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ALIMENTARY TRACT AND METABOLISM › DRUGS USED IN DIABETES › BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS › Combinations of oral blood glucose lowering drugs
metformin and enavogliflozin
A10BD34
Forms & Strengths
- Fixed-dose combination tablet: Metformin HCl 500 mg / Enavogliflozin 0.3 mg
- Fixed-dose combination tablet: Metformin HCl 1000 mg / Enavogliflozin 0.3 mg
Adult Dosing
- One tablet twice daily taken with meals
- Dose titration should be based on efficacy and tolerability while not exceeding the maximum recommended daily dose of 0.3 mg enavogliflozin and 2000 mg metformin
Pediatric Dosing
- Safety and effectiveness in pediatric patients below 18 years of age 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 metformin and enavogliflozin is appropriate
Mechanism of Action
- Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization
- Enavogliflozin is a potent, selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, reducing renal glucose reabsorption and lowering the renal threshold for glucose, thereby increasing urinary glucose excretion
Contraindications
- Severe renal impairment (eGFR less than 30 mL/min/1.73m2) or end-stage renal disease
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis
- History of serious hypersensitivity reaction to metformin or enavogliflozin
- Active conditions that may lead to tissue hypoxia, such as decompensated heart failure or respiratory failure
Adverse Reactions
- Hypoglycemia (especially when used with insulin or insulin secretagogues)
- Genital mycotic infections and urinary tract infections due to glucosuria
- Volume depletion leading to hypotension, dizziness, or dehydration
- Gastrointestinal disturbances (diarrhea, nausea, vomiting, flatulence) related to metformin
- Lactic acidosis (rare but serious, associated with metformin accumulation)
Drug Interactions
- Coadministration with diuretics may increase the risk of volume depletion and hypotension
- Insulin and insulin secretagogues increase the risk of hypoglycemia and may require dose reduction
- Cationic drugs eliminated by renal tubular secretion (e.g., cimetidine) may increase metformin plasma concentrations
- Alcohol ingestion increases the risk of metformin-associated lactic acidosis
Curated Content: Needs Vetting Before Put to Clinical Use