"The U.S. Food and Drug Administration today approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochlor"...
Monotherapy and Combination Therapy
KAZANO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings when treatment with both alogliptin and metformin is appropriate [see Clinical Studies].
Limitation of Use
DOSAGE AND ADMINISTRATION
Recommendations for All Patients
- Health care providers should individualize the starting dose of KAZANO based on the patient's current regimen.
- KAZANO should be taken twice daily with food with gradual dose escalation to reduce the gastrointestinal (GI) side effects due to metformin. KAZANO tablets must not be split before swallowing.
- Dosing may be adjusted based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 25 mg alogliptin and 2000 mg metformin HCl.
- The following doses are available:
12.5 mg alogliptin and 500 mg metformin HCl
12.5 mg alogliptin and 1000 mg metformin HCl
Dosage Forms And Strengths
- 12.5 mg/500 mg tablets are pale yellow, oblong, film-coated tablets with “12.5/500” debossed on one side and “322M” debossed on the other side
- 12.5 mg/1000 mg tablets are pale yellow, oblong, film-coated tablets with “12.5/1000” debossed on one side and “322M” debossed on the other side
Storage And Handling
KAZANO tablets are available in the following strengths and packages:
12.5 mg/500 mg tablet: pale yellow, oblong, film-coated tablets with “12.5/500” debossed on one side and “322M” debossed on the other side, available in:
NDC 64764-335-60 Bottles of 60 tablets
NDC 64764-335-80 Bottles of 180 tablets
NDC 64764-335-77 Bottles of 500 tablets
12.5 mg/1000 mg tablet: pale yellow, oblong, film-coated tablets with “12.5/1000” debossed on one side and “322M” debossed on the other side, available in:
NDC 64764-337-60 Bottles of 60 tablets
NDC 64764-337-80 Bottles of 180 tablets
NDC 64764-337-77 Bottles of 500 tablets
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
Distributed by: Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015. Revised: January 2013
Last reviewed on RxList: 2/11/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Kazano Information
Report Problems to the Food and Drug Administration
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