Metformina + Dapagliflozina Generis (Metformin Hydrochloride, Dapagliflozin)

Metformina + Dapagliflozina Generis is used in the management of type 2 diabetes mellitus, acting on both hepatic glucose production and renal glucose reabsorption.

• Type 2 diabetes mellitus (monotherapy): lowers fasting and post‑prandial glucose levels.
• Type 2 diabetes mellitus (add‑on therapy): provides additional glycaemic control when metformin alone is insufficient.
• Type 2 diabetes mellitus with renal impairment: offers glucose lowering with reduced risk of hypoglycaemia.

• Metformin decreases hepatic gluconeogenesis and improves peripheral insulin sensitivity, while dapagliflozin selectively blocks the renal sodium‑glucose co‑transporter‑2 (SGLT2), promoting urinary glucose excretion. The combined effect reduces overall blood glucose concentrations through complementary hepatic and renal pathways.

The combination may cause a range of adverse reactions, most of which are mild and reversible.

Common Side Effects

• Gastrointestinal upset: nausea, abdominal discomfort, or diarrhoea.
• Genital mycotic infection: increased risk of yeast infections in both sexes.
• Urinary tract infection: symptoms of dysuria or increased frequency.
• Mild hypoglycaemia: especially when used with insulin or sulfonylureas.
• Dehydration: due to osmotic diuresis.

Serious or Rare Side Effects

• Diabetic ketoacidosis: metabolic acidosis with elevated ketones.
• Lactic acidosis: rare but life‑threatening accumulation of lactate.
• Severe hypoglycaemia: profound low blood glucose requiring emergency care.
• Acute kidney injury: sudden decline in renal function.
• Severe allergic reaction: rash, swelling, or anaphylaxis.

Patients should be evaluated for renal and hepatic function before initiating therapy and monitored regularly.

• Renal function monitoring: assess eGFR prior to start and periodically thereafter.
• Hepatic impairment: avoid in severe liver disease due to lactic acidosis risk.
• Risk of ketoacidosis: educate patients on signs, especially during illness or reduced food intake.
• Volume depletion: advise adequate hydration, especially in hot climates.
• Pregnancy and breastfeeding: use only if clearly needed after risk‑benefit assessment.
• Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Co‑administration with certain drugs can alter efficacy or increase adverse events.

Major Interactions (Avoid)

• Other SGLT2 inhibitors: additive risk of ketoacidosis.
• Iodinated contrast agents in patients with renal dysfunction: may precipitate acute kidney injury.
• Strong CYP3A4 inhibitors (e.g., ketoconazole) with dapagliflozin: increase exposure.

Moderate Interactions (Monitor Closely)

• Cimetidine or other renal‑clearance reducing agents: may raise metformin levels.
• Loop or thiazide diuretics: heightened risk of volume depletion.
• NSAIDs: potential impact on renal function when combined with metformin.
• Insulin or sulfonylureas: increased likelihood of hypoglycaemia.