| TAH Drug Code | OJADU |
|---|---|
| Indications | Disorder of cardiovascular system; Prophylaxis - Heart failure - Type 2 diabetes mellitus. Disorder of cardiovascular system; Prophylaxis - Type 2 diabetes mellitus. Type 2 diabetes mellitus. |
| Dosing | Type 2 diabetes mellitus (Immediate-release) MAX: empagliflozin 25 mg/metformin 2000 mg per day. Currently taking metformin: Choose strength that will provide empagliflozin 5 mg PO BID plus similar total daily metformin dose; gradually adjust dose as needed. Currently taking empagliflozin: Choose strength that will provide metformin 500 mg PO BID plus similar total daily empagliflozin dose; gradually adjust dose as needed. Currently taking both components as separate tablets: Choose strength that provides the same daily dose of both components when administered PO BID ; gradually adjust dose as needed. Iodinated contrast imaging procedure in patients with history of liver disease, alcoholism, or heart failure, or patients receiving intraarterial administration of iodinated contrast: Discontinue use at time of or before procedure; evaluate eGFR 48 hours after imaging procedure; restart if renal function stable. Surgery: Withhold treatment for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume when the patient is clinically stable and has resumed oral intake. |
| Hepatic Impairment | Dose adjustment required |
| Renal Impairment | Dose adjustment required |
| Contraindications | Severe renal impairment (estimated GFR less than 30 mL/min/1.73 m(2)), ESRD, or dialysis. Acute or chronic metabolic acidosis, including diabetic ketoacidosis. History of serious hypersensitivity to empagliflozin, metformin hydrochloride, or any component of the product. |
| Adverse Effects | Common: Diarrhea (>5%), Flatulence (>5%), Indigestion (>5%), Nausea, Headache (>5%), Urinary tract infectious disease (6.9-9.4%), Female genital infection, Mycotic Serious: Hypotension, Hypovolemia, Diabetic ketoacidosis, Hypoglycemia (1.4-15.6%), Lactic acidosis, Vitamin B12 level below reference range, Acute renal failure, Pyelonephritis, Sepsis due to urinary tract infection, Necrotizing fasciitis, Perineum |
| Pregnancy | Human Data Suggest Low Risk |
| Lactation | No (Limited) Human Data - Potential Toxicity |
| More Info | UpToDate |