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Florone

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Overview

What is Florone?

Each gram of FLORONE Cream contains 0.5 mg diflorasone diacetate in a cream base.

Chemically, diflorasone diacetate is: 6α,9-Difluoro-11β, 17, 21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-diacetate.

The structural formula is represented below:

FLORONE Cream contains diflorasone diacetate in an emulsified and hydrophilic cream base of propylene glycol, stearic acid, polysorbate 60, sorbitan monostearate and monooleate, sorbic acid, citric acid and water. The corticosteroid is formulated as a solution in the vehicle using 15 percent propylene glycol to optimize drug delivery.



What does Florone look like?



What are the available doses of Florone?

Sorry No records found.

What should I talk to my health care provider before I take Florone?

Sorry No records found

How should I use Florone?

Sorry No records found


What interacts with Florone?

Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.



What are the warnings of Florone?

Sorry No Records found


What are the precautions of Florone?

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 which augment systemic absorption include the 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 by using the 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, requiring supplemental systemic corticosteroids.

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See .)

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

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

Information for the Patient











            Patients using topical corticosteroids should receive the following information and instructions:

            Laboratory Tests

            The following tests may be helpful in evaluating the HPA axis suppression:

              Urinary free cortisol test

              ACTH stimulation test

            Carcinogenesis, Mutagenesis, And Impairment Of Fertility

            Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect of topical corticosteroids on fertility.

            Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

            Pregnancy Category C

            Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, 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 on pregnant patients, in large amounts, or for prolonged periods of time.

            Nursing Mothers

            It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

            Pediatric Use

            Safety and effectiveness of FLORONE in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are, therefore, also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in pediatric patients.

            HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

            Geriatric Use

            Clinical studies of diflorasone diacetate topical formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.


            What are the side effects of Florone?

            The following local adverse reactions have been reported 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
            • Acneiform eruptions
            • Hypopigmentation
            • Perioral dermatitis
            • Allergic contact dermatitis
            • Maceration of the skin
            • Secondary infection
            • Skin atrophy
            • Striae
            • Miliaria



            What should I look out for while using Florone?

            Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

            Drug Interactions:

            Array

            WARNINGS: Concomitant Antiarrhythmic Therapy

            intravenous


            What might happen if I take too much Florone?

            Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See .)


            How should I store and handle Florone?

            FLORONE Cream is available in 30 gram and 60 gram collapsible tubesStore at controlled room temperature, 20° to 25° C (68° to 77° F) [see USP].FLORONE Cream is available in 30 gram and 60 gram collapsible tubesStore at controlled room temperature, 20° to 25° C (68° to 77° F) [see USP].