Cordran (Topical application)

Flurandrenolide topical is used to relieve redness, itching, swelling, or other discomfort from skin conditions. Flurandrenolide tape is used for dry and scaling skin lesions. 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 your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

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

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 using this medicine: blurred vision, dizziness or fainting, a 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.

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

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

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

Pediatric

Current studies have not shown any specific problems in children that would limit the usefulness of flurandrenolide topical. However, due to the potential toxicity of this medicine, it should be used with caution. Children may absorb significant amounts through their skin, leading to serious side effects. If your child is using this medicine, follow your doctor's instructions closely.

Geriatric

There is no information available regarding how age affects the effects of flurandrenolide topical in older patients.

Interactions with Medicines

Some medicines should not be used together, while others may be used together despite possible interactions. In such cases, your doctor may adjust the dose or take other precautions. Inform 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 taken around mealtime or with specific foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how you can use this medicine. Be sure to tell your doctor about any other medical issues, especially:

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. It 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—The risk of side effects may be higher.

• Moist lesions—Flurandrenolide tape should not be used in patients with these conditions.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

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

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin
• Irritation
• Itching, scaling, severe redness, soreness, or swelling of the skin
• Redness and scaling around the mouth
• Thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g., between the fingers)

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your health care professional may have ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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
• Lightening of the treated areas of dark skin
• 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.

• Cordran
• Cordran SP
• Cordran Tape

In Canada

• Drenison
• Drenison 1/4
• Drenison Tape

Available Dosage Forms:

• Ointment
• Lotion
• Cream
• Tape

Therapeutic Class: Corticosteroid, Strong

Pharmacologic Class: Adrenal Glucocorticoid

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.

Wash your hands with soap and water before and after using this medicine.

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

Do not use the tape in an area where the skin folds together (eg, between the fingers).

To use the cream, lotion, or ointment:

• Shake the lotion well before using.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried.

To use the tape:

• This medicine comes with patient directions. Read and follow the instructions carefully.
• Gently clean and wash the affected area with soap and water.
• Shave or clip the hair in the affected area to allow good application on the skin and comfortable removal of the tape.
• If you bathe or shower before applying this medicine, make sure that the area to be covered is completely dry.
• Measure and cut the tape to be used on the affected area. Do not tear or break the tape.
• Pull the white paper from the transparent tape. Be careful that the tape does not stick to itself.
• Apply and press the tape gently on the skin.
• Replace the tape every 12 hours, unless otherwise directed by your doctor. Clean and wash the skin. Allow it to dry for 1 hour before applying a new tape.

Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor. If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor. 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.

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 forms (cream, lotion, and ointment): Adults—Apply to the affected area of the skin 2 or 3 times per day. Children—Use and dose must be determined by your doctor. For topical dosage form (tape): Adults—Apply to the affected area of the skin every 12 hours. 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

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.

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

Keep the tape in the original container.