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Empagliflozin

    Brands

    DEA Class; Rx

    Common Brand Names; Jardiance

    • Antidiabetics, SGLT2 Inhibitors

    Oral sodium-glucose co-transporter 2 (SGLT2) inhibitor
    Used in adults with type 2 diabetes mellitus (DM); to reduce the risk of cardiovascular (CV) death in adults with type 2 DM and established CV disease; to reduce risk of CV death and heart failure (HF) hospitalization in adults with HF
    Not recommended for glycemic control in patients with severe renal impairment due to reduced efficacy

    Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

    Also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease

    Indicated to reduce the risk of cardiovascular death plus hospitalization in adults with heart failure (HF)

    Serious hypersensitivity to empagliflozin (eg, anaphylaxis, angioedema)

    Patients on dialysis

    • Urinary tract infection (7.6-9.3%)
    • Female genital mycotic infections (5.4-6.4%)
    • Upper respiratory tract infection (3.1-4%)
    • Increased urination (3.2-3.4%)
    • Dyslipidemia (2.9-3.9%)
    • Male genital mycotic infections (1.6-3.1%)
    • Arthralgia (2.3-2.4%)
    • Nausea (1.1-2.3%)
    • Polydipsia (1.5-1.7%)
    • Adverse reactions related to volume depletion (eg, blood pressure [ambulatory] decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolemia, orthostatic hypotension, and syncope)
    • Increased urination (eg, nocturia)
    • Ketoacidosis
    • Urosepsis and pyelonephritis
    • Necrotizing fasciitis of the perineum (Fournier’s gangrene)
    • Angioedema
    • Skin reactions
    • Acute kidney injury
    • Constipation

    Increases serum creatinine and decreases eGFR; risk increased in elderly or those with moderate renal impairment

    Increased incidence of bone fractures reported; American Diabetes Association recommends avoiding sodium glucose cotransporter-2 inhibitors in patients with fracture risk factors

    Genital mycotic infections may occur; patients with history of genital mycotic infections and uncircumcised males are more susceptible

    Increases risk of urinary tract infections (UTIs), including life-threatening urosepsis and pyelonephritis that started as UTIs

    Dose-related increases in LDL-C reported

    No conclusive evidence of macrovascular risk reduction with antidiabetic agent

    Serious hypersensitivity reactions (eg, angioedema) reported; if a hypersensitivity reaction occurs, discontinue treatment; treat promptly per standard of care, and monitor until signs and symptoms resolve

    Based on animal data showing adverse renal effects, use not recommended during the second and third trimesters of pregnancy

    Limited data available in pregnant women are insufficient to determine a drug-associated risk for major birth defects and miscarriage

    There is no information regarding presence in human milk, the effects on breastfed infant or on milk production

    Adults

    25 mg/day PO.

    Geriatric

    25 mg/day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Empagliflozin

    tablet

    • 10mg
    • 25mg