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Anzemet Indications, Dosage, Storage, Stability - Dolasetron

Anzemet Indications, Dosage, Storage, Stability - Dolasetron

INDICATIONS

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®
(dolasetron mesylate)
Tablets
Strength Quantity NDC Number

DESCRIPTION

50 mg 5 ct Bottle
10 ct Unit Dose
5 ct Blister Pack
0088-1202-05
0088-1202-43
0088-1202-29
Light pink, film coated, round tablet imprinted with "ANZEMET 50" on one side.
100 mg 5 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.

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