Emazid M 12.5 mg+500 mg (Tablet)

Indications

• Treatment of adults with type 2 diabetes mellitus
• Adjunct to diet and exercise
• In combination with other medicinal products for diabetes
• Patients insufficiently controlled on Metformin
• Patients on Empagliflozin and Metformin separately

Pharmacology

• Inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2)
• Reduces renal reabsorption of glucose
• Lowers renal threshold for glucose
• Decreases hepatic glucose production
• Improves insulin sensitivity

Dosage & Administration

• Individualized based on effectiveness and tolerability
• Take twice daily with meals
• Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg and Empagliflozin is 25 mg
• Dose escalation should be gradual to reduce gastrointestinal side effects

Interaction

• Diuretics
• Insulin or Insulin Secretagogues
• Positive Urine Glucose Test
• Drugs that Reduce Metformin Clearance
• Carbonic Anhydrase Inhibitors
• Drugs Affecting Glycemic Control
• Alcohol

Contraindications

• Hypersensitivity to Empagliflozin and Metformin
• Acute metabolic acidosis
• Severe renal failure
• Conditions altering renal function
• Disease causing tissue hypoxia
• Hepatic impairment
• Alcohol intoxication

Side Effects

• Urinary tract infection
• Genital mycotic infections
• Diarrhea
• Nausea/vomiting
• Flatulence
• Abdominal discomfort
• Headache
• Hypoglycemia
• Thirst
• Taste disturbance
• Rash
• Increased urination
• Increased serum lipids
• Lactic acidosis

Pregnancy & Lactation

• Potential risk to fetus
• Not recommended during breastfeeding

Precautions & Warnings

• Lactic Acidosis
• Hypotension
• Ketoacidosis
• Acute kidney injury & impairment
• Urinary tract infections
• Hypoglycemia
• Vitamin B12 Deficiency
• Increased LDL-C
• Macrovascular Outcomes

Overdose Effects

• No toxicity with single doses up to 800 mg Empagliflozin
• Hypoglycemia not seen with Metformin doses up to 85 g
• Lactic acidosis is a medical emergency
• Haemodialysis is the most effective method for removal of lactate and Metformin

Therapeutic Class

• Combination oral hypoglycemic preparations

Storage Conditions

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

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