Description
💊 Composition:
- Dapagliflozin: 10 mg
- Glimepiride: 2 mg
- Metformin Hydrochloride (Extended Release): 1000 mg
⚙️ Mechanism of Action:
- Dapagliflozin: Inhibits the sodium-glucose co-transporter 2 (SGLT2) in the renal proximal tubules, reducing glucose reabsorption and increasing urinary glucose excretion.
- Glimepiride: Stimulates insulin release from pancreatic β-cells by binding to ATP-sensitive potassium channels, enhancing insulin secretion.
- Metformin: Decreases hepatic glucose production, reduces intestinal glucose absorption, and improves insulin sensitivity in peripheral tissues.
✅ Indications:
- Type 2 Diabetes Mellitus: For adults inadequately controlled by diet and exercise alone.
- Combination Therapy: For patients requiring multiple agents to achieve optimal glycemic control.
📈 Clinical Benefits:
- Enhanced Glycemic Control: Targets multiple pathways to effectively lower blood glucose levels.
- Reduced Risk of Hypoglycemia: The combination minimizes the risk compared to monotherapy.
- Cardiovascular and Renal Protection: Dapagliflozin offers additional benefits in heart failure and chronic kidney disease.
- Weight Neutrality: Unlike many anti-diabetic medications, this combination may support weight management.
- Convenience: Combines three medications into a single tablet, improving patient adherence.
📊 Efficacy:
A Phase III, open-label, randomized clinical study demonstrated that the fixed-dose combination of Dapagliflozin, Glimepiride, and Metformin extended-release tablets significantly reduced HbA1c levels compared to dual therapy with Glimepiride and Metformin prolonged-release tablets. The study reported a mean reduction in HbA1c of -1.98% ± 1.01% in the triple therapy group, compared to -1.64% ± 0.86% in the dual therapy group (p = 0.0047) .
⚠️ Precautions:
- Renal Function: Regular monitoring is necessary, especially due to dapagliflozin and metformin’s renal clearance.
- Hypoglycemia Risk: Increased when combined with other insulin secretagogues or insulin.
- Lactic Acidosis: Rare but serious risk associated with metformin, especially in renal dysfunction, dehydration, or alcoholism.
- Volume Depletion: Dapagliflozin may cause diuresis and hypotension; monitor hydration status.
- Ketoacidosis: Though rare, SGLT2 inhibitors may cause euglycemic diabetic ketoacidosis (DKA).
- Pancreatic Function: Glimepiride may rarely affect pancreatic function; monitor if symptoms arise.
💊 Dosage and Administration:
- Dosage: One tablet once daily with meals, preferably with breakfast.
- Administration: Swallow the tablet whole with a glass of water; do not chew or crush.
- Adjustment: Dosage may be adjusted based on individual patient response and tolerability.
🧾 Side Effects:
Common side effects may include:
- Metformin: Nausea, diarrhea, abdominal discomfort, metallic taste.
- Glimepiride: Hypoglycemia, dizziness, headache, weight gain.
- Dapagliflozin: Urinary tract infections, genital mycotic infections, increased urination, hypotension.
Serious but rare side effects include:
- Lactic acidosis.
- Severe hypoglycemia.
- Acute kidney injury.
- Euglycemic ketoacidosis.
- Allergic reactions.
🧪 Drug Interactions:
- Alcohol: May potentiate the effect of metformin and increase the risk of lactic acidosis.
- Diuretics and NSAIDs: May increase the risk of renal dysfunction with SGLT2 inhibitors.
- Insulin and Insulin Secretagogues: May increase the risk of hypoglycemia.
- Cationic Drugs: May compete for renal tubular secretion, affecting metformin elimination.
🧑⚕️ Use in Special Populations:
- Geriatric Patients: Use with caution; monitor renal function closely.
- Pediatrics: Not established for individuals under 18 years.
- Pregnancy and Lactation: Should only be used if benefits clearly outweigh risks.
- Renal Impairment: Not recommended in patients with significantly reduced kidney function.
🗄️ Storage:
Store in a cool, dry place away from direct sunlight and moisture. Keep out of reach of children. Do not use after the expiry date printed on the packaging.
📦 Packaging:
Typically available in blister packs containing 10, 15, or 30 tablets, depending on brand and manufacturer. The product should be labeled with batch number, expiry date, and dosage instructions.
💡 Conclusion:
Dapagliflozin 10 mg + Glimepiride 2 mg + Metformin 1000 mg offers a well-balanced, multi-mechanistic approach to managing Type 2 Diabetes Mellitus. By targeting different aspects of glucose regulation—insulin secretion, glucose absorption, and renal glucose reabsorption—this combination ensures enhanced glycemic control, reduced complication risks, and improved patient compliance. It is an ideal choice for patients requiring intensified therapy and those who seek convenience without compromising efficacy.
