Overview
DESCRIPTION Fluticasone Propionate Cream, 0.05% contains fluticasone propionate [(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.
Mechanism of Action
CLINICAL PHARMACOLOGY Like other topical corticosteroids, fluticasone propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Fluticasone propionate is lipophilic and has a strong affinity for the glucocorticoid receptor.
Indications
- 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.
Common Doses
- Refer to label
Dosage
DOSAGE AND ADMINISTRATION 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.
Contraindications
- 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 ).
Side Effects
- 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.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.