Cordran

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Cordran

Classes

Plain Topical Corticosteroids

Administration
Topical Administration

All flurandrenolide products are for topical/external use. Avoid direct contact with conjunctival tissue and mucus membranes.

Cream/Ointment/Lotion Formulations

Cream or ointment: Apply furandrenolide sparingly in a thin film and rub gently. Until the medication has dried, protect area from washing, clothing, or rubbing.
Lotion: For hairy areas, part the hair and apply a small amount of flurandrenolide to the affected area; rub in gently. Hair may be washed as usual but not immediately after applying the medication. Avoid direct contact to the eyes or mucus membranes.

Other Topical Formulations

Tape: Apply the flurandrenolide tape to clean, dry areas. Remove tape from the package and cut a piece of tape slightly larger than the area that is to be covered. Round off the tape corners before application. Pull white paper away from the transparent tape. Press tape into place while keeping the skin smooth.

Adverse Reactions
Severe

skin atrophy / Delayed / Incidence not known
increased intracranial pressure / Early / Incidence not known
papilledema / Delayed / Incidence not known
visual impairment / Early / Incidence not known
ocular hypertension / Delayed / Incidence not known

Moderate

erythema / Early / 1.0-10.0
withdrawal / Early / Incidence not known
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
hypertension / Early / Incidence not known
hyperglycemia / Delayed / Incidence not known
pseudotumor cerebri / Delayed / Incidence not known
growth inhibition / Delayed / Incidence not known
glycosuria / Early / Incidence not known
adrenocortical insufficiency / Delayed / Incidence not known
Cushing's syndrome / Delayed / Incidence not known
cataracts / Delayed / Incidence not known
impaired wound healing / Delayed / Incidence not known
skin ulcer / Delayed / Incidence not known
tolerance / Delayed / Incidence not known
contact dermatitis / Delayed / Incidence not known

Mild

pruritus / Rapid / 1.0-10.0
skin irritation / Early / 1.0-10.0
xerosis / Delayed / 1.0-10.0
maculopapular rash / Early / 1.0-10.0
infection / Delayed / Incidence not known
miliaria / Delayed / Incidence not known
purpura / Delayed / Incidence not known
skin hypopigmentation / Delayed / Incidence not known
acneiform rash / Delayed / Incidence not known
hypertrichosis / Delayed / Incidence not known
folliculitis / Delayed / Incidence not known
telangiectasia / Delayed / Incidence not known
striae / Delayed / Incidence not known
headache / Early / Incidence not known

Common Brand Names

Cordran, Cordran SP, Cordran Tape, Nolix

Dea Class

Rx

Description

Topical low- to medium-potency fluorinated corticosteroid; products of less than 0.25% are low potency
Used for corticosteroid-responsive dermatoses
Impregnated tape useful for occlusive therapy in small areas

Dosage And Indications
For the treatment of corticosteroid-responsive dermatoses, including atopic dermatitis, localized vitiligo, eczema, phimosis, lichen planus, and localized bullous pemphigoid. Topical dosage (lotion, cream, or ointment) Adults

Apply a thin layer topically to the affected skin area(s) 2 to 3 times daily. If no response is seen within 2 weeks, reassess treatment options.

Children and Adolescents

Apply a thin layer topically to the affected skin area(s) 2 to 3 times daily. If no response is seen within 2 weeks, reassess treatment options.

Topical dosage (tape) Adults

Apply topically to the affected skin area(s) every 12 to 24 hours.

Children and Adolescents

Apply topically to the affected skin area(s) every 12 to 24 hours.

For the treatment of psoriasis. Topical dosage (cream, ointment, or lotion) Adults

Apply topically to the affected skin area(s) 2 to 3 times daily. If no improvement is seen within 2 weeks, reassess diagnosis. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 5 topical corticosteroids for up to 4 weeks for plaque psoriasis not involving intertriginous areas and class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.

Children and Adolescents

Apply topically to the affected skin area(s) 2 to 3 times daily. If no response is seen within 2 weeks, reassess diagnosis. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

Topical dosage (tape) Adults


Apply topically to the affected skin area(s) every 12 to 24 hours. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 5 topical corticosteroids for up to 4 weeks for plaque psoriasis not involving intertriginous areas and class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.

Children and Adolescents


Apply topically to the affected skin area(s) every 12 to 24 hours. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

Metyrapone: (Major) Medications which affect pituitary or adrenocortical function, including all corticosteroid therapy, should be discontinued prior to and during testing with metyrapone. Patients taking inadvertent doses of corticosteroids on the test day may exhibit abnormally high basal plasma cortisol levels and a decreased response to the test. Although systemic absorption of topical corticosteroids is minimal, temporary discontinuation of these products should be considered if possible to reduce the potential for interference with the test results.

How Supplied

Cordran Tape Topical Tape: 4mcg
Cordran/Cordran SP/Flurandrenolide/Nolix Topical Cream: 0.025%, 0.05%
Cordran/Flurandrenolide Topical Ointment: 0.05%
Cordran/Flurandrenolide/Nolix Topical Lotion: 0.05%

Maximum Dosage

NOTE: In general, corticosteroid dosage must be individualized and is highly variable depending on the nature and severity of the disease, dosage form used, and on patient age and response. The area of skin where flurandrenolide is applied should be limited.

Adults

3 applications/day topically.

Elderly

3 applications/day topically.

Adolescents

3 applications/day topically.

Children

3 applications/day topically.

Mechanism Of Action

Topical corticosteroids exhibit anti-inflammatory, antipruritic, and vasoconstrictive properties. At the cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, keloid (scar) formation also are inhibited by corticosteroids. Clinically, these actions correspond to decreased edema, erythema, pruritus, plaque formation and scaling of the affected skin.

Pharmacokinetics

Flurandrenolide is applied topically.  Corticosteroids are bound to plasma proteins in varying degrees. They are metabolized primarily in the liver and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Topical Route

Percutaneous flurandrenolide absorption is dependent on many factors including the vehicle, integrity of the epidermal barrier, use of occlusive dressings, and location of drug administration on the body. Once corticosteroids are absorbed through the skin, they undergo pharmacokinetic pathways similar to systemically administered corticosteroids.

Pregnancy And Lactation
Pregnancy

There are no adequate and well-controlled studies of topical application of flurandrenolide during pregnancy. Topical corticosteroids, including flurandrenolide, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Guidelines recommend mild to moderate potency agents over potent corticosteroids, which should be used in short durations. Fetal growth restriction and a significantly increased risk of low birthweight has been reported with use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than 300 grams. 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.

According to the manufacturer, it is not known whether topical administration of flurandrenolide could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, most dermatologists stress that topical corticosteroids can be safely used during lactation and breast-feeding. If applied topically, care should be used to ensure the infant will not come into direct contact with the area of application, such as the breast. Increased blood pressure has been reported in an infant whose mother applied a high potency topical corticosteroid ointment directly to the nipples. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.