Zofran Tablets 8 mg (Ondansetron Hydrochloride Hydrate)

Adult dosage

1. Nausea and vomiting induced 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) With relatively mildly emetogenic chemotherapy and radiotherapy ① Administer 8mg orally 1∼2 hours before chemotherapy or radiotherapy, 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) When administering highly emetogenic chemotherapy (e.g., high-dose cisplatin) ① 12mg of oral dexamethasone sodium phosphate and a single dose of up to 24mg of ondansetron may be administered together orally 1~2 hours before chemotherapy. ② To prevent delayed vomiting, administer 8mg per dose orally twice daily for up to 5 days after treatment. 3) Elderly patients Follow the recommended adult dose. 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 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 Administer a single 16mg dose orally 1 hour before induction of anesthesia. (2) Treatment of postoperative nausea and vomiting Administer 4mg per dose slowly by intravenous or intramuscular injection. 3) Elderly patients Experience with use in patients aged 65 years and 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 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. In these patients, repeated administration of this medicine does not result in drug exposure that differs 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 induced 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 based on body weight is higher than the total daily dose based on body surface area. Zofran 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 with 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 ondansetron 5mg/㎡ (body surface area) by intravenous injection. Administer the oral dose 12 hours after the intravenous injection; treatment may continue for up to 5 days. (Table 1) Table 1. Dose based on body surface area (6 months and 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: Do not exceed the adult total daily dose of 32mg. (2) Alternatively, immediately before chemotherapy, administer ondansetron 0.15 mg/kg by intravenous injection. Two additional intravenous injections may be administered at 4-hour intervals. Administer the oral dose 12 hours after the intravenous injection; treatment may continue for up to 5 days. (Table 2) Table 2. Dose based on body weight (6 months and older) ≤ 10 kg: Day 1 (a, b) 0.15 mg/kg per dose by intravenous injection every 4 hours, for a maximum of 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, for a maximum of 3 doses; Days 2~6 (b) 4mg per dose orally every 12 hours *a: Do not exceed 8mg by intravenous injection. b: Do not exceed the adult total daily dose of 32mg. (3) Do not exceed 8mg per intravenous injection. Do not exceed the adult total daily dose of 32mg. (4) There are no controlled clinical trial data on the prevention of delayed or persistent nausea and vomiting induced by emetogenic chemotherapy. There are no controlled pediatric clinical trial data on nausea and vomiting induced by radiotherapy. 2. Postoperative nausea and vomiting 2) Children (2 years and older) There are insufficient data in children under 2 years of age for the prevention and treatment of postoperative nausea and vomiting. 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 in patients who are hypersensitive to its ingredients. Additionally, since it contains lactose, it should not be administered to patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption. The use of this medication with apomorphine may lead to severe hypotension and loss of consciousness, so ondansetron and apomorphine should not be used together. Caution is also advised when using this medication in patients with hypersensitivity to other 5HT3 receptor antagonists, and immediate treatment is required in the event of respiratory adverse reactions. It may delay the gastric transit time, so patients with symptoms of subacute intestinal obstruction should be closely monitored after administration. In patients with severely impaired liver function, careful administration is required, and special caution is necessary for those with heart disease or electrolyte abnormalities due to the potential for QT interval prolongation. This medication should be administered only after correcting hypokalemia and hypomagnesemia. Additionally, when used concurrently with serotonergic medications such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), there is a risk of serotonin syndrome, so patient status should be closely monitored. When using this medication to prevent nausea and vomiting after adenoidectomy, potential bleeding may be concealed, so careful observation is required. In pediatric patients receiving hepatotoxic chemotherapy, liver function should be monitored closely. Some patients receiving this medication have reported myocardial ischemia, necessitating vigilance during and after administration. This medication may cause side effects such as headache, drowsiness, dizziness, diarrhea, or constipation, and rarely may result in arrhythmias or visual disturbances. In the event of severe hypersensitivity reactions, administration should be discontinued immediately, and appropriate treatment should be initiated. It is advisable not to use this medication during early pregnancy, and women of childbearing potential should confirm their pregnancy status before administration and use effective contraception during treatment. Breastfeeding women are advised to discontinue nursing since this medication can be transmitted through breast milk. In cases of overdose, symptoms such as visual disturbances, severe constipation, hypotension, and cardiac conduction abnormalities may occur, and since there is no specific antidote, appropriate treatment and monitoring according to symptoms are necessary. This medication should be kept out of the reach of children, and transferring it to another container is not advisable for quality maintenance.

Rash, itching, anaphylaxis, headache, heaviness, drowsiness, flushing, warmth in the head and abdomen, transient asymptomatic increase in aminotransferases, dizziness, ocular motor seizures, muscle rigidity reactions, dyskinesia, seizures, diarrhea, constipation, palpitations, elevated blood pressure, 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, warmth sensation, facial flushing, fever, generalized malaise, hiccups, myocardial ischemia, visual impairment, severe constipation, transient second-degree atrioventricular block, signs of vagus nerve dysfunction, serotonin syndrome

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is best stored at room temperature below 30 degrees Celsius. Proper storage will help maintain the drug's efficacy over time.

Appearance

Yellow, double convex, egg-shaped film-coated tablet

Package unit

15 tablets (5 tablets/PTP packaging x 3)