How Supplied:
0.05% lotion, 120 mL bottle
Indications and Usage:
Cutivate Lotion is indicated for the relief of the inflammatory and pruritic manifestations of all severities of atopic dermatitis in patients 1 year of age or older.
Prescribing Instructions:
Prescribing Information Instructions [PDF]
Side Effects and Contraindications:
Cutivate Lotion is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. The safety and efficacy of drug use for longer than four weeks in this population have not been established. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. For topical use only. In clinical studies, drug-related side effects following the use of Cutivate Lotion consisted primarily of localized burning and stinging, and were usually mild and self-limiting. No skin atrophy, changes in pigmentation, or evidence of HPA-axis suppression were observed following the use of Cutivate Lotion in these studies. Adrenal suppression has been observed in studies with other fluticasone propionate topical formulations. Local adverse reactions associated with topical corticosteroids may occur more frequently in higher potency formulations or when used with occlusive dressings.
Company:
PharmaDerm, a division of Fougera Pharmaceuticals Inc.
866-337-6457
www.pharmaderm.com
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