Psorcon

A synthetic fluorinated corticosteroid.a

General

• Consider location of the lesion and the condition being treated when choosing a dosage form.b

• Creams are suitable for most dermatoses, but ointments may also provide some occlusion and are usually used for the treatment of dry, scaly lesions.b

• Formulation affects percutaneous penetration and subsequent activity; extemporaneous preparation or dilution of commercially available products with another vehicle may decrease effectiveness.b

• Patients applying a topical corticosteroid to a large surface area and/or to areas under occlusion should be evaluated periodically for evidence of hypothalamic-pituitary-adrenal (HPA)-axis suppression by appropriate endocrine testing (e.g., ACTH stimulation, plasma cortisol, urinary free cortisol). b f g (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

Administration

Topical Administration

For dermatologic use only; avoid contact with eyes.c e g

Apply creams and ointments topically to the skin or scalp.c e

Do not use cream on face, groin, or axillae.e g

The area of skin to be treated may be thoroughly cleansed before topical application to reduce the risk of infection; however, some clinicians believe that, unless an occlusive dressing is used, cleansing of the treated area is unnecessary and may be irritating.b

Apply cream or ointment sparingly in a thin film and rub gently into the affected area.c f h

After a favorable response is achieved, frequency of application or concentration (strength) may be decreased to the minimum necessary to maintain control and to avoid relapse; discontinue if possible.b

Occlusive dressings may be used for severe or resistant dermatoses.c (See Occlusive Dressings under Cautions.)

Soak or wash the affected area to remove scales; apply a thin film of cream or ointment; rub gently into the lesion; and apply another thin film.b Cover affected area with a thin, pliable plastic film and seal it to adjacent normal skin with adhesive tape or hold in place with a gauze or elastic bandage.b

If affected area is moist, incompletely seal the edges of the plastic film or puncture the film to allow excess moisture to escape.b For added moisture in dry lesions, apply cream or ointment and cover with a dampened cloth before the plastic film is applied or briefly soak the affected area in water before application of the drug and plastic film.b

Thin polyethylene gloves may be used on the hands and fingers, plastic garment bags may be used on the trunk or buttocks, a tight shower cap may be used for the scalp, or whole-body suits may be used instead of plastic film to provide occlusion.b

Frequency of occlusive dressing changes depends on the condition being treated; cleansing of the skin and reapplication of the corticosteroid are essential at each dressing change.b

Occlusive dressing is usually left in place for 12–24 hours and therapy is repeated as needed.b Although occlusive dressing may be left in place for 3–4 days at a time in resistant conditions, most clinicians recommend intermittent use of occlusive dressings for 12 hours daily to reduce the risk of adverse effects (particularly infection) and systemic absorption and for greater convenience.b

The drug and an occlusive dressing may be used at night, and the drug or a bland emollient may be used without an occlusive dressing during the day.b

In patients with extensive lesions, sequential occlusion of only one portion of the body at a time may be preferable to whole-body occlusion.b (See Occlusive Dressings under Cautions.)

Dosage

Pediatric Patients

Administer the least amount of topical preparations that provide effective therapy.b c (See Pediatric Use under Cautions.)

Apply ointment sparingly 1–3 times daily.c

Adults

Apply cream sparingly twice daily.e

Apply ointment or emollient cream sparingly 1–3 times daily.c f

Apply emollient ointment sparingly 1–4 times daily.h

Special Populations

No special population dosage recommendations at this time.c e f g h

Storage

Topical

≤25°C;e g keep tightly closed.g

15–30°C; keep tightly closed.c

20–25°C.f h

In the U.S.

• Apexicon
• Apexicon E
• Maxiflor
• Psorcon
• Psorcon E

In Canada

• Florone
• Flutone

Available Dosage Forms:

• Ointment
• Cream

Therapeutic Class: Corticosteroid, Strong

Pharmacologic Class: Diflorasone

• Store at room temperature.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Rx only
For External Use Only - Not for Ophthalmic Use.

Psorcon (diflorasone diacetate cream USP), 0.05% contains the active compound diflorasone diacetate, a synthetic corticosteroid for topical dermatological use. Chemically, diflorasone diacetate is 6α, 9α-difluoro-11β,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21 diacetate, with the empirical formula C26H32F2O7, a molecular weight of 494.5, and the following structural formula:

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

Psorcon (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.

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) Psorcon (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) Psorcon (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 (see PRECAUTIONS: Pediatric Use).

If irritation develops, diflorasone diacetate cream USP should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Psorcon (diflorasone diacetate cream USP), 0.05% should be discontinued until the infection has been adequately controlled. Psorcon (diflorasone diacetate cream USP), 0.05% should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin, or axillae.

Information for Patients

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

Laboratory Tests

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of diflorasone diacetate. Diflorasone diacetate was not found to be mutagenic in a micronucleus test in rats at dosages of 2400 mg/kg. Studies in the rat following topical administration at doses up to 0.5 mg/kg revealed no effects on fertility.

Pregnancy

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

Diflorasone diacetate has been shown to be teratogenic (cleft palate) in rats when applied topically at a dose of approximately 0.001 mg/kg/day to the shaven thorax of pregnant animals. This is approximately 0.3 times the human topical dose of Psorcon (diflorasone diacetate cream USP), 0.05%. When pregnant rats were treated topically with approximately 0.5 mg/kg/day, uterine deaths were higher in the treated animals than in control animals.

In rabbits, cleft palate was seen when diflorasone diacetate was applied in topical doses as low as 20 mg/kg/day. In addition, fetal weight was depressed and litter sizes were smaller. There are no adequate and well-controlled studies of the teratogenic potential of diflorasone diacetate in pregnant women. Psorcon (diflorasone diacetate cream USP), 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when diflorasone diacetate cream USP is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Psorcon (diflorasone diacetate cream USP), 0.05% in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a 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.

Psorcon (diflorasone diacetate cream USP), 0.05% is available in 5 g physician sample (NDC 51672-5292-5) and 60 g (51672-5292-3) tubes.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

TaroPharma® is a registered trademark of Taro Pharmaceuticals U.S.A., Inc. and/or its affiliates.

Revised: March, 2015
PK-7229-1
57
0315-1