EMPA PLUS XR
(5/1000,10/1000,12.5/1000 ,25/1000 mg) extended-release F.C tablets
Composition:
Each extended release film coated tablet contains:
• 1000 mg metformin hydrochloride extended-release and 5 mg empagliflozin,or :
• 1000 mg metformin hydrochloride extended-release and 10 mg empagliflozin,or :
• 1000 mg metformin hydrochloride extended-release and 12.5 mg empagliflozin,or
• 1000 mg metformin hydrochloride extended- release and 25 mg empagliflozin.
Mechanism of Action
This product combines 2 antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes: empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a member of the biguanide class.
Empagliflozin:
Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Metformin hydrochloride:
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose.
Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Indications:
This product is a combination of empagliflozin and metformin hydrochloride indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate.
Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. However, the effectiveness of the combination on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established.
Contraindications
• Moderate to severe renal impairment (eGFR less than 45 mL/min/1.73 m2), end stage renal disease, or dialysis.
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.
• History of serious hypersensitivity reaction to empagliflozin or metformin.
Dosage and Administration :
• In patients with volume depletion not previously treated with empagliflozin, correct this condition before initiating this product.
• Individualize the starting dose based on the patient’s current regimen:
− In patients on metformin hydrochloride, switch to the strength containing a similar total daily dose of metformin hydrochloride and a total daily dose of empagliflozin 10 mg.
− In patients on empagliflozin, switch to the strength containing the same total daily dose of empagliflozin and a total daily dose of metformin hydrochloride extended-release 1000 mg.
− In patients already treated with empagliflozin and metformin hydrochloride, switch to the strength containing the same total daily doses of empagliflozin and a similar total daily dose of metformin hydrochloride.
• Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of metformin hydrochloride 2000 mg and empagliflozin 25 mg.
• The dose of metformin hydrochloride should be gradually escalated to reduce the gastrointestinal side effects due to metformin hydrochloride.
• Take this product orally once daily with a meal in the morning.
• Swallow the product tablets whole. Do not split, crush, dissolve, or chew before swallowing.
• The 10 mg/1000 mg and 25 mg/1000 mg tablets should be taken as a single tablet once daily. The 5 mg/1000 mg and 12.5 mg/1000 mg tablets should be taken as two tablets together once daily.
Packaging:
Pack of 28 extended release film coated tablets for all strengths.