Hana Ondansetron Injection (Ondansetron Hydrochloride Hemihydrate)

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 the chemotherapeutic agent, concomitant medications, and type of radiotherapy. The route and dose may be appropriately selected within the range of 8∼32mg of ondansetron per day, administered orally, intravenously, or intramuscularly. (1) During treatment with relatively mildly emetogenic chemotherapeutic agents or radiotherapy ① Immediately before chemotherapy or radiotherapy, administer 8mg of ondansetron by slow intravenous injection (over at least 30 seconds) or intramuscular injection, or administer 8mg orally 1∼2 hours before treatment and 8mg orally 12 hours later. ② To prevent delayed vomiting, administer 8mg orally twice daily for up to 5 days after treatment. (2) During treatment with highly emetogenic chemotherapeutic agents (e.g., high-dose cisplatin) ① Immediately before chemotherapy, administer 8mg of ondansetron by slow intravenous injection (over at least 30 seconds) or intramuscular injection, followed by 2 additional doses of 8mg at 4-hour intervals by intravenous injection (over at least 30 seconds) or intramuscular injection, or administer by continuous 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 Since 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 medicine may be enhanced by slowly administering 20mg of dexamethasone sodium phosphate intravenously before chemotherapy (for injection only). ⑤ 1~2 hours before chemotherapy, up to 24mg of ondansetron may be administered orally as a single dose together with 12mg of oral dexamethasone sodium phosphate (for oral formulations only). ⑥ To prevent delayed vomiting, administer 8mg orally twice daily for up to 5 days after treatment. 3) Elderly patients ⦁Oral administration: Follow the recommended adult dose. ⦁Intravenous administration: For patients aged 65 to 74 years, follow the recommended adult dose. For intravenous administration, dilute all doses 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 should not exceed 8mg. For intravenous administration, dilute all doses 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 necessary. 5) Patients with hepatic impairment In patients with moderate to severe hepatic impairment, the clearance of this medicine is substantially reduced and its 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 Administer 4mg by slow intravenous or intramuscular injection at induction of anesthesia. (2) Treatment of postoperative nausea and vomiting Administer 4mg by slow intravenous or intramuscular injection as a single dose. 3) Elderly patients Experience with use in patients aged 65 years or older is limited; however, tolerability was good in patients who received chemotherapy. 4) Patients with renal impairment No special dosage adjustment is necessary. 5) Patients with hepatic impairment In patients with moderate to severe hepatic impairment, the clearance of this medicine is substantially reduced and its 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 medicine is unchanged in patients with impaired sparteine/debrisoquine metabolism. Since drug exposure in these patients does not differ from that in the general population following repeated administration, no adjustment of the daily dose, dosing frequency, or route of administration is necessary.

Children's dosage

1. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy 2) Pediatric patients (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 trials, ondansetron was diluted in 25~50mL of normal saline injection 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 by intravenous injection. Administer the oral dose 12 hours after the intravenous injection; treatment 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, administer 5mg/㎡ by intravenous injection, followed 12 hours later by 2mg orally; days 2~6, administer 2mg per dose orally every 12 hours. a: Do not exceed a maximum of 8mg by intravenous injection. b: Do not exceed the total daily dose of 32mg, the adult dose. ≥ 0.6 ㎡, 1.2㎡ ≤: Day 1, administer 5mg/㎡ by intravenous injection, followed 12 hours later by 4mg orally; days 2~6, administer 4mg per dose orally every 12 hours. a: Do not exceed a maximum of 8mg by intravenous injection. b: Do not exceed the total daily dose of 32mg, the adult dose. > 1.2㎡: Day 1, administer 5mg/㎡ or 8mg by intravenous injection, followed 12 hours later by 8mg orally; days 2~6, administer 8mg per dose orally every 12 hours. a: Do not exceed a maximum of 8mg by intravenous injection. b: Do not exceed the total daily dose of 32mg, the adult dose. (2) Alternatively, immediately before chemotherapy, administer 0.15 mg/kg of ondansetron by intravenous injection. Two additional intravenous injections may be given at 4-hour intervals. Administer the oral dose 12 hours after the intravenous injection; treatment 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, administer 0.15 mg/kg per dose by intravenous injection every 4 hours for up to 3 doses; days 2~6, administer 2mg per dose orally every 12 hours. a: Do not exceed a maximum of 8mg by intravenous injection. b: Do not exceed the total daily dose of 32mg, the adult dose. > 10 kg: Day 1, administer 0.15 mg/kg per dose by intravenous injection every 4 hours for up to 3 doses; days 2~6, administer 4mg per dose orally every 12 hours. a: Do not exceed a maximum of 8mg by intravenous injection. b: Do not exceed the total daily dose of 32mg, the adult dose. (3) Do not exceed a maximum of 8mg per intravenous injection. Do not exceed the total daily dose of 32mg, the adult dose. (4) There are no controlled clinical trial data on the prevention of delayed or persistent nausea and vomiting caused by emetogenic chemotherapy. There are no controlled pediatric clinical trial data on nausea and vomiting caused by radiotherapy. 2. Postoperative nausea and vomiting 2) Pediatric patients (2 years and older) (1) Prevention of postoperative nausea and vomiting Before, during, or after induction of anesthesia, slowly administer a single dose of 0.1mg/kg up to a maximum of 4mg by intravenous injection. (2) Treatment of postoperative nausea and vomiting Slowly administer a single dose of 0.1mg/kg up to a maximum of 4mg by intravenous injection. (3) Data are insufficient for patients younger than 2 years regarding the prevention and treatment of postoperative nausea and vomiting. (4) As no clinical trials 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.

