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Author: Admin | 2025-04-28
Post dose, respectively. Weight/Dose normalized AUC and Cmax values were the same in pediatric patients ages 6 to 12 years as the adults following single doses of 30 mg to 70 mg VYVANSE capsule.Effect of Food on Capsule FormulationNeither food (a high fat meal or yogurt) nor orange juice affects the observed AUC and Cmax of dextroamphetamine in healthy adults after single-dose oral administration of 70 mg of VYVANSE capsules. Food prolongs Tmax by approximately 1 hour (from 3.8 hours at fasted state to 4.7 hours after a high fat meal or to 4.2 hours with yogurt). After an 8-hour fast, the AUC for dextroamphetamine following oral administration of lisdexamfetamine dimesylate in solution and as intact capsules were equivalent.Chewable Tablet FormulationAfter a single dose administration of 60 mg VYVANSE chewable tablet in healthy subjects under fasted conditions, Tmax of lisdexamfetamine and dextroamphetamine was reached at approximately 1 hour and 4.4 hours post dose, respectively. Compared to 60 mg VYVANSE capsule, exposure (Cmax and AUC) to lisdexamfetamine was about 15% lower. The exposure (Cmax and AUCinf) of dextroamphetamine is similar between VYVANSE chewable tablet and VYVANSE capsule.Effect of Food on Tablet FormulationAdministration of 60 mg VYVANSE chewable tablet with food (a high-fat meal) decreases the exposure (Cmax and AUCinf) of dextroamphetamine by about 5% to 7%, and prolongs mean Tmax by approximately 1 hour (from 3.9 hours at fasted state to 4.9 hours).EliminationPlasma concentrations of unconverted lisdexamfetamine are low and transient, generally becoming non-quantifiable by 8 hours after administration. The plasma
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