سعر سينجاردي 5/1000 مجم 60 قرص 2024

Fixed-dose combination film-coated tablet of empagliflozin 5 mg and metformin hydrochloride 1000 mg (Boehringer Ingelheim) for type 2 diabetes; 60 tablets.

• Type 2 diabetes mellitus as an adjunct to diet and exercise in patients insufficiently controlled on maximally tolerated metformin alone or with other antidiabetic medicines, or already taking empagliflozin and metformin as separate tablets.Population: Adults and children aged 10 years and aboveEuropean Medicines Agency (EMA)

• Most common: hypoglycaemia with insulin and/or sulphonylurea, and gastrointestinal symptoms (nausea, vomiting, diarrhoea, abdominal pain, loss of appetite). Very common/common: genital infections, urinary tract infection, increased urination, thirst, vitamin B12 decrease, taste disturbance. Rare: diabetic ketoacidosis, necrotising fasciitis of the perineum (Fournier gangrene); very rare: lactic acidosis.International label, same product · European Medicines Agency (EMA)

• Hypersensitivity to the active substances or excipients; any acute metabolic acidosis (lactic acidosis, diabetic ketoacidosis); diabetic pre-coma.International label, same product · European Medicines Agency (EMA)
• Severe renal failure (eGFR <30); acute conditions that may alter renal function (dehydration, severe infection, shock); diseases causing tissue hypoxia (decompensated heart failure, respiratory failure, recent myocardial infarction, shock); hepatic impairment, acute alcohol intoxication, alcoholism.International label, same product · European Medicines Agency (EMA)

• Lactic acidosis (rare, serious): risk rises with acute worsening of renal function, cardiorespiratory illness, sepsis, dehydration, alcohol and fasting; stop temporarily during dehydration and stop before/at iodinated contrast imaging, restarting no sooner than 48 h after with stable renal function.International label, same product · European Medicines Agency (EMA)
• Diabetic ketoacidosis (rare, may be life-threatening, sometimes with only moderately raised glucose): assess for ketoacidosis with non-specific symptoms; interrupt for major surgery or acute serious illness; not for type 1 diabetes.International label, same product · European Medicines Agency (EMA)
• US boxed warning: postmarketing cases of metformin-associated lactic acidosis, including fatal cases; risk factors include renal impairment, certain drugs, age >=65, radiological contrast studies, surgery, hypoxic states, excessive alcohol and hepatic impairment.International label, same formulation · DailyMed (US National Library of Medicine)

• Insulin and insulin secretagogues (sulphonylureas)Increased risk of hypoglycaemia; a lower dose of insulin/secretagogue may be required.European Medicines Agency (EMA)
• Thiazide and loop diureticsEmpagliflozin may add to the diuretic effect and increase the risk of dehydration and hypotension.European Medicines Agency (EMA)
• LithiumEmpagliflozin may increase renal lithium excretion and decrease lithium levels; monitor serum lithium more often.European Medicines Agency (EMA)

• No data on use of this product or empagliflozin in pregnancy; animal studies showed adverse effects on postnatal development. When planning pregnancy and during pregnancy, diabetes should be treated with insulin rather than this product.International label, same product · European Medicines Agency (EMA)
• Should not be used during breast-feeding (metformin passes into milk; risk to infants cannot be excluded).International label, same product · European Medicines Agency (EMA)

• Empagliflozin: Inhibits SGLT2 in the proximal renal tubule, reducing renal reabsorption of filtered glucose and lowering the renal threshold for glucose, thereby increasing urinary glucose excretion (US label).
• Metformin: Decreases hepatic glucose production, decreases intestinal glucose absorption and improves insulin sensitivity by increasing peripheral glucose uptake and utilization; insulin secretion remains unchanged (US label).