Emparol 10

Presentation: Each film-coated tablet contains 10 mg of empagliflozin.

Indications: Emparol 10 is indicated in adults with type 2 diabetes mellitus:  

• As monotherapy when diet and exercise alone do not provide adequate glycemic control in patients for whommetformin is considered inappropriate due to intolerance.
• As add-on therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequateglycemic control.
• To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease.  

Dosage and Administration: Emparol 10 tablets are for oral administration and should be swallowed whole with water. It can be taken with or without food, preferably at the same time each day.

• For Glycemic Control: The recommended starting dose is 10 mg once daily. In patients tolerating empagliflozin 10 mg once daily who have an eGFR ≥60mL/min/1.73 m², the dose can be increased to 25 mg once daily for additional glycemic control.
• To Reduce the Risk of Cardiovascular Death and Hospitalization for Heart Failure: The recommended dose is 10 mg once daily.
• Renal Impairment:
  • For glycemic control, a dose of 10 mg once daily is recommended in patients with an eGFR ≥20mL/min/1.73 m². Empagliflozin should not be initiated in patients with an eGFR < 20 mL/min/1.73 m².
  • For reduction of cardiovascular risk and hospitalization for heart failure, the recommended dose is 10 mg once daily in patients with an eGFR ≥20mL/min/1.73 m².
  • If eGFR falls below 20 mL/min/1.73 m² during therapy, empagliflozin should be discontinued.
• Hepatic Impairment: No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Empagliflozin is not recommended in patients with severe hepatic impairment.
• Elderly: No dose adjustment is generally required based on age. However, renal function should be assessed.

Side Effects: Common adverse reactions may include hypoglycemia (when used with sulfonylureas or insulin), urinary tract infections, increased urination, thirst, and genital mycotic infections.

Less common but potentially serious side effects may include diabetic ketoacidosis (symptoms may include nausea, vomiting, abdominal pain, confusion, unusual drowsiness or tiredness, shortness of breath), acute kidney injury, and Fournier's gangrene (a rare but serious infection of the genitals and perineum).

Precautions:Empagliflozin should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.  

Assess renal function prior to initiation of Emparol 10 and periodically thereafter.

Caution should be exercised in patients with conditions that may predispose them to dehydration (e.g., elderly patients, patients on diuretics, or patients with gastrointestinal illness).

Patients should be monitored for signs and symptoms of urinary tract infections and genital mycotic infections and treated promptly if they occur.

Rare cases of diabetic ketoacidosis, a serious life-threatening condition, have been reported in patients taking SGLT2 inhibitors, including empagliflozin. Patients should be educated on the risk factors and symptoms of DKA.

Rare cases of Fournier's gangrene have been reported with SGLT2 inhibitors. Patients experiencing pain, tenderness, erythema, or swelling in the genital or perineal area, with fever or malaise, should seek medical attention promptly.

Inform healthcare professionals about all other medications being taken, including over-the-counter drugs and herbal supplements, as interactions may occur.

Inform healthcare professionals regarding pregnancy and breastfeeding status before starting treatment with Emparol 10. Empagliflozin is not recommended during the second and third trimesters of pregnancy and is not recommended during breastfeeding.

Storage: Store at room temperature (15°C to 30°C), protected from moisture. Keep out of reach of children. Do not use after the expiry date.

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.