← Search & browse all drugs

gemigliptin and dapagliflozin

A10BD30

Forms & Strengths

Gemigliptin 50 mg / Dapagliflozin 10 mg fixed-dose combination tablets

Adult Dosing

One tablet (Gemigliptin 50 mg / Dapagliflozin 10 mg) orally once daily in the morning with or without food

Pediatric Dosing

Safety and efficacy in pediatric patients below 18 years have not been established

Indications

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both gemigliptin and dapagliflozin is appropriate

Mechanism of Action

Gemigliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that slows inactivation of incretin hormones, increasing insulin synthesis and release and decreasing glucagon levels
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that reduces renal glucose reabsorption and increases urinary glucose excretion

Contraindications

History of serious hypersensitivity reaction to gemigliptin, dapagliflozin, or any component of the formulation
Severe renal impairment (eGFR less than 30 mL/min/1.73m2), end-stage renal disease, or patients on dialysis
Type 1 diabetes mellitus or diabetic ketoacidosis

Adverse Reactions

Hypoglycemia (especially when combined with insulin or secretagogues)
Genitourinary infections (vulvovaginal candidiasis, urinary tract infections)
Volume depletion and hypotension
Nasopharyngitis and upper respiratory tract infections
Rare: Diabetic ketoacidosis, necrotizing fasciitis of the perineum (Fournier's gangrene), acute kidney injury, severe joint pain

Drug Interactions

Insulin or insulin secretagogues (sulfonylureas, glinides) increase risk of hypoglycemia; dose reduction of these agents may be required
Diuretics combined with dapagliflozin may potentiate the risk of volume depletion and hypotension
Strong CYP3A4 inducers may decrease exposure of dapagliflozin
Moderate CYP3A4 inhibitors may alter gemigliptin exposure

Curated Content: Needs Vetting Before Put to Clinical Use