Product Description.:
ANZEMET, 100
tablet , film-coated , pink , oval oblong
Black ink
ANZEMET
(dolasetron mesylate) Tablets
DRUG DESCRIPTION
ANZEMET (dolasetron mesylate) is an antinauseant and antiemetic agent. Chemically, dolasetron mesylate is (2α,6α,8α,9aβ)-octahydro-3-oxo-2,6-methano-2H-quinolizin-8-yl-1H indole-3-carboxylate monomethanesulfonate, monohydrate. It is a highly specific and selective serotonin subtype 3 (5-HT3) receptor antagonist both in vitro and in vivo.
Dolasetron mesylate monohydrate is a white to off-white powder that is freely soluble in water and propylene glycol, slightly soluble in ethanol, and slightly soluble in normal saline.
Each ANZEMET Tablet for oral administration contains dolasetron mesylate (as the monohydrate) and also contains the inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch, synthetic red iron oxide, titanium dioxide, and white wax. The tablets are printed with black ink, which contains lecithin, pharmaceutical glaze, propylene glycol, and synthetic black iron oxide.
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
