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Urea and hydrocortisone: Drug information

Urea and hydrocortisone: Drug information
(For additional information see "Urea and hydrocortisone: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • U-Cort [DSC]
Brand Names: Canada
  • Ti-U-Lac® H;
  • Uremol® HC
Pharmacologic Category
  • Corticosteroid, Topical
Dosing: Adult
Steroid-responsive dermatoses

Steroid-responsive dermatoses: Topical: Apply thin film and rub in well 2-4 times/day. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

Refer to adult dosing.

Adverse Reactions

See individual agents.

Contraindications

Hypersensitivity to urea, hydrocortisone, or any components of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Systemic absorption of topical corticosteroids 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.

• Immunosuppression: Prolonged use may result in fungal or bacterial superinfection; discontinue if dermatological infection persists despite appropriate antimicrobial therapy.

• Sensitization: Topical use has been associated with local sensitization (redness, irritation); discontinue if sensitization is noted.

• 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.

Special populations:

• Pediatric: Children may absorb proportionally larger amounts of corticosteroids 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.

Dosage form specific issues:

• Sulfite: May contain sodium metabisulfate; use caution in patients with sulfite allergy.

Dosage Forms: US

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

Cream, topical:

U-Cort: Urea 10% and hydrocortisone acetate 1% (28 g [DSC])

Generic Equivalent Available: US

No

Pricing: US

Cream (U-Cort External)

1-10% (28.35 g): $35.65

Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for reimbursement or purchasing functions. Pricing data is updated monthly.

Administration: Adult

Occlusive dressings may be used during treatment of psoriasis or recalcitrant conditions; discontinue use of occlusive dressings if infection develops.

Administration: Pediatric

Topical: Apply thin film to affected area(s); may use occlusive dressings during treatment of psoriasis or recalcitrant conditions; discontinue use of occlusive dressings if infection develops.

Use: Labeled Indications

Inflammation of corticosteroid-responsive dermatoses

Medication Safety Issues
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

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Calcipotriene: Hydrocortisone (Topical) may diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with hydrocortisone valerate. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy

Pregnancy Considerations

Teratogenic effects have been observed in animals administered potent topical corticosteroids. Topical products are not recommended for extensive use, in large quantities, or for long periods of time in pregnant women.

Breastfeeding Considerations

It is not known if topical application will result in detectable quantities in breast milk.

Mechanism of Action

See individual agents.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

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

  • (BE) Belgium: Alphaderm;
  • (BG) Bulgaria: Keratolan H;
  • (CL) Chile: Hipoge-U;
  • (DE) Germany: Hydrodexan | Nubral 4 hc;
  • (FI) Finland: Calmuril hydrocort;
  • (GB) United Kingdom: Alphaderm | Sential | Sential k/p;
  • (HK) Hong Kong: Handlife;
  • (IE) Ireland: Alphaderm;
  • (MY) Malaysia: Ucort;
  • (NO) Norway: Hydrokortison med Karbamid;
  • (PR) Puerto Rico: Carmol hc | U-cort;
  • (SG) Singapore: Ucort;
  • (TR) Turkey: Ureacort;
  • (TW) Taiwan: Eureson | Fulicorn | Handlife | Humidy | Japison | Lifuzon | Sinpharderm HC | Ucort | Ueraly | Urealoe | Ureson | Yurea | Zenco | Zenfu
  1. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
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