Cordran

Flurandrenolide is a steroid. It reduces the actions of chemicals in the body that cause inflammation.

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

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

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Contraindications

• Known hypersensitivity to flurandrenolide or any ingredient in the formulation.c d e

• Tape: Lesions exuding serum or in intertriginous areas.d

Warnings/Precautions

Sensitivity Reactions

Allergic contact dermatitis may manifest as failure to heal rather than irritation as occurs with other topical preparations that do not contain corticosteroids; confirm with diagnostic patch testing.b

General Precautions

Topically applied corticosteroids can be absorbed in sufficient amounts to reversibly suppress the HPA axis.b c d e

Perform periodic HPA-axis evaluation by appropriate testing (e.g., ACTH stimulation,b c d e morning plasma cortisol,b urinary free cortisolb c d e ), especially in patients applying a topical corticosteroid to a large surface area or to areas under occlusion.b c d e

If HPA-axis suppression occurs, withdraw the drug, reduce the frequency of application, and/or substitute a less potent corticosteroid.b c d e

HPA-axis function recovery generally is prompt and complete following drug discontinuance.b c d e

Rarely, glucocorticosteroid insufficiency may require systemic corticosteroid therapy.b c d e

Systemic absorption following topical administration may result in manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.b c d e

Adverse systemic effects may occur when corticosteroids are used on large areas of the body, for prolonged periods of time, with an occlusive dressing, and/or concurrently with other corticosteroid-containing preparations.b

Infants and children may be more susceptible to adverse systemic effects. c d e (See Pediatric Use under Cautions.)

Possible adverse local reactions (e.g., burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria); may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.b

Prolonged use of topical corticosteroids may cause atrophy of the epidermis and subcutaneous tissue;b these effects are most likely to occur (even with short-term use) in intertriginous (e.g., axilla, groin), flexor, and facial areas.b

If irritation occurs, discontinue drug and institute appropriate therapy.b c d e

If concurrent skin infection is present or develops, initiate appropriate anti-infective therapy.b c d e If infection does not respond promptly, consult clinician and discontinue topical corticosteroid therapy until the infection has been controlled.b c d e

When topical corticosteroids and topical anti-infectives are used concomitantly, consider that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation.b In addition, consider the cautions, precautions, and contraindications associated with the anti-infective.b (See Occlusive Dressings under Cautions.)

Some manufacturers state that topical corticosteroids are contraindicated in patients with tuberculosis of the skin, dermatologic fungal infections, and cutaneous or systemic viral infection (including vaccinia and varicella and herpes simplex of the eye or adjacent skin).b However, most clinicians believe topical corticosteroids can be used with caution if the infection is treated.b

Adverse systemic corticosteroid effects may occur with use of occlusive dressings on large areas of the body and for prolonged periods of time; monitor accordingly.b (See Hypothalamic-Pituitary-Adrenal Axis Suppression and also Systemic Effects, under Cautions.)

Adverse local reactions may occur more frequently with the use of occlusive dressings, especially with prolonged therapy.b (See Local Effects under Cautions.)

Do not use occlusive dressings on weeping or exudative lesions.b c

Do not use occlusive dressings in patients with primary skin infection.b

Remove occlusive dressings covering large areas if body temperature increases; thermal homeostasis may be impaired.b c

Restrict use in hospitalized patients; increased hazard of secondary infection from resistant strains of staphylococci.c e

If infection develops, discontinue use of occlusive dressings and institute appropriate antimicrobial therapy.c e (See Skin Infection under Cautions.)

Use plastic occlusive material with care to avoid the risk of suffocation.b c e

If miliaria or folliculitis occurs, discontinue use of occlusive dressing; may continue corticosteroid treatment.c e

Do not use flammable plastic films as occlusive material.c e

Specific Populations

Category C.c d e

Not known whether topical flurandrenolide is distributed into milk.c d e Caution advised if topical flurandrenolide is used.c d e

Tight-fitting diapers or plastic pants should not be used on a child being treated in the diaper area, since such garments may constitute occlusive dressings.c d e

Children are more susceptible to topical corticosteroid-induced HPA-axis suppression and Cushing’s syndrome than mature individuals because of a greater skin surface area-to-body weight ratio,b c d e especially when topical corticosteroids are applied to >20% of body surface area.f The risk of adrenal suppression appears to increase with decreasing age.b (See Systemic Effects under Cautions.)

Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol concentrations, and lack of response to corticotropin (ACTH) stimulation.b c d e

Children also are at greater risk of glucocorticoid insufficiency during and/or after withdrawal of treatment.d

Intracranial hypertension has occurred in children; manifestations include bulging fontanelles, headaches, and bilateral papilledema.b c d e

Topical corticosteroid therapy in children should be limited to the minimum amount necessary for therapeutic efficacy; chronic topical corticosteroid therapy may interfere with growth and development.b c d e

Common Adverse Effects

Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.c d e

• Importance of using only as directed, only for the disorder for which it was prescribed, and for no longer than prescribed; avoid contact with the eyes and only apply externally as directed.c d e (See Topical Administration under Dosage and Administration.)

• Importance of informing patients that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by a clinician.c d e

• Importance of reporting any local adverse reactions, especially those occurring under occlusive bandage, to a clinician.b c d e

• Importance of informing parents of children not to use diapers or plastic pants on children being treated in the diaper area as these garments may constitute occlusive dressings.c d

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.c d e

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c d e

• Importance of advising patients of other important precautionary information. (See Cautions.)

This section provides information on the proper use of a number of products that contain flurandrenolide. It may not be specific to Cordran. Please read with care.

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 in 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 (e.g. 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.
• 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. If you have any questions about this, check with your doctor.

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.

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 two or three 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

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.

Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

For moist lesions, a small quantity of the cream should be rubbed gently into the affected areas 2 or 3 times a day. For dry, scaly lesions, the ointment is applied as a thin film to affected areas 2 or 3 times daily.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Cordran® (flurandrenolide, USP) should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.

Cordran® Cream is supplied in aluminum tubes as follows:

Cordran® Ointment is supplied in aluminum tube as follows:

Keep out of reach of children.

Storage

Keep tightly closed.

Protect from light.

Store at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F) [See USP controlled room temperature.].

Rx Only

Revision: 08/2013

Manufactured by DPT Laboratories, San Antonio, TX 78215
For Aqua Pharmaceuticals, West Chester, PA 19380

140165

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.