Caution should be exercised when administering this injection, especially to children and the elderly, as there is a risk of glass fragments being mixed in. Patients with a known allergy to this medication or concurrent use with certain drugs may experience severe hypotension and loss of consciousness, so it should not be used in conjunction with those medications. This medication can cause hypersensitivity reactions in some patients, especially respiratory symptoms that require immediate treatment. It can delay the transit time of food through the intestines, so patients with symptoms of intestinal obstruction should be carefully monitored after administration. Administration should be cautious in patients with severe liver dysfunction and those with heart conditions or electrolyte imbalances, as it can affect cardiac electrical activity. Serotonin syndrome, a serious side effect, may occur when used with other serotonergic drugs; therefore, the patient's condition should be closely monitored if combined. When used for the prevention of nausea and vomiting after certain surgical procedures, it may mask signs of bleeding, requiring careful monitoring after administration. In pediatric patients, liver function should be closely monitored during administration. Side effects such as rash, itching, headache, drowsiness, dizziness, diarrhea, constipation, arrhythmias, hypotension, bradycardia, abnormal liver function tests (AST, ALT, LDH, γ-ALT, total bilirubin levels), temporary visual disturbances (such as blurred vision), temporary vision loss, and involuntary movements may occur after receiving this medication, and any unusual symptoms should be reported immediately to healthcare personnel. This medication does not affect the patient's ability to drive or operate machinery; however, caution should be taken with increased risk of side effects when used with other medications. This medication is metabolized by various enzymes in the liver, and its blood concentration may change when used with certain drugs, so caution is necessary regarding drug interactions. The safety of this medication during pregnancy is uncertain; use in pregnant women is not recommended, and breastfeeding should be discontinued while using this medication. In cases of overdose, symptoms such as visual disturbances, severe constipation, hypotension, and cardiac conduction abnormalities may occur; if overdose is suspected, healthcare personnel should be notified immediately for appropriate treatment. This medication can be mixed with other drugs for administration, but only with the specified injection solution, and it must be used or discarded immediately after opening. It should be stored in a sealed container protected from light and kept in a safe place out of the reach of children; transferring it to another container is not advisable.

Rash, itching, anaphylaxis, headache, heaviness, drowsiness, redness, warmth in the head and abdomen, temporary increase in amino transferase levels, dizziness, eye movement seizures, abnormal muscle tone responses, movement disorders, seizures, diarrhea, constipation, palpitations, increased blood pressure, ST segment suppression, chest pain, arrhythmia, hypotension, bradycardia, QTc prolongation, temporary elevation in liver function tests, visual disturbances, vision loss, toxic epidermal necrolysis, toxic skin rash, involuntary movements, warmth, generalized malaise, hiccups, sweating, vascular pain, local hypersensitivity at the injection site, redness, urticaria, itching, visual impairment, severe constipation, hypotension, transient second-degree AV block, signs of vagus nerve involvement, serotonin syndrome

This medication should be stored in a sealed container to prevent exposure to air or light. It is best kept in a cool place below 30 degrees Celsius.

Appearance

A colorless and transparent liquid contained in a colorless and transparent ampoule

Package unit

2mL, 4mL X 10 ampoules