Cordran® Tape (Flurandrenolide Tape, USP) is a transparent, inconspicuous, plastic surgical tape, impervious to moisture. It contains Cordran® (Flurandrenolide, USP), a potent corticosteroid for topical use. Flurandrenolide occurs as white to off-white, fluffy crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One g dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52.

The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21 dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 16α)-; its empirical formula is C₂₄ H₃₃ FO₆. The structural formula is as follows:

Each square centimeter contains 4 μg (0.00916 μmol) flurandrenolide uniformly distributed in the adhesive layer. The tape is made of a thin, matte-finish polyethylene film that is slightly elastic and highly flexible.

The adhesive is a synthetic copolymer of acrylate ester and acrylic acid that is free from substances of plant origin. The pressure-sensitive adhesive surface is covered with a protective paper liner to permit handling and trimming before application.

For relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, particularly dry, scaling localized lesions.

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

If an infection develops, the use of Cordran Tape and other occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Replacement of the tape every 12 hours produces the lowest incidence of adverse reactions, but it may be left in place for 24 hours if it is well tolerated and adheres satisfactorily. When necessary, the tape may be used at night only and removed during the day.

If ends of the tape loosen prematurely, they may be trimmed off and replaced with fresh tape.

The directions given below are included on a separate package insert for the patient to follow unless otherwise instructed by the physician.

APPLICATION OF CORDRAN TAPE

DIRECTIONS FOR USE:

1. Prepare skin as directed by your physician or as follows: Gently clean the area to be covered to remove scales, crusts, dried exudates, and any previously used ointments or creams. A germicidal soap or cleanser should be used to prevent the development of odor under the tape. Shave or clip the hair in the treatment area to allow good contact with the skin and comfortable removal. If shower or tub bath is to be taken, it should be completed before the tape is applied. The skin should be dry before application of the tape.
2. Remove tape from package and cut a piece slightly larger than area to be covered. Round off corners.
3. Pull white paper from transparent tape. Be careful that tape does not stick to itself.
4. Apply tape, keeping skin smooth; press tape into place.

REPLACEMENT OF TAPE:

Unless instructed otherwise by your physician, replace tape after 12 hours. Cleanse skin and allow it to dry for 1 hour before applying new tape.

IF IRRITATION OR INFECTION DEVELOPS, REMOVE TAPE AND CONSULT PHYSICIAN.

Tape:

4 mcg/sq cm-small roll, 24 in x 3 in (60 cm x 7.5 cm) NDC 55515-014-24
4 mcg/sq cm-large roll, 80 in x 3 in (200 cm x 7.5 cm) NDC 55515-014-80

Directions for the patient are included in each package.

Store at 25°C (77°F); excursions permitted to15-30°C (59-86°F).

REFERENCES

Bard JW: Flurandrenolide tape in the treatment of lichen simplex chronicus. J Ky Med Assoc 1969;67:668.

Baxter DL, Stoughton RB: Mitotic index of psoriatic lesions treated with anthralin, glucocorticosteroid and occlusion only. J Invest Dermatol 1970;54:410.

Compilation of clinical reports on Cordran Tape received by Eli Lilly and Company.

Halprin KM, Fukui K, Ohkawara A: Flurandrenolone (Cordran) tape and carbohydrate metabolizing enzymes. Arch Dermatol 1969;100:336.

Labow TA, Eisert J, Sanders SL: Flurandrenolide tape in treatment of psoriasis. NY State J Med 1969;69:3138.

Ronchese F: Flurandrenolone tape therapy. RI Med J 1969;52:389.

Sellers FM: Investigative study of flurandrenolone tape in a series of ambulatory outpatients. J Indiana State Med Assoc 1970;63:34.

Weiner MA: Flurandrenolone tape, a new preparation for occlusive therapy, J Invest Dermatol 1966;47:63.

Mfd. by 3M Company, St. Paul, MN 55144. Mfd. For: Oclassen DERMATOLOGICS, A Division of Watson Pharma, Inc. Corona, CA 92880. FDA revision date: 7/19/2000

The following local adverse reactions are reported infrequently 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:

Burning
Itching
Irritation
Dryness
Folliculitis
Hypertrichosis
Acneform eruptions
Hypopigmentation
Perioral dermatitis
Allergic contact dermatitis

The following may occur more frequently with occlusive dressings:

Maceration of the skin
Secondary infection
Skin atrophy
Striae
Miliaria

No information provided.

No information provided.

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 that augment systemic absorption include 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 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 on discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, so that supplemental systemic corticosteroids are required.

Pediatric patients may absorb proportionately larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see Pediatric Use under PRECAUTIONS).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatologic infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, Cordran should be discontinued until the infection has been adequately controlled.

Information for the Patient

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 that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped in order to be occlusive unless the patient is directed to do so 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 a patient being treated in the diaper area, because these garments may constitute occlusive dressings.

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.

Usage in Pregnancy

Pregnancy Category C-Corticosteroids are generally teratogenic 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 for pregnant patients or 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 corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical-corticosteroid-induced HPA axis suppression and Cushing's syndrome than do mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (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.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

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

Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations. Use of Cordran Tape is not recommended for lesions exuding serum or in intertriginous areas.

