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Flurandrenolide (Fludroxycortide): Drug information

Flurandrenolide (Fludroxycortide): Drug information
(For additional information see "Flurandrenolide (Fludroxycortide): Patient drug information" and see "Flurandrenolide (Fludroxycortide): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cordran;
  • Nolix [DSC]
Pharmacologic Category
  • Corticosteroid, Topical
Dosing: Adult
Corticosteroid-responsive dermatoses

Corticosteroid-responsive dermatoses: Topical: Note: Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Cream, lotion, ointment: Apply thin film to affected area 2 to 3 times daily.

Tape: Apply 1 to 2 times daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Flurandrenolide (Fludroxycortide): Pediatric drug information")

Note: Dosage should be based on severity of disease and patient response; use smallest amount for shortest period of time to avoid hypothalamic-pituitary-adrenal axis suppression. If no improvement is seen within 2 weeks of therapy initiation, reassessment of diagnosis may be necessary. Therapy should be discontinued when control is achieved.

Dermatoses

Dermatoses (steroid-responsive, including contact/atopic dermatitis):

Infants, Children, and Adolescents: Topical:

Cream, lotion, ointment: Apply small quantity or thin film 2 to 3 times daily.

Tape: Apply 1 to 2 times daily; particularly useful on dry, scaling localized lesions.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Central nervous system: Burning sensation

Dermatologic: Acne vulgaris, acneiform eruptions, allergic contact dermatitis, atrophic striae, folliculitis, hypopigmentation, hypertrichosis, maceration of the skin, miliaria, perioral dermatitis, pruritus, skin atrophy, xeroderma

Infection: Secondary infection

Local: Local irritation

Postmarketing and/or case reports: Hypersensitivity, skin discoloration

Contraindications

Hypersensitivity to flurandrenolide or any component of the formulation; lesions exuding serum or in intertriginous areas (tape)

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Patients receiving large doses of potent topical steroids should be periodically evaluated for HPA axis suppression using urinary free cortisol and ACTH stimulation tests. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully by reducing the frequency of application or substitution of a less potent steroid. Recovery is usually prompt and complete upon drug discontinuation, but may require supplemental systemic corticosteroids if signs and symptoms of steroid withdrawal occur.

• Contact dermatitis: Allergic contact dermatitis can occur and it is usually diagnosed by failure to heal rather than clinical exacerbation; discontinue if dermatological infection persists despite appropriate antimicrobial therapy (Del Ross, 2005).

• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.

Disease-related concerns:

• Skin infections: Use appropriate antibacterial or antifungal agents to treat concomitant skin infections; discontinue flurandrenolide treatment if infection does not resolve promptly.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Tape: Most effective for dry, scaling, localized lesions

Special populations:

• Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.

Other warnings/precautions:

• Appropriate use: Avoid contact with eyes; generally not for routine use on the face, underarms, or groin area (including diaper area). Avoid use with occlusive dressing (including tight-fitting diapers or plastic pants) unless directed by a health care provider. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Cordran: 0.025% (120 g [DSC]); 0.05% (120 g) [contains cetyl alcohol, propylene glycol]

Nolix: 0.05% (60 g [DSC]) [contains cetyl alcohol, propylene glycol]

Generic: 0.05% (60 g [DSC], 120 g)

Lotion, External:

Cordran: 0.05% (120 mL) [contains benzyl alcohol, cetyl alcohol, menthol]

Nolix: 0.05% (120 mL [DSC]) [contains benzyl alcohol, cetyl alcohol, menthol]

Generic: 0.05% (120 mL)

Ointment, External:

Cordran: 0.05% (60 g [DSC]) [contains cetyl alcohol]

Generic: 0.05% (60 g [DSC])

Tape, External:

Cordran: 4 mcg/cm2 (1 ea)

Generic Equivalent Available: US

May be product dependent

Pricing: US

Cream (Cordran External)

0.05% (per gram): $12.99

Cream (Flurandrenolide External)

0.05% (per gram): $8.25

Lotion (Cordran External)

0.05% (per mL): $12.99

Lotion (Flurandrenolide External)

0.05% (per mL): $3.00

Tape (Cordran External)

4 mcg/cm2 (per each): $982.67

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Cream, lotion, ointment: For external use only. Apply a thin film to clean, dry skin and rub in gently. Avoid contact with eyes; generally not for routine use on the face, underarms, or groin area. Use of occlusive dressings is not recommended unless directed by a healthcare provider. Shake lotion well before use.

Tape: Apply to clean, dry skin (allow skin to dry 1 hour before applying new tape). Remove scales, crusts, dried exudates, and previously used ointments or creams from areas to be covered, use a germicidal soap or cleanser to prevent the development of odor under the tape. Shave or clip hair in the treatment area to promote adherence and easy removal. If a shower or bath is to be taken, it should be completed before the tape is applied and the skin should be dry prior to application of the tape. Keep skin smooth and press into place. Do not tear tape; always cut. If tape ends loosen prematurely, they may be cut off and replaced with fresh tape. Use of occlusive dressings (including tight-fitting diapers or plastic pants) is not recommended unless used for management of psoriasis or recalcitrant conditions. Replacement of tape every 12 hours is best tolerated, but may be left in place for 24 hours if well tolerated. If necessary, may be used just at night and removed during the day.

