Onseran Tablets 8 mg (Ondansetron Hydrochloride)

Adult dosage

1. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy 1) Adults The emetogenic potential of cancer treatment varies depending on 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) For chemotherapy and radiotherapy with relatively low emetogenic potential ① 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. ② To prevent delayed vomiting, administer 8mg orally twice daily for up to 5 days after treatment. (2) For chemotherapy with high emetogenic potential (e.g., high-dose cisplatin) ① 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 continuous intravenous infusion at a rate of 1mg per hour for up to 24 hours. ② 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. ③ Because the risk of QT prolongation increases in a dose-dependent manner, do not exceed a single dose of 16mg (for injection only). ④ The effect of this drug may be enhanced by slow intravenous injection of 20mg of dexamethasone sodium phosphate before chemotherapy (for injection only). ⑤ 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 (for oral formulations only). ⑥ To prevent delayed vomiting, administer 8mg orally twice daily for up to 5 days after treatment. 3) Elderly patients ⦁Oral administration: Follow the recommended adult dose. ⦁Intravenous administration: For patients aged 65 to 74 years, follow 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 or 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. 4) Patients with renal impairment No specific dose adjustment is necessary. 5) Patients with hepatic impairment In patients with moderate to severe hepatic impairment, clearance of this drug is significantly reduced and its 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 ① Administer 16mg orally as a single dose 1 hour before induction of anesthesia. ② Administer 4mg as a single dose by slow intravenous or intramuscular injection at induction of anesthesia. (2) Treatment of postoperative nausea and vomiting Administer 4mg as a single dose by slow intravenous or intramuscular injection. 3) Elderly patients Experience with use in patients aged 65 years or older is limited; however, tolerability was good in patients who received chemotherapy. 4) Patients with renal impairment No specific dose adjustment is necessary. 5) Patients with hepatic impairment In patients with moderate to severe hepatic impairment, clearance of this drug is significantly reduced and its 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 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 when this drug is administered repeatedly, no adjustment of the daily dose, dosing frequency, or route of administration is necessary.

Children's dosage

1. Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy 2) Children (6 months and older) (1) Immediately before chemotherapy, administer 5mg/㎡ (body surface area) of ondansetron intravenously. Administer the oral dose 12 hours after the intravenous dose; treatment may continue for up to 5 days. (Table 1) Body surface area < 0.6 ㎡: On day 1, administer 5mg/㎡ intravenously, followed 12 hours later by 2mg orally; on days 2~6, administer 2mg orally per dose every 12 hours. The total daily dose must 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 orally per dose every 12 hours. The total daily dose must 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 orally per dose every 12 hours. The intravenous dose must not exceed 8mg. The total daily dose must not exceed the adult dose of 32mg. (2) Alternatively, immediately before chemotherapy, administer 0.15 mg/kg of ondansetron intravenously. Two additional intravenous doses may be administered at 4-hour intervals. Administer the oral dose 12 hours after the intravenous dose; treatment may continue for up to 5 days. (Table 2) 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 orally per dose every 12 hours. The intravenous dose must not exceed 8mg. The total daily dose must 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 orally per dose every 12 hours. The intravenous dose must not exceed 8mg. The total daily dose must not exceed the adult dose of 32mg. (3) The intravenous dose must not exceed 8mg. The total daily dose must not exceed the adult dose of 32mg. (4) There are no controlled clinical trial data on 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 2) Children (2 years and older) (1) Prevention of postoperative nausea and vomiting Before, at, or after induction of anesthesia, administer 0.1mg/kg up to a maximum of 4mg as a single dose by slow intravenous injection. (2) Treatment of postoperative nausea and vomiting Administer 0.1mg/kg up to a maximum of 4mg as a single dose by slow intravenous injection. (3) Data are insufficient for children under 2 years of age regarding prevention and treatment of postoperative nausea and vomiting. (4) Since no clinical trials have been conducted on the use of oral ondansetron for prevention and treatment of postoperative nausea and vomiting, slow intravenous injection (over at least 30 seconds) is recommended.

This medicine contains the artificial sweetener aspartame and should not be used by patients with the hereditary condition phenylketonuria. The daily allowable amount of aspartame should be controlled to be below the WHO recommended level, and it should not exceed a maximum of 2.4g for adults per day. Patients with allergic reactions to this medication or those taking apomorphine hydrochloride should not use this drug. Particularly, when used in conjunction with apomorphine, severe hypotension and loss of consciousness can occur, so it should be strictly avoided. Patients who have had allergic reactions to other 5-HT3 receptor antagonists may experience hypersensitivity reactions to this medication, so caution is necessary. It may delay the transit time of food through the intestine, so patients with subacute bowel obstruction symptoms should be closely monitored after use. Patients with severe liver impairment should use this medication cautiously. This medication can extend the QT interval, hence caution or avoidance is warranted in patients with congenital long QT syndrome, electrolyte abnormalities, heart failure, or arrhythmias. When this medication is used with other serotonergic drugs, serotonin syndrome may occur, thus close monitoring of the patient is required when used together. In patients undergoing adenoid tonsil surgery, the risk of bleeding can be concealed, necessitating careful observation after administration. Pediatric patients undergoing hepatotoxic chemotherapy should have liver function monitored carefully. This medication may cause hypersensitivity reactions such as rash, itching, and in severe cases anaphylaxis, so treatment should be immediately discontinued at the first sign of symptoms. Neurological disturbances such as headache, drowsiness, dizziness, movement disorders, and seizures may occur, as well as gastrointestinal symptoms like diarrhea or constipation. Cardiovascular discrepancies such as palpitations, blood pressure changes, arrhythmias, hypotension, bradycardia have been reported, and arrhythmias can occur rarely. Transient elevations in liver enzyme levels and visual disturbances or temporary vision loss may occur, requiring caution. Rarely, severe skin rashes or toxic skin reactions may occur. This medication does not significantly affect the ability to drive or operate machinery, but caution is necessary for the potential of serotonin syndrome when used with other serotonergic drugs. This medication is metabolized by several liver enzymes, and there may be interactions with specific drugs, so it is essential to inform about any concomitant medications. Safety during pregnancy has not been established, and as this medication is secreted in breast milk, it is recommended to discontinue breastfeeding while on the drug. In case of overdose, symptoms like visual impairment, severe constipation, hypotension, cardiac electrical abnormalities may occur, thus immediate medical attention and appropriate treatment are necessary. Do not push the blister pack to remove the tablet; gently take it out after peeling off the foil and keep it out of reach of children. Moreover, transferring the medication to another container can be detrimental to maintaining quality, so care is advised.

Rash, itching, anaphylaxis, headache, heaviness, drowsiness, flushing, warmth in the head and abdomen, temporary increase in aminotransferases, dizziness, ocular myoclonus, abnormal muscle tone reactions, movement disorders, seizures, diarrhea, constipation, palpitations, elevated blood pressure, ST segment suppression, chest pain, arrhythmia, hypotension, bradycardia, QTc prolongation, temporary rise in liver function test values, visual impairment, loss of vision, toxic skin rash, Stevens-Johnson syndrome, involuntary movements, sensation of heat, facial flushing, fever, malaise, hiccups, visual disturbances, severe constipation, hypotension, transient second-degree atrioventricular block, vagal nerve symptoms of the vascular system, serotonin syndrome

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 degree and 30 degrees Celsius to maintain the medication's effectiveness over time.

Appearance

White round tablet that dissolves in the mouth

Package unit

12 tablets (4 tablets/PTP x 3)