Generic Name and Formulations:
Empagliflozin, metformin HCl; 5mg/500mg, 12.5mg/500mg, 5mg/1000mg, 12.5mg/1000mg; tabs.

Company:
Boehringer Ingelheim and Lilly
Indications for SYNJARDY:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled on metformin or empagliflozin regimen, or who are already being treated with both.

Limitations Of use:
Not for treating type 1 diabetes or diabetic ketoacidosis.

Adult:
See full labeling. Individualize. Take twice daily with meals; increase dose gradually. Max daily dose: 25mg/2000mg.

Children:
<18yrs: not established.

Contraindications:
Renal impairment (SCr ≥1.5mg/dL [men], ≥1.4mg/dL [women], or eGFR <45mL/min/1.73m2), ESRD, or on dialysis. Metabolic acidosis, diabetic ketoacidosis.

Warnings/Precautions:
Confirm normal renal function before starting and monitor thereafter (esp. in elderly). Discontinue if lactic acidosis, renal impairment, shock, acute MI or CHF, hypoxemia, dehydration, or sepsis occur. Avoid in hepatic disease. Discontinue prior to any intravascular radiocontrast study or surgery; withhold for 48hrs after procedure. Correct volume depletion before initiating. Monitor for symptomatic hypotension after starting therapy (esp. elderly, renal impairment, low systolic BP, on diuretics). Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, eva luate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Elderly, debilitated, uncompensated strenuous exercise, malnourished, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Monitor for genital mycotic infections, UTIs, Vit. B12 deficiency, increases in LDL-C; treat if occur. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
Cationic drugs eliminated by renal tubular secretion (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin); may increase metformin levels; monitor. Increased risk of lactic acidosis with topiramate or other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide). Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, sympathomimetics, nicotinic acid, CCBs, and isoniazid may cause hyperglycemia. Avoid excessive alcohol. Concomitant drugs that may affect renal function or metformin disposition; monitor. Consider a lower dose of concomitant insulin or insulin secretagogue to reduce risk of hypoglycemia. β-blockers may mask hypoglycemia. May cause false (+) urine glucose tests or unreliable measurements of 1, 5-AG assay; use alternative methods to monitor glycemic control.

Pharmacological Class:
Sodium-glucose co-transporter 2 (SGLT2) inhibitor + biguanide.

Adverse Reactions:
UTIs (may be serious), female genital mycotic infections, diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, headache; lactic acidosis (rare), hypotension, ketoacidosis.

Generic Availability:
NO

How Supplied:
Tabs—60, 180