Indications for KOMBIGLYZE XR:
Adjunct to diet and exercise in type 2 diabetes when treatment with both saxagliptin and metformin is appropriate. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis. Not studied in patients with history of pancreatitis.
Adult:
Take once daily with evening meal. Swallow whole. Individualize; titrate based on response. Max saxagliptin 5mg/day and metformin ext-rel 2000mg/day. Concomitant strong CYP3A4/5 inhibitors: max saxagliptin 2.5mg/day.
Children:
<18yrs: not established.
Pharmacological Class:
Dipeptidyl peptidase-4 (DPP4) inhibitor + biguanide.
Contraindications:
Renal impairment (serum creatinine ≥1.5mg/dL [men], ≥1.4mg/dL [women], or abnormal CrCl). Metabolic acidosis, diabetic ketoacidosis. History of serious hypersensitivity reactions (eg, anaphylaxis, angioedema, exfolitative skin conditions).
Warnings/Precautions:
Discontinue if lactic acidosis is suspected. Monitor for signs/symptoms of pancreatitis; discontinue if suspected. Confirm normal renal function before starting; monitor (esp. in patients ≥80yrs). Avoid in hepatic disease. Discontinue if shock, acute CHF or MI, sepsis, or hypoxemia occurs. Suspend therapy if dehydration occurs or before surgery. Monitor hepatic function, hematology (esp. serum Vit. B12 in susceptible patients). Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Concomitant intravascular iodinated contrast agents (suspend during and for 48 hours after use). History of angioedema to other DPP4 inhibitors. Pregnancy (Cat.B), nursing mothers: not recommended; consider using insulin instead.
Interactions:
Saxagliptin potentiated by strong CYP3A4/5 inhibitors (eg, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin). Cationic drugs eliminated by renal tubular secretion (eg, cimetidine, amiloride, digoxin, morphine, procainamide, quinidine, quinine, triamterene, trimethoprim, ranitidine, vancomycin): may increase metformin levels. Avoid excessive alcohol intake (potentiates effects of metformin on lactate). Diuretics, steroids, phenothiazines, phenytoin, sympathomimetics, calcium channel blockers, isoniazid, niacin, thyroid products, estrogens, oral contraceptives may cause hyperglycemia. May need lower dose of concomitant sulfonylurea or insulin to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia.
Adverse Reactions:
Diarrhea, nausea, vomiting, URI, UTI, headache, nasopharyngitis, hypersensitivity reactions (discontinue if suspected); lactic acidosis (rare, ½ the cases are fatal).
How Supplied:
Tabs 5/500—30; 5/1000—30, 90, 500; 2.5/1000—60, 500
