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Radiant Pharmaceuticals LtdProduct Description
Ardance-M (Empagliflozin + Metformin): Ardance-M is a combination oral antidiabetic medication indicated for the treatment of type 2 diabetes mellitus in adults as an adjunct to diet and exercise. It is used in patients inadequately controlled with metformin alone, in combination with other antidiabetic agents, or as a replacement for separate empagliflozin and metformin tablets. Empagliflozin is an SGLT2 inhibitor that lowers blood glucose by reducing renal glucose reabsorption and increasing urinary glucose excretion, while metformin is a biguanide that decreases hepatic glucose production, reduces intestinal glucose absorption, and improves insulin sensitivity without causing hypoglycemia. The dose should be individualized and taken with meals; the maximum daily dose is Empagliflozin 25 mg and Metformin 2000 mg. It is contraindicated in patients with hypersensitivity to either drug, metabolic acidosis (including lactic acidosis and diabetic ketoacidosis), diabetic pre-coma, severe renal impairment (eGFR <30 mL/min), acute conditions affecting renal function, tissue hypoxia, hepatic impairment, and acute alcohol intoxication or alcoholism. Common adverse effects include urinary tract infection, genital fungal infection, diarrhea, nausea, vomiting, abdominal discomfort, increased urination, thirst, headache, and hypoglycemia (especially when combined with insulin or sulfonylureas); rare but serious effects include diabetic ketoacidosis and lactic acidosis. Important drug interactions occur with diuretics (volume depletion), insulin or insulin secretagogues (hypoglycemia), drugs reducing metformin clearance (e.g., cimetidine, dolutegravir), carbonic anhydrase inhibitors (lactic acidosis), and alcohol (increased risk of lactic acidosis). It should be used with caution in patients at risk of hypotension, kidney injury, ketoacidosis, urinary tract infections, vitamin B12 deficiency, and elevated LDL cholesterol, with regular monitoring of renal function and vitamin B12 levels. Ardance-M is not recommended during pregnancy (especially the second and third trimesters), breastfeeding, or in patients under 18 years of age. In overdose, supportive treatment is required, and hemodialysis effectively removes metformin and lactate. The tablets should be stored below 30°C, protected from light and moisture, and kept out of the reach of children.
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