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Cutivate
Generic Name: Fluticasone Propionate (Ointment)
Drug Category: Corticosteroid
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 4 weeks.
| Approved Uses |
|
Indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. CUTIVATE Ointment is for topical use only; it is not for ophthalmic, oral or intravaginal use. If concomitant skin infections are present or develop, use an appropriate antimicrobial. If a favorable response does not occur promptly, discontinue use of CUTIVATE Ointment until the infection has been adequately controlled. Topical corticosteroids, including CUTIVATE Ointment, can produce reversible HPA axis suppression with the potential for clinical glucocorticoid insufficiency. Factors that predispose to HPA axis suppression include large treatment surface areas, prolonged use, use under occlusion, altered skin barrier, liver failure, and young age. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. HPA axis suppression may occur during or after withdrawal of treatment. If HPA axis suppression is suspected, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Evaluation of HPA axis suppression may be done by using the cosyntropin stimulation test. The following systemic adverse reactions have been identified during post-approval use of CUTIVATE Cream and CUTIVATE Ointment: immunosuppression, pneumocystis jirovecii, pneumonia, leukopenia, thrombocytopenia, hyperglycemia, glycosuria, cushing syndrome, generalized body edema, blurred vision, and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling). The following local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis, and miliaria. Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroids. Avoid contact of CUTIVATE Ointment with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. There are no adequate and well-controlled studies in pregnant women. Animal studies: decreased fetal weights, omphalocele, cleft palate, and retarded skeletal ossification. Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource • Rosacea, acne vulgaris, perioral dermatitis, primary cutaneous viral infections (e.g. herpes simplex, chickenpox), perianal and genital pruritus, pruritus without inflammation and primary infected skin lesions caused by infection with fungi or bacteria. GoToSource |
| Adverse Events |
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Striae (stretch marks) rosacea, perioral dermatitis (facial rash) acne, purpura (red or purple discolored skin spots), skin atrophy (thinning of the skin), erythema (redness of the skin), telangiectasia (dilated blood vessels), hypertrichosis (excessive hair growth), pigment alteration, delayed wound healing, glaucoma, folliculitis (inflammation of the hair follicles), hypothalamic-pituitary axis suppression, cushing syndrome (excess cortisol hormone), hypertension (high blood pressure) and hyperglycemia (high blood sugar). GoToSource Unmasking of latent diabetes, edema (excess fluid in body tissues), miliaria (heat rash) urticaria (hives) and secondary infection. GoToSource Contact dermatitis. GoToSource Bone fractures with long-term use. GoToSource Chronic skin dryness. GoToSource Steroid-induced glaucoma. GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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