Diflorasone (Topical application)

Diflorasone topical is used to relieve redness, pain, itching, swelling, or other discomfort caused by skin conditions (for example, dermatoses). This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

This medicine may increase your risk for cataracts or glaucoma. Do not get this medicine into your eyes. Check with your doctor if you have eye pain, blurred vision, or any changes in vision.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision, dizziness or fainting, fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

Check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin after using this medicine.

Do not use cosmetics or other skin care products on the treated areas.

In deciding to use a medicine, you need to consider the risks against the benefits. This is a choice you will make with your doctor. For this medicine, think about the following:

Allergies

Tell your doctor if you have had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown that diflorasone topical has specific problems for children that would limit its usefulness. However, because this medicine can be toxic, it should be used carefully. Children might absorb large amounts through their skin, which can lead to serious side effects. If your child is using this medicine, follow your doctor's instructions closely. Safety and effectiveness have not been established.

Geriatric

Studies performed so far have not shown that Florone® cream, Psorcon® E cream, Psorcon® E ointment, or Psorcon® ointment have specific problems for older adults that would limit their usefulness.

There is no information available about how age affects the effects of diflorasone topical cream or ointment in older patients.

Breast Feeding

There are no adequate studies in women to determine the risks to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if there might be interactions. In these cases, your doctor may want to adjust the dose, or other precautions may be needed. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Cataracts or
• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Glaucoma or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May worsen these conditions.

• Infection of the skin at or near the application site or
• Large sores, broken skin, or severe skin injury at the application site—This may increase the chance of side effects.

• Perioral dermatitis (skin problem) or
• Rosacea (skin problem)—Diflorasone topical cream should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Blindness
• blistering, burning, crusting, dryness, or flaking of the skin
• blurred vision
• decreased vision
• eye pain
• headache
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• nausea
• redness and scaling around the mouth
• tearing
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color or of treated areas of dark skin color
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it into your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use the diflorasone topical cream on the face, groin, or underarms unless directed to do so by your doctor.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless your doctor tells you to.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless your doctor tells you to.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For redness, itching, and swelling of the skin:For topical dosage form (cream): Diflorasone topical cream: Adults—Apply to the affected area of the skin two times a day. Children—Use and dose must be determined by your doctor. Florone® cream: Adults—Apply to the affected area of the skin one to four times a day. Children—Use and dose must be determined by your doctor. Psorcon® E cream: Adults—Apply to the affected area of the skin one to three times a day. Children—Use and dose must be determined by your doctor. For topical dosage form (ointment): Diflorasone topical ointment: Adults—Apply to the affected area of the skin one to three times a day. Children—Apply to the affected area of the skin one to three times a day. Psorcon® ointment: Adults—Apply to the affected area of the skin one to three times a day. Children—Use and dose must be determined by your doctor. Psorcon® E ointment: Adults—Apply to the affected area of the skin one to four times daily. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.