenously, followed 12 hours later by 2mg orally; Days 2~6 (b) 2mg per dose orally every 12 hours ≥ 0.6 ㎡, 1.2㎡ ≤: Day 1 (a, b) 5mg/㎡ intravenously, followed 12 hours later by 4mg orally; Days 2~6 (b) 4mg per dose orally every 12 hours > 1.2㎡: Day 1 (a, b) 5mg/㎡ or 8mg intravenously, followed 12 hours later by 8mg orally; Days 2~6 (b) 8mg per dose orally every 12 hours *a: Do not exceed 8mg by intravenous injection. b: The total daily dose must not exceed the adult dose of 32mg. (2) Alternatively, immediately before chemotherapy, administer 0.15 mg/kg of ondansetron intravenously. Two additional intravenous doses may be administered at 4-hour intervals. Oral doses are given 12 hours after the intravenous dose and may be continued for up to 5 days. (Table 2) Table 2. Dosage based on body weight (6 months and older) ≤ 10 kg: Day 1 (a, b) 0.15 mg/kg per dose intravenously every 4 hours, up to 3 doses; Days 2~6 (b) 2mg per dose orally every 12 hours > 10 kg: Day 1 (a, b) 0.15 mg/kg per dose intravenously every 4 hours, up to 3 doses; Days 2~6 (b) 4mg per dose orally every 12 hours *a: Do not exceed 8mg by intravenous injection. b: The total daily dose must not exceed the adult dose of 32mg. (3) Do not exceed 8mg per intravenous dose. The total daily dose must not exceed the adult dose of 32mg. (4) There are no controlled clinical trial data on the prevention of delayed or persistent nausea and vomiting caused by emetogenic chemotherapy agents. There are no controlled pediatric clinical trial data on nausea and vomiting caused by radiotherapy. 2. Postoperative nausea and vomiting 2) Children (2 years and older) (1) Prevention of postoperative nausea and vomiting Before, during, or after induction of anesthesia, slowly administer 0.1mg/kg up to a maximum of 4mg as a single dose by intravenous injection. (2) Treatment of postoperative nausea and vomiting Slowly administer 0.1mg/kg up to a maximum of 4mg as a single dose by intravenous injection. (3) Data are insufficient for children under 2 years of age for the prevention and treatment of postoperative nausea and vomiting. (4) As no clinical studies have been conducted on the use of oral ondansetron for the prevention and treatment of postoperative nausea and vomiting, slow intravenous injection (over at least 30 seconds) is recommended.

When opening the injection container, there is a possibility of glass fragments mixing, so care must be taken when cutting the container, especially when administering to children or the elderly. Patients allergic to this medication or who are taking it with certain other drugs may experience serious side effects, so concomitant use should be avoided. Patients who have previously shown allergic reactions to similar medications should also exercise caution when using this medication, as respiratory issues or other hypersensitivity reactions may occur, necessitating careful observation of symptoms. This medication may slow intestinal movements, so patients with signs of intestinal obstruction need to be closely monitored after administration. Use cautiously in patients with severely impaired liver function, as it may affect cardiac electrical activity, requiring attention in patients with heart disease or electrolyte imbalances. Serious side effects known as serotonin syndrome may occur if taken with other serotonin-related medications, so patients on such medications should consult healthcare providers. Children receiving this medication or patients undergoing hepatotoxic chemotherapy should have their liver function monitored closely. This medication can cause various side effects such as headaches, drowsiness, dizziness, indigestion, irregular heartbeat, elevation of liver function tests, temporary visual disturbances, and loss of vision. Prompt reporting of any unusual symptoms and seeking appropriate treatment is necessary. It is known not to significantly affect driving or machinery operation, but caution may be needed as effects can vary among individuals. This medication may interact with multiple other drugs, so patients should be sure to inform healthcare providers of any other medications they are taking. It is not recommended for pregnant or breastfeeding women as its safety has not been established; breastfeeding should be discontinued if taking this medication. In case of overdose, symptoms such as visual disturbances, severe constipation, and hypotension may occur, so immediate hospital visit for appropriate treatment is necessary. This medication should only be used once, and any remaining solution should be disposed of, using only the specified solutions and containers if mixing with other drugs. Store in a dark container to protect from light and keep in a safe place out of reach of children; transferring to other containers should be avoided.

Rash, itching, anaphylaxis, headache, heaviness, drowsiness, flushing, warmth in the head and abdomen, transient increase in aminotransferase enzymes, dizziness, ocular movement seizures, abnormal muscle tone reactions, movement disorders, seizures, diarrhea, constipation, palpitations, elevated blood pressure, ST segment suppression, chest pain, arrhythmia, hypotension, bradycardia, QTc prolongation, transient increase in liver function test values, visual disturbances, vision loss, toxic skin rash, toxic epidermal necrolysis, involuntary movements, warmth sensation, generalized malaise, hiccups, sweating, vascular pain, localized hypersensitivity reaction at the injection site, redness, urticaria, pruritus, visual impairment, severe constipation, hypotension, signs of vagal nerve abnormalities, transient second-degree atrioventricular block

This medication is sensitive to light, so it should be stored in a dark container to avoid exposure. Additionally, it is essential to keep it in a cool place at a temperature below 30 degrees Celsius to maintain its effectiveness.

Appearance

A brown vial containing a colorless and transparent liquid

Package unit

2 mL/vial x 1, 2 mL/vial x 10 4 mL/vial x 1, 4 mL/vial x 10