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Diflorasone Diacetate 0.05% Ointment 30 Gm By Taro Pharma

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Diflorasone Diacetate 0.05% Ointment 30 Gm By Taro Pharma

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Diflorasone Diacetate 0.05% Ointment 30 Gm By Taro Pharma. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD2877496/RXB10042924
Size : 30 GM
Selling UoM : EA
NDC: 51672-1295-02
UPC Barcode : 351672129521
Supplier: 0050000602 TARO PHARMACEUTICALS
Supplier Material : 129502
Generic Code : 007630 DIFLORASONE DIACETATE TOPICAL OINT. (G)
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Ge

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Product Description.:

Diflorasone diacetate cream USP, 0.05% contains the active compound diflorasone diacetate, a synthetic corticosteroid for topical dermatological use.

Each gram of diflorasone diacetate cream USP, 0.05% contains 0.5 mg diflorasone diacetate in a cream base consisting of purified water, citric acid, mineral oil, lanolin alcohol, isopropyl myristate, cetyl alcohol, glyceryl stearate/PEG 100 stearate, polysorbate 60, sorbitan monostearate, polyoxyl 40 stearate, butylated hydroxytoluene, vegetable oil, propylene glycol, monobasic sodium phosphate.

INDICATION AND USAGE

Diflorasone diacetate cream USP, 0.05% is a high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

Diflorasone diacetate cream USP is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients receiving a large dose of a higher potency topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH-stimulation, A.M. plasma cortisol, and urinary free-cortisol tests.

This product has a greater ability to produce adrenal suppression than does diflorasone diacetate ointment USP, 0.05%. At 30 g per day (applied as 15 g twice daily) diflorasone diacetate cream USP, 0.05% was shown to cause inhibition of the HPA axis in one of two patients following application for one week to psoriatic skin. At 15 g per day (applied as 7.5 g twice daily) diflorasone diacetate cream USP, 0.05% was shown to cause mild inhibition of the HPA axis in one of five patients following application for one week to diseased skin (psoriasis or atopic dermatitis). These effects were reversible upon discontinuation of treatment. By comparison, diflorasone diacetate ointment USP, 0.05% did not produce significant HPA axis suppression when used in divided doses at 30 g per day for one week in patients with psoriasis or atopic dermatitis.

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 corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios

Information for Patients

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

1. The medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2. The medication should not be used for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
4. Patients should report to their physician any signs of local adverse reactions.