Empadus25 mg

Established Indication - Type 2 Diabetes (Glycemic Control)

Empadus is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.

Established Indication - Cardiovascular Risk Reduction

Empadus is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

Established Indication - Heart Failure

Empadus is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults, regardless of ejection fraction and regardless of the presence of type 2 diabetes.

Established Indication - Chronic Kidney Disease (CKD)

Empadus is indicated to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.

Not an Approved Use

Empadus is not approved for use in type 1 diabetes mellitus and is not recommended for the treatment of type 1 diabetes or diabetic ketoacidosis.

Each film-coated tablet contains Empagliflozin (as the active ingredient) 10 mg or 25 mg.

Empadus is a prescription medicine that belongs to a class of drugs called SGLT2 inhibitors, used to help control blood sugar in adults and children aged 10 years and older with type 2 diabetes. Empadus is also used in adults to lower the risk of cardiovascular death and hospitalization related to heart failure, and to slow the progression of certain forms of chronic kidney disease, even in people who do not have diabetes. Empadus works by helping the kidneys remove extra glucose from the body through urine. Empadus is taken once daily as a tablet and is generally used as part of a long-term treatment plan alongside diet, exercise, and other prescribed therapies. Empadus should only be used under the supervision of a qualified healthcare professional.

Antidiabetic (SGLT2 Inhibitor)

Empagliflozin inhibits sodium-glucose cotransporter 2 (SGLT2), the transporter responsible for the majority of glucose reabsorption in the kidney's proximal tubule. By blocking SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, leading to increased urinary glucose excretion. This insulin-independent mechanism lowers blood glucose in type 2 diabetes and also produces modest reductions in body weight and blood pressure through osmotic diuresis and caloric loss. Independent of its glucose-lowering effect, Empagliflozin has demonstrated benefits on cardiovascular and renal outcomes, thought to involve effects on cardiac preload/afterload, sodium handling, and intraglomerular pressure.

• Take Empadus by mouth once daily, in the morning, with or without food.
• Swallow the tablet whole with a glass of water; do not crush or split unless advised.
• Take Empadus at approximately the same time each day to maintain a consistent routine.
• If a dose of Empadus is missed, take it as soon as remembered on the same day; do not double the dose the next day.
• Continue taking Empadus even if you feel well, unless your doctor advises otherwise.
• Do not stop Empadus abruptly without consulting your doctor, especially before surgery or during illness, as instructed by your healthcare provider.

• Diuretics (water pills): Combining Empadus with diuretics may increase the risk of volume depletion, dehydration, and symptomatic hypotension.
• Insulin and insulin secretagogues (e.g., sulfonylureas): Using Empadus together with insulin or sulfonylureas increases the risk of hypoglycemia; a lower dose of the insulin or secretagogue may be needed.
• Lithium: Empadus may decrease serum lithium concentrations; lithium levels should be monitored more frequently when Empadus is started, changed, or stopped.
• Urine glucose and 1,5-anhydroglucitol (1,5-AG) laboratory tests: Empadus causes false-positive urine glucose readings and unreliable 1,5-AG assay results, so alternative methods should be used to monitor glycemic control.

Common Side Effects

Urinary tract infection, female genital mycotic (yeast) infection, male genital mycotic infection, increased urination, thirst, and nasopharyngitis (common cold-like symptoms).

Serious Side Effects (Seek Medical Attention)

Diabetic ketoacidosis (see Precautions and Warnings for full details), signs of Fournier's gangrene such as severe genital or perineal pain, swelling, redness, or fever (see Precautions and Warnings), symptoms of dehydration or low blood pressure such as dizziness or fainting, signs of kidney problems, hypoglycemia (especially when used with insulin or sulfonylureas), urosepsis or pyelonephritis (serious urinary tract infection with fever, back pain, or vomiting), and hypersensitivity reactions such as angioedema (swelling of the face, lips, tongue, or throat, or difficulty breathing). Seek immediate medical attention if any of these occur.

Pregnancy

Empadus is generally not recommended during pregnancy. Based on the mechanism of action, Empadus may affect renal maturation and development when used during the second and third trimesters, and patients should be advised of the potential risk to the fetus. If pregnancy is detected, Empadus should be discontinued and the treatment plan reassessed by a healthcare professional.

Breastfeeding

Use of Empadus is not recommended while breastfeeding, as it is unknown whether Empadus passes into human milk and potential effects on a nursing infant's kidney development are a concern. A healthcare provider should be consulted to select an appropriate alternative during lactation.

