Ivermectin

Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. Ivermectin cream, 1% is indicated for the treatment of inflammatory lesions of rosacea. ( 1 )

None. None. ( 4 )

In vitro studies have shown that ivermectin cream, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.

8.1Pregnancy Pregnancy Category C.

There are no adequate and well-controlled studies in pregnant women. Ivermectin cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Note: The animal multiples of human exposure calculations were based on AUC comparisons. The maximum topical human dose (MTHD) of ivermectin cream is 1 g applied once daily. Systemic embryofetal development studies were conducted in rats and rabbits.

Oral doses of 1.5 mg/kg/day, 4 mg/kg/day, and 12 mg/kg/day ivermectin were administered during the period of organogenesis (gestational days 6 to 17) to pregnant female rats. Maternal death occurred at 12 mg/kg/day (1909X MTHD). Cleft palate occurred in the fetuses from the 12 mg/kg/day (1909X MTHD) group. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 4 mg/kg/day (708X MTHD). Oral doses of 0.5 mg/kg/day, 1.5 mg/kg/day, 2.5 mg/kg/day, 3.5 mg/kg/day, and 4.5 mg/kg/day ivermectin were administered during the period of organogenesis (gestational days 7 to 20) to pregnant female rabbits.

Maternal death occurred at doses greater than or equal to 2.5 mg/kg/day (72X MTHD). Carpal flexure occurred in the fetuses from the 4.5 mg/kg/day (354X MTHD) group. Fetal weight decrease was noted at 3.5 mg/kg/day (146X MTHD). No treatment related effects on embryofetal toxicity were noted at 2.5 mg/kg/day (72X MTHD) and no treatment related effects on teratogenicity were noted at 3.5 mg/kg/day (146X MTHD). A pre- and post-natal development study was conducted in rats.

Oral doses of 1 mg/kg/day, 2 mg/kg/day, and 4 mg/kg/day ivermectin were administered to pregnant female rats during gestational days 6 to 20 and lactation days 2 to 20. Neonatal death occurred at doses greater than or equal to 2 mg/kg/day. Behavior development of newborn rats was adversely affected at all doses.