Fluticasone propionate

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.

• Fluticasone Propionate Cream, 0.05% may be used in adult and pediatric patients 3 months of age or older. Safety and efficacy of Fluticasone Propionate Cream, 0.05% 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, 0.05% in pediatric patients below 3 months of age have not been established
• Atopic Dermatitis - Apply a thin film of Fluticasone Propionate Cream, 0.05% to the affected skin areas once or twice daily
• Rub in gently
• Other Corticosteroid-Responsive Dermatoses - Apply a thin film of Fluticasone Propionate Cream, 0.05% 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, 0.05% should not be used with occlusive dressings
• Fluticasone Propionate Cream, 0.05% 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, 0.05%, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended

• 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
• Fluticasone Propionate Cream, 0.05% should be discontinued if control is achieved before 4 weeks
• If no improvement is seen within 2 weeks, contact a physician. …

- A limited number of patients above 65 years of age (n=126) have been treated with fluticasone propionate cream, 0.05% in US and non-US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. …

• Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician
• It is for external use only
• Avoid contact with the eyes
• This medication should not be used for any disorder other than that for which it was prescribed
• The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician
• Patients should report to their physician any signs of local adverse reactions as well as non-healing or worsening of skin condition
• Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis. …

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 ).

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. …

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. …

Pregnancy: Teratogenic Effects: Pregnancy Category C - Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. …

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

STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.