Ardance-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 diabetes
• Patients with volume depletion not previously treated with Empagliflozin
• Already being treated with the combination of Empagliflozin and Metformin as separate tablets

Pharmacology

• Empagliflozin inhibits Sodium-Glucose Co-Transporter 2 (SGLT2)
• Reduces renal reabsorption of glucose
• Lowers renal threshold for glucose
• Increases urinary glucose excretion
• Metformin Hydrochloride is a 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

• Take twice daily with meals
• Individualized based on effectiveness and tolerability
• Dose escalation should be gradual
• Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg
• Maximum recommended daily dose of Empagliflozin is 25 mg
• Extended-release formulations available
• Renal impaired patient assessment required
• Pediatric patients under 18 years of age: Safety and effectiveness not established

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
• Risk of lactic acidosis with carbonic anhydrase inhibitors
• Drugs affecting glycemic control
• 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)
• Acute conditions altering renal function
• Diseases causing tissue hypoxia
• Hepatic impairment, acute alcohol intoxication, alcoholism

Side Effects

• Common adverse reactions associated with Empagliflozin
• Common adverse reactions associated with Metformin
• Important adverse reactions including hypoglycemia and gastrointestinal symptoms

Pregnancy & Lactation

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

Precautions & Warnings

• Lactic Acidosis warning
• Hypotension assessment and monitoring
• Ketoacidosis evaluation and treatment
• Acute kidney injury & impairment in renal function
• Urosepsis, Pyelonephritis, Fournier’s gangrene & Genital mycotic infections evaluation and treatment
• Hypoglycemia risk reduction
• Vitamin B12 Deficiency monitoring
• Increased LDL-C monitoring and treatment
• No conclusive evidence of macrovascular risk reduction

Overdose Effects

• No toxicity seen with up to 800 mg Empagliflozin in healthy volunteers
• No toxicity seen with up to 100 mg Empagliflozin in patients with type 2 diabetes
• No hypoglycemia seen with Metformin doses of up to 85 g
• Lactic acidosis is a medical emergency

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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