Onseran Tablets 4 mg (Ondansetron Hydrochloride)

Adult dosage

Place this medicine on the tongue and swallow it once it has dispersed within a few seconds. 1. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy Adults The emetogenicity 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 and administered within a range of 8∼32mg of ondansetron per day, by oral, intravenous, or intramuscular administration. For chemotherapy and radiotherapy with relatively low emetogenic potential: Immediately before chemotherapy or radiotherapy, slowly administer 8mg of ondansetron intravenously (over at least 30 seconds) or intramuscularly, or administer 8mg orally 1∼2 hours before treatment, followed by 8mg orally 12 hours later. To prevent delayed vomiting, administer 8mg orally twice daily for up to 5 days after treatment. For administration of highly emetogenic chemotherapeutic agents (e.g., high-dose cisplatin): Immediately before chemotherapy, slowly administer 8mg of ondansetron intravenously (over at least 30 seconds) or intramuscularly, followed by 2 additional intravenous (over at least 30 seconds) or intramuscular doses of 8mg at 4-hour intervals, or administer by continuous intravenous infusion at a rate of 1mg per hour for up to 24 hours. 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. Do not exceed a single dose of 16mg, as the risk of QT prolongation increases in a dose-dependent manner (for injection only). The effect of this medicine may be enhanced by slowly administering 20mg of dexamethasone sodium phosphate intravenously before chemotherapy (for injection only). 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). To prevent delayed vomiting, administer 8mg orally twice daily for up to 5 days after treatment. Elderly patients: For oral administration, follow the recommended adult dose. For intravenous administration, patients aged 65~74 years should receive the recommended adult dose. 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 and 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. Patients with renal impairment: No special dosage adjustment is required. 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 Adults, prevention of postoperative nausea and vomiting: Administer 16mg orally as a single dose 1 hour before induction of anesthesia. Slowly administer 4mg intravenously or intramuscularly as a single dose at induction of anesthesia. Adults, treatment of postoperative nausea and vomiting: Slowly administer 4mg intravenously or intramuscularly as a single dose. Elderly patients: Experience with use in patients aged 65 years and older is limited; however, tolerability was good in patients receiving chemotherapy. Patients with renal impairment: No special dosage adjustment is required. 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. 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 to these patients results in drug exposure comparable to that in the general population; therefore, no adjustment of the daily dose, dosing frequency, or route of administration is required.

Children's dosage

Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy, children (6 months and older), body surface area < 0.6 ㎡: On day 1, administer 5mg/㎡ (body surface area) of ondansetron intravenously immediately before chemotherapy, then administer 2mg orally 12 hours later; on days 2~6, administer 2mg orally every 12 hours. Do not exceed 8mg by intravenous administration. The total daily dose must not exceed the adult dose of 32mg. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy, children (6 months and older), body surface area ≥ 0.6 ㎡, 1.2㎡ ≤: On day 1, administer 5mg/㎡ (body surface area) of ondansetron intravenously immediately before chemotherapy, then administer 4mg orally 12 hours later; on days 2~6, administer 4mg orally every 12 hours. Do not exceed 8mg by intravenous administration. The total daily dose must not exceed the adult dose of 32mg. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy, children (6 months and older), body surface area > 1.2㎡: On day 1, administer 5mg/㎡ or 8mg of ondansetron intravenously immediately before chemotherapy, then administer 8mg orally 12 hours later; on days 2~6, administer 8mg orally every 12 hours. Do not exceed 8mg by intravenous administration. The total daily dose must not exceed the adult dose of 32mg. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy, children (6 months and older), body weight ≤ 10 kg: On day 1, administer 0.15 mg/kg of ondansetron intravenously immediately before chemotherapy, then administer 0.15 mg/kg intravenously every 4 hours for up to 3 doses; on days 2~6, administer 2mg orally every 12 hours. Do not exceed 8mg by intravenous administration. The total daily dose must not exceed the adult dose of 32mg. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy, children (6 months and older), body weight > 10 kg: On day 1, administer 0.15 mg/kg of ondansetron intravenously immediately before chemotherapy, then administer 0.15 mg/kg intravenously every 4 hours for up to 3 doses; on days 2~6, administer 4mg orally every 12 hours. Do not exceed 8mg by intravenous administration. The total daily dose must not exceed the adult dose of 32mg. Postoperative nausea and vomiting, children (2 years and older), prevention of postoperative nausea and vomiting: Before, during, or after induction of anesthesia, slowly administer 0.1mg/kg intravenously as a single dose, up to a maximum of 4mg. Postoperative nausea and vomiting, children (2 years and older), treatment of postoperative nausea and vomiting: Slowly administer 0.1mg/kg intravenously as a single dose, up to a maximum of 4mg. Postoperative nausea and vomiting, under 2 years: Data are insufficient regarding the prevention and treatment of postoperative nausea and vomiting in children under 2 years.

