Brand Name: Empacoza Tablet
Composition
Each Empacoza tablet contains:
Empagliflozin
Therapeutic Indications
- Type 2 Diabetes Mellitus
- 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
- Heart Failure
- Indicated to reduce the risk of cardiovascular death plus hospitalization in adults with heart failure (HF)
Dosage and Administration
- 10 mg PO qDay
- May increase to 25 mg/day if needed and tolerated
Contraindications
- Serious hypersensitivity to empagliflozin (eg, anaphylaxis, angioedema)
- Patients on dialysis
Warnings and precautions
- Increases serum creatinine and decreased 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
Volume depletion
- Intravascular volume depletion, which may manifest as symptomatic hypotension or acute changes in creatinine, occurred
- Acute kidney injury, some requiring hospitalization and dialysis, in patients with T2DM receiving SGLT2 inhibitors reported
- Patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension
- Before initiating therapy in patients with one or more of these characteristics, assess volume status and renal function; in patients with volume depletion, correct this condition before initiating treatment; monitor for signs and symptoms of volume depletion, and renal function after initiating therapy
Renal function
- Acute kidney injury reported
- Consider risk factors, including hypovolemia, heart failure, and chronic renal insufficiency or use of medications, including diuretics, ACE inhibitors, NSAIDs, or angiotensin receptor blockers
- Correct volume status before initiating if needed and monitor renal function periodically thereafter
Necrotizing fasciitis
- Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors
- Signs and symptoms include pain or tenderness, erythema, or swelling in genital or perianal area, along with fever or malaise
- If suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary
Ketoacidosis
- Ketoacidosis, including fatal cases, reported in patients treated with SGLT2 inhibitors
- Not indicated for treatment of type 1 diabetes mellitus
- Before initiating therapy, consider factors in patient history that may predispose to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse
- Consider temporarily discontinuing therapy for at least 3 days for patients who undergo scheduled surgery
- Consider monitoring for ketoacidosis and temporarily discontinuing therapy in other clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or post-surgery); ensure risk factors for ketoacidosis are resolved prior to restarting therapy
- Restart once the patient’s oral intake is back to baseline and any other risk factors for ketoacidosis (blood acid buildup) are resolved
Undesirable 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%)
Pharmacological Properties
Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney. It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies, for the management of type 2 diabetes mellitu
Packaging
Empacoza Tablets: Box containing 3 blisters of 10 tablets each
