Ondansetron Injection 2 mg/mL (Vial) (Ondansetron Hydrochloride)

Adult dosage

1. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy 1) Adults The emetogenicity of cancer treatment varies according to the dose of the chemotherapeutic agent, 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 and radiotherapy with relatively low emetogenic potential 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) For administration of 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 two 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 infusion solution and administer by intravenous infusion over at least 15 minutes immediately before chemotherapy. ③ Because 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 12mg of dexamethasone sodium phosphate may be administered orally together with a single dose of up to 24mg of ondansetron 1~2 hours before chemotherapy (for oral formulation 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 dosage. ⦁Intravenous administration: For patients aged 65~74 years, follow the recommended adult dosage. For intravenous administration, dilute each dose in 50∼100mL of normal saline or another compatible infusion 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 intravenous administration, dilute each dose in 50∼100mL of normal saline or another compatible infusion solution and administer by intravenous infusion over at least 15 minutes. 4) Patients with renal impairment No specific dosage adjustment is necessary. 5) Patients with hepatic impairment In patients with moderate to severe hepatic impairment, clearance of this medicine is significantly 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 a single 16mg oral dose 1 hour before induction of anesthesia. ② Slowly administer a single 4mg dose by intravenous or intramuscular injection at induction of anesthesia. (2) Treatment of postoperative nausea and vomiting Slowly administer a single 4mg dose by intravenous or intramuscular injection. 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 specific dosage adjustment is necessary. 5) Patients with hepatic impairment In patients with moderate to severe hepatic impairment, clearance of this medicine is significantly 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 medicine is unchanged in patients with impaired sparteine/debrisoquine metabolism. As drug exposure in these patients does not differ from that in the general population with 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) 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 must be diluted with 5% dextrose injection, 0.9% sodium chloride injection, or another compatible infusion solution and administered by intravenous infusion over at least 15 minutes. In pediatric clinical trials, ondansetron was diluted in 25~50mL of normal saline or another compatible infusion solution and administered by intravenous infusion over at least 15 minutes. (1) Administer 5mg/㎡ (body surface area) of ondansetron intravenously immediately before chemotherapy. Administer the oral dose 12 hours after the intravenous dose; 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 (a, b) 5mg/㎡ intravenously, then 2mg orally 12 hours later; Days 2~6 (b) 2mg per dose orally every 12 hours ≥ 0.6 ㎡, 1.2㎡ 󰀃: Day 1 (a, b) 5mg/㎡ intravenously, then 4mg orally 12 hours later; Days 2~6 (b) 4mg per dose orally every 12 hours > 1.2㎡: Day 1 (a, b) 5mg/㎡ or 8mg intravenously, then 8mg orally 12 hours later; Days 2~6 (b) 8mg per dose orally every 12 hours *a: Do not exceed 8mg by intravenous administration. b: Do not exceed the adult total daily dose of 32mg. (2) Alternatively, administer 0.15 mg/kg of ondansetron intravenously immediately before chemotherapy. Two additional intravenous doses may be administered at 4-hour intervals. Administer the oral dose 12 hours after the intravenous dose; 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 (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 administration. b: Do not exceed the adult total daily dose of 32mg. (3) Do not exceed 8mg per intravenous dose. Do not exceed the adult total daily dose of 32mg. (4) No data are available from controlled clinical trials on prevention of delayed or persistent nausea and vomiting caused by emetogenic chemotherapeutic agents. No data are available from controlled pediatric clinical trials 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 Slowly administer a single dose of 0.1mg/kg, up to a maximum of 4mg, intravenously before, at, or after induction of anesthesia. (2) Treatment of postoperative nausea and vomiting Slowly administer a single dose of 0.1mg/kg, up to a maximum of 4mg, intravenously. (3) Data on prevention and treatment of postoperative nausea and vomiting in children under 2 years of age are insufficient. (4) As no clinical trials have been conducted on the use of oral ondansetron for prevention and treatment of postoperative nausea and vomiting, slow intravenous injection (over at least 30 seconds) is recommended.

This medication should be handled with care when opening the injection container to avoid the risk of glass particles entering, especially for children and the elderly. Patients with allergies to this medication's components or those using it in conjunction with certain drugs may experience severe hypotension and loss of consciousness, hence it should not be used in such cases. Patients who have had allergic reactions to similar medications in the past should use this medication cautiously since there is a risk of allergic reactions occurring. This medication may slow intestinal motility, so patients with symptoms of intestinal obstruction should be closely monitored after administration. Patients with severely impaired liver function or heart abnormalities should exercise special caution when using this medication, and any electrolyte imbalances should be corrected in advance. This medication may affect heart rhythm; therefore, patients with heart disease or those at risk of QT prolongation must consult healthcare professionals before use. Severe side effects such as serotonin syndrome may occur when used in combination with other serotonin-related medications, so careful monitoring is necessary when used together. After administration of this medication, patients should be closely observed for allergic symptoms such as rash, itching, and difficulty breathing, and should seek medical attention immediately if any abnormal symptoms occur. Neurological symptoms such as headache, dizziness, and drowsiness may occur, and in rare cases, severe movement disorders or seizures may develop. Gastrointestinal side effects might include diarrhea or constipation, so symptoms should be closely monitored. Cardiovascular side effects such as palpitations, blood pressure changes, and arrhythmias may occur, and if any abnormal symptoms arise, medical personnel should be informed immediately. Liver function tests may temporarily show increased values, so it is advisable to regularly check liver health. Transient visual disturbances may occur, but most recover within a short time post-administration. Severe rashes or toxic skin reactions may rarely occur, so skin conditions should be monitored closely. This medication does not significantly affect driving or machinery operation abilities, but caution is advised as individual responses may vary. In cases of overdose, cardiac rhythm abnormalities, visual disturbances, and severe constipation may occur, thus prompt hospital visit is necessary if such conditions are suspected. There are specific precautions when mixing or using this medication with others, so it should always be used under medical guidance, and any leftover substance should be discarded after opening. Pregnant or nursing women should consult healthcare providers before using this medication, and especially in nursing cases, discontinuation of breastfeeding is recommended. This medication should be stored away from direct sunlight and out of reach of children, and it is advisable not to transfer the contents to different containers.

Rash, itching, anaphylaxis, headache, feeling of heaviness in the head, drowsiness, flushing, warmth in the head and abdomen, transient asymptomatic elevation of aminotransferases, dizziness, ocular movement seizures, abnormal muscle tone responses, movement disorders, seizures, diarrhea, constipation, palpitations, increased blood pressure, chest pain, arrhythmia, hypotension, bradycardia, QTc prolongation, transient asymptomatic rise in liver function test items, visual disturbances, vision loss, toxic skin rash, toxic epidermal necrolysis, involuntary movements, warmth, generalized fatigue, hiccups, sweating, vascular pain, local hypersensitivity reaction at the injection site

This medication is sensitive to light and should be stored in a container that does not allow light penetration. Furthermore, to maintain its effectiveness, it is important to store it in a cool place below 30 degrees Celsius.

Appearance

A colorless and transparent solution in a brown vial.

Package unit

10 vials/box [4 mL/vial], 10 vials/box [2 mL/vial]