Formulary Monographs [, 682018]
Metformin/Empagliflozin
682018
Sodium Glucose Co-Transporter Inhibitor
Type 2 diabetes mellitus not controlled by metformin alone or by metformin in combination with other antidiabetic drugs or insulin.
Empagliflozin, when used in combination with metformin, is also indicated in T2DM to reduce risk of
Cardiovascular death in adults with established cardiovascular disease
Cardiovascular death and hospitalization for heart failure in adults with heart failure
Urinary tract infection ,Decreased vitamin B12 levels; Female genital mycotic infections ;Increased urination ;Male genital mycotic infections; Necrotizing fasciitis of the perineum (Fournier’s gangrene);Acute kidney injury; Constipation

Empagliflozin total daily dose: 10 mg
For additional glycemic control, empagliflozin may be increased to maximum total daily dose of 25 mg in patients tolerating 10 mg/day and metformin may be increased to maximum total daily dose of 2,000 mg/day, with gradual escalation to reduce gastrointestinal adverse reactions with metformin
Not recommended during second and third trimester of pregnancy based on animal data
Limited available data with use in pregnant women is not sufficient to determine a drug-associated risk for major birth defects and miscarriages;
Metformin may result in
There is no information regarding presence in human milk, the effects on breastfed infant or on milk production
Empagliflozin is present in the milk of lactating rats
Since human kidney maturation occurs in utero and during first 2 years of life when la
Lactic acidosis is a metabolic complication that can occur due to metformin accumulation during treatment and is fatal in ~50% of cases (see Black Box Warnings)

Serious hypersensitivity reactions, (eg, angioedema) in patients receiving treatment reported postmarketing; discontinue therapy and treat promptly if it occurs per standard of care

Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors; signs and symptoms include tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4ºF or a general feeling of being unwell; if suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary