API

Dapagliflozin (10mg)

Drug classification

Dapagliflozin is an antidiabetic agent; specifically, a sodium-glucose co-transporter 2 (SGLT2) inhibitor.

Dosage form

Film-coated oral tablet containing 10 mg dapagliflozin.

API strength per dosage

Dose

Dapagliflozin 10mg is typically taken once daily in adults for type 2 diabetes or heart failure. Not recommended in patients with severe renal impairment (eGFR <30 mL/min/1.73m²) or severe hepatic impairment. Safety and efficacy in children have not been established. Dose adjustments may be needed based on renal function; consult product information.

Mechanism of action

Dapagliflozin selectively inhibits sodium-glucose co-transporter 2 (SGLT2) in the proximal renal tubules, reducing glucose reabsorption and increasing urinary glucose excretion. This lowers blood glucose levels independently of insulin secretion, aiding glycemic control in type 2 diabetes mellitus.

Indications

Treatment of Type 2 diabetes mellitus

Side effects

Polyuria Nausea Vomiting Dyslipidemia Genital fungal infection Nasopharyngitis inflammation of the throat and nasal passages Urinary tract infection

Pregnancy category

Dapagliflozin is not recommended during pregnancy due to potential fetal risks; use only if potential benefits justify potential risks to the fetus.

Precautions

Assess renal function before and during treatment, monitor for hypoglycemia (especially with insulin or sulfonylureas), watch for signs of urinary tract and genital infections, monitor volume status and blood pressure, assess for ketoacidosis symptoms, monitor lipid levels, use caution in elderly and patients with cardiovascular disease.

Contraindications

Hypersensitivity to dapagliflozin, severe renal impairment, end-stage renal disease, dialysis, history of serious hypersensitivity reactions to dapagliflozin, type 1 diabetes mellitus, diabetic ketoacidosis.