Empagliflozin

Adults: reduces cardiovascular death/HF hospitalization in heart failure; reduces sustained eGFR decline, end-stage kidney disease, cardiovascular death and hospitalization in CKD at risk of progression; reduces cardiovascular death in type 2 diabetes with established cardiovascular disease. With diet/exercise, improves type 2 diabetes glycemic control in adults and children ≥10 years. HF and CKD indication wording does not require diabetes.

Not recommended for type 1 diabetes glycemic control due to ketoacidosis risk, or type 2 glycemic control at eGFR <30 mL/min/1.73 m² because glucose lowering is likely ineffective. CKD treatment is not recommended in polycystic kidney disease or with current/recent IV immunosuppression or >45 mg prednisone-equivalent for kidney disease. These limitations are distinct from the formal allergy contraindication.

Take once daily in the morning, with or without food.

Withhold at least 3 days, if possible, before surgery or procedures involving prolonged fasting. Resume when clinically stable and oral intake has resumed. Also consider temporary interruption during illnesses or situations predisposing to ketoacidosis. For a missed dose, take when remembered unless almost time for the next; skip rather than double.

Glycemic use is not recommended below eGFR 30 mL/min/1.73 m². HF trials enrolled eGFR ≥20; CKD trial eGFR 20–90. Trials did not enroll eGFR <20 or patients already on dialysis, so do not infer an initiation regimen there. Enrolled patients were not required to stop solely for later decline below 20 or starting dialysis; reassess clinically. Hepatic impairment is permitted without a labeled dose change.

Hypersensitivity to empagliflozin or any Jardiance ingredient; serious reactions including angioedema have occurred. Renal/indication limitations and ketoacidosis risks are discussed separately.

The selected current Jardiance label has no boxed warning. Ketoacidosis, severe genitourinary infection, volume depletion and other serious risks remain labeled precautions.

Common reported reactions include urinary tract infection and female genital mycotic infection; increased urination, thirst, male genital infection and nausea also occur. Hypoglycemia risk depends on population/co-therapy. Serious risks are summarized above; postmarketing reports cannot establish incidence. For overdose seek medical/Poison Help guidance (U.S. 1-800-222-1222); removal by hemodialysis is unstudied.

Not recommended in the second/third trimesters because animal data raise fetal kidney-development concerns; limited human data cannot define congenital/miscarriage risk. Poorly controlled diabetes also poses risk; review alternatives with the clinician. Breastfeeding is not recommended because of potential postnatal kidney effects; human milk data are limited.

Type 2 diabetes glycemic control is established at age ≥10; younger children and pediatric outcome indications are not established. Children have higher hypoglycemia risk regardless of insulin use. Older adults, especially ≥75 in glucose-control trials, had more volume-depletion/UTI reactions; assess hydration and renal function.

Glucose lowering declines with worsening kidney function and renal/volume/UTI adverse risks rise. Distinguish eGFR <30 glycemic limitation from HF/CKD trials at ≥20. No trial enrollment below 20 or on dialysis establishes initiation there. Hepatic impairment is allowed; no dose adjustment is specified.

Empagliflozin blocks proximal renal SGLT2 glucose reabsorption, increasing urinary glucose loss. Reduced sodium reabsorption increases distal sodium delivery and may contribute to tubuloglomerular feedback and other cardiovascular/renal effects. Glucosuria typically approaches baseline about 3 days after stopping, though prolonged postmarketing cases occur.

Absorption

Peak approximately 1.5 hours after oral dosing; food effect is not clinically important.

Protein binding

Approximately 86.2%.

Metabolism

Mainly glucuronidation; no major plasma metabolite, with each major conjugate <10% of drug-related material.

Elimination

Apparent terminal half-life about 12.4 hours; radiolabeled material recovered in urine (~54%) and feces (~41%).

• Check renal function and volume status before starting and as clinically indicated; monitor dehydration, dizziness and changes after diuretics.
• Follow glucose/HbA1c as appropriate; educate all patients about lows and use closer observation in children or insulin/sulfonylurea users.
• Assess ketones when clinical risk/symptoms warrant; evaluate acidosis even with glucose <250 mg/dL.
• Review urinary/genital infection symptoms, feet/ulcers and lithium levels when relevant.

• Take the prescribed tablet each morning; do not double missed doses. Arrange stopping ≥3 days before surgery/prolonged fasting and clinician-directed restart.
• Report inability to eat/drink, vomiting or acute illness; agree on fluid advice appropriate to HF/CKD rather than forcing an arbitrary fluid intake.
• Stop and seek urgent care for ketoacidosis symptoms; genital/perineal pain, redness or swelling with fever/malaise also needs immediate care.
• Report urinary infection, genital yeast symptoms, new foot sores or pain, and pregnancy. Discuss breastfeeding alternatives.

Dosage form / strength

Film-coated tablet · 10 mg

Distributor

Boehringer Ingelheim Pharmaceuticals, Inc.

Appearance / imprint

Pale yellow, round, biconvex/beveled · S 10 / company symbol

Example NDC

0597-0152-30 · 30-tablet bottle

Standalone Jardiance tablets: 10 mg round (S 10) and 25 mg oval (S 25), pale yellow and film-coated. Bottles and institutional blister cards are described in the label. Empagliflozin combinations such as metformin/linagliptin products are outside this reference.

Store at 20–25°C; permitted excursions 15–30°C. Dispense in a well-closed container and keep out of children’s reach. Read the Medication Guide.