Empagliflozin INN
10 mg & 25 mg Tablet

Empagliflozin is an inhibitor of Sodium-glucose co-transporter 2 (SGLT2). SGLT2 is the predominant transporter responsible for reabsorption of glucose from the kidney back into the circulation. By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

  • Composition

    Empa 10 Tablet: Each film coated tablet contains Empagliflozin INN 10 mg.
    Empa 25 Tablet: Each film coated tablet contains Empagliflozin INN 25 mg.
  • Indication

    Empa 10 is indicated

    - as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and
    - to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease
  • Dosage & Administration

    The recommended dose of Empa 10 is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.
  • Contraindication

    Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.
  • Precaution

    Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 mL/min/1.73m2. No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73m2.
  • Side Effects

    The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.
  • Drug Interaction

    Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.

    Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

    Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

    Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

  • Overdose

  • Pregnancy & Lactation

    There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.
  • Storage Condition

    Keep in a cool & dry place (below 30o C), protected from light & moisture. Keep out of the reach of children.
  • How Supplied

    Each box contains 20 tablets in Alu-Alu Blister pack