Glycenor M 5 mg+500 mg (Tablet)

Indications

• Adjunct to diet and exercise for adults with type 2 diabetes mellitus
• Treatment for patients insufficiently controlled on Metformin alone
• Combination therapy for patients insufficiently controlled with Metformin and other medicinal products
• Treatment for patients already being treated with the combination of Empagliflozin and Metformin as separate tablets

Pharmacology

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

Dosage & Administration

• Individualized dosage based on effectiveness and tolerability
• Take twice daily with meals
• Gradual dose escalation to reduce gastrointestinal side effects
• Maximum daily doses of Metformin Hydrochloride and Empagliflozin
• Extended-release formulations available
• Special dosing for renal impaired patients
• Not recommended for pediatric patients under 18 years of age

Interaction

• Effects of co-administration with diuretics
• Increased risk of hypoglycemia with insulin or insulin secretagogues
• Monitoring glycemic control with urine glucose tests not recommended
• Drugs that may reduce Metformin clearance
• Risk of lactic acidosis with carbonic anhydrase inhibitors
• Effect of drugs affecting glycemic control
• Potentiation of Metformin effect by alcohol

Contraindications

• Hypersensitivity to Empagliflozin and Metformin
• Acute metabolic acidosis or diabetic pre-coma
• Severe renal failure (GFR <30 ml/min)
• Conditions altering renal function or causing tissue hypoxia
• Hepatic impairment, acute alcohol intoxication, alcoholism

Side Effects

• Common adverse reactions associated with Empagliflozin and Metformin
• Most common adverse reactions for each component
• Important adverse reactions including hypoglycemia, genital infections, urinary tract infections, thirst
• Rare adverse reactions like volume depletion, urticaria, diabetic ketoacidosis

Pregnancy & Lactation

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

Precautions & Warnings

• Risk of Metformin-associated lactic acidosis
• Assessment and correction of volume status before initiating therapy
• Evaluation for ketoacidosis in patients presenting with signs of metabolic acidosis
• Consideration of temporary discontinuation in settings of reduced oral intake or fluid losses
• Increased risk for urinary tract infections and genital mycotic infections
• Continuous monitoring and treatment for hypoglycemia, vitamin B12 deficiency, increased LDL-C

Overdose Effects

• Toxicity studies for Empagliflozin and Metformin
• Absence of hypoglycemia with Metformin overdose
• Emergency treatment for lactic acidosis
• Potential use of haemodialysis for Metformin removal

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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