Empagliflozin

FDA label

Read the full label on DailyMed ↗

Titration Glycemic control: may increase 10 mg to 25 mg QD once the patient is tolerating 10 mg (no minimum interval specified)

Renal Assess eGFR before initiating and as indicated; glycemic-control use not recommended if eGFR <30 mL/min/1.73m2; HF/CKD outcome trials enrolled to eGFR >=20; not studied at eGFR <20 or on dialysis

Hepatic May be used in hepatic impairment (no dosage adjustment specified)

Instructions

• Take once daily in the morning, with or without food.
• Assess volume status and correct volume depletion before initiating.
• Withhold for at least 3 days, if possible, before major surgery or procedures with prolonged fasting; resume when clinically stable and eating.
• Missed dose: take as soon as possible; do not double the next dose.

Available strengths

• tab 10, 25 mg

Cautions

• Ketoacidosis, incl. fatal cases and euglycemic presentations (glucose may be <250 mg/dL): markedly increased risk in type 1 diabetes (not indicated for T1DM glycemic control); assess regardless of glucose, discontinue if suspected; withhold in predisposing situations (surgery, fasting, acute illness, alcohol abuse).
• Volume depletion, symptomatic hypotension, and acute kidney injury: risk higher with eGFR <60, elderly, or loop diuretics — assess and correct volume status first.
• Urosepsis and pyelonephritis: increases UTI risk; evaluate and treat promptly.
• Hypoglycemia when combined with insulin or insulin secretagogues (consider lowering their dose); pediatric patients >=10 y had higher hypoglycemia risk regardless of insulin.
• Necrotizing fasciitis of the perineum (Fournier's gangrene), in females and males: assess genital/perineal pain, erythema, swelling with fever or malaise; treat urgently and discontinue.
• Genital mycotic infections, esp. with prior history.
• Lower limb amputation: imbalance seen in some SGLT2-inhibitor trials; monitor for foot infections, ulcers, new pain; routine preventive foot care.
• Serious hypersensitivity reactions incl. angioedema: discontinue if they occur.

Adverse reactions

• Urinary tract infections (9.3%)
• Female genital mycotic infections (5.4-6.4%)
• Increased urination (polyuria/pollakiuria/nocturia)
• Male genital mycotic infections (balanitis/balanoposthitis)
• Upper respiratory tract infection
• Hypoglycemia when combined with insulin or sulfonylurea

Pregnancy Not recommended during the second and third trimesters (animal data: adverse renal development effects at ~13x clinical exposure); limited human data.

Lactation Not recommended while breastfeeding — present in rat milk and potential risk to the developing infant kidney (human kidney matures through first 2 years).