Product Description.:
Compare to: Cutivate?
CUTIVATE?
(fluticasone propionate) Cream & Ointment, 0.05%
Topical Anti-inflammatory Corticosteroid
DRUG DESCRIPTION
Drug Substance
Proper Name: fluticasone propionate (BAN, INN, USAN)
Chemical Name: S-fluoromethyl 6α,9α-difluoro-llβ-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-l,4-diene-17β-carbothioate
Description: Fluticasone propionate is a white to off-white powder.
Solubility: Fluticasone propionate is freely soluble in dimethyl sulfoxide and dimethylformamide, sparingly soluble in acetone, dichlo-romethane, ethyl acetate and chloroform, slightly soluble in methanol and 95% ethanol, and practically insoluble in water.
Melting Point: Fluticasone propionate decomposes without melting.Onset of decomposition occurs at about 225?C.
Composition
Each gram of CUTIVATE (fluticasone propionate) Cream & Ointment, 0.05% w/w contains fluticasone propionate 500 micrograms in a Cream & Ointment base. Non-medicinal ingredients: propylene glycol, mineral oil, cetostearyl alcohol, polyoxyl 20 cetostearyl ether, isopropyl myristate, dibasic sodium phosphate, citric acid, purified water and imidurea as a preservative.
INDICATIONS
CUTIVATE (fluticasone propionate) Cream & Ointment, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Studies performed with CUTIVATE Cream & Ointment, 0.05% indicate that this is in the medium range of potency as compared with other topical corticosteroids.
DOSAGE AND ADMINISTRATION
Eczema: Apply a thin film of CUTIVATE (fluticasone propionate) Cream & Ointment to the affected skin areas once or twice daily. Rub in gently.
Other Corticosteroid Responsive Dermatoses: Apply a thin film of CUTIVATE Cream & Ointment 0.05% to the affected skin areas twice daily. Rub in gently.
SIDE EFFECTS
In controlled clinical trials, the total incidence of adverse reactions associated with the use of fluticasone propionate Cream & Ointment, 0.05% was approximately 4%. These adverse reactions were mild and self-limiting. For fluticasone propionate Cream & Ointment 0.05%, these reactions 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.
The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, dilation of the superficial blood vessels and miliaria. Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical steroid products.