This medicine contains the artificial sweetener aspartame and should not be administered to patients with phenylketonuria, a hereditary disease. The daily allowable dose of aspartame is restricted to less than 40mg per kg of body weight, so the minimum amount should be used if possible. Patients who have hypersensitivity to this medication or are taking another drug called apomorphine should not use this medication. Patients who have shown allergic reactions to similar classes of medications in the past should be especially cautious when using this medication. This medication may delay the passage of food through the intestines, so patients with symptoms of bowel obstruction should be monitored carefully after use. Patients with severely impaired liver function should also use this medication with caution. This medication can prolong the QT interval of cardiac electrical signals, so patients with congenital long QT syndrome or cardiac issues such as electrolyte imbalance, heart failure, or bradycardia should be cautious. Additionally, patients with hypokalemia and hypomagnesemia must correct these conditions before medication administration. There may be a risk of serotonin syndrome, a serious side effect, when used with other serotonergic medications, so it should be taken under a doctor’s supervision. When used for the prevention of nausea and vomiting following adenoid tonsillectomy, close monitoring for the possibility of bleeding is necessary. Pediatric patients undergoing hepatotoxic chemotherapy should closely monitor their liver function. This medication may occasionally cause skin rashes, itching, or rarely severe allergic reactions such as anaphylaxis, so administration should be stopped immediately if symptoms occur. Neurological adverse reactions such as headaches, drowsiness, dizziness, movement disorders, or seizures have also been reported, so caution is required. Gastrointestinal symptoms such as diarrhea or constipation may also occur. Cardiac side effects may include palpitations, changes in blood pressure, arrhythmias, hypotension, and rarely serious heart rhythm abnormalities. There may be a temporary increase in liver function test values and transient visual disturbances, so these symptoms should be monitored. Rarely, severe skin conditions may occur, so skin conditions should be closely monitored. This medication does not significantly affect driving or machinery operation, but changes in mental state or neuromuscular symptoms may occur when taken with other serotonergic medications, so caution is advised. This medication is metabolized by several liver enzymes, so there is a possibility of interactions with other drugs, especially when used with certain anticonvulsants, antibiotics, or antiarrhythmics, the risk of side effects may increase. The safety during pregnancy has not been established, therefore it is not recommended for use in pregnant women, and breastfeeding should be discontinued if nursing. In case of overdose, visual disturbances, severe constipation, hypotension, cardiac conduction abnormalities may occur, and immediate medical attention should be sought as there is no specific antidote for this medication. The packaged tablets should be removed gently after peeling off the foil and stored out of reach of children. Transferring to another container can cause accidents or quality deterioration, so caution is required.

Rash, itching, anaphylaxis, headache, heaviness, drowsiness, flushing, warmth in the head and abdomen, transient asymptomatic increase in aminotransferases, dizziness, ocular motor seizures, muscle rigidity abnormal reactions, movement disorders, seizures, diarrhea, constipation, palpitations, hypertension, chest pain, arrhythmia, hypotension, bradycardia, QTc prolongation, transient asymptomatic increase in liver function test items, transient visual disturbances, transient vision loss, toxic skin rash, toxic epidermal necrolysis, involuntary movements, heat sensation, facial flushing, fever, general fatigue, hiccups

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is safe to store at room temperature between 1°C and 30°C.

Appearance

White round tablet that dissolves in the mouth

Package unit

12 tablets (4 tablets/PTP x 3)