INDICATIONS AND USAGE

CORDRAN^®Tape (Flurandrenolide Tape, USP) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses, particularly dry, scaling localized lesions.

IMPORTANT SAFETY INFORMATION

Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations. Use of CORDRAN^®Tape is not recommended for lesions exuding serum or in intertriginous areas.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Use over large surface areas, prolonged use, and the addition of occlusive dressings augment systemic absorption. Pediatric patients may absorb proportionately larger amounts of topical corticosteroids and thus may be more susceptible to systemic toxicity.

HPA axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Patients receiving a large dose applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression, and therapy should be modified or discontinued as appropriate.

Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively for pregnant patients or in large amounts or for prolonged periods of time. Caution should be exercised when topical corticosteroids are administered to a nursing woman.

Local adverse reactions may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis. Reactions that may occur more frequently with occlusive dressings include: maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

For more information on CORDRAN^®Tape, please see accompanying Full Prescribing Information.

To report an adverse event or product complaint, call or email:
Medical Affairs and Customer Relations
Phone: 1-866-665-2782
Fax: 510-595-8183
Email: almirallmc@eversana.com

REFERENCES:

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