SAMSUNG Ondansetron Injection (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 the chemotherapeutic agent, concomitant medications, and type of radiotherapy. The route and dose may be appropriately selected within a range of 8∼32mg of ondansetron per day for oral, intravenous, or intramuscular administration. (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 infusion 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 (injection only). ④ The effect of this drug may be enhanced by slowly administering 20mg of dexamethasone sodium phosphate by intravenous injection before chemotherapy (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 (oral formulation 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 dosage. ⦁Intravenous administration: For patients aged 65~74 years, follow the recommended adult dosage. For all intravenous doses, dilute 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 all intravenous doses, dilute 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 adjustment of the dosage or administration is necessary. 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 a single oral dose of 16mg 1 hour before induction of anesthesia. ② Administer a single dose of 4mg by slow intravenous or intramuscular injection at induction of anesthesia. (2) Treatment of postoperative nausea and vomiting Administer a single dose of 4mg by slow 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 who received chemotherapy. 4) Patients with renal impairment No special adjustment of the dosage or administration is necessary. 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. When this drug is repeatedly administered to these patients, drug exposure does not differ from that in the general population; therefore, 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 or 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 by intravenous injection. Administer the oral dose 12 hours after the intravenous dose; treatment may continue for up to 5 days. (Table 1) Table 1. Dosage based on body surface area (6 months or older) < 0.6 ㎡: Day 1 (a, b) 5mg/㎡ by intravenous injection, 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/㎡ by intravenous injection, 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 by intravenous injection, 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 by intravenous injection. Two additional intravenous doses may be administered at 4-hour intervals. Administer the oral dose 12 hours after the intravenous dose; treatment may continue for up to 5 days. (Table 2) Table 2. Dosage based on body weight (6 months or older) ≤ 10 kg: Day 1 (a, b) 0.15 mg/kg per dose by intravenous injection 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 by intravenous injection 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 chemotherapeutic 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 or older) (1) Prevention of postoperative nausea and vomiting Before, during, or after induction of anesthesia, administer a single dose of 0.1mg/kg, up to a maximum of 4mg, by slow intravenous injection. (2) Treatment of postoperative nausea and vomiting Administer a single dose of 0.1mg/kg, up to a maximum of 4mg, by slow intravenous injection. (3) Data are insufficient for children under 2 years of age 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.

This medication should not be used by individuals who have an allergic reaction to any of its components. Furthermore, using this drug in conjunction with apomorphine may result in severe side effects such as hypotension or loss of consciousness, so it must never be used together. Individuals who have had allergic reactions to similar medications should be careful, as similar reactions may occur with this drug. This drug can slow down the movement of food through the intestines, so those with symptoms of intestinal blockage must observe their condition after using it. Patients with severe liver dysfunction should use this drug cautiously. This drug can prolong the electrical signal intervals of the heart, which may increase the risk of arrhythmias, so special caution is needed for those with heart disease or electrolyte imbalances. If there are electrolyte abnormalities such as hypokalemia or hypomagnesemia, they must be corrected before using this drug. In addition, using this drug with serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) may lead to serious side effects known as serotonin syndrome, which requires careful monitoring. When using this drug to prevent nausea and vomiting after tonsil surgery, caution should be exercised as bleeding symptoms may be masked. Pediatric patients receiving chemotherapy that causes hepatic toxicity should have their liver function monitored closely. When using this drug, hypersensitivity reactions such as rashes, itching, and in severe cases anaphylaxis can occur, so if these symptoms appear, discontinue use immediately and seek treatment. Neurological side effects such as headache, drowsiness, dizziness can occur rarely, and some patients may experience symptoms such as movement disorders or seizures. Gastrointestinal side effects may include diarrhea or constipation. Cardiac-related symptoms such as palpitations, blood pressure changes, and arrhythmias may occur rarely, and in severe cases, cardiac rhythm abnormalities can occur. Liver function test values may temporarily increase, and some patients may experience visual disturbances or temporary vision loss. Severe skin rashes may occur rarely, requiring caution. This drug is known not to affect the ability to drive or operate machinery; however, when used with other serotonergic drugs, there is a risk of serotonin syndrome, so patient monitoring is necessary. This drug does not significantly affect the metabolism of many other medications, but caution is needed as the blood concentration may change when used in combination with certain medications. Especially when used with phenytoin, carbamazepine, or rifampicin, this drug's effectiveness may be reduced. In case of overdose, symptoms like visual disturbances, severe constipation, hypotension, or cardiac rhythm abnormalities may occur, so if overdose is suspected, immediate notification of medical personnel is required, and ECG monitoring may be necessary. This drug should only be used once, and any remaining medication after opening should be discarded after immediate use or dilution. Store in a dark container to protect from light and keep out of reach of children; transferring to another container may compromise quality.

Rash, itching, anaphylaxis, headache, heaviness in the head, drowsiness, flushing, warmth in the head and abdomen, temporary increase in aminotransferases, dizziness, eye movement seizures, muscle rigidity abnormal reactions, movement disorders, seizures, diarrhea, constipation, palpitations, increased blood pressure, chest pain, arrhythmia, low blood pressure, bradycardia, QTc prolongation, temporary elevation in liver function tests, visual disturbances, vision loss, toxic skin rash, involuntary movements, warmth, general malaise, hiccups, sweating, vascular pain, local hypersensitivity reactions at the injection site, visual impairment, severe constipation, transient second-degree atrioventricular block, signs of vascular vagal nerve abnormalities

This medication is sensitive to light, so it should be stored in a dark container. It is also important to store it at a cool temperature below 30 degrees Celsius to maintain its effectiveness.

Appearance

A brown vial containing a colorless translucent liquid

Package unit

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