Emjard M 12.5 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 diabetes
• Already treated with the combination of Empagliflozin and Metformin as separate tablets

Pharmacology

• Empagliflozin inhibits Sodium-Glucose Co-Transporter 2 (SGLT2)
• Reduces renal reabsorption of filtered glucose
• Lowers renal threshold for glucose
• Increases urinary glucose excretion
• Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug
• Lowers both basal and postprandial plasma glucose
• Does not produce hypoglycemia
• Decreases hepatic glucose production
• Decreases intestinal absorption of glucose
• Improves insulin sensitivity

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 is 2000 mg
• Maximum recommended daily dose of Empagliflozin is 25 mg
• Recommended individualized starting dose for patients on Metformin Hydrochloride and Empagliflozin
• Extended-release formulations available
• Dosage adjustment for renal impaired patients
• Not recommended for pediatric patients under 18 years of age

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
• Diabetic pre-coma
• Severe renal failure (GFR <30 ml/min)
• Acute conditions altering renal function
• Conditions causing tissue hypoxia
• Hepatic impairment
• Acute alcohol intoxication or 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
• Rash
• Increased urination
• Increased serum lipids
• Volume depletion
• Urticaria
• Dysuria
• Increased blood creatinine/GFR decreased
• Increased haematocrit
• Diabetic ketoacidosis

Pregnancy & Lactation

• Potential risk to fetus 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 with single doses of up to 800 mg Empagliflozin
• No hypoglycemia with Metformin doses of up to 85 g
• Lactic acidosis is a medical emergency
• Hemodialysis may be effective for removal of lactate and Metformin

Therapeutic Class

• Combination Oral hypoglycemic preparations

Storage Conditions

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

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