Empaglif-M 5 mg+500 mg (Tablet)

Indications

• Treatment of adults with type 2 diabetes mellitus
• Adjunct to diet and exercise
• Insufficiently controlled on maximally tolerated dose of Metformin alone
• In combination with other medicinal products for treatment of diabetes
• In patients already being treated with a combination of Empagliflozin and Metformin as separate tablets

Pharmacology

• Inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2)
• Reduces renal reabsorption of filtered glucose
• Lowers renal threshold for glucose
• Increases urinary glucose excretion
• Biguanide type 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

Dosage & Administration

• Twice daily with meals
• Gradual dose escalation to reduce gastrointestinal side effects
• Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg
• Maximum recommended daily dose of Empagliflozin is 25 mg
• Recommended individualized starting dose
• Extended-release formulations available
• Dosage individualization based on patient's current drug regimen
• Dosage adjustments for renal impaired patients
• Not recommended for pediatric patients under 18 years of age

Interaction

• Co-administration with diuretics
• Co-administration with insulin or insulin secretagogues
• Monitoring glycemic control with urine glucose tests not recommended
• Drugs that reduce Metformin clearance
• Carbonic Anhydrase Inhibitors
• Drugs affecting glycemic control
• Alcohol

Contraindications

• Hypersensitivity to Empagliflozin and Metformin
• Acute metabolic acidosis
• Diabetic pre-coma
• Severe renal failure (GFR <30 ml/min)
• Acute conditions with potential to alter renal function
• Disease which may cause 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 and other genital infection
• Thirst
• Taste disturbance
• Pruritus (generalised)
• Rash
• Increased urination
• Serum lipids increased
• Volume depletion
• Urticaria
• Dysuria
• Blood creatinine increased/Glomerular filtration rate decreased
• Haematocrit increased
• Diabetic ketoacidosis

Pregnancy & Lactation

• Potential risk to fetus especially during second and third trimesters
• Not recommended during breastfeeding

Precautions & Warnings

• Lactic Acidosis
• Hypotension
• Ketoacidosis
• Acute kidney injury & impairment in renal function
• Urosepsis, Pyelonephritis, Fournier’s gangrene & Genital mycotic infections
• Hypoglycemia
• Vitamin B12 Deficiency
• Increased LDL-C
• Macrovascular Outcomes

Overdose Effects

• No toxicity observed at high single doses
• Hypoglycemia not seen at high Metformin doses
• Lactic acidosis observed in high Metformin doses
• Treatment should be initiated based on patient's clinical status
• Haemodialysis for lactate and Metformin removal

Therapeutic Class

• Combination Oral hypoglycemic preparations

Storage Conditions

• Store below 30°C temperature
• Protected from light & moisture
• Keep out of the reach of children

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