Ondant Tablets 8 mg (Ondansetron)

Adult dosage

Nausea and vomiting induced 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 per day of ondansetron, by oral, intravenous, or intramuscular administration. For relatively mildly emetogenic chemotherapy and radiotherapy: 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. 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, administer 8mg of ondansetron by slow intravenous injection (over at least 30 seconds) or intramuscular injection, followed by 2 additional doses of 8mg by intravenous injection (over at least 30 seconds) or intramuscular injection at 4-hour intervals, or administer by intravenous infusion at a rate of 1mg per hour for up to 24 hours. Alternatively, dilute 16mg of ondansetron in 50∼100mL of saline injection or another compatible injectable solution and administer by intravenous infusion over at least 15 minutes immediately before chemotherapy. Since the risk of QT prolongation increases in a dose-dependent manner, do not exceed a single dose of 16mg (injection only). The effect of this drug may be enhanced by slow intravenous injection of 20mg of dexamethasone sodium phosphate before chemotherapy (injection only). Oral dexamethasone sodium phosphate 12mg and a single oral dose of up to 24mg of ondansetron may be administered together 1~2 hours before chemotherapy (oral dosage form 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 in patients aged 65 to 74 years, follow the recommended adult dose. For all doses administered intravenously, dilute in 50∼100mL of saline injection or another compatible injectable solution and administer by intravenous infusion over at least 15 minutes. In patients aged 75 years or older, the initial intravenous dose must not exceed 8mg. For all doses administered intravenously, dilute in 50∼100mL of saline injection or another compatible injectable 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 drug is significantly reduced and the serum half-life is markedly prolonged; therefore, do not exceed 8mg per day. Postoperative nausea and vomiting — Adults Prevention of postoperative nausea and vomiting: Administer a single oral dose of 16mg 1 hour before induction of anesthesia. Administer a single dose of 4mg by slow intravenous or intramuscular injection at induction of anesthesia. Treatment of postoperative nausea and vomiting: Administer a single dose of 4mg by slow intravenous or intramuscular injection. Elderly patients: Experience with use in patients aged 65 years or older is limited; however, tolerability was good in patients who received 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 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: With repeated administration of this drug, no adjustment of the daily dose, dosing frequency, or route of administration is required.

