Zofran Zydis 8 mg (Ondansetron)

Adult dosage

1. Nausea and vomiting due to cytotoxic chemotherapy or radiotherapy 1) Adults The emetogenic potential of cancer treatment varies depending on the dose of chemotherapy agents, concomitant medications, and type of radiotherapy. The route and dose may be appropriately selected within the range of 8∼32mg of ondansetron daily, administered orally, intravenously, or intramuscularly. (1) For chemotherapy agents and radiotherapy with relatively low emetogenic potential 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 twice daily for up to 5 days after treatment. (2) For highly emetogenic chemotherapy agents (e.g., high-dose cisplatin) ① Up to 24mg of ondansetron may be administered orally as a single dose together with 12mg of oral dexamethasone sodium phosphate 1~2 hours before chemotherapy. ② To prevent delayed vomiting, administer 8mg per dose 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 required. 5) Patients with hepatic impairment In patients with moderate to severe hepatic impairment, the clearance of this medication is substantially reduced and the serum half-life is markedly prolonged; therefore, do not exceed 8mg daily. 2. Postoperative nausea and vomiting 1) Adults (1) Prevention of postoperative nausea and vomiting Administer 16mg orally as a single dose 1 hour before induction of anesthesia. (2) Treatment of postoperative nausea and vomiting Administer 4mg per dose by slow intravenous or intramuscular injection. 3) Elderly patients Experience with use in patients aged 65 years and older is limited, but tolerability was good in patients receiving chemotherapy. 4) Patients with renal impairment No special dosage adjustment is required. 5) Patients with hepatic impairment In patients with moderate to severe hepatic impairment, the clearance of this medication is substantially reduced and the serum half-life is markedly prolonged; therefore, do not exceed 8mg daily. 6) Patients with impaired sparteine/debrisoquine metabolism The elimination half-life of this medication is unchanged in patients with impaired sparteine/debrisoquine metabolism. As drug exposure in these patients does not differ from that in the general population when this medication is administered repeatedly, no adjustment of the daily dose, frequency, or route of administration is required.

Children's dosage

1. Nausea and vomiting due to cytotoxic chemotherapy or radiotherapy 2) Children (6 months and older) (1) Immediately before chemotherapy, administer ondansetron 5mg/㎡ (body surface area) by intravenous injection. Administer orally 12 hours after the intravenous injection; treatment may be continued for up to 5 days. (Table 1) < 0.6 ㎡: Day 1, administer 5mg/㎡ intravenously, then 2mg orally 12 hours later; 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. ≥ 0.6 ㎡, 1.2㎡ ≤: Day 1, administer 5mg/㎡ intravenously, then 4mg orally 12 hours later; 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. > 1.2㎡: Day 1, administer 5mg/㎡ or 8mg intravenously, then 8mg orally 12 hours later; 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. (2) Alternatively, immediately before chemotherapy, administer ondansetron 0.15 mg/kg intravenously. Two additional intravenous injections may be given at 4-hour intervals. Administer orally 12 hours after the intravenous injection; treatment may be continued for up to 5 days. (Table 2) ≤ 10 kg: Day 1, administer 0.15 mg/kg per dose intravenously every 4 hours for up to 3 doses; 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. > 10 kg: Day 1, administer 0.15 mg/kg per dose intravenously every 4 hours for up to 3 doses; 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. (3) Do not exceed 8mg by intravenous injection. The total daily dose should not exceed the adult dose of 32mg. 2. Postoperative nausea and vomiting 2) Children (2 years and older) There are insufficient data on 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 contains the artificial sweetener aspartame and should not be administered to patients with phenylketonuria, a genetic disorder. Patients allergic to any ingredient of this medication should not use it, and it should not be used in combination with the drug apomorphine as it may cause severe hypotension and loss of consciousness. Patients who have had allergic reactions to similar medications in the past should be cautious, as allergic reactions may occur with this medication as well. This medication may slow intestinal food transit, so patients with symptoms of intestinal obstruction should carefully monitor their condition after taking it. It should be used with caution in patients with severe liver impairment, and it may prolong the QT interval, which is an electric signal related to heartbeats, so those with heart disease or electrolyte imbalances should be cautious. When used in conjunction with other serotonin-related medications, there is a risk of serotonin syndrome, a serious side effect, so careful monitoring is required. When this medication is used to prevent vomiting after adenoidectomy, there may be a risk of masking bleeding signs, so caution is warranted. Children receiving liver-toxic chemotherapy should have their liver function closely monitored, and symptoms of myocardial ischemia have been reported while taking this medication, necessitating vigilance during and after administration. If rash, itching, or severe allergic reactions occur while taking this medication, usage should be stopped immediately and appropriate treatment sought. Neurological symptoms such as headache, dizziness, drowsiness, or movement disorders, as well as digestive symptoms like diarrhea or constipation may occur. Cardiac irregularities, blood pressure changes, and, in rare cases, cardiac rhythm disturbances may be observed, along with transient increases in liver function test values. Transient visual disturbances or skin rashes, fever, and facial flushing can also occur rarely. This medication does not significantly affect the ability to drive or operate machinery; however, when taken with other serotonergic medications, the risk of serotonin syndrome should be considered, and guidance from a physician should be followed. This medication is metabolized by several hepatic enzymes, so there may be interactions with some drugs, particularly when used with specific antiepileptic or antibiotic agents. Use of this medication is not recommended in early pregnancy, and women of childbearing potential should confirm pregnancy before use and ensure effective contraception while taking it. Breastfeeding women should discontinue breastfeeding as this medication may be passed into breast milk. In case of overdose, symptoms such as visual disturbances, severe constipation, and hypotension may occur, and medical consultation should be sought immediately, as there is no specific antidote, and symptomatic treatment is necessary. This medication should not be extracted from the blister by pressing; instead, gently remove it by peeling off the foil. After use, store it in a safe place out of reach of children, and it is advisable not to transfer it to another container.

Rash, itching, anaphylaxis, headache, heaviness, drowsiness, flushed face, warmth in the head and abdomen, transient asymptomatic increase in aminotransferases, dizziness, ocular myoclonus, muscular hypertonicity, movement disorders, seizures, diarrhea, constipation, palpitations, increased blood pressure, chest pain, arrhythmia, hypotension, bradycardia, QTc prolongation, transient asymptomatic elevation in liver function tests, visual impairment, vision loss, toxic skin rash, toxic epidermal necrolysis, involuntary movements, warmth, facial flushing, fever, generalized malaise, hiccups, myocardial ischemia

This medication should be stored in a sealed container to prevent air or moisture from entering, and the temperature should be maintained below 30 degrees Celsius. Therefore, it is important to store it in a cool place away from direct sunlight.

Appearance

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

Package unit

10 tablets (10 tablets/PTP pack X1)