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Anzemet Injection

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Anzemet Injection

Indications
Dosage
How Supplied

INDICATIONS

ANZEMET Injection (dolasetron mesylate injection) is indicated for the following:

(1) the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high dose cisplatin;
(2)  the prevention of postoperative nausea and 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 where nausea and/or vomiting must be avoided postoperatively, ANZEMET Injection is recommended even where the incidence of postoperative nausea and/or vomiting is low;
(3) the treatment of postoperative nausea and/or vomiting.

DOSAGE AND ADMINISTRATION

The recommended dose of ANZEMET Injection (dolasetron mesylate injection) should not be exceeded.

Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting

Adults

The recommended intravenous dosage of ANZEMET Injection (dolasetron mesylate 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 (dolasetron mesylate injection) mixed in apple or apple-grape juice may be used for oral dosing of pediatric patients. When ANZEMET Injection (dolasetron mesylate 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 (dolasetron mesylate 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 (dolasetron mesylate injection) mixed in apple or apple-grape juice may be used for oral dosing of pediatric patients. When ANZEMET Injection (dolasetron mesylate 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 (dolasetron mesylate 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 (dolasetron mesylate injection) should not be mixed with other drugs. Flush the infusion line before and after administration of ANZEMET Injection (dolasetron mesylate injection) .

Stability

After dilution, ANZEMET Injection (dolasetron mesylate 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 (dolasetron mesylate 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.

HOW SUPPLIED

ANZEMET Injection (dolasetron mesylate injection) is supplied as a clear, colorless solution in single and multidose vials, and Carpuject® sterile cartridges with Luer Lock.

ANZEMET® Injection
(dolasetron mesylate injection)
20 mg/mL
Strength Description NDC Number
     
12.5 mg 12.5 mg 0.625mL single use vial* (Box of 6) 0088-1208-06
12.5 mg 0.625mL fill in single-use 2mL Carpuject with Luer Lock
(Box of 10)
0088-1208-76
100 mg/5 mL 5mL single-use vial* 0088-1206-32
500 mg/25 mL 25 mL multidose vial* 0088-1209-26

Store at 20-25°C (68-77°F) with excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Protect from light.

Prescribing information as of June 2006
Mfd by Hospira, Inc. McPherson, KS 67460 USA
Mfd. for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 Carpuject is a registered trademark of Hospira Inc.
FDA Rev date: 6/30/2007

Last reviewed on RxList: 10/27/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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