Empagliflozin: Advanced SGLT2 Inhibition for Cardiorenal Protection
Empagliflozin
| Product dosage: 10 mg | |||
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| Product dosage: 25 mg | |||
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Synonyms | |||
Empagliflozin is a high-affinity, selective sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated for the management of type 2 diabetes mellitus, heart failure, and chronic kidney disease. By blocking glucose reabsorption in the proximal tubule, it promotes glucosuria and exerts pleiotropic effects beyond glycemic control, including hemodynamic improvement, natriuresis, and metabolic modulation. Its robust evidence base from landmark trials supports significant reductions in cardiovascular mortality, hospitalization for heart failure, and progression of renal disease, establishing it as a cornerstone therapy in modern cardiorenal medicine.
Features
- Selective SGLT2 inhibitor with minimal affinity for SGLT1
- Available in 10 mg and 25 mg film-coated tablets
- Once-daily oral administration, with or without food
- Exhibits linear pharmacokinetics and dose-proportional exposure
- Mean plasma half-life of approximately 12–13 hours
- Primarily metabolized via glucuronidation by UGT enzymes
- Excreted largely unchanged in feces (41.2%) and urine (54.4%)
Benefits
- Reduces risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease
- Lowers incidence of hospitalization for heart failure in both diabetic and non-diabetic populations
- Slows progression of chronic kidney disease, including reduction in end-stage kidney disease risk
- Provides effective glycemic control with low intrinsic hypoglycemia risk when used without insulin or sulfonylureas
- Promotes modest weight loss and blood pressure reduction through osmotic diuresis and caloric excretion
- Offers a favorable safety and tolerability profile with once-daily dosing convenience
Common use
Empagliflozin is approved for use in adults with type 2 diabetes mellitus to improve glycemic control, as an adjunct to diet and exercise. It is also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Additionally, it is approved for the treatment of heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease, irrespective of diabetes status, to reduce cardiovascular death and hospitalization for heart failure, and to slow kidney function decline.
Dosage and direction
The recommended starting dose is 10 mg orally once daily, taken with or without food. For additional glycemic control or cardiorenal benefits, the dose may be increased to 25 mg once daily. In heart failure and chronic kidney disease, treatment should be initiated at 10 mg once daily. Dose adjustment is recommended in patients with estimated glomerular filtration rate (eGFR) below certain thresholds: 10 mg once daily is recommended for eGFR ≥20 mL/min/1.73m²; use is not recommended when eGFR is persistently below 20 mL/min/1.73m². Tablets should be swallowed whole with water; they should not be split, crushed, or chewed.
Precautions
Monitor renal function before initiation and periodically during treatment. Assess volume status and correct volume depletion before starting. Consider temporary interruption in situations of reduced oral intake or fluid loss (e.g., acute illness, prolonged fasting). Monitor for signs and symptoms of ketoacidosis, even in the presence of normal or mildly elevated blood glucose levels. Increased risk of genital mycotic infections; maintain appropriate hygiene. Monitor for lower limb amputations, particularly in patients with history of amputation, peripheral vascular disease, neuropathy, or diabetic foot ulcers. Not recommended during the second and third trimesters of pregnancy. Discontinue at least 3 days before scheduled surgery; resume based on clinical judgment of recovery.
Contraindications
History of serious hypersensitivity reaction to empagliflozin or any excipient. Severe renal impairment (eGFR <20 mL/min/1.73m²), end-stage renal disease, or patients on dialysis. Concomitant use with other SGLT2 inhibitors is contraindicated.
Possible side effects
Common adverse reactions (≥2%) include urinary tract infections, female genital mycotic infections, upper respiratory tract infections, increased urination, thirst, nausea, and volume depletion. Less common but serious adverse effects include ketoacidosis, acute kidney injury, urosepsis and pyelonephritis, hypoglycemia (when used with insulin or insulin secretagogues), necrotizing fasciitis of the perineum (Fournier’s gangrene), and lower limb amputations. Cases of hypersensitivity reactions (e.g., angioedema, urticaria) have been reported.
Drug interaction
Diuretics: Concomitant use may increase the risk of volume depletion. Insulin or insulin secretagogues: May increase risk of hypoglycemia; consider lower doses of these agents. Inducers of UGT enzymes (e.g., rifampin) may decrease empagliflozin exposure. Positive urine glucose tests are expected; use alternative methods for monitoring glycemic control. Interference with 1,5-anhydroglucitol (1,5-AG) assay may occur.
Missed dose
If a dose is missed, it should be taken as soon as possible on the same day. If the missed dose is not remembered until the next day, the missed dose should be skipped and the regular dosing schedule resumed. Do not take a double dose to make up for a missed one.
Overdose
Limited data are available on overdose. Expected clinical effects may include hypoglycemia and dehydration due to SGLT2 inhibition. In the event of suspected overdose, blood glucose should be monitored and supportive measures instituted as clinically indicated, including correction of dehydration and hypoglycemia. Removal of empagliflozin by hemodialysis has not been studied.
Storage
Store at room temperature (20°C to 25°C); excursions permitted between 15°C and 30°C. Keep in the original container to protect from moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.
Disclaimer
This information is intended for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a qualified healthcare provider with any questions regarding a medical condition or treatment. Do not disregard professional medical advice or delay in seeking it because of something you have read in this document. The prescribing physician should be consulted for specific dosing, indications, and patient-specific recommendations.
Reviews
Empagliflozin has been evaluated in multiple large-scale, randomized controlled trials demonstrating consistent cardiorenal benefits. The EMPA-REG OUTCOME trial showed a 38% reduction in cardiovascular death and 35% reduction in hospitalization for heart failure in patients with type 2 diabetes and cardiovascular disease. The EMPEROR-Reduced and EMPEROR-Preserved trials confirmed significant reductions in cardiovascular death and heart failure hospitalization in patients with heart failure, regardless of ejection fraction. EMPA-KIDNEY demonstrated a 28% reduction in risk of kidney disease progression or cardiovascular death in a broad population of patients with chronic kidney disease. Real-world evidence studies have corroborated these findings, supporting its role as a foundational therapy in cardiorenal metabolic management.