Cordran is primarily effective because of its anti-inflammatory, antipruritic, and vasoconstrictive actions.

The mechanism of the anti-inflammatory effect of topical corticosteroids is not completely understood.

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. Corticosteroids with anti-inflammatory activity may stabilize cellular and lysosomal membranes. There is also the suggestion that the effect on the membranes of lysosomes prevents the release of proteolytic enzymes and, thus, plays a part in reducing inflammation.

The tape serves as both a vehicle and an occlusive dressing. Retention of insensible perspiration by the tape results in hydration of the stratum corneum and improved diffusion of the medication. The skin is protected from scratching, rubbing, desiccation, and chemical irritation. The tape acts as a mechanical splint to fissured skin. Since it prevents removal of the medication by washing or the rubbing action of clothing, the tape formulation provides a sustained action.

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 those of systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. They are metabolized primarily in the liver and then excreted in the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Cordran® Tape
Flurandrenolide Tape, USP

DIRECTIONS FOR USE
APPLICATION OF MEDICATED TRANSPARENT TAPE

1. Prepare skin as directed by your physician or as follows: Gently clean the area to be covered to remove scales, crusts, dried exudates, and any previously used ointments or creams. A germicidal soap or cleanser should be used to prevent the development of odor under the tape. Shave or clip the hair in the treatment area to allow both good contact with the skin and comfortable removal. If a shower or tub bath is to be taken, it should be completed before the tape is applied. The skin should be dry before application of the tape.

2. Remove tape from package and cut a piece slightly larger than area to be covered. Round off corners.

3. Pull white paper backing from transparent tape. Be careful that tape does not stick to itself.

4.Apply tape, keeping skin smooth; press tape into place.

REPLACEMENT OF TAPE

Unless instructed otherwise by your physician, replace tape after 12 hours. Cleanse skin and allow it to dry for 1 hour before applying new tape.

DISPENSING THE TAPE

To use the roll as a dispenser, pull the tape as illustrated.

IF IRRITATION OR INFECTION DEVELOPS, REMOVE TAPE AND CONSULT PHYSICIAN.

Store at 25°C (77°F); excursions permitted to 15-30°C

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

FLURANDRENOLIDE - TOPICAL (TAPE)

(flewr-an-DREN-oh-lide)

COMMON BRAND NAME(S): Cordran

USES: This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Flurandrenolide reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid. The tape acts to protect the treated skin and makes the medication more effective and longer-lasting.

HOW TO USE: Use this medication on the skin only. However, do not use it on the face, groin, or underarms unless directed to do so by your doctor.

Wash and dry your hands before using. Clean and dry the affected area before applying the tape. Measure the proper amount of tape to be used. Tape should always be cut, never torn. Apply the tape to the skin and press on the tape to keep it in place. Remove the tape after 12 hours and replace with fresh tape unless directed otherwise by your doctor. Do not use other bandages or cover/wrap the area unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants.

After applying the medication, wash your hands, unless you are using this medication to treat the hands. Use carefully if applying to the face. Avoid contact with the eyes because this may worsen or cause glaucoma. Also, avoid applying this medication in the nose or mouth. If you get the medication in your eyes, nose, or mouth, remove the tape and rinse with plenty of water.

Use this medication only for the condition prescribed. Do not use more tape than prescribed, apply more often, or use for longer than prescribed. Your condition will not clear faster, but your risk of side effects may be increased.

Inform your doctor if your condition persists or worsens after 2 weeks.

SIDE EFFECTS: Stinging, burning, itching, irritation, dryness, or redness of the skin may occur when the tape is first applied to the skin. These effects should disappear in a few days as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stretch marks, skin thinning/discoloration, acne, too much hair growth, hair bumps (folliculitis).

Skin infections can become worse when using this medication. Notify your doctor promptly if redness, swelling, or irritation does not improve.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using flurandrenolide, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, immune system problems, other skin conditions (e.g., rosacea, perioral dermatitis).

Do not use if there is an infection or sore in the area to be treated.

Though very unlikely, it is possible this medication will be absorbed into your bloodstream. This may have undesirable consequences that may require additional corticosteroid treatment. This is especially true for children and for those who have used this drug for an extended period of time, especially if they also have serious medical problems such as serious infections, injuries, or surgeries. This precaution applies for up to one year after stopping use of this drug. Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst/urination, unusual weakness, unusual weight loss, dizziness.

Consult your doctor or pharmacist for more details, and inform them that you use or have used this medication.

Children may be more sensitive to the effects of too much steroid hormone. Though it is unlikely to occur with corticosteroids applied to the skin, this medication may affect growth in infants and children if used for long periods. Monitor your child's height and rate of growth from time to time.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription or nonprescription/herbal products you may use, especially of: corticosteroids taken by mouth (e.g., prednisone), other corticosteroids applied to the skin (e.g., hydrocortisone), drugs that weaken the immune system (e.g., cyclosporine).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another skin problem unless told to do so by your doctor. A different medication may be necessary in that case.

Laboratory and/or medical tests (e.g., adrenal gland function tests, morning cortisol blood test) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.

Inform all your doctors that you use or have used this medication.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.