y distress, increasing somnolence and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate [see Warnings and Precautions (5.1)].
•
If acidosis is suspected, KAZANO (alogliptin and metformin HCl) should be discontinued and the patient hospitalized immediately [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
1.1 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 (14)].
1.2 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.
2 DOSAGE AND ADMINISTRATION
2.1 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
3 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