• Diabetic ketoacidosis (DKA): Empadus, like other SGLT2 inhibitors, has been associated with cases of ketoacidosis, including fatal cases. Blood glucose levels at presentation may be only mildly elevated or even near-normal (for example, below 250 mg/dL), which can delay recognition. Patients should be assessed for ketoacidosis if symptoms such as nausea, vomiting, abdominal pain, malaise, or unusual fatigue occur, regardless of blood glucose level, and Empadus should be stopped promptly if DKA is suspected or confirmed. The risk is further increased in situations such as reduced food/fluid intake, surgery, serious illness, or off-label use in type 1 diabetes, for which Empadus is not approved.
• Genital mycotic infections and Fournier's gangrene: Empadus increases the risk of genital yeast infections in both women and men because of increased urinary glucose excretion. Rare but serious, life-threatening cases of necrotizing fasciitis of the perineum (Fournier's gangrene) have been reported with SGLT2 inhibitors, including Empadus, in both females and males; patients should seek urgent medical care for genital or perineal pain, tenderness, redness, or swelling accompanied by fever or malaise.
• Volume depletion and hypotension: Empadus can cause intravascular volume depletion, which may present as symptomatic low blood pressure or transient changes in kidney function, particularly in the elderly, patients on diuretics, or those with low blood pressure or impaired renal function.
• Kidney function monitoring: Renal function should be assessed before starting Empadus and periodically during treatment, since effectiveness and appropriate use depend on eGFR.
• Lower limb amputation: In cardiovascular outcome trials, lower limb amputations occurred at a slightly higher rate with Empadus than with placebo; patients should be monitored and counselled on routine preventive foot care, and Empadus used with caution in those with a history of amputation, peripheral vascular disease, neuropathy, or diabetic foot ulcers.
• Hypoglycemia: Combining Empadus with insulin or sulfonylureas increases hypoglycemia risk; a dose adjustment of the other agent may be required.
• Urosepsis and pyelonephritis: Serious urinary tract infections, including urosepsis and pyelonephritis, have been reported with Empadus; patients should be evaluated promptly for signs of urinary tract infection.
• Hypersensitivity reactions: Angioedema has been reported with Empadus; discontinue Empadus and seek prompt medical care if a hypersensitivity reaction occurs.

There is no specific antidote for Empadus overdose. In case of a suspected overdose, do not induce vomiting unless specifically directed to do so by a healthcare professional or poison control service. Contact emergency medical services or a poison control center immediately, and provide supportive treatment as appropriate to the patient's clinical status, including monitoring of fluid and electrolyte status and renal function. Excess glucose removal through hemodialysis has not been well studied for Empadus.

Store according to the product label.

Children: Empadus is approved for glycemic control in children aged 10 years and older with type 2 diabetes; safety and effectiveness for younger children, or for the heart failure, chronic kidney disease, or cardiovascular death-reduction indications, have not been established in pediatric patients.

Elderly: Older adults may be at greater risk of volume depletion and its consequences (such as hypotension) when taking Empadus; renal function should be monitored more closely in this group.

Renal impairment: Use of Empadus for glycemic control is not recommended when eGFR is below 30 mL/min/1.73 m²; Empadus is not recommended in patients with severe renal impairment, end-stage renal disease, or those on dialysis. For the heart failure and chronic kidney disease indications, use has been studied down to lower eGFR levels, but initiation and continuation should always be individualized by a physician based on current renal function.

Hepatic impairment: No dosage adjustment of Empadus is required based on hepatic impairment alone; clinical judgment should still guide use in patients with significant liver disease.

Empadus is typically used as a long-term, chronic therapy for type 2 diabetes, heart failure, or chronic kidney disease, as directed by a healthcare professional. Duration of treatment should be periodically reviewed by the prescribing physician based on ongoing clinical response and tolerability.

Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitor; Antidiabetic agent.

Empagliflozin selectively inhibits SGLT2 in the renal proximal tubule, reducing glucose reabsorption and lowering the renal threshold for glucose, which increases urinary glucose excretion and lowers blood glucose independent of insulin secretion or action.

Empadus's safety and effectiveness for improving glycemic control have been established only in pediatric patients aged 10 years and older with type 2 diabetes mellitus, as an adjunct to diet and exercise. Empadus's safety and effectiveness for the heart failure, chronic kidney disease, or cardiovascular death-reduction indications have not been established in patients under 18 years of age. Empadus is not approved for use in type 1 diabetes at any age.