Cordran Lotion

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-[(l-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows:

Each mL of Cordran Lotion contains 0.5 mg (1.145 μmol) (0.05%) flurandrenolide in an oil-in-water emulsion base composed of glycerin, cetyl alcohol, stearic acid, glyceryl monostearate, mineral oil, polyoxyl 40 stearate, menthol, benzyl alcohol, and purified water.

Cordran® Lotion, 0.05% is supplied in plastic squeeze bottles as follows:

15 mL (NDC 16110-052-15);
60 mL (NDC 16110-052-60)
120 mL (NDC 16110-052-12)

Keep out of reach of children.

Storage

Avoid freezing. 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]

Marketed by: Aqua Pharmaceuticals, LLC, West Chester, PA 19380 USA. Under License from: Watson Laboratories, Inc. Corona, CA 92880 USA. Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 USA

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. Do not use Cordran Lotion on the face, underarms, or groin areas unless directed by your physician.
3. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
4. 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.
5. Patients should report any signs of local adverse reactions, especially under occlusive dressing.
6. 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.
7. If no improvement is seen within 2 weeks, contact your physician.
8. Do not use other corticosteroid-containing products while using Cordran Lotion without first consulting your physician.

Do not use flurandrenolide topical to treat any skin condition that has not been checked by your doctor.

Do not apply to your face, underarms, or groin area unless your doctor tells you to.

Avoid getting this medication in your eyes. If this does happen, rinse with water.

Avoid using other steroid medications on the areas you treat with flurandrenolide topical unless your doctor tells you to.

Your pharmacist can provide more information about flurandrenolide topical.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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• Allergy Drugs: Prescription and OTC
• Itch (Itching or Pruritus)

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.

Evaporation of water from the lotion vehicle produces a cooling effect, which is often desirable in the treatment of acutely inflamed or weeping lesions.

PharmacokineticsThe 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.

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.

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