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Anzemet (Dolasetron Mesylate Monohydrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ANZEMET Tablets are indicated for:

  • 1) the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, including initial and repeat courses;
  • 2) the prevention of postoperative nausea and vomiting.

DOSAGE AND ADMINISTRATION

The recommended doses of ANZEMET Tablets should not be exceeded.

Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting

Adults

The recommended oral dosage of ANZEMET (dolasetron mesylate) is 100 mg given within one hour before chemotherapy.

Pediatric Patients

The recommended oral dosage in pediatric patients 2 to 16 years of age is 1.8 mg/kg given within one hour before chemotherapy, up to a maximum of 100 mg. Safety and effectiveness in pediatric patients under 2 years of age have not been established.

Use in the Elderly, Renal Failure Patients, or Hepatically Impaired Patients

No dosage adjustment is recommended. (See Pharmacokinetics in Humans.)

Prevention of Postoperative Nausea and Vomiting

Adults

The recommended oral dosage of ANZEMET (dolasetron mesylate) is 100 mg within two hours before surgery.

Pediatric Patients

The recommended oral dosage in pediatric patients 2 to 16 years of age is 1.2 mg/kg given within two hours before surgery, up to a maximum of 100 mg. Safety and effectiveness in pediatric patients under 2 years of age have not been established.

Use in the Elderly, Renal Failure Patients, or Hepatically Impaired Patients

No dosage adjustment is recommended. (See Pharmacokinetics in Humans.)

HOW SUPPLIED

ANZEMET®
Tablets (dolasetron mesylate)
StrengthQuantityNDC NumberDescription
50 mg5 ct Bottle
10 ct Unit Dose Pack
0088-1202-05
0088-1202-43
Light pink, film coated, round tablet imprinted with "A" on one side and"50"on the other.
100 mg5 ct Bottle
10 ct Unit Dose
5 ct Blister Pack
0088-1203-05
0088-1203-43
0088-1203-29
Pink, film coated, elongated oval tablet imprinted with "100" on one side and "ANZEMET" on the other.

Store at controlled room temperature 20–25°C (68–77°F). Protect from light.

Prescribing Information as of August 2008

Manufactured by: Patheon Pharmaceuticals Inc.
Cincinnati, OH 45237

Manufactured for: sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

©2008 sanofi-aventis U.S. LLC

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