سعر اتوميتافلوزين 12.5/1000مجم 30 قرص 2024

Atometaflozine 12.5/1000 mg tablets, pack of 30 (Atos Pharma, Egypt): fixed-dose combination of empagliflozin 12.5 mg and metformin hydrochloride 1000 mg for type 2 diabetes mellitus.

• Adjunct to diet and exercise to improve glycaemic control in type 2 diabetes mellitusPopulation: Adults and pediatric patients aged 10 years and older (SYNJARDY)DailyMed (US National Library of Medicine)
• Empagliflozin component: reduce risk of cardiovascular death (established CV disease), CV death and hospitalisation for heart failure (heart failure), and kidney disease progression (chronic kidney disease)Population: Adults with type 2 diabetes mellitusDailyMed (US National Library of Medicine)

• Empagliflozin (at least 2% and more than placebo): urinary tract infection, female genital mycotic infections, upper respiratory tract infection, increased urination, dyslipidaemia, arthralgia, male genital mycotic infections, nausea.International label, equivalent formulation · DailyMed (US National Library of Medicine)
• Metformin (more than 5% on initiation): diarrhoea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia and headache.International label, equivalent formulation · DailyMed (US National Library of Medicine)

• Severe renal impairment (eGFR below 30 mL/min/1.73 m2); acute or chronic metabolic acidosis including diabetic ketoacidosis; hypersensitivity to empagliflozin, metformin or any excipient (e.g. angioedema).International label, equivalent formulation · DailyMed (US National Library of Medicine)

• Boxed warning: metformin-associated lactic acidosis (can be fatal); risk factors include renal impairment, carbonic anhydrase inhibitors such as topiramate, age 65 or older, contrast studies, surgery, hypoxic states, excessive alcohol, hepatic impairment. Discontinue immediately if suspected; prompt haemodialysis recommended.International label, equivalent formulation · DailyMed (US National Library of Medicine)
• Ketoacidosis (including euglycaemic) can occur in type 2 diabetes; not for type 1 diabetes. Withhold in situations predisposing to ketoacidosis; assess for ketoacidosis regardless of glucose level.International label, equivalent formulation · DailyMed (US National Library of Medicine)
• Volume depletion (symptomatic hypotension, acute kidney injury), genitourinary infections including urosepsis, pyelonephritis and Fournier's gangrene, genital mycotic infections, hypoglycaemia with insulin or secretagogues, lower limb amputation, hypersensitivity reactions and vitamin B12 deficiency.International label, equivalent formulation · DailyMed (US National Library of Medicine)

• Carbonic anhydrase inhibitors (topiramate, zonisamide, acetazolamide, dichlorphenamide)May increase the risk of lactic acidosis; consider more frequent monitoring.DailyMed (US National Library of Medicine)
• Drugs that reduce metformin clearance (OCT2/MATE inhibitors such as ranolazine, vandetanib, dolutegravir, cimetidine)Could increase metformin exposure and lactic acidosis risk; weigh benefits and risks.DailyMed (US National Library of Medicine)
• AlcoholPotentiates the effect of metformin on lactate metabolism; avoid excessive intake.DailyMed (US National Library of Medicine)

• Limited data are insufficient to determine a drug-associated risk of major birth defects or miscarriage; published metformin data show no clear association. Poorly controlled diabetes carries maternal and fetal risks.International label, equivalent formulation · DailyMed (US National Library of Medicine)
• Not recommended while breastfeeding: metformin is present in human milk and empagliflozin in rat milk, with potential risk to the developing infant kidney.International label, equivalent formulation · DailyMed (US National Library of Medicine)

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