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U.S. Department of Health and Human Services

Safety

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Cutivate (fluticasone propionate) lotion

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010

Summary View

 

PRECAUTIONS

  • Cutivate 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 Lotion should not be used in individuals with hypersensitivity to formaldehyde as it may prevent healing or worsen dermatitis.
  • 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.
Pediatric Use
  • Cutivate 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 Lotion should not be used in individuals with hypersensitivity to formaldehyde as it may prevent healing or worsen dermatitis.
  • Cutivate 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 Lotion for longer than 4 weeks has 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 Lotion should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing.
  • ...Administration of topical corticosterois 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.

ADVERSE REACTIONS

Post Marketing Experience
  • ...during post approval use of Cutivate Lotion: erythema, edema/swelling, bleeding, and a reported lack of efficacy.
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.