Psorcon E Emollient Cream (Diflorasone Diacetate Cream)
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Psorcon E Emollient Cream (Diflorasone Diacetate Cream)

PSORCON®e™
(diflorasone diacetate) Cream 0.05%

Not For Ophthalmic Use

DRUG DESCRIPTION

Each gram of Psorcon E Emollient Cream contains 0.5 mg diflorasone diacetate in a cream base.

Chemically, diflorasone diacetate is: 6α,9-difluoro-11β,17, 21-trihydroxy-16β-methyl-pregna-1,4-diene-3,20-dione 17,21-diacetate. The structural formula is represented below:

Psorcon E (diflorasone diacetate) structural formula illustration

Each gram of Psorcon E Emollient Cream contains 0.5 mg diflorasone diacetate in a hydrophilic vanishing cream base of propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polysorbate 60, mineral oil and purified water.

What are the possible side effects of diflorasone topical (ApexiCon, ApexiCon E, Maxiflor, Psorcon E)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing diflorasone topical through your skin, such as:

  • blurred vision, or seeing halos around lights;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • muscle weakness,...

Read All Potential Side Effects and See Pictures of Psorcon E Emollient Cream »

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

DOSAGE AND ADMINISTRATION

Psorcon E Emollient Cream (diflorasone diacetate cream) should be applied to the affected areas as a thin film from one to three times daily depending on the severity or resistant nature of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.

HOW SUPPLIED

Psorcon E Emollient Cream (diflorasone diacetate cream) is available in the following size tubes:

15 gram NDC 0066-0272-17
30 gram NDC 0066-0272-31
60 gram NDC 0066-0272-60

Store at controlled room temperature, 20° to 25° C (68° to 77° F) [see USP].

Prescribing Information as of December 2001. Manufactured for: Dermik Laboratories, Inc. Berwyn, PA 19312 USA. By Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation Kalamazoo, MI, USA 49001. FDA rev date: 5/30/2003

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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:

  1. Burning
  2. Itching
  3. Irritation
  4. Dryness
  5. Folliculitis
  6. Hypertrichosis
  7. Acneiform eruptions
  8. Hypopigmentation
  9. Perioral dermatitis
  10. Allergic contact dermatitis
  11. Maceration of the skin
  12. Secondary infection
  13. Skin atrophy
  14. Striae
  15. Miliaria

Read the Psorcon E Emollient Cream (diflorasone diacetate cream) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

No information provided.

PRECAUTIONS

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 PRECAUTIONS: Pediatric Use.)

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 cortico-steroid should be discontinued until the infection has been adequately controlled.

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 on fertility of topical corticosteroids.

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

Pregnancy Category C

Corticosteroids are generally terato-genic 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 not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corti-costeroids are administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Psorcon E (diflor-asone diacetate cream) 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.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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

CONTRAINDICATIONS

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

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION.)

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to sys-temically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. They are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
  3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
  4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
  5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on an infant or child being treated in the diaper area, as these garments may constitute occlusive dressings.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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

  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
  3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
  4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
  5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on an infant or child being treated in the diaper area, as these garments may constitute occlusive dressings.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

PSORCON®e™
(diflorasone diacetate) Cream 0.05%

Not For Ophthalmic Use

DRUG DESCRIPTION

Each gram of Psorcon E Emollient Cream contains 0.5 mg diflorasone diacetate in a cream base.

Chemically, diflorasone diacetate is: 6α,9-difluoro-11β,17, 21-trihydroxy-16β-methyl-pregna-1,4-diene-3,20-dione 17,21-diacetate. The structural formula is represented below:

Psorcon E (diflorasone diacetate) structural formula illustration

Each gram of Psorcon E Emollient Cream contains 0.5 mg diflorasone diacetate in a hydrophilic vanishing cream base of propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polysorbate 60, mineral oil and purified water.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

PSORCON®e™
(diflorasone diacetate) Cream 0.05%

Not For Ophthalmic Use

DRUG DESCRIPTION

Each gram of Psorcon E Emollient Cream contains 0.5 mg diflorasone diacetate in a cream base.

