| TAH Drug Code | OJAR2 |
|---|---|
| Indications | As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. To reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. |
| Dosing | Initial 10 mg once daily, may increase to 25 mg once daily as tolerated. |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment required |
| Contraindications | Hypersensitivity (eg, angioedema) to empagliflozin or any component of the formulation. |
| Adverse Effects | 1-10%: Dyslipidemia (4%), increased thirst (2%), Nausea (2%), Genitourinary fungal infection (2-6%), increased urine output (3%), urinary tract infection (8-9%; incidence higher in females), Increased hematocrit (3-4%) <1%: Phimosis Postmarketing: Skin rash, urticaria, Hypovolemia (higher incidence in older patients), ketoacidosis (patients may be euglycemic; without concomitant insulin), Acute pancreatitis, constipation, Urinary tract infection with sepsis, Angioedema, hypersensitivity angiitis, Necrotizing fasciitis (perineum), Acute interstitial nephritis, acute kidney injury, decreased estimated GFR (eGFR) (occurring early after initiation), increased serum creatinine, pyelonephritis, Asthma |
| Pregnancy | No (Limited) Human Data – Animal Data Suggest Low Risk |
| Lactation | No (Limited) Human Data – Potential Toxicity(Mother) |
| More Info | UpToDate |