Usage And Safety
Dosage
Monotherapy and add-on combination therapy – Adults : The recommended starting dose is 10mg empagliflozin once daily with or without food for monotherapy. 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 . Children : Not Recommended . Always consult your doctor or pharmacist for dose adjustments.
Side Effects
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
Drug Interactions
Diuretics , thiazide and loop diuretics , SGLT2 inhibitors
Indication
Empagliflozin is 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.
When not to Use
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.
Warnings
Warning 1
Insulin and insulin secretagogues are known to cause hypoglycemia. The risk of hypoglycemia is increased when empagliflozin is used in combination with insulin secretagogues (e.g., sulphonylurea) or insulin.Therefore, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with empagliflozin.
Warning 2
Empagliflozin increases the risk for urinary tract infections including urosepsis and pyelonephritis requiring hospitalisation in patients receiving SGLT2 inhibitors, including empagliflozin. Monitor and treat asappropriate. Discontinuation of empagliflozin may be considered in cases of recurrent urinary tract infections.
Warning 3
Empagliflozin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (DKA). In patients where DKA is suspected or diagnosed, treatment with empagliflozin should bediscontinued immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. In both cases, treatment with empagliflozin may be restarted once the patient’s condition has stabilised.
