Indication:
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus as:
Monotherapy
When diet and exercise alone do not provide adequate glycemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
Add-on combination therapy
In combination with other glucose–lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycemic control.
Active Ingredient:
EMPAGLIFLOZIN
DOSAGE & ADMINISTRATION
Monotherapy and add-on combination therapy
The recommended starting dose is 10mg empagliflozin once daily with or without food for monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin. In patients tolerating empagliflozin 10mg once daily who have an eGFR ≥60 ml/min/1.73 m2 and need tighter glycemic control, the dose can be increased to 25mg once daily. The maximum daily dose is 25mg. When empagliflozin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycemia .
ADVERSE REACTIONS
Very Common Hypoglycemia (when used with sulphonylurea or insulin). Common Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection, urinary tract infection, pruritus (generalised) and increased urination. Uncommon Volume depletion, dysuria and blood creatinine increased / glomerular filtration rate decreased. Rare Diabetic ketoacidosis. CONTRAINDICATIONS Empagliflozin is contraindicated in: • Patients with known hypersensitivity to empagliflozin or to any excipient of the product. • Severe renal impairment, end-stage renal disease, or dialysis.
