Cutivate (Fluticasone) (fluticasone propionate) Lotion, 0.05% contains fluticasone propionate [S-(fluoromethyl)6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate], 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 CHFOS. It has the following structural formula:
Fluticasone propionate is a white to off-white powder with a molecular weight of 500.6. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.
Each gram of Cutivate (Fluticasone) Lotion contains 0.5mg fluticasone propionate in a base of cetostearyl alcohol, isopropyl myristate, propylene glycol, cetomacrogol 1000, dimethicone 360, citric acid, sodium citrate, and purified water, with imidurea, methylparaben, and propylparaben as preservatives.
Cutivate (Fluticasone) Lotion contains the excipient imidurea which releases formaldehyde as a breakdown product. Formaldehyde may cause allergic sensitization or irritation upon contact with the skin. Cutivate (Fluticasone) Lotion should not be used in individuals with hypersensitivity to formaldehyde as it may prevent healing or worsen dermatitis.
General:
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 cosyntropin (ACTH) stimulation testing.
Forty-two pediatric patients (4 months to
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.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see ).
The following local adverse reactions have been reported 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.
Cutivate (Fluticasone) Lotion, 0.05% may cause local cutaneous adverse reactions (see ).
If irritation develops, Cutivate (Fluticasone) Lotion 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 Cutivate (Fluticasone) Lotion should be discontinued until the infection has been adequately controlled.
Cutivate (Fluticasone) Lotion should not be used in the presence of preexisting skin atrophy and should not be used where infection is present at the treatment site. Cutivate (Fluticasone) Lotion should not be used in the treatment of rosacea and perioral dermatitis.
Patients that apply Cutivate (Fluticasone) Lotion to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).
Information for Patients:
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Laboratory Tests:
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In an oral (gavage) mouse carcinogenicity study, doses of 0.1, 0.3 and 1 mg/kg/day fluticasone propionate were administered to mice for 18 months. Fluticasone propionate demonstrated no tumorigenic potential at oral doses up to 1 mg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study.
In a dermal mouse carcinogenicity study, 0.05% fluticasone propionate ointment (40 μl) was topically administered for 1, 3 or 7 days/week for 80 weeks. Fluticasone propionate demonstrated no tumorigenic potential at dermal doses up to 6.7 μg/kg/day (less than the MRHD in adults based on body surface area comparisons) in this study.
In a 52 week dermal photo-carcinogenicity study conducted in hairless albino mice with concurrent exposure to low level ultraviolet radiation (40 weeks of treatment followed by 12 weeks of observation), topically treated lotion vehicle animals and 0.05% fluticasone propionate lotion animals demonstrated shorter time to benign skin tumor formation compared to untreated control animals. Lotion vehicle treated animals developed benign skin tumors in a shorter time than 0.05% fluticasone propionate lotion treated animals. Although applicability of results to clinical use of Cutivate (Fluticasone) Lotion in humans is unknown, and enhanced tumor growth in patients treated with Cutivate (Fluticasone) Lotion has not been reported, patients should exercise general precautions in minimizing UV light exposure by avoiding excessive or unnecessary exposure to either natural or artificial sunlight (including sunbathing, tanning booths, sun lamps, etc.)
Fluticasone propionate revealed no evidence of mutagenic or clastogenic potential based on the results of five in vitro genotoxicity tests (Ames assay, fluctuation test, gene conversion test, Chinese hamster ovary cell chromosome aberration assay and human lymphocyte chromosome aberration assay) and one in vivo genotoxicity test (mouse micronucleus assay).
No evidence of impairment of fertility or effect on mating performance was observed in a fertility and general reproductive performance study conducted in male and female rats at subcutaneous doses up to 50 μg/kg/day (less than the MRHD in adults based on body surface area comparisons).
Nursing Mothers:
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Pediatric Use:
Cutivate (Fluticasone) Lotion should be discontinued if control is achieved before 4 weeks. If no improvement is seen within 2 weeks, contact a physician. The safety of the use of Cutivate (Fluticasone) Lotion for longer than 4 weeks has not been established.
The safety and efficacy of Cutivate (Fluticasone) Lotion in pediatric patients below 1 year of age have not been established.
Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis unless directed by the physician. Cutivate (Fluticasone) Lotion should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing.
Forty-two pediatric patients (4 months to
In other studies with fluticasone propionate topical formulations, adrenal suppression has been observed. Cutivate (Fluticasone) (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 patients, demonstrated a normally responsive HPA axis.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include low plasma cortisol levels to an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
In addition, local adverse events including cutaneous atrophy, striae, telangiectasia, and pigmentation change have been reported with topical use of corticosteroids in pediatric patients.
Geriatric Use:
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