July 26, 2016
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Kazano

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Kazano




Indications
Dosage
How Supplied

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 when treatment with both alogliptin and metformin is appropriate [see Clinical Studies].

Important Limitations Of Use

KAZANO is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

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

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: April 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/25/2016

Indications
Dosage
How Supplied

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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