Onsia Dosage/Direction for Use

Film-coated tablet: Dosage: Prevention of chemotherapy and/or radiotherapy-induced nausea and vomiting: Adult: For highly emetogenic chemotherapy: Administer 24 mg orally as a single dose 1-2 hours before the start of single-day chemotherapy and/or radiotherapy.
For emetogenic chemotherapy and/or radiotherapy: Administer 8 mg orally up to 1-2 hours before chemotherapy and/or radiotherapy, and subsequent dose of 8 mg is administered 8-12 hours after the first dose.
To protect against delayed emesis, 24 hours after chemotherapy and/or radiotherapy, Ondansetron 8 mg should be administered orally every 12 hours for up to 5 days after the end of chemotherapy and/or radiotherapy.
Children (4-11 years): For emetogenic chemotherapy and/or radiotherapy: Administer 4 mg orally 1-2 hours before chemotherapy and/or radiotherapy, subsequent doses of 4 mg are administered 4 and 8 hours after the first dose.
To protect against delayed emesis 24 hours after chemotherapy and/or radiotherapy Ondansetron 4 mg should be administered orally every 8 hours for 1-2 days after the end of chemotherapy and/or radiotherapy.
Prevention of post-operative nausea and vomiting: Adult: Administer 16 mg orally as a single dose 1 hour before anesthesia.
Dosage in children: Little information currently is available regarding dosage for children younger than 4 years of age.
Dosage in elderly: Dosage adjustment is not required.
Dosage in renal function impairment: Dosage adjustment is not required.
Plasma clearance is reduced to 50% in patients with severe renal function impairment (creatinine clearance less than 30 mL/min).
Dosage in hepatic function impairment: In patient with mild to moderate hepatic function impairment drug clearance is reduced 50% compared to patients with normal hepatic function and half-life is increased to 11.6 hours compared to 5.7 hours in patients with normal hepatic function.
The total daily dose in patient with moderate or severe liver disease should not exceed 8 mg.
Injection: Mode of Administration: ONSIA INJECTION is given by intravenous bolus injection (IV bolus injection) or intravenous infusion (IV infusion) as the hydrochloride dihydrate or IM injection.
IV bolus injection: The undiluted drug is administered by IV injection at least 2-5 minutes.
IV infusion: The drug should be diluted in 50 mL of compatible solutions such as dextrose 5% injection or sodium chloride 0.9% injection and infused IV over at least 15-30 minutes. Should be infused via IV infusion equipment.
Although Ondansetron injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. Do not store any unused portion of the IV infusion solution for reuse.
Parenteral drug product should be inspected visually for particulate matter and discoloration before administration.
Recommended Dose: Management of chemotherapy and/or radiotherapy-induced nausea and vomiting: Dose regimen of Ondansetron should be determined by the severity of emetic response caused by different chemotherapy and/or radiotherapy, and individual-patient assessment, or under the prescription.
Adult: Administered as a single 8 mg by slow IV or IM immediately before chemotherapy and/or radiotherapy.
For highly emetogenic chemotherapy: Administered as a single 8 mg by slow IV or IM immediately before chemotherapy as diluted in 50 mL of compatible solutions such as dextrose 5% injection or sodium chloride 0.9% injection over 15 minutes, beginning 30 minutes before chemotherapy; Or alternatively administered as a single 8 mg by slow IV or IM immediately before chemotherapy, followed by IV or IM 2 further doses of 8 mg 2-4 hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.
The efficacy of Ondansetron in highly emetogenic chemotherapy may be enhanced by giving IV dexamethasone sodium phosphate 20 mg before chemotherapy.
To protect against delayed emesis, followed by Ondansetron 8 mg orally twice daily for up to 5 days after the end of a course of chemotherapy.
Children (6 months to 17 years): Administered 5 mg/m² dose of Ondansetron by single IV dose immediately before chemotherapy and/or radiotherapy, followed by oral Ondansetron 4 mg 12 hours later, may be continued for up to 5 days after the end of a course of chemotherapy; Or administered as a single 8 mg by IV before chemotherapy followed by oral Ondansetron 8 mg 12 hours later, oral Ondansetron 8 mg can be given twice daily for up to 5 days after the end of a course of chemotherapy.
Children over 6 months of age administered single IV dose 0.15 mg/kg/dose (Not to excess 8 mg) before chemotherapy, subsequent doses are administered 4 and 8 hours after the first dose.
Prevention of post-operative nausea and vomiting: Adult: The recommended dose is 4 mg as a single by IV bolus injection or IM before induction of anesthesia.
Children (1 month to 17 years): weight less than 40 kg: Administered 0.1 mg/kg as a single dose by IV bolus injection at induction of anesthesia; weight more than 40 kg: Administered 4 mg as a single dose by IV bolus injection at induction of anesthesia.
Treatment of Post-operative nausea and vomiting: Adult: The recommended dose is 4 mg as a single dose by IV bolus injection or IM.
Children (1 month to 17 years): weight less than 40 kg: Administered 0.1 mg/kg as a single dose by IV bolus injection; weight more than 40 kg: Administered 4 mg as a single dose by IV bolus injection.
Dosage in children: Little information currently is available regarding dosages for children younger than 4 years of age.
Dosage in elderly: In elderly patients do not require Ondansetron dosage adjustment.
Dosage in renal function impairment: In patient with renal function impairment do not require Ondansetron dosage adjustment.
In patient with severe renal function impairment (creatinine clearance less than 30 mL/min) mean plasma clearance has been decreased by about 50%.
Dosage in hepatic function impairment: In patient with mild to moderate hepatic function impairment, clearance is reduced 2-fold and mean half-life is increased to 11.6 hours, compared with 5.7 hours in healthy patients.
In patient with severe hepatic function impairment, a single maximal daily dose of 8 mg to be infused over 15 minutes before chemotherapy and/or radiation 30 minutes.