Oncelan Injection (Ondansetron Hydrochloride)

Adult dosage

1. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy 1) Adults The emetogenic potential 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, slowly inject 8mg of ondansetron intravenously (over at least 30 seconds) or intramuscularly, or administer 8mg orally 1∼2 hours before treatment and 8mg orally 12 hours later. ② To prevent delayed vomiting, administer 8mg per dose orally, twice daily, for up to 5 days after treatment. (2) For administration of highly emetogenic chemotherapy (e.g., high-dose cisplatin) ① Immediately before chemotherapy, slowly inject 8mg of ondansetron intravenously (over at least 30 seconds) or intramuscularly, followed by 2 additional intravenous (over at least 30 seconds) or intramuscular injections of 8mg at 4-hour intervals, 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 (injection only). ④ The effect of this medicine may be enhanced by slowly injecting 20mg of dexamethasone sodium phosphate intravenously before chemotherapy (injection only). ⑤ 12mg of oral dexamethasone sodium phosphate and a single oral dose of up to 24mg of ondansetron may be administered together 1~2 hours before chemotherapy (oral formulation only). ⑥ To prevent delayed vomiting, administer 8mg per dose orally, twice daily, for up to 5 days after treatment. 3) Older adults ⦁Oral administration: Follow the recommended adult dosage. ⦁Intravenous administration: For patients aged 65~74 years, follow the recommended adult dosage. For intravenous administration, dilute all doses 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 should not exceed 8mg. For intravenous administration, dilute all doses 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 special dosage adjustment is necessary. 5) Patients with hepatic impairment In patients with moderate to severe hepatic impairment, the clearance of this medicine is significantly 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 Slowly inject 4mg per dose intravenously or intramuscularly at induction of anesthesia. (2) Treatment of postoperative nausea and vomiting Slowly inject 4mg per dose intravenously or intramuscularly. 3) Older adults 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 significantly 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. Repeated administration of this medicine in these patients does not result in differences in drug exposure compared with the general population; therefore, no adjustment of the daily dose, frequency of administration, 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 should 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) Immediately before chemotherapy, administer 5mg/㎡ (body surface area) of ondansetron intravenously. Administer the oral dose 12 hours after the intravenous dose, and continue for up to 5 days. (Table 1) Body surface area < 0.6 ㎡: Day 1, administer 5mg/㎡ intravenously, then administer 2mg orally 12 hours later; days 2~6, administer 2mg per dose orally every 12 hours Body surface area ≥ 0.6 ㎡, 1.2㎡ ≤: Day 1, administer 5mg/㎡ intravenously, then administer 4mg orally 12 hours later; days 2~6, administer 4mg per dose orally every 12 hours Body surface area > 1.2㎡: Day 1, administer 5mg/㎡ or 8mg intravenously, then administer 8mg orally 12 hours later; days 2~6, administer 8mg per dose orally every 12 hours *a: Do not exceed a maximum intravenous dose of 8mg. b: The total daily dose should not exceed the adult 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, and continue for up to 5 days. (Table 2) Body weight ≤ 10 kg: Day 1, administer 0.15 mg/kg per dose intravenously every 4 hours, up to 3 doses; days 2~6, administer 2mg per dose orally every 12 hours Body weight > 10 kg: Day 1, administer 0.15 mg/kg per dose intravenously every 4 hours, up to 3 doses; days 2~6, administer 4mg per dose orally every 12 hours *a: Do not exceed a maximum intravenous dose of 8mg. b: The total daily dose should not exceed the adult dose of 32mg. (3) Do not exceed a maximum intravenous dose of 8mg. The total daily dose should 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. 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 inject 0.1mg/kg per dose, up to a maximum of 4mg, intravenously. (2) Treatment of postoperative nausea and vomiting Slowly inject 0.1mg/kg per dose, up to a maximum of 4mg, intravenously. (3) There are insufficient data for the prevention and treatment of postoperative nausea and vomiting in children under 2 years of age. (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.

This medication may have glass particles mixed in when using the injection ampoule, so care must be taken to avoid any glass fragments, especially when administering to children or the elderly. It should not be used in patients with hypersensitivity to this drug or those taking apomorphine hydrochloride, as severe hypotension and loss of consciousness may occur when used in combination with apomorphine. Patients who have had hypersensitive reactions to other 5HT3 receptor antagonists may experience similar reactions to this drug, so caution is required. Additionally, this medication can slow down bowel activity; therefore, patients with signs of intestinal obstruction must be carefully monitored after administration. Patients with severe liver dysfunction, abnormal heart rates, or electrolyte imbalances should use this medication with special caution and may need to correct their electrolyte status beforehand. This medication can significantly increase the risk of serotonin syndrome when taken in conjunction with other serotonin-related medications; hence, close monitoring by medical personnel is required during co-administration. When used to prevent nausea and vomiting following adenoid and tonsil surgery, care must be taken as the risk of bleeding can be concealed, necessitating careful observation. Pediatric patients receiving this drug must have their liver function closely monitored. Allergic reactions such as rash, itching, and difficulty breathing may occur; immediate discontinuation and appropriate treatment should be initiated if abnormal symptoms arise. Headaches, drowsiness, dizziness, gastrointestinal symptoms such as diarrhea or constipation, and heart rhythm abnormalities may also be observed, thus severe symptoms should prompt consultation with medical personnel. This medication does not significantly affect driving or the ability to operate machinery, but caution is necessary as effects may vary by individual. In case of overdose, symptoms such as visual disturbances, severe constipation, hypotension, and cardiac conduction abnormalities may occur, requiring immediate medical attention, as no specific antidote is available; treatment must be symptomatic. Care should be taken when mixing this medication with other drugs, and it should only be mixed with the recommended injection solutions. When storing, this medication should be kept in a sealed container away from direct sunlight and out of reach of children, and it is safest not to transfer it to another container.

Rash, itching, anaphylaxis, headache, feeling of heaviness in the head, drowsiness, flushing, warmth in the head and abdomen, transient increase in aminotransferases, dizziness, eye movement seizures, muscle hypertonicity, movement disorders, seizures, diarrhea, constipation, palpitations, increased blood pressure, chest pain, arrhythmia, hypotension, bradycardia, QTc prolongation, transient elevation in liver function test items, vision disturbances, vision loss, toxic skin rash, involuntary movements, feeling of heat, general malaise, hiccups, sweating, vascular pain, localized hypersensitivity reaction at the injection site, visual impairment, severe constipation, transient second-degree AV block, signs of vascular vagus nerve abnormalities

This medication should be stored in a sealed container to protect it from exposure to air and light, and it should be kept in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance

A brown ampoule containing a colorless transparent liquid

Package unit

2 mL/ampoule x 10, 4 mL/ampoule x 10