• Diabetes

Kazano Generic Name & Formulations

General Description

Alogliptin, metformin (as HCl); 12.5mg/500mg, 12.5mg/1000mg; tabs.

Pharmacological Class

Dipeptidyl peptidase-4 (DPP-4) inhibitor + biguanide.

How Supplied

Tabs—60, 180, 500

Generic Availability


Mechanism of Action

Alogliptin is a DPP-4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus. Alogliptin selectively binds to and inhibits DPP-4 but not DPP-8 or DPP-9 activity in vitro at concentrations approximating therapeutic exposures. Metformin is a biguanide which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.

Kazano Indications


Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use

Not for treatment of type 1 diabetes mellitus.

Kazano Dosage and Administration


Individualize. Swallow whole. Take twice daily with food; increase dose gradually to reduce GI effects. Max 25mg alogliptin/2000mg metformin per day. Renal impairment (eGFR 30–59mL/min/1.73m2): not recommended.


Not established.

Kazano Contraindications


Severe renal impairment (eGFR <30mL/min/1.73m2). Metabolic acidosis. Diabetic ketoacidosis.

Kazano Boxed Warnings

Not Applicable

Kazano Warnings/Precautions


Increased risk of metformin-associated lactic acidosis in renal or hepatic impairment, concomitant use of certain drugs (eg, cationic drugs), ≥65yrs of age, undergoing radiological contrast study, surgery and other procedures, hypoxic states, and excessive alcohol intake; discontinue if lactic acidosis occurs. Discontinue at time of, or prior to intravascular iodinated contrast imaging in patients with eGFR 30–60mL/min/1.73m2, history of hepatic impairment, alcoholism, hypoxemia, or will be given intra-arterial contrast; reevaluate eGFR 48hrs after procedure and restart therapy if renally stable. Suspend therapy if dehydration occurs or before surgery. Avoid if clinical or lab evidence of hepatic disease. Consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Assess renal function prior to initiation and periodically thereafter; more frequently in elderly. Discontinue if pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid is suspected or occurs. History of angioedema to other DPP-4 inhibitors. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Measure hematologic parameters annually and serum Vit. B12 at 2–3 year intervals. Premenopausal women with anovulatory: ovulation may occur. Pregnancy. Nursing mothers.

Kazano Pharmacokinetics


Alogliptin: Peak plasma concentration (median Tmax) occurred 1 to 2 hours after dosing. Absolute bioavailability: approximately 100%.

Metformin: Absolute bioavailability is approximately 50–60% after administration of metformin HCl 500mg tablet under fasting conditions.


Alogliptin: Volume of distribution during the terminal phase: 417 L. Plasma protein bound: 20%.

Metformin: Volume of distribution after a single oral dose of immediate release metformin HCl tablets 850mg averaged 654 ± 358 L. Plasma protein bound: negligibly.


Alogliptin does not undergo extensive metabolism and 60–71% of the dose is excreted as unchanged drug in the urine.

Metformin does not undergo hepatic metabolism or biliary excretion.


Alogliptin: renal (76%), fecal (13%). Half-life: ~21 hours.

Metformin: renal (~90%). Half-life: ~17.6 hours (blood); ~6.2 hours (plasma).

Kazano Interactions


Cationic drugs eliminated by renal tubular secretion (eg, amiloride, digoxin, morphine, procainamide, quinine, quinidine, ranitidine, triamterene, trimethoprim, vancomycin), cimetidine: may increase metformin levels. Avoid excessive alcohol intake (potentiates effects of metformin on lactate). Caution with concomitant topiramate, or other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); may induce metabolic acidosis. Diuretics, steroids, estrogens, oral contraceptives, phenothiazines, phenytoin, thyroid products, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid may cause hyperglycemia. May need lower dose of concomitant sulfonylurea or insulin to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia.

Kazano Adverse Reactions

Adverse Reactions

Upper respiratory tract infection, nasopharyngitis, diarrhea, hypertension, headache, back pain, UTI; pancreatitis, heart failure, hypersensitivity reactions, hepatic failure, severe and disabling arthralgia; rare: lactic acidosis (may be fatal).

Kazano Clinical Trials

See Literature

Kazano Note

Not Applicable

Kazano Patient Counseling

See Literature