FLUTICASONE PROPIONATE

INDICATIONS AND USAGE Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.

ADVERSE REACTIONS In controlled clinical trials of twice daily administration, the total incidence of adverse reactions associated with the use of fluticasone propionate cream, 0.05% was approximately 4%. These adverse reactions were usually mild, self-limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and burning. These events occurred in 2.9%, 1.2%, 1.0%, and 0.6% of patients, respectively. Two clinical studies compared once to twice-daily administration of fluticasone propionate cream, 0.05% for the treatment of moderate to severe eczema. The local drug-related adverse events for the 491 patients enrolled in both studies are shown in Table 1 . In the study enrolling both adult and pediatric patients, the incidence of local adverse events in the 119 pediatric patients ages 1 to 12 years was comparable to the 140 patients ages 13 to 62 years. Fifty-one pediatric patients ages 3 months to 5 years, with moderate to severe eczema, were enrolled in an open-label HPA axis safety study. Fluticasone propionate cream, 0.05% was applied twice daily for 3 to 4 weeks over and arithmetic mean body surface area of 64% (range 35% to 95%). The mean morning cortisol levels with standard deviations before treatment (pre-stimulation mean value =13.76±6.94 mcg/dL, post-stimulation mean value =30.53±7.23 mcg/dL) and at end treatment (pre-stimulation mean value =12.32±6.92 mcg/dL, poststimulation mean value =28.84±7.16 mcg/dL) showed little change. In 2 of 43 (4.7%) patients with end-treatment results, peak cortisol levels following cosyntropin stimulation testing were ≤18 mcg/dL indicating adrenal suppression. Follow-up testing after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis. Local drug-related adverse events were (see Table 2 ): transient burning, resolving the same day it was reported; transient urticaria, resolving the same day it was reported; erythematous rash; dusky erythema, resolving within one month after cessation of fluticasone propionate cream, 0.05%; and telangiectasia resolving within 3 months after stopping fluticasone propionate cream, 0.05%. Table 1: Drug-Related Adverse Events—Skin Adverse Events Fluticasone Once Daily (n=210) Fluticasone Twice Daily (n=203) Vehicle Twice Daily (n=78) Skin infection 1 (0.5%) 0 0 Infected eczema 1 (0.5%) 2 (1.0%) 0 Viral warts 0 1 (0.5%) 0 Herpes simplex 0 1 (0.5%) 0 Impetigo 1 (0.5%) 0 0 Atopic dermatitis 1 (0.5%) 0 0 Eczema 1 (0.5%) 0 0 Exacerbation of eczema 4 (1.9%) 1 (0.5%) 1 (1.3%) Erythema 0 2 (1.0%) 0 Burning 2 (1.0%) 2 (1.0%) 2 (2.6%) Stinging 0 2 (1.0%) 1 (1.3%) Skin irritation 6 (2.9%) 2 (1.0%) 0 Pruritus 2 (1.0%) 4 (1.9%) 4 (5.1%) Exacerbation of Pruritus 4 (1.9%) 1 (0.5%) 1 (1.3%) Folliculitis 1 (0.5%) 1 (0.5%) 0 Blisters 0 1 (0.5%) 0 Dryness of skin 3 (1.4%) 1 (0.5%) 0 Table 2: Adverse Events* from Pediatric Open-label Trial (n=51) *See text for additional detail. † n=41 Adverse Events Fluticasone Twice Daily Burning 1 (2.0%) Dusky Erythema 1 (2.0%) Erythematous Rash 1 (2.0%) Facial Telangiectasia † 2 (4.9%) Non Facial Telangiectasia 1 (2.0%) Urticaria 1 (2.0%) The following local adverse reactions have been reported infrequently with topical corticosteroids and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis and miliaria. Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.