metformin and evogliptin

A10BD22

Forms & Strengths

Fixed-dose combination tablet: Metformin hydrochloride 1000 mg / Evogliptin 5 mg
Fixed-dose combination tablet: Metformin hydrochloride 500 mg / Evogliptin 5 mg
Fixed-dose combination tablet: Metformin hydrochloride 1000 mg / Evogliptin 2.5 mg

Adult Dosing

Type 2 Diabetes Mellitus: One tablet once or twice daily with meals, individualized based on current regimen, effectiveness, and tolerability
Maximum daily dose: 2000 mg metformin hydrochloride / 5 mg evogliptin
Renal impairment adjustment: Contraindicated if eGFR < 30 mL/min/1.73m2; evaluate renal function before initiation and annually thereafter

Pediatric Dosing

Safety and efficacy in pediatric patients below 18 years of age have not been established
Not recommended for use in children and adolescents

Indications

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on metformin or evogliptin alone, or in patients already treated with the combination

Mechanism of Action

Metformin: Biguanide that decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization
Evogliptin: Dipeptidyl peptidase-4 (DPP-4) inhibitor that slows the inactivation of incretin hormones (GLP-1 and GIP), increasing insulin secretion and decreasing glucagon levels in a glucose-dependent manner

Contraindications

Hypersensitivity to metformin, evogliptin, or any excipient
Severe renal impairment (eGFR < 30 mL/min/1.73m2) or end-stage renal disease
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
Acute conditions with the potential to alter renal function (e.g., dehydration, severe infection, shock)
Intravascular administration of iodinated contrast materials (discontinue prior to or at the time of the procedure)

Adverse Reactions

Common: Diarrhea, nausea, vomiting, flatulence, abdominal discomfort, upper respiratory tract infection, nasopharyngitis
Serious: Lactic acidosis (associated with metformin accumulation), acute pancreatitis, severe hypersensitivity reactions (anaphylaxis, angioedema, Stevens-Johnson syndrome), severe joint pain (arthralgia)

Drug Interactions

Cationic drugs eliminated by renal tubular secretion (e.g., cimetidine, digoxin, morphines, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin) may increase metformin concentration
Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide) increase risk of metabolic acidosis
Alcohol may potentiate the effect of metformin on lactate metabolism
Strong CYP3A4 inhibitors or inducers may affect evogliptin exposure, though clinical significance is generally low

Curated Content: Needs Vetting Before Put to Clinical Use