Flurandrenolide

What it is used for

Flurandrenolide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

How to take it

For dry, scaly lesions, the ointment is applied as a thin film to affected areas 2 or 3 times daily.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Flurandrenolide ointment should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.

Side effects, and when to stop

The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis

The following may occur more frequently with occlusive dressings:

Maceration of the skin Secondary infection Skin atrophy Striae Miliaria

To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Who should not take it

Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.

Storing it

Keep tightly closed. Protect from light. Store at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F)

Teligent Pharma, Inc. Buena, New Jersey 08310 Rev. 05/16

General -

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.

Conditions that augment systemic absorption include application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression using urinary-free cortisol and ACTH stimulation tests. 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 and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, so that supplemental systemic corticosteroids are required.

Pediatric patients may absorb proportionately larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see Pediatric Use under PRECAUTIONS ).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, Flurandrenolide Ointment should be discontinued until the infection has been adequately controlled.