Description

🩺 Product Overview

Dapagliflozin 10 mg, Glimepiride 1 mg, and Metformin 1000 mg—this tablet addresses multiple pathophysiological aspects of T2DM, offering enhanced glycemic control and improved patient adherence.

💊 Composition

Dapagliflozin (10 mg): A Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor that reduces glucose reabsorption in the kidneys, promoting glucose excretion through urine.
Glimepiride (1 mg): A sulfonylurea that stimulates insulin release from pancreatic β-cells, enhancing insulin secretion.
Metformin (1000 mg): A biguanide that decreases hepatic glucose production and improves insulin sensitivity in peripheral tissues.

⚙ Mechanism of Action

Dapagliflozin: Inhibits SGLT2 in the renal proximal tubules, leading to increased urinary glucose excretion and a reduction in blood glucose levels.
Glimepiride: Binds to ATP-sensitive potassium channels on pancreatic β-cells, causing depolarization and subsequent insulin release.
Metformin: Suppresses hepatic glucose production and enhances insulin sensitivity, facilitating improved glucose uptake by peripheral tissues.

✅ Indications

DAPA-GM-MET 10/1/1000 Tablet is indicated for:

Adults with Type 2 Diabetes Mellitus inadequately controlled by diet and exercise alone.
Patients requiring combination therapy with Metformin and Glimepiride.
Individuals seeking to minimize pill burden while achieving optimal glycemic control.

📈 Clinical Benefits

Enhanced Glycemic Control: Targets multiple mechanisms to effectively lower blood glucose levels.
Reduced Risk of Hypoglycemia: The combination of agents helps mitigate the risk of low blood sugar.
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 conducted in India 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 of renal function is advised, as Dapagliflozin is contraindicated in patients with severe renal impairment.
Hypoglycemia: Caution is required when used with other antidiabetic agents that may cause hypoglycemia.
Lactic Acidosis: A rare but serious side effect associated with Metformin; avoid in patients with conditions that predispose to acidosis.
Volume Depletion: Dapagliflozin may cause diuresis; ensure adequate hydration.

💊 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: Gastrointestinal disturbances such as nausea, vomiting, and diarrhea.
Glimepiride: Hypoglycemia, dizziness, and headache.
Dapagliflozin: Urinary tract infections, genital infections, and increased urination.

Serious but rare side effects include:

Lactic Acidosis: Symptoms include muscle pain, respiratory distress, and fatigue.
Severe Hypoglycemia: Symptoms include confusion, sweating, and rapid heartbeat.

🧪 Drug Interactions

Alcohol: May potentiate the effect of Metformin and increase the risk of lactic acidosis.
Diuretics: May increase the risk of dehydration and hypotension when used with Dapagliflozin.
Insulin and Insulin Secretagogues: May increase the risk of hypoglycemia.

🧑‍⚕ Use in Special Populations

Pregnancy and Lactation: Not recommended; consult a healthcare provider before use.
Geriatric Patients: Use with caution; monitor renal function closely.
Pediatric Patients: Safety and efficacy have not been established.

🗄 Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.