Finished product reference

Empagliflozin

Tablet · Oral · 10 mg

List code
52138
Pharmacologic class
Sodium-Glucose Cotransporter 2 Inhibitor

What it is and how it works

Mechanism of Action Empagliflozin is an inhibitor of SGLT2, the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule.

Mechanism class: Sodium-Glucose Transporter 2 Inhibitors

Indications

is indicated: • 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. • to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. • 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. JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated: • 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. • To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

Dosage and administration (summary)

• Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating. • Recommended dosage is 10 mg orally once daily in the morning, taken with or without food. • For additional glycemic control, dosage may be increased to 25 mg orally once daily in patients tolerating JARDIANCE. • Withhold JARDIANCE for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. Testing Prior to Initiation of JARDIANCE • Assess renal function before initiating JARDIANCE and as clinically indicated . o Use for glycemic control is not recommended in patients with an eGFR less than 30 mL/min/1.73 m 2 .

Contraindications

is contraindicated in patients: • with a hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred . • Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE.

Warnings and precautions

• Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue JARDIANCE if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting.

Pregnancy

Pregnancy Risk Summary Based on animal data showing adverse renal effects, JARDIANCE is not recommended during the second and third trimesters of pregnancy. The limited available data with JARDIANCE in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage.

Storage and supply

Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

Source: Empagliflozin (Jardiance) — US FDA prescribing information, 2026-02-17, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Other presentations of the same active ingredient

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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