Zofran Zydis 4 mg (Ondansetron)

Adult dosage

1. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy 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 appropriately selected within a range of 8∼32mg of ondansetron per day for oral, intravenous, or intramuscular administration. For chemotherapy and radiotherapy with relatively low emetogenic potential: Administer 8mg orally 1∼2 hours before chemotherapy or radiotherapy, and 8mg orally 12 hours later. To prevent delayed emesis, administer 8mg per dose twice daily by mouth for up to 5 days after treatment. For highly emetogenic chemotherapy (e.g., high-dose cisplatin): 12mg of oral dexamethasone sodium phosphate and a single dose of up to 24mg of ondansetron may be administered orally together 1~2 hours before chemotherapy. To prevent delayed emesis, administer 8mg per dose twice daily by mouth for up to 5 days after treatment. Older adults: Follow the recommended adult dose. Patients with renal impairment: No specific dosage adjustment is necessary. Patients with hepatic impairment: In patients with moderate to severe hepatic impairment, the clearance of this drug is significantly reduced and the 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 a single 16mg oral dose 1 hour before induction of anesthesia. Treatment of postoperative nausea and vomiting: Administer 4mg per dose by slow intravenous or intramuscular injection. Older adults: Experience with use in older adults aged 65 years and over is limited, but tolerability was good in patients receiving chemotherapy. Patients with renal impairment: No specific dosage adjustment is necessary. Patients with hepatic impairment: In patients with moderate to severe hepatic impairment, the clearance of this drug is significantly reduced and the 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 drug is unchanged in patients with impaired sparteine/debrisoquine metabolism. Since drug exposure in these patients does not differ from that in the general population after repeated administration, adjustment of the daily dose, dosing frequency, or route of administration is not necessary.

Children's dosage

1. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy Children (6 months and older): Immediately before chemotherapy, administer 5mg/㎡ (body surface area) of ondansetron by intravenous injection. Administer the oral dose 12 hours after the intravenous injection; treatment may continue for up to 5 days. Body surface area < 0.6 ㎡: On day 1, administer 5mg/㎡ intravenously, followed 12 hours later by 2mg orally; on days 2~6, administer 2mg per dose orally every 12 hours. Do not exceed 8mg by intravenous injection. The total daily dose should not exceed the adult dose of 32mg. Body surface area ≥ 0.6 ㎡, 1.2㎡ ≤: On day 1, administer 5mg/㎡ intravenously, followed 12 hours later by 4mg orally; on days 2~6, administer 4mg per dose orally every 12 hours. Do not exceed 8mg by intravenous injection. The total daily dose should not exceed the adult dose of 32mg. Body surface area > 1.2㎡: On day 1, administer 5mg/㎡ or 8mg intravenously, followed 12 hours later by 8mg orally; on days 2~6, administer 8mg per dose orally every 12 hours. Do not exceed 8mg by intravenous injection. The total daily dose should not exceed the adult dose of 32mg. Alternatively, immediately before chemotherapy, administer 0.15 mg/kg of ondansetron intravenously. Two further intravenous doses 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. Body weight ≤ 10 kg: On day 1, administer 0.15 mg/kg per dose intravenously every 4 hours for up to 3 doses; on days 2~6, administer 2mg per dose orally every 12 hours. Do not exceed 8mg by intravenous injection. The total daily dose should not exceed the adult dose of 32mg. Body weight > 10 kg: On day 1, administer 0.15 mg/kg per dose intravenously every 4 hours for up to 3 doses; on days 2~6, administer 4mg per dose orally every 12 hours. Do not exceed 8mg by intravenous injection. The total daily dose should not exceed the adult dose of 32mg. 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 Children (2 years and older): Since 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. Data on the prevention and treatment of postoperative nausea and vomiting in children under 2 years of age are insufficient.

This medication contains the artificial sweetener aspartame and should not be administered to patients with phenylketonuria, a genetic disorder. Additionally, patients who have had allergic reactions to this medication or those taking apomorphine hydrochloride may experience severe hypotension and loss of consciousness, so it should not be used in conjunction. Caution should also be taken when administering this medication to patients who have shown hypersensitivity to other selective 5-HT3 receptor antagonists, and patients with symptoms of intestinal obstruction should be observed particularly as this medication can delay gastrointestinal transit time. This medication should not be used in patients with severely impaired liver function or congenital long QT syndrome, and it should be used cautiously in patients at risk of electrolyte disturbances or cardiac arrhythmias. Furthermore, caution is advised when this medication is used in combination with serotonergic drugs, as serotonin syndrome may occur. Use of this medication is not recommended in early pregnancy, and breastfeeding women should discontinue nursing while taking this medication. In case of overdose, symptoms such as visual disturbances, severe constipation, and hypotension may occur, and immediate medical attention should be sought as there is no specific antidote, requiring treatment according to symptoms. Store this medication out of reach of children, and maintain it in its original packaging for safety.

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

This medication should be stored in a tightly closed container to keep out air and moisture, at a temperature below 30 degrees Celsius. This storage helps maintain the drug's efficacy and prevents degradation.

Appearance

White, round tablet that dissolves in the mouth with one side convex

Package unit

10 tablets (10 tablets/PTP packaging x 1)