Active Ingredient: SERTRALINE
(Hérité de ZOLOFT 25 mg) Sertraline demonstrates a dose-dependent, mild to moderate effect on cardiac repolarization. In a thorough QT study of 54 healthy subjects, a supratherapeutic dose of 400 mg/day (double the maximum recommended clinical dose) showed a positive signal for QTc prolongation. The mean placebo-corrected change in QTcF (ΔΔQTcF) reached 9.65 ms at 4 hours post-dose, with the upper 90% confidence interval bound reaching 11.67 ms, exceeding the 10 ms regulatory threshold. Exposure-response analysis confirmed a significant positive correlation (slope = 0.036 ms/ng/mL) between plasma levels and QTcF. However, at standard therapeutic doses, the predicted effect remains low (approx. 3.6 ms). Caution is advised in case of overdose or co-administration with other QT-prolonging agents.
https://doi.org/10.1002/cpdd.749, https://www.fda.gov/media/178811/download, https://doi.org/10.5114/aoms.2019.86928