diflorasone


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diflorasone

 [di-flor´ah-sōn]
a synthetic corticosteroid used topically as the diacetate salt in the treatment of inflammation and pruritus in certain dermatoses.

diflorasone

(dye-flor-a-sone)

Classification

Therapeutic: anti inflammatories steroidal
Pharmacologic: corticosteroids
Pregnancy Category: C

Indications

Management of inflammation and pruritis associated with various allergic/immunologic skin problems.

Action

Suppresses normal immune response and inflammation.

Therapeutic effects

Suppression of dermatologic inflammation and immune processes.

Pharmacokinetics

Absorption: Minimal. Prolonged use on large surface areas, application of large amounts, or use of occlusive dressings may increase systemic absorption.
Distribution: Remains primarily at site of action.
Metabolism and Excretion: Usually metabolized in skin.
Half-life: Unknown.

Time/action profile (response depends on condition being treated)

ROUTEONSETPEAKDURATION
Topicalmin–hrshrs–dayshrs–days

Contraindications/Precautions

Contraindicated in: Hypersensitivity or known intolerance to corticosteroids or components of vehicles (ointment or cream base, preservative, alcohol); Untreated bacterial or viral infections.
Use Cautiously in: Hepatic dysfunction; Diabetes mellitus, cataracts, glaucoma, or tuberculosis (use of large amounts of high-potency agents may worsen condition); Patients with pre-existing skin atrophy; Obstetric / Lactation / Pediatric: Chronic high-dose usage may result in adrenal suppression in mother, growth suppression in children; children may be more susceptible to adrenal and growth suppression.

Adverse Reactions/Side Effects

Dermatologic

  • allergic contact dermatitis
  • atrophy
  • burning
  • dryness
  • edema
  • folliculitis
  • hypersensitivity reactions
  • hypertrichosis
  • hypopigmentation
  • irritation
  • maceration
  • miliaria
  • perioral dermatitis
  • secondary infection
  • striae

Miscellaneous

  • adrenal suppression (use of occlusive dressings, long-term therapy)

Interactions

Drug-Drug interaction

None significant.

Route/Dosage

Topical (Adults) Apply to affected area(s) 1–4 times daily (depends on condition being treated).
Topical (Children) Apply to affected area(s) once daily.

Availability (generic available)

Cream: 0.05%
Ointment: 0.05%

Nursing implications

Nursing assessment

  • Assess affected skin before and daily during therapy. Note degree of inflammation and pruritus. Notify health care professional if symptoms of infection (increased pain, erythema, purulent exudate) develop.
  • Lab Test Considerations: Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal (HPA) axis suppression in chronic topical therapy if suspected. Children and patients with dose applied to a large area, using an occlusive dressing, or using high-potency products are at highest risk for HPA suppression.
    • May cause increased serum and urine glucose concentrations if significant absorption occurs.

Potential Nursing Diagnoses

Risk for impaired skin integrity (Indications)
Risk for infection (Side Effects)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Choice of vehicle depends on site and type of lesion. Ointments are more occlusive and preferred for dry, scaly lesions. Creams should be used on oozing or intertriginous areas, where the occlusive action of ointments might cause folliculitis or maceration. Creams may be preferred for aesthetic reasons even though they may be more drying to skin than ointments.
  • Topical: Apply ointment orcream sparingly as a thin film to clean, slightly moist skin. Wear gloves. Apply occlusive dressing only if specified by physician or other health care professional.

Patient/Family Teaching

  • Instruct patient on correct technique of medication administration. Emphasize importance of avoiding the eyes. If a dose is missed, it should be applied as soon as remembered unless almost time for the next dose.
  • Caution patient to use only as directed. Avoid using cosmetics, bandages, dressings, or other skin products over the treated area unless directed by health care professional.
  • Advise parents of pediatric patients not to apply tight-fitting diapers or plastic pants on a child treated in the diaper area; these garments work like an occlusive dressing and may cause more of the drug to be absorbed.
  • Advise patient to consult health care professional before using medicine for condition other than indicated.
  • Instruct patient to inform health care professional if symptoms of underlying disease return or worsen or if symptoms of infection develop.
  • Caution women that medication should not be used extensively, in large amounts, or for protracted periods if they are pregnant or planning to become pregnant.

Evaluation/Desired Outcomes

  • Resolution of skin inflammation, pruritus, or other dermatologic conditions.

diflorasone

/di·flor·a·sone/ (di-flor´ah-sōn) a synthetic corticosteroid used topically as the diacetate salt in the treatment of inflammation and pruritus in certain dermatoses.
References in periodicals archive ?
Taro's May 1999 approval for Diflorasone Diacetate Ointment USP, 0.
Food and Drug Administration (FDA) approving its Abbreviated New Drug Application (ANDA) for Diflorasone Diacetate Cream USP, 0.
TARC and RANTES, but not CTACK, are induced in two models of allergic contact dermatitis: effects of cilomilast and diflorasone diacetate on T-cell-attracting chemokines.
Over the next 5 to 6 months, her discomfort precipitated 5 visits to her primary care physician, who treated her with diflorasone diacetate ointment 0.
The topical products were Diflorasone Diacetate Cream, bioequivalent to Dermik Laboratories' Psorcon(R) Cream, with a U.
Taro also received ANDA approval for Diflorasone Diacetate Cream, all three strengths of Clorazepate Dipotassium Tablets, all four strengths of Nortriptyline Hydrochloride Capsules, and Clobetasol Emollient Cream, as well as a supplemental ANDA approval for an additional strength of Etodolac Tablets.
During the second quarter of 2000, Taro received FDA approval for its New Drug Application for Clotrimazole 3-Day Vaginal Cream, its ANDAs for Diflorasone Diacetate Cream, Clorazepate Dipotassium Tablets, Nortriptyline Hydrochloride Capsules, and Clobetasol E Cream, as well as a supplemental ANDA approval for an additional strength of Etodolac Tablets.
Earlier this quarter, Taro's NDA for Clotrimazole Three-Day Cream 2% was approved, as well as ANDAs for Diflorasone Diacetate Cream, Clorazepate Dipotassium Tablets and a supplemental ANDA approval for Etodolac Tablets, 500mg.
In April, Taro received FDA approval for its NDA for Clotrimazole 3-Day Vaginal Cream, its ANDAs for Diflorasone Diacetate Cream and Clorazepate Dipotassium Tablets, and a supplemental ANDA approval for an additional strength of Etodolac Tablets.
Three of these approvals were for high-potency topical corticosteroid products indicated for the treatment of moderate to severe dermatologic conditions: Diflorasone Diacetate Ointment, 0.
The Company expects that the topical products, Diflorasone Diacetate Ointment, Clobetasol Propionate Gel and Fluocinonide Ointment will enable it to further enhance its leadership position in the dermatological market.
Taro's Diflorasone Diacetate Ointment, is a high-potency topical corticosteroid indicated for the treatment of moderate to severe dermato Dermik Laboratories' Psorcon(R).