Glycenor M ER 5 mg+1000 mg (Tablet (Extended Release))

Indications

• Indicated for the treatment of adults with type 2 diabetes mellitus
• Adjunct to diet and exercise
• Treatment in combination with other medicinal products for diabetes
• Usable in patients uncontrolled with Metformin
• Usable in patients with volume depletion

Pharmacology

• Empagliflozin is an inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2)
• Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug
• Empagliflozin reduces renal reabsorption of filtered glucose
• Metformin Hydrochloride decreases hepatic glucose production
• Metformin Hydrochloride lowers postprandial plasma glucose

Dosage & Administration

• Should be individualized based on effectiveness and tolerability
• Should be taken twice daily with meals
• Dose escalation should be gradual
• Extended-release formulations available
• Renal impaired patient assessment required

Interaction

• Interacts with diuretics
• Interacts with insulin or insulin secretagogues
• Monitor glycemic control with alternative methods
• Drugs that reduce Metformin clearance may increase its accumulation
• Alcohol can potentiate the effect of Metformin on lactate metabolism

Contraindications

• Hypersensitivity to Empagliflozin and Metformin
• Severe renal failure (GFR <30 ml/min)
• Acute metabolic acidosis or diabetic pre-coma
• Severe conditions altering renal function

Side Effects

• Common adverse reactions include urinary tract infection and genital mycotic infections
• Most common adverse reactions associated with Metformin are diarrhea, nausea, and abdominal discomfort
• Other adverse reactions include hypoglycemia, increased urination, and increased serum lipids

Pregnancy & Lactation

• Not recommended during pregnancy
• Advice against use when breastfeeding

Precautions & Warnings

• Lactic acidosis may occur
• Assess and correct volume status before initiation
• Monitor for signs and symptoms of hypotension
• Evaluate patients for signs of urinary tract infections
• Consider lowering the dose of insulin to reduce hypoglycemia risk

Overdose Effects

• No toxicity shown with single doses of up to 800 mg Empagliflozin
• No hypoglycemia seen with Metformin doses of up to 85 g
• Lactic acidosis may occur in overdose situations

Therapeutic Class

• Combination Oral hypoglycemic preparations

Storage Conditions

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

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