"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
ANZEMET Tablets are indicated for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, including initial and repeat courses in adults and children 2 years and older.
DOSAGE AND ADMINISTRATION
The recommended doses of ANZEMET Tablets should not be exceeded.
The recommended oral dosage of ANZEMET (dolasetron mesylate) is 100 mg given within one hour before chemotherapy.
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.
In children for whom the 100 mg tablet is not appropriate based on their weight or ability to swallow tablets, the ANZEMET Injection solution may be mixed into apple or apple-grape juice for oral dosing in pediatric patients. The diluted product may be kept up to 2 hours at room temperature before use. However, ANZEMET Injection solution when administered intravenously is contraindicated in adult and pediatric patients for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy due to dose dependent QT prolongation.
Use in the Elderly, Renal Failure Patients, or Hepatically Impaired Patients
ANZEMET® Tablets (dolasetron mesylate)
|50 mg||5 ct Bottle||0088-1202-05||Light pink, film coated, round tablet imprinted with “A” on one side and “50”on the other.|
|10 ct Unit Dose Pack||0088-1202-43|
|100 mg||5 ct Bottle||0088-1203-05||Pink, film coated, elongated oval tablet imprinted with “100” on one side and “ANZEMET” on the other.|
|10 ct Unit Dose||0088-1203-43|
|5 ct Blister Pack||0088-1203-29|
Store at controlled room temperature 20-25°C (68-77°F). Protect from light.
Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. A Sanofi Company. Revised: September of 2013
Last reviewed on RxList: 9/27/2013
This monograph has been modified to include the generic and brand name in many instances.
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