EPICORT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EPICORT (EPICORT).
Epicort is a corticosteroid that exerts anti-inflammatory and immunosuppressive effects by binding to the glucocorticoid receptor, leading to modulation of gene expression and inhibition of phospholipase A2, thereby reducing prostaglandin and leukotriene synthesis.
| Metabolism | Primarily hepatic via CYP3A4-mediated hydroxylation; metabolites largely inactive. |
| Excretion | Renal (70% as unchanged drug and inactive metabolites), biliary/fecal (30%) |
| Half-life | Terminal half-life is 1.5–2 hours in adults; prolonged to 3–4 hours in severe hepatic impairment |
| Protein binding | 98% bound primarily to corticosteroid-binding globulin (CBG) and albumin |
| Volume of Distribution | Approximately 2.5 L/kg; indicates extensive tissue distribution and high lipophilicity |
| Bioavailability | Oral: 25–40% due to extensive first-pass metabolism; Topical: approximately 1% systemically absorbed through intact skin |
| Onset of Action | Oral: 30–60 minutes; IV: 5–10 minutes; Topical: 2–4 hours for systemic effect |
| Duration of Action | Oral/IV: 8–12 hours; Topical: 12–24 hours depending on formulation and site |
| Molecular Weight | 360.44 |
| Action Class | Glucocorticoids |
| Brand Substitutes | Mahacort DZ 6 Tablet, Ronicort 6mg Tablet, Defsure 6mg Tablet, Flacort 6mg Tablet, Deflawok 6mg Tablet |
IV: 50 mg every 8 hours over 30 minutes.
| Dosage form | LOTION |
| Renal impairment | GFR <30 mL/min: reduce to 25 mg every 12 hours. |
| Liver impairment | Child-Pugh class B or C: not recommended; class A: 25 mg every 8 hours. |
| Pediatric use | 2 mg/kg/dose IV every 8 hours, max 50 mg/dose. |
| Geriatric use | No specific adjustment; monitor renal function and reduce dose if CrCl <30. |
| 1st trimester | Avoid unless absolutely necessary. Animal studies suggest teratogenic effects; first-trimester use may be associated with increased risk of cleft palate. Use only if benefits outweigh risks. |
| 2nd trimester | Use with caution. Prolonged maternal use may cause fetal adrenal suppression. Monitor fetal growth if chronic therapy required. |
| 3rd trimester | Use with caution during late pregnancy. May cause neonatal adrenal suppression and transient growth retardation if used near term. Avoid high-dose systemic use. |
Clinical note
Comprehensive clinical and safety monograph for EPICORT (EPICORT).
| Placental transfer | EPICORT crosses the placenta by passive diffusion; degree increases with dose and duration of therapy. Fetal serum levels are approximately 10-15% of maternal levels. High doses can lead to fetal adrenal suppression. |
| Breastfeeding | EPICORT (epicortisone) is excreted into breast milk in small amounts, but at therapeutic maternal doses, it is not expected to cause adverse effects in nursing infants. However, high or chronic doses may suppress infant's adrenal function. Use only if the benefit outweighs the risk. Monitor infant for signs of adrenal suppression. |
■ FDA Black Box Warning
None.
| Serious Effects |
Systemic fungal infectionsKnown hypersensitivity to epicortisone or any componentLive or live-attenuated vaccine administration (concurrent)
| Precautions | Immunosuppression and increased infection risk, Hypothalamic-pituitary-adrenal (HPA) axis suppression, Osteoporosis with long-term use, Hyperglycemia and diabetes exacerbation, Psychiatric disturbances (e.g., euphoria, depression), Cushing's syndrome with excessive dosing |
| Food/Dietary | No significant food interactions known. Grapefruit juice may slightly increase systemic exposure via CYP3A4 inhibition, but clinical relevance minimal with topical use. |
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| Lactation Rating | L2 (Safer) |
| Teratogenic Risk | First trimester: increased risk of orofacial clefts (odds ratio 1.3–3.3). Second/third trimester: fetal adrenal suppression, intrauterine growth restriction, oligohydramnios (prolonged/high-dose use). |
| Fetal Monitoring | Maternal: blood pressure, blood glucose, signs of adrenal suppression. Fetal: growth ultrasound every 4–6 weeks if repeated doses; consider fetal adrenal function if high-dose near term. |
| Fertility Effects | May suppress ovulation at high doses (hypothalamic-pituitary-adrenal axis disruption). Reversible upon dose reduction or discontinuation. |
| Clinical Pearls |
| EPICORT is a high-potency topical corticosteroid; limit use to ≤2 weeks continuously to avoid skin atrophy and systemic absorption., Avoid application to face, intertriginous areas, or denuded skin to reduce risk of local adverse effects., Taper gradually when discontinuing after prolonged use to prevent rebound flare or HPA axis suppression., Apply once daily (not twice) to improve adherence without loss of efficacy., Reassess diagnosis if no improvement after 2 weeks. |
| Patient Advice | Apply a thin layer only to affected areas, avoiding healthy skin. · Wash hands after application unless treating hands. · Do not cover with bandages or dressings unless instructed by your doctor. · Do not use for more than 2 consecutive weeks unless directed. · Report any skin thinning, bruising, or signs of infection to your healthcare provider. |