The USFDA has approved oral empagliflozin and a combination of empagliflozin and metformin hydrochloride for pediatric type 2 diabetes patients aged ≥ 10 years . These medications are indicated as additions to diet and exercise. The approval was granted based on the safety and efficacy outcomes of empagliflozin in pediatric patients in a clinical trial.
Clinical trial Empagliflozin was superior to placebo in reducing HbA1c (0.8%) in patients aged 10 to 17 years (n=157) with inadequately controlled type 2 diabetes. In addition, empagliflozin significantly reduced fasting plasma glucose compared to the placebo. Dosage Empagliflozin 10 mg orally once, everyday morning, with or without food Can be increased to 25 mg daily for additional glycemic control if the patient tolerates the 10 mg dose Empagliflozin and metformin combination Maximum daily dose: Empagliflozin – 25 mg; Metformin HCl…
