Fluticasone Propionate .5 mg/g Cream, 30 g — NDC 63187-959-30 (Billing 63187-0959-30)

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%-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 μg/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.

PRECAUTIONS: Fluticasone Propionate Cream, 0.05% contains the excipient imidurea which releases formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin. Fluticasone Propionate Cream, 0.05% should not be used in individuals with hypersensitivity to formaldehyde as it may prevent healing or worsen dermatitis.

General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing's syndrome, hyperglycemia and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a potent topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products. Fluticasone propionate cream, 0.05% caused depression of A.M. plasma cortisol levels in 1 of 6 adult patients when used daily for 7 days in patients with psoriasis or eczema involving at least 30% of the body surface.

After 2 days of treatment, this patient developed a 60% decrease from pretreatment values in the A.M. plasma cortisol level. There was some evidence of corresponding decrease in the 24-hour urinary free cortisol levels. The A.M. plasma cortisol level remained slightly depressed for 48 hours but recovered by day 6 of treatment.

Fluticasone propionate cream, 0.05%, caused HPA axis suppression in 2 of 43 pediatric patients, ages 2 and 5 years old, who were treated for 4 weeks covering at least 35% of the body surface area. Follow-up testing 12 days after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis (see PRECAUTIONS: Pediatric Use ). Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use ).

Fluticasone propionate cream, 0.05%, may cause local cutaneous adverse reactions (see ADVERSE REACTIONS ). Fluticasone propionate cream, 0.05% contains the excipient imidurea which releases traces of formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin.

If irritation develops, Fluticasone Propionate Cream, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Fluticasone Propionate Cream, 0.05% should be discontinued until the infection has been adequately controlled. Fluticasone Propionate Cream, 0.05% should not be used in the presence of preexisting skin atrophy and should not be used where infection is present at the treatment site.

Fluticasone Propionate Cream, 0.05% should not be used in the treatment of rosacea and perioral dermatitis. Information for Patients: Patients using topical corticosteroids should receive t… [Excerpted — this section continues on DailyMed.]