SOOLANTRA

AbsorptionThe absorption of ivermectin from SOOLANTRA cream was evaluated in a clinical trial in 15 adult male and female subjects with severe papulopustular rosacea applying 1 g SOOLANTRA cream, 1% once daily. At steady state (after 2 weeks of treatment), the highest mean ± standard deviation plasma concentrations of ivermectin peaked (T max ) at 10 ± 8 hours post dose, the maximum concentration (C max ) was 2.10 ± 1.04 ng/mL (range: 0.69 - 4.02 ng/mL) and the area under the concentration curv...

SOOLANTRA cream applied once daily at bedtime was evaluated in the treatment of inflammatory lesions of rosacea in two randomized, double-blind, vehicle controlled clinical trials, which were identical in design. The trials were conducted in 1371 subjects aged 18 years and older who were treated once daily for 12 weeks with either SOOLANTRA cream or vehicle cream. Overall, 96% of subjects were Caucasian and 67% were female. Using the 5-point Investigator Global Assessment (IGA) scale (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe), 79% of subjects were scored as moderate (IGA=3) and 21...

In controlled clinical trials with SOOLANTRA cream the most common adverse reactions (incidence ≤ 1 %) included skin burning sensation and skin irritation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared ...

None. None. ( 4 )

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