Cordran® (Flurandrenolide, USP) is a potent corticosteroid intended 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 structure is as follows:

Each g of Cordran® SP Cream (Flurandrenolide Cream, USP) contains 0.5 mg (1.145 μmol; 0.05%) or 0.25 mg (0.57 μmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water.

Each g of Cordran® Ointment (Flurandrenolide Ointment, USP) contains 0.5 mg (1.145 μmol; 0.05%) or 0.25 mg (0.57 μmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum.

Cordran is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Topical corticosteroids are generally applied to the affected area as a thin film 1 to 4 times daily, depending on the severity of the condition.

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.

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 instituted.

Use With Occlusive Dressings

The technique of occlusive dressings (for management of psoriasis and other persistent dermatoses) is as follows:

1. Remove as much as possible of the superficial scaling before applying Cordran SP Cream or Cordran Ointment. Soaking in a bath will help soften the scales and permit easier removal by brushing, picking, or rubbing.
2. Rub Cordran SP Cream or Cordran Ointment thoroughly into the affected areas.
3. Cover with an occlusive plastic film, such as polyethylene, Saran™ Wrap, or Handi-Wrap®. (When Cordran SP Cream is used, added moisture may be provided by placing a slightly dampened cloth or gauze over the lesion before the plastic film is applied.)
4. Seal the edges to adjacent normal skin with tape or hold in place by a gauze wrapping.
5. For convenience, the patient may remove the dressing during the day. The dressing should then be reapplied each night.
6. For daytime therapy, the condition may be treated by rubbing Cordran SP Cream or Cordran Ointment sparingly into the affected areas.
7. In more resistant cases, leaving the dressing in place for 3 to 4 days at a time may result in a better response.
8. Thin polyethylene gloves are suitable for treatment of the hands and fingers; plastic garment bags may be utilized for treating lesions on the trunk or buttocks. A tight shower cap is useful in treating lesions on the scalp.

Occlusive Dressings Have the Following Advantages-

1. Percutaneous penetration of the corticosteroid is enhanced.
2. Medication is concentrated on the areas of skin where it is most needed.
3. This method of administration frequently is more effective in very resistant dermatoses than is the conventional application of Cordran.

Precautions to Be Observed in Therapy With Occlusive Dressings-Treatment should be continued for at least a few days after clearing of the lesions. If it is stopped too soon, a relapse may occur. Reinstitution of treatment frequently will cause remission.

Because of the increased hazard of secondary infection from resistant strains of staphylococci among hospitalized patients, it is suggested that the use of occlusive plastic films for corticosteroid therapy in such cases be restricted.

Generally, occlusive dressings should not be used on weeping, or exudative, lesions.

When large areas of the body are covered, thermal homeostasis may be impaired. If elevation of body temperature occurs, use of the occlusive dressing should be discontinued.

Rarely, a patient may develop miliaria, folliculitis, or a sensitivity to either the particular dressing material or a combination of Cordran and the occlusive dressing. If miliaria or folliculitis occurs, use of the occlusive dressing should be discontinued. Treatment by inunction with a corticosteroid such as Cordran may be continued. If the sensitivity is caused by the particular material of the dressing, substitution of a different material may be tried.

Warnings-Some plastic films are readily flammable. Patients should be cautioned against the use of any such material.

When plastic films are used on pediatric patients, the persons caring for the patients must be reminded of the danger of suffocation if the plastic material accidentally covers the face.

Cream:

0.025%, 30 g, NDC 16110-034-30; 60 g, NDC 16110-034-60
0.05%, 15 g, NDC 16110-035-15; 30 g, NDC 16110-035-30;
60 g, NDC 16110-035-60

Ointment:

0.025%, 30 g, NDC 16110-024-30; 60 g, NDC 16110-024-60
0.05%, 15 g, NDC 16110-026-15; 30 g, NDC 16110-026-30;
60 g, NDC 16110-026-60

Store at controlled room temperature, 59°-86°F (15°-30°C).

Marketed by: Aqua Pharmaceuticals, LLC Malvern, PA 19355. Under License from: Oclassen Dermatologics, A Division of Watson Pharma, Inc. Corona, CA 92880, USA. Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215. FDA revision date: 7/17/2002

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 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 upon 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.

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.

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.

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 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.

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.

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

(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.

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. Apply a thin film of medication to the affected area and gently rub in, usually 2-3 times a day or as directed by your doctor. Do not bandage, cover or 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. When applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting this medication in the nose or mouth. If you get the medication in your eyes, nose, or mouth, rinse with plenty of water.

Use this medication only for the condition prescribed.

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 first applied to the skin. This 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, excessive 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 unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 or 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 steroid excess. Though it is unlikely to occur with topical corticosteroids, 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.

This medication should be used only when clearly needed during pregnancy. 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 healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. 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: oral corticosteroids (e.g., prednisone), other topical corticosteroids (e.g., hydrocortisone), drugs that suppress 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: If 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. Canadian residents should call their local poison control center directly. This medication may be harmful if swallowed.

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

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, apply it over large areas of the body, or bandage/wrap the treated areas. Consult your doctor for more details.

Inform all your doctors 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 may cause complications in a medical emergency. For enrollment information 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.