High-dose males: 24% decrease in lymphocytes and 19% decrease in total white blood cells
“HD males: 24% decrease in lymphocytes and 19% decrease in total white blood cells”
✓ VerifiedFDA multi-discipline review, p. 67Source ↗
Biodistribution & persistence
Radioactivity retained in meninges up to 336 h and uveal tract up to 840 h, suggesting melanin affinity
“The levels of radioactivity detected in the meninges up to 336 hours and uveal tract up to 840 hours post-dose suggest an affinity of amisulpride for the melanin pigmented tissues.”
✓ VerifiedFDA multi-discipline review, p. 63Source ↗
Modality-specific risk
QT prolongation; possible additive QTc effect with ondansetron
“As both ondansetron and amisulpride prolong QT interval in a concentration-dependent manner, pharmacodynamic interaction in terms of QTc prolongation is possible with additive effect.”
✓ VerifiedFDA multi-discipline review, p. 97Source ↗