Ondansetron Hydrochloride Injection

【DOSAGE FORMS AND STRENGTHS】C₁₈H₁₉N_30：2ml:4mg，4ml:8mg

【 INDICATIONS AND USAGE】

1. Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy

Ondansetron Hydrochloride Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.

Ondansetron Hydrochloride is approved for patients aged 6 months and older.

2. Prevention of Postoperative Nausea and/or Vomiting

Ondansetron Hydrochloride Injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Hydrochloride Injection  is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Hydrochloride Injection  and experience nausea and/or vomiting postoperatively, Ondansetron Hydrochloride Injection  may be given to prevent further episodes.

Ondansetron Hydrochloride is approved for patients aged 1 month and older.

【DOSAGE AND ADMINISTRATION】

1. Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Chemotherapy

Important Preparation Instructions

Dilution of Ondansetron Hydrochloride Injection in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection is required before administration to adult and pediatric patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy.
For pediatric patients between 6 months and 1 year of age and/or 10 kg or less: Depending on the fluid needs of the patient, Ondansetron Hydrochloride Injection may be diluted in 10 to 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

Occasionally, ondansetron 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.

Do not mix Ondansetron Hydrochloride Injection with solutions for which physical and chemical compatibility has not been established. In particular, this applies to alkaline solutions as a precipitate may form.

Inspect the diluted Ondansetron Hydrochloride Injection solution for particulate matter and discoloration before administration; discard if present.

Storage: After dilution, do not use beyond 24 hours. Although Ondansetron Hydrochloride Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. 

Compatibility: Ondansetron Hydrochloride Injection is compatible and stable at room temperature under normal lighting conditions for 48 hours after dilution with the following intravenous fluids: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, and 3% Sodium Chloride Injection.

Dosage and Administration

The recommended dosage for adult and pediatric patients 6 months of age and older for prevention of nausea and vomiting associated with emetogenic chemotherapy is 0.15-mg/kg per dose for 3 doses (maximum of 16 mg per dose).

Caution: Dilution of Ondansetron Hydrochloride Injection is required in adult and pediatric patients prior to administration.

Infuse intravenously over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy and then repeat 4 and 8 hours after the first dose.

2. Prevention of Postoperative Nausea and/or Vomiting

Important Preparation Instructions

· Dilution ofOndansetron Hydrochloride Injection is not required before administration to adult and pediatric patients.

· Inspect Ondansetron Hydrochloride Injection visually for particulate matter and discoloration before administration; discard if present.

· Dosage and Administration

· The recommended dose and administration instructions for adult and pediatric patients 1 month of age and older for prevention of postoperative nausea and vomiting are shown in Table 1.

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3.Dosage Adjustment for Patients With Hepatic Impairment

· 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