EmpaMet 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
• Combination with other medicinal products for diabetes treatment
• In patients with volume depletion

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
• Improves insulin sensitivity

Dosage And Administration

• Individualized based on effectiveness and tolerability
• Take twice daily with meals
• Gradual dose escalation to reduce gastrointestinal side effects
• Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg and Empagliflozin is 25 mg
• Extended-release formulations available
• Adjust dosing based on effectiveness and tolerability

Interaction

• Diuretics
• Insulin or Insulin Secretagogues
• 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
• Conditions altering renal function
• Hepatic impairment
• Acute alcohol intoxication

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
• Rash
• Increased urination
• Increased serum lipids
• Volume depletion
• Urticaria
• Dysuria
• Increased blood creatinine/Glomerular filtration rate decreased
• Increased haematocrit
• Diabetic ketoacidosis

Pregnancy And Lactation

• Potential risk to fetus
• Not recommended during breastfeeding

Precautions And Warnings

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

Overdose Effects

• No toxicity observed at high doses of Empagliflozin
• Lactic acidosis in Metformin overdose
• Hypoglycemia not seen at high Metformin doses
• Immediate hospitalization for lactic acidosis
• Haemodialysis for removal of lactate and Metformin

Therapeutic Class

• Oral hypoglycemic preparations

Storage Conditions

• Temperature below 30°C
• Protected from light and moisture
• Keep out of the reach of children

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