Children's dosage

Nausea and vomiting induced by cytotoxic chemotherapy or radiotherapy — Pediatric patients (6 months and older) Body surface area-based dosage (6 months and older): < 0.6 ㎡ — Day 1: 5mg/㎡ intravenously, followed 12 hours later by 2mg orally; days 2–6: 2mg per dose orally every 12 hours. Do not exceed a maximum of 8mg by intravenous administration. The total daily dose should not exceed the adult dose of 32mg. Body surface area-based dosage (6 months and older): ≥ 0.6 ㎡, 1.2㎡ ≤ — Day 1: 5mg/㎡ intravenously, followed 12 hours later by 4mg orally; days 2–6: 4mg per dose orally every 12 hours. Do not exceed a maximum of 8mg by intravenous administration. The total daily dose should not exceed the adult dose of 32mg. Body surface area-based dosage (6 months and older): > 1.2㎡ — Day 1: 5mg/㎡ or 8mg intravenously, followed 12 hours later by 8mg orally; days 2–6: 8mg per dose orally every 12 hours. Do not exceed a maximum of 8mg by intravenous administration. The total daily dose should not exceed the adult dose of 32mg. Weight-based dosage (6 months and older): ≤ 10 kg — Day 1: 0.15 mg/kg per dose intravenously every 4 hours for up to 3 doses; days 2–6: 2mg per dose orally every 12 hours. Do not exceed a maximum of 8mg by intravenous administration. The total daily dose should not exceed the adult dose of 32mg. Weight-based dosage (6 months and older): > 10 kg — Day 1: 0.15 mg/kg per dose intravenously every 4 hours for up to 3 doses; days 2–6: 4mg per dose orally every 12 hours. Do not exceed a maximum of 8mg by intravenous administration. The total daily dose should not exceed the adult dose of 32mg. 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. Immediately before chemotherapy, administer ondansetron 5mg/㎡ (body surface area) intravenously. Administer the oral dose 12 hours after the intravenous dose, and continue for up to 5 days. Alternatively, immediately before chemotherapy, administer ondansetron 0.15 mg/kg intravenously. Two additional intravenous doses may be given at 4-hour intervals. Administer the oral dose 12 hours after the intravenous dose, and continue for up to 5 days. Do not exceed 8mg per intravenous dose. The total daily dose should not exceed the adult dose of 32mg. Postoperative nausea and vomiting — Pediatric patients (2 years and older) Prevention of postoperative nausea and vomiting: Administer a single dose of 0.1mg/kg, up to a maximum of 4mg, by slow intravenous injection before, during, or after induction of anesthesia. Treatment of postoperative nausea and vomiting: Administer a single dose of 0.1mg/kg, up to a maximum of 4mg, by slow intravenous injection. There are insufficient data for the prevention and treatment of postoperative nausea and vomiting in children younger than 2 years. 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, which is converted into phenylalanine in the body; therefore, patients with the genetic disorder phenylketonuria should not take this medication. Patients who have an allergic reaction to the components of this medication should also refrain from using it, and it should not be taken in conjunction with the specific medication apomorphine, as this may result in severe hypotension and loss of consciousness. Patients who have previously exhibited allergic reactions to similar medications should exercise particular caution when using this drug, as respiratory problems may arise, requiring close monitoring of symptoms. This medication can slow the movement of food through the intestine; thus, patients with intestinal obstruction symptoms should carefully monitor their condition after taking this medication. Patients with severely impaired liver function should also use this medication with caution, as it can prolong the intervals of cardiac electrical signals and increase the risk of arrhythmias, necessitating particular caution in patients with congenital heart issues or electrolyte imbalances. Before taking this medication, potassium and magnesium levels should be confirmed to be normal, and if deficient, supplementation should occur. Additionally, this medication may cause serotonin syndrome, a serious side effect, when taken with other medications that affect serotonin; therefore, close monitoring by healthcare providers is necessary for patients taking these medications concurrently. When using this medication to prevent postoperative nausea and vomiting, special observation should be given to the possibility of concealing bleeding. Children taking this medication alongside hepatotoxic anticancer drugs should carefully monitor liver function. During the course of using this medication, side effects such as skin rash, itching, headache, drowsiness, dizziness, diarrhea, constipation, abnormal heartbeats, elevated blood pressure, ST segment suppression, chest pain, arrhythmias, hypotension, bradycardia, temporary increases in liver function tests, vision impairment, vision loss, involuntary movements, heat sensation, facial flushing, fever, generalized fatigue, and hiccups may occur, so if these symptoms arise, immediate consultation with healthcare professionals is necessary. Driving or operating machinery may not be significantly affected, but caution is advised as effects can vary between individuals. The safety of this medication during pregnancy has not been established, so it is not recommended, and nursing mothers should discontinue breastfeeding as this medication can transfer to breast milk. In cases of overdose, visual disturbances, severe constipation, hypotension, cardiac electrical abnormalities, etc., may occur, requiring immediate medical attention and appropriate treatment, such as ECG monitoring. Do not press the blister when opening the packaging; peel off the foil and gently remove it. Store in a safe place out of the reach of children and avoid transferring it to another container.

Rash, itching, anaphylaxis, headache, heaviness, drowsiness, flushing, warmth in the head and abdomen, transient asymptomatic increase in aminotransferases, dizziness, ocular motor seizures, muscle tone abnormal response, movement disorders, seizures, diarrhea, constipation, palpitations, hypertension, chest pain, arrhythmia, hypotension, bradycardia, QTc prolongation, transient asymptomatic elevation in liver function test items, visual disturbances, loss of vision, toxic skin rash, toxic epidermal necrolysis, involuntary movements, feeling of warmth, facial flushing, fever, general malaise, hiccups, visual impairments, severe constipation, transient second-degree atrioventricular block, signs of vascular vagus nerve abnormalities

This medication should be stored in a tightly closed container to prevent air or moisture from entering, ideally in a cool place below 30 degrees Celsius. This will help maintain the effectiveness of the medication for a longer duration.

Appearance

White round tablet that dissolves in the mouth

Package unit

10 tablets/box [10 tablets/PTP×1]