Administration: Pediatric

Topical:

Cream, lotion, ointment: For external use only. Apply a thin film to clean, dry skin and rub in gently. Avoid contact with eyes; generally not for routine use on the face, underarms, or groin area. Use of occlusive dressings is not recommended unless directed by the health care provider. Do not use tight-fitting diapers or plastic pants on infants and children being treated in the diaper area. Shake lotion well before use.

Tape: For external use only. Apply to clean, dry skin (allow skin to dry 1 hour before applying new tape). Remove scales, crusts, dried exudates, and previously used ointments or creams from areas to be covered. Shave or clip hair in the treatment area to promote adherence and easy removal. If a shower or bath is to be taken, it should be completed before the tape is applied and the skin should be dry prior to application of the tape. Do not tear tape; always cut. Use of occlusive dressings (including tight-fitting diapers or plastic pants) is not recommended unless used for management of psoriasis or recalcitrant conditions. Replacement of tape every 12 hours is best tolerated, but tape may be left in place for 24 hours if it is well tolerated and adheres satisfactorily. May be used just at night and removed during the day.

Use: Labeled Indications

Corticosteroid-responsive dermatoses: Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Medication Safety Issues
Sound-alike/look-alike issues:

Cordran may be confused with Cardura, codeine, Cordarone

Pediatric patients: High-risk medication:

KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Topical corticosteroids may be used for the treatment of corticosteroid-responsive dermatosis, such as atopic dermatitis, in patients planning a pregnancy (Vestergaard 2019).

Pregnancy Considerations

Systemic bioavailability of topical corticosteroids is variable (eg, integrity of skin, use of occlusion) and may be further influenced by trimester of pregnancy (Chi 2017). In general, the use of topical corticosteroids is not associated with a significant risk of adverse pregnancy outcomes. However, there may be an increased risk of low birth-weight infants following maternal use of potent or very potent topical products, especially in high doses, although this risk is likely to be low (Andersson 2021; Chi 2015; Chi 2017).

When first-line treatments, such as emollients, are insufficient, topical corticosteroids may be used for the treatment of atopic dermatitis in pregnant patients (Vestergaard 2019). Topical corticosteroids are classified by potency; the medication and formulation (eg, cream, gel, and/or salt form) contribute to the potency classification (Oakley 2021; Stacey 2021; Tadicherla 2009). In general, use of the least potent product in limited amounts is recommended during pregnancy. Mild to moderate potency corticosteroids are preferred; potent to very potent topical corticosteroids should only be used as alternative therapy in limited amounts under obstetrical care. Pregnant patients should avoid application of topical corticosteroids to areas with high percutaneous absorption (eg, arm pit, skin folds, vulva) (Chi 2017), and caution should be used when applying to areas prone to striae formation (eg, abdomen, breast, thighs) (Vestergaard 2019).

Breastfeeding Considerations

It is not known if sufficient quantities of flurandrenolide are absorbed following topical administration to produce detectable amounts in breast milk. However, systemic corticosteroids are present in breast milk.

Although the manufacturer recommends that caution be used, topical corticosteroids are generally considered acceptable for use in patients who are breastfeeding (Butler 2014; WHO 2002).

Avoid application of topical corticosteroids to the nipple and areola area until breastfeeding ceases; hypertension was noted in a breastfed infant when a high-potency topical corticosteroid was applied to the nipple (AAD-NPF [Elmets 2021]; Butler 2014; Leachman 2006). If needed, apply topical corticosteroids immediately after breastfeeding then clean nipples prior to the next feeding (Vestergaard 2019).

Monitoring Parameters

If HPA axis suppression is suspected, evaluate patient using the following tests: ACTH stimulation test and urinary-free cortisol test; growth in children

Mechanism of Action

Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Flurandrenolide has intermediate range potency.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Adequate with intact skin; repeated applications lead to depot effects on skin, potentially resulting in enhanced percutaneous absorption. Absorption increased in inflamed skin or use of occlusive dressings.

Metabolism: Hepatic

Excretion: Urine; feces (small amounts)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BR) Brazil: Drenison;
  • (GB) United Kingdom: Haelan;
  • (IE) Ireland: Haelan;
  • (JP) Japan: Drenison;
  • (PE) Peru: Drenison;
  • (PR) Puerto Rico: Cordran | Flurandrenolide | Nolix;
  • (TH) Thailand: Drenison
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  3. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014;70(3):417.e1-10. doi:10.1016/j.jaad.2013.09.009 [PubMed 24528912]
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  6. Chi CC, Wang SH, Wojnarowska F, Kirtschig G, Davies E, Bennett C. Safety of topical corticosteroids in pregnancy. Cochrane Database Syst Rev. 2015;(10):CD007346. doi:10.1002/14651858.CD007346.pub3 [PubMed 26497573]
  7. Cordran Cream and Ointment (flurandrenolide) [prescribing information]. Exton, PA: Aqua Pharmaceuticals; May 2017.
  8. Cordran Tape (flurandrenolide) [prescribing information]. Exton, PA: Almirall, LLC; July 2019.
  9. Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021;84(2):432-470. doi:10.1016/j.jaad.2020.07.087 [PubMed 32738429]
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  20. World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. https://apps.who.int/iris/handle/10665/62435
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