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Kazano

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Kazano

INDICATIONS

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

KAZANO should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

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

HOW SUPPLIED

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

Storage

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.

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