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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 when treatment with both alogliptin and metformin is appropriate [see Clinical Studies].
Important Limitations Of Use
DOSAGE AND ADMINISTRATION
Recommendations For All Patients
- Healthcare 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
Recommendations For Use In Renal Impairment
Assess renal function prior to initiation of KAZANO and periodically thereafter.
KAZANO is not recommended in patients with an eGFR between 30 and 60 mL/min/1.73 m² because these patients require a lower daily dosage of alogliptin than what is available in the fixed combination KAZANO product.
Discontinuation For Iodinated Contrast Imaging Procedures
Discontinue KAZANO at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m²; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Reevaluate eGFR 48 hours after the imaging procedure; restart KAZANO if renal function is stable [see WARNINGS AND PRECAUTIONS].
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: Dec 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/2/2017
Additional Kazano Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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