Empagliflozin

Empagliflozin

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Product dosage: 10 mg
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Product dosage: 25 mg
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Synonyms

Empagliflozin: Advanced SGLT2 Inhibition for Cardiorenal Protection

Empagliflozin is a highly 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 of the nephron, it promotes glycosuria and offers a unique mechanism of action distinct from other antidiabetic agents. Its benefits extend beyond glycemic control to include significant cardiovascular and renal risk reduction, positioning it as a cornerstone therapy in modern evidence-based treatment algorithms for appropriate patient populations.

Features

  • Selective inhibition of SGLT2 in the renal proximal tubules
  • Once-daily oral dosing regimen
  • Available in 10 mg and 25 mg film-coated tablets
  • Not dependent on insulin secretion for efficacy
  • Exhibits consistent pharmacokinetics across diverse patient demographics

Benefits

  • Reduces HbA1c by promoting urinary glucose excretion
  • Lowers risk of major adverse cardiovascular events, including cardiovascular death
  • Slows progression of chronic kidney disease and reduces albuminuria
  • Promotes weight loss and modest blood pressure reduction
  • Decreases hospitalization for heart failure in both diabetic and non-diabetic patients
  • Offers a favorable safety profile with low risk of hypoglycemia when used as monotherapy

Common use

Empagliflozin is primarily prescribed for adults with type 2 diabetes mellitus to improve glycemic control, either as monotherapy or in combination with other glucose-lowering agents. 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, regardless of diabetes status, based on outcomes from large-scale clinical trials.

Dosage and direction

The recommended starting dose is 10 mg orally once daily, taken with or without food. Depending on tolerability and clinical need, the dose may be increased to 25 mg once daily. For heart failure and chronic kidney disease indications, the recommended dose is 10 mg once daily. Renal function should be assessed prior to initiation and periodically during treatment; use is not recommended when eGFR is persistently below 20 mL/min/1.73m². Tablets should be swallowed whole with water.

Precautions

Monitor renal function before and during treatment. Assess volume status and correct volume depletion before initiation. Observe for signs and symptoms of genital mycotic infections and urinary tract infections. Consider periodic monitoring of hematocrit. Use with caution in patients at risk for ketoacidosis, including those with pancreatic insulin deficiency, reduced caloric intake, or excessive alcohol intake. Discontinue promptly if ketoacidosis is suspected. Not recommended during the second and third trimesters of pregnancy.

Contraindications

History of serious hypersensitivity reaction to empagliflozin or any product component. Patients with severe renal impairment (eGFR <30 mL/min/1.73m²), end-stage renal disease, or those 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, and thirst. Less frequently, cases of hypotension, impaired renal function, elevated LDL cholesterol, and male genital mycotic infections may occur. Rare but serious adverse effects include ketoacidosis, Fournier’s gangrene, and bone fractures.

Drug interaction

Diuretics may enhance the risk of volume depletion. Insulin or insulin secretagogues may increase the risk of hypoglycemia; consider dose reduction of these agents. Drugs that reduce glomerular filtration rate or affect renal tubular function may alter empagliflozin efficacy. No clinically significant interactions with metformin, sitagliptin, glimepiride, or warfarin have been observed.

Missed dose

If a dose is missed, it should be taken as soon as remembered 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 dose.

Overdose

In the event of overdose, employ supportive measures aimed at correcting dehydration and electrolyte abnormalities, including hypoglycemia if present. Removal of empagliflozin by hemodialysis has not been studied, but given its high protein binding, significant clearance via dialysis is unlikely. Contact a poison control center for latest guidance.

Storage

Store at room temperature (20–25°C or 68–77°F); excursions permitted between 15–30°C (59–86°F). 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 clinical judgment or the approved prescribing information. Treatment decisions must be based on the individual patient’s clinical status, contraindications, and latest clinical guidelines. Always verify dosing and indications with the most current product labeling.

Reviews

Empagliflozin has received strong endorsements in international treatment guidelines following robust outcomes from the EMPA-REG OUTCOME, EMPEROR-Reduced, and EMPA-KIDNEY trials. Clinical experts highlight its cardiorenal benefits, though many emphasize the importance of patient selection, monitoring, and awareness of rare adverse effects. Real-world evidence continues to support its efficacy and safety profile in diverse populations.