DOSAGE AND ADMINISTRATION
The recommended dose of ANZEMET Injection should not be exceeded.
Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting
Adults
The recommended intravenous dosage of ANZEMET Injection from clinical trial results is 1.8 mg/kg given as a single dose approximately 30 minutes before chemotherapy (see Administration). Alternatively, for most patients, a fixed dose of 100 mg can be administered over 30 seconds.
Pediatric Patients
The recommended intravenous dosage in pediatric patients 2 to 16 years of age is 1.8 mg/kg given as a single dose approximately 30 minutes before chemotherapy, up to a maximum of 100 mg (see Administration). Safety and effectiveness in pediatric patients under 2 years of age have not been established.
ANZEMET Injection mixed in apple or apple-grape juice may be used for oral dosing of pediatric patients. When ANZEMET Injection is administered orally, the recommended dosage in pediatric patients 2 to 16 years of age is 1.8 mg/kg up to a maximum 100 mg dose given within 1 hour before chemotherapy.
The diluted product may be kept up to 2 hours at room temperature before use.
Use in the Elderly, in Renal Failure Patients, or in Hepatically Impaired Patients
No dosage adjustment is recommended.
Prevention or Treatment of Postoperative Nausea and/or Vomiting
Adults
The recommended intravenous dosage of ANZEMET Injection is 12.5 mg given as a single dose approximately 15 minutes before the cessation of anesthesia (prevention) or as soon as nausea or vomiting presents (treatment).
Pediatric Patients
The recommended intravenous dosage in pediatric patients 2 to 16 years of age is 0.35 mg/kg, with a maximum dose of 12.5 mg, given as a single dose approximately 15 minutes before the cessation of anesthesia or as soon as nausea or vomiting presents. Safety and effectiveness in pediatric patients under 2 years of age have not been established.
ANZEMET Injection mixed in apple or apple-grape juice may be used for oral dosing of pediatric patients. When ANZEMET Injection is administered orally, the recommended oral dosage in pediatric patients 2 to 16 years of age is 1.2 mg/kg up to a maximum 100-mg dose given within 2 hours before surgery. The diluted product may be kept up to 2 hours at room temperature before use.
Use in the Elderly, in Renal Failure Patients, or in Hepatically Impaired Patients
No dosage adjustment is recommended.
ADMINISTRATION
ANZEMET Injection can be safely infused intravenously as rapidly as 100 mg/30 seconds or diluted in a compatible intravenous solution (see below) to 50 mL and infused over a period of up to 15 minutes. ANZEMET Injection should not be mixed with other drugs. Flush the infusion line before and after administration of ANZEMET Injection.
STABILITY
After dilution, ANZEMET Injection is stable under normal lighting conditions at room temperature for 24 hours or under refrigeration for 48 hours with the following compatible intravenous fluids: 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.45% sodium chloride injection, 5% dextrose and Lactated Ringer's injection, Lactated Ringer's injection, and 10% mannitol injection. Although ANZEMET Injection is chemically and physically stable when diluted as recommended, sterile precautions should be observed because diluents generally do not contain preservative. After dilution, do not use beyond 24 hours, or 48 hours if refrigerated.
Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
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