سعر ميتفوجليزين 5/850مجم 30 قرص 2023

Fixed-dose film-coated tablet containing dapagliflozin 5 mg and metformin hydrochloride 850 mg (immediate release), pack of 30; Egyptian product by Nobel Pharm. Industries (Debeiky).

• Type 2 diabetes mellitus in adults as adjunct to diet and exercise (insufficient control on metformin, with other antidiabetics, or replacing separate tablets)Population: AdultsEuropean Medicines Agency (EMA)

• Reported with the components include hypoglycaemia (with insulin/sulfonylurea), genital infections, urinary tract infections, polyuria, gastrointestinal symptoms (metformin) and rare diabetic ketoacidosis.International label, same formulation · European Medicines Agency (EMA)

• Hypersensitivity to the active substances or excipients.International label, same formulation · European Medicines Agency (EMA)
• Any acute metabolic acidosis (lactic acidosis, diabetic ketoacidosis) and diabetic pre-coma.International label, same formulation · European Medicines Agency (EMA)
• Severe renal failure (GFR below 30 mL/min) and acute conditions that may alter renal function (dehydration, severe infection, shock).International label, same formulation · European Medicines Agency (EMA)

• Lactic acidosis (metformin): stop in dehydration and seek care; caution with drugs that impair renal function.International label, same formulation · European Medicines Agency (EMA)
• Diabetic ketoacidosis, including atypical cases with only moderately raised glucose, has been reported with SGLT2 inhibitors; interrupt treatment for major surgery or acute serious illness.International label, same formulation · European Medicines Agency (EMA)
• Volume depletion/hypotension risk due to osmotic diuresis; stop before or at the time of iodinated contrast imaging and restart after at least 48 hours if renal function is stable; may lower vitamin B12.International label, same formulation · European Medicines Agency (EMA)

• Iodinated contrast agentsMay cause contrast nephropathy and metformin accumulation; discontinue before/at the procedure.European Medicines Agency (EMA)
• Insulin and sulfonylureasIncreased risk of hypoglycaemia; a lower insulin or sulfonylurea dose may be needed.European Medicines Agency (EMA)

• Not recommended in the second and third trimesters (renal developmental toxicity of dapagliflozin in rats); insulin is preferred to treat diabetes during pregnancy.International label, same formulation · European Medicines Agency (EMA)
• Should not be used while breastfeeding; metformin passes into milk in small amounts and dapagliflozin is excreted in animal milk.International label, same formulation · European Medicines Agency (EMA)

• Dapagliflozin: Inhibits renal SGLT2, reducing glucose reabsorption and increasing urinary glucose excretion (EU SmPC).
• Metformin hydrochloride: Reduces hepatic glucose production and improves peripheral insulin sensitivity (EU SmPC).