Chemically, diflorasone diacetate is: 6α,9-difluoro-11β,17, 21-trihydroxy-16β-methyl-pregna-1,4-diene-3,20-dione 17,21-diacetate. The structural formula is represented below:

Psorcon E (diflorasone diacetate) structural formula illustration

Each gram of Psorcon E Emollient Cream contains 0.5 mg diflorasone diacetate in a hydrophilic vanishing cream base of propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polysorbate 60, mineral oil and purified water.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

PSORCON®e™
(diflorasone diacetate) Cream 0.05%

Not For Ophthalmic Use

DRUG DESCRIPTION

Each gram of Psorcon E Emollient Cream contains 0.5 mg diflorasone diacetate in a cream base.

Chemically, diflorasone diacetate is: 6α,9-difluoro-11β,17, 21-trihydroxy-16β-methyl-pregna-1,4-diene-3,20-dione 17,21-diacetate. The structural formula is represented below:

Psorcon E (diflorasone diacetate) structural formula illustration

Each gram of Psorcon E Emollient Cream contains 0.5 mg diflorasone diacetate in a hydrophilic vanishing cream base of propylene glycol, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polysorbate 60, mineral oil and purified water.

Last reviewed on RxList: 10/30/2008
This monograph has been modified to include the generic and brand name in many instances.

Psorcon E Emollient Cream Patient Information Including Side Effects

Brand Names: ApexiCon, ApexiCon E, Maxiflor, Psorcon E

Generic Name: diflorasone topical (Pronunciation: dye FLOR a sone)

What is diflorasone topical (Psorcon E Emollient Cream)?

Diflorasone is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Diflorasone topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Diflorasone topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of diflorasone topical (Psorcon E Emollient Cream)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing diflorasone topical through your skin, such as:

  • blurred vision, or seeing halos around lights;
  • mood changes;
  • sleep problems (insomnia);
  • weight gain, puffiness in your face; or
  • muscle weakness, feeling tired.

Less serious side effects may include:

  • mild skin itching, burning, or dryness;
  • thinning or softening of your skin;
  • skin rash or irritation around your mouth;
  • swollen hair follicles;
  • changes in color of treated skin;
  • blisters, pimples, or crusting of treated skin; or
  • stretch marks.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Psorcon E Emollient Cream (diflorasone diacetate cream) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about diflorasone topical (Psorcon E Emollient Cream)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. Plastic film covering (such as plastic wrap) is sometimes used when treating psoriasis. Follow your doctor's instructions.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with diflorasone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve, or if you develop signs of a bacterial, fungal, or viral skin infection.

Psorcon E Emollient Cream Patient Information including How Should I Take

What should I discuss with my healthcare provider before using diflorasone topical (Psorcon E Emollient Cream)?

Do not use this medication if you are allergic to diflorasone.

Before using diflorasone topical, tell your doctor if you are allergic to any drugs, or if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether diflorasone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

How should I use diflorasone topical (Psorcon E Emollient Cream)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Wash your hands before and after using diflorasone topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. Plastic film covering (such as plastic wrap, plastic gloves, or a shower cap) is sometimes used to cover areas of psoriasis that are treated with diflorasone topical. Follow your doctor's instructions.

Avoid plastic covering over skin lesions that are oozing or draining pus or any type of fluid.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with diflorasone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Contact your doctor if your condition does not improve, or if you develop signs of a bacterial, fungal, or viral skin infection. It is important to use diflorasone topical regularly to get the most benefit.

If you are treating psoriasis, use the medication for at least a few days after the skin clears. Stopping too soon could cause a relapse.

To be sure this medication is not causing harmful effects with long-term use, you may need blood tests. Do not miss any scheduled appointments.

Store diflorasone topical at room temperature away from moisture and heat. Keep from freezing.

Psorcon E Emollient Cream Patient Information including If I Miss a Dose

What happens if I miss a dose (Psorcon E Emollient Cream)?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Psorcon E Emollient Cream)?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of diflorasone is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using diflorasone topical (Psorcon E Emollient Cream)?

Diflorasone topical should not be used to treat any skin condition your doctor has not prescribed it for.

Avoid getting this medication in your eyes. If contact does occur, rinse with water. Do not use diflorasone topical on broken or infected skin. Also avoid using this medication in open wounds.

What other drugs will affect diflorasone topical (Psorcon E Emollient Cream)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied diflorasone topical. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about diflorasone topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.03. Revision date: 12/15/2010.

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