LOCORTEN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LOCORTEN (LOCORTEN).
Corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Binds to glucocorticoid receptors, modulating gene expression to inhibit prostaglandin and leukotriene synthesis, reduce cytokine release, and suppress immune cell activation.
| Metabolism | Primarily hepatic metabolism via cytochrome P450 enzymes (CYP3A4). |
| Excretion | Renal: ~75% (inactive metabolites); biliary/fecal: ~25%. <1% unchanged. |
| Half-life | 100 hours (terminal). Clinical context: prolonged in hepatic impairment; single daily dosing sufficient for psoriasis. |
| Protein binding | 99.7% bound to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | 1.4 L/kg. Clinical meaning: extensive tissue distribution, high peripheral binding. |
| Bioavailability | Topical: <1% (occluded: up to 3%). Oral: ~60% (not formulated orally). |
| Onset of Action | Topical: 24-48 hours for initial response in eczema. |
| Duration of Action | 24 hours (single application); effect persists for 48-72 hours due to high potency. |
For mild to moderate dermatoses: Apply a thin film to affected area twice daily. For severe dermatoses: Apply a thin film to affected area three to four times daily. Topical use only. Not for ophthalmic use.
| Dosage form | CREAM |
| Renal impairment | No dosage adjustment required for renal impairment due to minimal systemic absorption with topical use. |
| Liver impairment | No dosage adjustment required for hepatic impairment due to minimal systemic absorption with topical use. |
| Pediatric use | Children: Apply a thin film to affected area once or twice daily for no longer than 2 weeks. Avoid use in diaper area or under occlusive dressings due to increased absorption risk. Do not use in infants less than 2 years old unless directed by physician. |
| Geriatric use | Elderly: Use with caution due to increased risk of skin atrophy and systemic effects. Apply sparingly and for shortest duration necessary. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LOCORTEN (LOCORTEN).
| Breastfeeding | Clobetasone butyrate is excreted into breast milk in small amounts after topical application, with an estimated M/P ratio unknown. Systemic absorption is minimal with appropriate use, making significant infant exposure unlikely. However, caution is advised if applied to large areas or nipples; avoid application to breasts to prevent infant ingestion. Use the lowest effective dose for the shortest duration. |
| Teratogenic Risk | Topical corticosteroids, including clobetasone butyrate (Locorten), are generally considered low risk for teratogenicity when used at recommended doses. However, systemic absorption is possible with prolonged use on large areas, occluded areas, or damaged skin. In animal studies, corticosteroids have been shown to be teratogenic (cleft palate, intrauterine growth restriction). Human data are limited; risks in the first trimester are not well established, but theoretical risks exist. Second and third trimester use is generally safe if used sparingly; high potency or prolonged use may be associated with low birth weight. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
["Hypersensitivity to any component of the formulation","Untreated bacterial, fungal, or viral skin infections","Tuberculosis of the skin","Varicella (chickenpox) or vaccinia (cowpox)"]
| Precautions | ["Topical corticosteroids may cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression","Systemic absorption may manifest as Cushing's syndrome, hyperglycemia, or glucosuria","Use on large surface areas, occlusive dressings, or prolonged therapy increases risk","Local irritation, atrophy, striae, and telangiectasia may occur","Avoid use in perioral dermatitis, rosacea, or infected lesions unless appropriately treated"] |
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| Fetal Monitoring | No specific monitoring required for short-term topical use. For chronic or widespread use, monitor maternal blood pressure and blood glucose (steroid-induced effects). Monitor fetal growth if prolonged high-potency use occurs due to potential for intrauterine growth restriction. |
| Fertility Effects | No known adverse effects on fertility from topical corticosteroid use. Systemic corticosteroids can disrupt menstrual cycles and reduce sperm count, but topical application at recommended doses does not result in significant systemic levels to impact fertility. |