Emfogen M XR 5 mg+1000 mg (Tablet (Extended Release))

Indications

• treatment of adults with type 2 diabetes mellitus
• adjunct to diet and exercise

Mode of Action

• inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2)
• reduces renal reabsorption of glucose
• lowers renal threshold for glucose
• increases urinary glucose excretion
• oral antihyperglycemic drug
• lowers basal and postprandial plasma glucose
• does not produce hypoglycemia
• decreases hepatic glucose production
• decreases intestinal absorption of glucose
• improves insulin sensitivity
• increases peripheral glucose uptake and utilization

Dosage & Administration

• individualized based on effectiveness and tolerability
• take twice daily with meals
• dose escalation should be gradual
• maximum recommended daily dose of Metformin Hydrochloride: 2000 mg, Empagliflozin: 25 mg
• extended-release formulations available
• renal function assessment required before initiation
• contraindicated in patients with eGFR below 45 mL/min/1.73 m2
• not established for pediatric patients under 18 years of age

Interaction

• with diuretics may increase urine volume and frequency of voids
• with insulin or insulin secretagogues increases risk for hypoglycemia
• monitoring glycemic control with urine glucose tests not recommended
• drugs that reduce Metformin clearance may increase its accumulation
• carbonic anhydrase inhibitors may increase risk of lactic acidosis
• drugs affecting glycemic control should be closely observed
• alcohol can potentiate the effect of Metformin on lactate metabolism

Contraindications

• hypersensitivity to Empagliflozin and Metformin
• acute metabolic acidosis
• diabetic pre-coma
• severe renal failure (GFR <30 ml/min)
• conditions altering renal function
• disease causing tissue hypoxia
• hepatic impairment
• acute alcohol intoxication
• alcoholism

Side Effects

• urinary tract infection
• female genital mycotic infections
• diarrhea
• nausea/vomiting
• flatulence
• abdominal discomfort
• indigestion
• asthenia
• headache
• hypoglycemia
• vaginal moniliasis
• vulvovaginitis
• balanitis
• urinary tract infection
• thirst
• taste disturbance
• pruritus
• rash
• increased urination
• serum lipids increased
• volume depletion
• urticaria
• dysuria
• blood creatinine increased
• glomerular filtration rate decreased
• haematocrit increased
• diabetic ketoacidosis

Pregnancy & Lactation

• advised females of potential risk to fetus during second and third trimesters
• not recommended during breastfeeding

Precautions & Warnings

• lactic acidosis reported in postmarketing cases
• hypotension risk in certain patient groups
• ketoacidosis assessment required before initiation
• consider temporary discontinuation in settings of reduced oral intake or fluid losses
• increased risk for urinary tract infections
• consider dose adjustment to reduce risk of hypoglycemia
• Metformin Hydrochloride may lower vitamin B12 levels
• monitor and treat increased LDL-C as appropriate
• no conclusive evidence of macrovascular risk reduction

Overdose Effects

• Empagliflozin did not show any toxicity in controlled clinical studies
• Metformin overdose may lead to lactic acidosis
• treatment should be initiated based on patient's clinical status
• haemodialysis may be effective for Metformin removal

Therapeutic Class

• Combination Oral hypoglycemic preparations

Storage Conditions

• keep below 30°C temperature
• protected from light & moisture
• keep out of the reach of children

Related Brands

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• Emfogen M 12.5 mg+500 mg (Tablet) - general-pharmaceuticals-ltd
• Emfogen M 5 mg+1000 mg (Tablet) - general-pharmaceuticals-ltd
• Glifo-M XR 5 mg+1000 mg (Tablet (Extended Release)) - acme-laboratories-ltd