Fluticasone Propionate

INDICATIONS AND USAGE Fluticasone Propionate Cream, USP 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone Propionate Cream, USP 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, USP 0.05% in pediatric patients below 3 months of age have not been established.

DOSAGE AND ADMINISTRATION Fluticasone propionate cream may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of fluticasone propionate cream in pediatric patients for more than 4 weeks of use have not been established (see PRECAUTIONS : Pediatric Use ). The safety and efficacy of fluticasone propionate cream in pediatric patients below 3 months of age have not been established. Atopic Dermatitis: Apply a thin film of fluticasone propionate cream to the affected skin areas once or twice daily. Rub in gently. Other Corticosteroid-Responsive Dermatoses: Apply a thin film of fluticasone propionate cream to the affected skin areas twice daily. Rub in gently. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Fluticasone propionate cream should not be used with occlusive dressings. Fluticasone propionate cream should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressings. Geriatric Use: In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with fluticasone propionate cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended. CLINICAL STUDIES Psoriasis Studies: In 2 vehicle-controlled studies, fluticasone propionate cream applied twice daily was significantly more effective than the vehicle in the treatment of moderate to severe psoriasis. The investigator’s global evaluation after 28 days of treatment is shown in Table 3. Table 3: Physician’s Assessment of Clinical Response Fluticasone Propionate Cream Vehicle Study 1 (n = 59) Study 2 (n = 74) Study 1 (n = 66) Study 2 (n = 75) Cleared 8% 1% 3% 1% Excellent 29% 28% 11% 17% Good 27% 34% 20% 28% Fair 27% 15% 33% 25% Poor 7% 22% 24% 27% Worse 2% 0 9% 1% The clinical signs of psoriasis were scored on a scale of 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The mean improvements over baseline in the clinical signs at the end of treatment are shown in Table 4. Table 4: Clinical Signs: Mean Improvements Over Baseline Fluticasone Propionate Cream Vehicle Study 1 Study 2 Study 1 Study 2 Erythema 1.19 1.07 0.55 0.84 Thickening 1.22 1.17 0.81 0.97 Scaling 1.53 1.39 0.95 1.21 Atopic Dermatitis Studies: In 2 controlled 28-day studies, fluticasone propionate cream once daily was equivalent to fluticasone propionate cream twice daily in the treatment of moderate to severe eczema. The investigator’s global evaluation after 28 days of treatment is shown in Table 5. Table 5: Physician’s Assessment of Clinical Response Fluticasone Propionate Cream Once Daily Fluticasone Propionate Cream Twice Daily Study 1 (n = 64) Study 2 (n = 106) Study 1 (n = 65) Study 2 (n = 100) Cleared 30% 20% 48% 21% Excellent 42% 32% 32% 50% Good 17% 26% 5% 12% Fair 3% 14% 6% 10% Poor 5% 3% 8% 4% Worse 3% 6% 2% 3% The clinical signs and symptoms of atopic dermatitis were scored on a scale of 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. The mean improvements over baseline at the end of treatment are shown in Table 6. Table 6: Clinical Signs and Symptoms: Mean Improvements Over Baseline Fluticasone Propionate Cream Once Daily Fluticasone Propionate Cream Twice Daily Study 1 Study 2 Study 1 Study 2 Erythema 1.7 1.5 1.8 1.7 Pruritus 2.1 1.6 2.1 1.7 Thickening 1.6 1.3 1.6 1.5 Lichenification 1.2 1.2 1.2 1.3 Vesiculation 0.5 0.4 0.5 0.5 Crusting 0.6 0.7 0.8 0.8

CONTRAINDICATIONS Fluticasone Propionate Cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation (see PRECAUTIONS ).

ADVERSE REACTIONS Clinical Trial Experience - 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 an arithmetic mean body surface area of 64% (range, 35% to 95%). The mean morning cortisol levels with standard deviations before treatment (prestimulation mean value = 13.76 ± 6.94 mcg/dL, poststimulation mean value = 30.53 ± 7.23 mcg/dL) and at end treatment (prestimulation 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 transient burning, resolving the same day it was reported; transient urticaria, resolving the same day it was reported; erythematous rash; dusky erythema, resolving within 1 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 Infected eczema Viral warts Herpes simplex Impetigo Atopic dermatitis Eczema Exacerbation of eczema Erythema Burning Stinging Skin irritation Pruritus Exacerbation of pruritus Folliculitis Blisters Dryness of skin 1 (0.5%) 1 (0.5%) 0 0 1 (0.5%) 1 (0.5%) 1 (0.5%) 4 (1.9%) 0 2 (1.0%) 0 6 (2.9%) 2 (1.0%) 4 (1.9%) 1 (0.5%) 0 3 (1.4%) 0 2 (1.0%) 1 (0.5%) 1 (0.5%) 0 0 0 1 (0.5%) 2 (1.0%) 2 (1.0%) 2 (1.0%) 2 (1.0%) 4. (1.9%) 1 (0.5%) 1 (0.5%) 1 (0.5%) 1 (0.5%) 0 0 0 0 0 0 0 1 (1.3%) 0 2 (2.6%) 1 (1.3%) 0 4 (5.1%) 1 (1.3%) 0 0 0 Table 2: Adverse Events* From Pediatric Open-Label Trial (n=51) Adverse Events Fluticasone Twice Daily Burning Dusky erythema Erythematous rash Facial telangiectasia† Non-facial telangiectasia Urticaria 1 (2.0%) 1 (2.0%) 1 (2.0%) 2 (4.9%) 1 (2.0%) 1 (2.0%) * See text for additional detail. † n=41. Post Marketing Experience - Systemic adverse events with fluticasone propionate cream, 0.05% and fluticasone propionate ointment have included: immunosuppression/Pneumocystis carinii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/glycosuria; Cushing’s syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling). The following localized adverse reactions have been reported during post approval use of fluticasone propionate cream, 0.05%: skin discoloration, erythema, irritation, edema/swelling, atrophy, contusion, dermatitis, pain, sepsis, hemorrhage, acneiform eruptions. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causa …

DESCRIPTION Fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP [(6α,11β,16α,17α)-6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S -fluoromethyl ester], a synthetic fluorinated corticosteroid, for topical dermatologic use. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Chemically, fluticasone propionate is C 25 H 31 F 3 O 5 S. It has the following structural formula: Fluticasone propionate USP has a molecular weight of 500.6. It is a white to off-white powder and is insoluble in water. Each gram of fluticasone propionate cream USP, 0.05% contains fluticasone propionate USP 0.5 mg in a base of propylene glycol, mineral oil, cetostearyl alcohol, Ceteth-20, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water and imidurea as preservative. Structural Formula

OVERDOSAGE: Topically applied Fluticasone Propionate Cream, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

HOW SUPPLIED Fluticasone Propionate Cream USP, 0.05% is supplied in: NDC 21922-075-04 15g tubes NDC 21922-075-05 30g tubes NDC 21922-075-07 60g tubes Store between 2° and 30°C (36° and 86°F). [see USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Revised: 08/2023