Classes
DEA Class; Rx
Common Brand Names; Jardiance
- Antidiabetics, SGLT2 Inhibitors
Description
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
Indications
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)
Contraindications
Serious hypersensitivity to empagliflozin (eg, anaphylaxis, angioedema)
Patients on dialysis
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
25 mg/day PO.
25 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Empagliflozin
tablet
- 10mg
- 25mg