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Onzet

Onzet Dosage/Direction for Use

ondansetron

Manufacturer:

Cathay Drug

Distributor:

Cathay Drug
Full Prescribing Info
Dosage/Direction for Use
Tablet: ADULTS: 8 mg can be given by mouth up to 2 hours before treatment followed by 8 mg to 12 hours later.
To protect against delayed emesis, these regimens are followed by Ondansetron 8 mg by mouth twice daily for up to 5 days after the end of a course of chemotherapy.
Or as prescribed by the physician.
PEDIATRIC USE: For children aged 4 to 11 years a dose of 4 mg can be given 30 minutes before start of chemotherapy, with subsequent 4 mg doses given 4 and 8 hours thereafter. A dose of 4 mg three times daily by mouth may be given for 1 to 2 days after the end of chemotherapy.
PREVENTION AND TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING: Adults: 16 mg orally an hour before anaesthesia or 8 mg orally an hour before anaesthesia followed by 2 further doses of 8 mg at 8-hour intervals.
PATIENTS WITH RENAL/HEPATIC IMPAIRMENT Patients with renal impairment: A total dose should not exceed 8 mg.
Injection: Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Chemotherapy:
Ondansetron (Onzet) Injection should be diluted in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection before administration.
Adults: The recommended adult intravenous dosage of Ondansetron (Onzet) Injection is a single 32-mg dose or three 0.15-mg/kg doses. A single 32-mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Efficacy of the 32-mg single dose beyond 24 hours has not been established. The recommended infusion rate should not be exceeded. With the three-dose (0.15-mg/kg) regimen, the first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Ondansetron Injection.
Pediatrics: For pediatric patients 6 months through 18 years of age, the intravenous dosage of Ondansetron (Onzet) Injection is three 0.15-mg/kg doses. The first dose is to be administered 30 minutes before the start of moderately to highly emetogenic chemotherapy. Subsequent doses (0.15 mg/kg) are administered 4 and 8 hours after the first dose of Ondansetron (Onzet) Injection. The drug should be infused intravenously over 15 minutes.
Prevention of Postoperative Nausea and Vomiting: Ondansetron (Onzet) Injection should not be mixed with solutions for which physical and chemical compatibility have not been established. In particular, this applies to alkaline solutions as a precipitate may form.
Adults: The recommended adult intravenous dosage of Ondansetron (Onzet) Injection is 4 mg undiluted administered intravenously in not less than 30 seconds, preferably over 2 to 5 minutes, immediately before induction of anesthesia, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring within 2 hours after surgery. Alternatively, 4 mg undiluted may be administered intramuscularly as a single injection for adults. While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, intravenous dose of ondansetron (Onzet) 4 mg, administration of a second intravenous dose of 4 mg ondansetron (Onzet) postoperatively does not provide additional control of nausea and vomiting.
Pediatrics: For pediatric patients 1 month through 12 years of age, the dosage is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg. The rate of administration should not be less than 30 seconds, preferably over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively if the patient did not receive prophylactic antiemetics and experiences nausea and/or vomiting occurring shortly after surgery. Prevention of further nausea and vomiting was only studied in patients who had not received prophylactic Ondansetron (Onzet) Injection or as prescribed by the physician.
Stability and Handling: After dilution, do not use beyond 24 hours. Although Ondansetron (Onzet) Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain a preservative.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
Precaution: Occasionally, ondansetron (Onzet) precipitates at the stopper/vial interface in vials stored upright. Potency and safety are not affected. If a precipitate is observed, resolubilize by shaking the vial vigorously.
Dosage Adjustment for Patients with Impaired Hepatic Function: In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), a single maximal daily dose of 8 mg infused over 15 minutes beginning 30 minutes before the start of the emetogenic chemotherapy is recommended. There is no experience beyond first-day administration of ondansetron in these patients.
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