Empagliflozin: Advanced SGLT2 Inhibition for Cardiorenal Protection
| Product dosage: 10 mg | |||
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| Product dosage: 25 mg | |||
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Synonyms | |||
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 SGLT2 receptors in the proximal tubule of the nephron, it reduces renal glucose reabsorption and promotes glycosuria, thereby lowering plasma glucose levels. Its mechanism extends beyond glycemic control, offering significant cardiorenal benefits through hemodynamic, metabolic, and anti-inflammatory effects. This agent represents a cornerstone in modern therapeutic strategies for patients with overlapping metabolic and cardiovascular conditions.
Features
- Selective inhibition of SGLT2 receptors in the proximal convoluted tubule
- Available in 10 mg and 25 mg film-coated tablets
- Once-daily oral administration, with or without food
- Linear pharmacokinetics with dose-proportional exposure
- Extensive plasma protein binding and minimal metabolism via UGT2B7, UGT1A3, UGT1A8, and UGT1A9
- Elimination primarily via feces (41.2%) and urine (54.4%)
- Half-life of approximately 12.4 hours
Benefits
- Significant reduction in HbA1c by promoting urinary glucose excretion
- Demonstrated cardiovascular risk reduction, including lower incidence of major adverse cardiovascular events (MACE)
- Proven renal protective effects, slowing the progression of kidney disease and reducing albuminuria
- Modest weight loss and blood pressure reduction through osmotic diuresis and natriuresis
- Decreased risk of hospitalization for heart failure in both diabetic and non-diabetic patients
- Low risk of hypoglycemia when used as monotherapy
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 used for the treatment of heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease, irrespective of diabetes status, to reduce the risk of cardiovascular death and hospitalization for heart failure, and to slow the progression of renal impairment.
Dosage and direction
The recommended starting dose is 10 mg once daily, taken orally with or without food. For additional glycemic control or cardiorenal benefits, the dose may be increased to 25 mg once daily. Dosage adjustment is not required based on age, gender, race, or body weight. In patients with renal impairment, the use of empagliflozin is not recommended when eGFR is persistently below 20 mL/min/1.73 m², and it should be discontinued if eGFR falls below this threshold during treatment. For hepatic impairment, no dosage adjustment is necessary. Tablets should be swallowed whole with water.
Precautions
- Monitor renal function before initiation and periodically during treatment.
- Assess volume status and correct volume depletion before starting therapy.
- Increased risk of genital mycotic infections; maintain appropriate hygiene.
- Monitor for signs and symptoms of ketoacidosis, even in the presence of normal or mildly elevated blood glucose levels.
- Consider temporary discontinuation in situations known to predispose to ketoacidosis (e.g., prolonged fasting, acute illness, surgery).
- Observe for hypotension, especially in patients on diuretics, with impaired renal function, or elderly patients.
- Increased risk of lower limb amputations; monitor and advise patients to report any foot sores, ulcers, or infections.
Contraindications
- History of serious hypersensitivity reaction to empagliflozin or any excipient.
- Patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
- Severe renal impairment (eGFR <20 mL/min/1.73 m²), end-stage renal disease, or patients on dialysis.
Possible side effect
Common adverse reactions (≥2%) include:
- Urinary tract infections
- Female genital mycotic infections
- Upper respiratory tract infections
- Increased urination
- Male genital mycotic infections
- Dyslipidemia
- Arthralgia
- Nausea
Less common but serious side effects may include:
- Ketoacidosis
- Acute kidney injury and impairment in renal function
- Urosepsis and pyelonephritis
- Hypotension
- Fournier’s gangrene
- Lower limb amputations
- Hypersensitivity reactions
Drug interaction
- Diuretics: Concomitant use may increase the risk of volume depletion and hypotension.
- Insulin or insulin secretagogues: May increase the risk of hypoglycemia; consider lower doses of these agents.
- UGT inducters (e.g., rifampin): May decrease empagliflozin exposure.
- Positive urine glucose tests: SGLT2 inhibitors will cause positive results; use alternative methods for monitoring glycemic control.
- Interference with 1,5-anhydroglucitol (1,5-AG) assay: Not recommended for monitoring glycemic control.
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 one.
Overdose
In the event of overdose, contact a poison control center or seek immediate medical attention. Symptoms may include severe volume depletion, hypoglycemia (if taken with other glucose-lowering agents), and electrolyte abnormalities. Management should involve supportive measures, including correction of dehydration, hypoglycemia, and electrolyte imbalance. Hemodialysis is unlikely to be effective due to high protein binding.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 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 professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or treatment. Never disregard professional medical advice or delay in seeking it because of something you have read in this product card. The efficacy and safety of empagliflozin may vary based on individual patient factors and concomitant conditions.
Reviews
“Empagliflozin has revolutionized the management of type 2 diabetes with cardiovascular disease. Its dual benefits in glycemic control and cardiorenal protection make it a first-line agent in high-risk patients.” – Endocrinologist, 15 years of experience
“In heart failure patients, empagliflozin provides consistent benefits in reducing hospitalizations and improving functional status. It is well-tolerated with a manageable side effect profile.” – Cardiologist, academic medical center
“The renal outcomes data are compelling. We are now using empagliflozin earlier in the course of chronic kidney disease, observing significant delays in progression.” – Nephrologist, large healthcare system
“While genital infections and volume-related issues require monitoring, the overall risk-benefit profile favors empagliflozin, especially in patients with multiple comorbidities.” – Internal Medicine Specialist, group practice