CORT-DOME
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CORT-DOME (CORT-DOME).
Corticosteroid that binds to glucocorticoid receptors, modulating gene expression to suppress inflammation and immune responses, and inhibit phospholipase A2, reducing prostaglandin and leukotriene synthesis.
| Metabolism | Primarily hepatic via CYP3A4; undergoes phase I and phase II metabolism to inactive conjugates. |
| Excretion | Primarily hepatic metabolism; renal excretion of inactive metabolites accounts for approximately 40-60% of elimination; less than 5% excreted unchanged in urine; biliary/fecal elimination is minor (<5%). |
| Half-life | Plasma half-life is approximately 1-2 hours; biological half-life (duration of adrenal suppression) is 18-36 hours. |
| Protein binding | Approximately 90-95% bound to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | Apparent volume of distribution is approximately 0.3-0.5 L/kg for hydrocortisone; distributes widely into tissues, including skin. |
| Bioavailability | Topical: Absorption is minimal through intact skin (<1%) but can increase with inflammation or occlusion; oral: approximately 96% absorbed; intramuscular: 100% bioavailable. |
| Onset of Action | Topical: Onset of anti-inflammatory effect within 30-60 minutes; systemic (intramuscular) onset occurs within 1-2 hours. |
| Duration of Action | Topical: Duration of anti-inflammatory effect is 4-6 hours after application; systemic: duration of adrenal suppression up to 18-36 hours after a single dose. |
Hydrocortisone (Cort-Dome) typical adult dose: 100 mg intravenously or intramuscularly as a loading dose, followed by 50-100 mg intravenously every 6 hours for stress dosing; for replacement therapy: oral 20-30 mg daily in divided doses. Topical: apply sparingly to affected area 1-4 times daily.
| Dosage form | LOTION |
| Renal impairment | No specific dose adjustment based on GFR; however, use with caution in severe renal impairment due to potential fluid retention and electrolyte disturbances. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: consider dose reduction due to reduced clearance; Child-Pugh C: avoid or use with extreme caution. |
| Pediatric use | For acute adrenal insufficiency: 1-2 mg/kg intramuscularly or intravenously, then 50-100 mg/m²/day divided every 6 hours. Replacement: oral 10-20 mg/m²/day divided twice daily. Topical: apply sparingly; use low-potency agents in infants. |
| Geriatric use | Start at lowest recommended adult dose; monitor for osteoporosis, hypertension, glucose intolerance, and immune suppression. Consider shorter duration and taper. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CORT-DOME (CORT-DOME).
| Breastfeeding | Topical hydrocortisone is minimally excreted into breast milk. The M/P ratio is not well defined for topical formulations, but estimated systemic absorption is <1% of applied dose. Risk to nursing infant is considered low. Caution is advised if applied to large areas or under occlusive dressings. Avoid application to breast or nipple area to prevent direct infant ingestion. |
| Teratogenic Risk | Corticosteroids, including hydrocortisone (active ingredient in CORT-DOME), are associated with increased risk of cleft palate and intrauterine growth restriction (IUGR) when used systemically during the first trimester. Topical use, as with CORT-DOME, has lower systemic absorption but high-potency or prolonged use may still pose risks. During the second and third trimesters, chronic high-dose exposure may lead to fetal adrenal suppression and low birth weight. Overall, topical corticosteroids are considered low risk if used sparingly and for short durations. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Absolute: known hypersensitivity to any component of the formulation, untreated bacterial, fungal, viral (e.g., herpes simplex, vaccinia, varicella), or parasitic infections at the treatment site.","Relative: ocular herpes simplex, history of corticosteroid hypersensitivity, impaired immune function, pregnancy (topical use with caution, especially in first trimester)."]
| Precautions | ["Local irritation, allergic contact dermatitis, skin atrophy, striae, telangiectasias, and secondary infection.","Systemic absorption may cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia, and glycosuria.","Not for ophthalmic use; avoid on infected skin unless appropriate antimicrobial therapy is concurrent.","Use in children may lead to systemic toxicity, including growth retardation.","Prolonged use, large body surface area application, or occlusion increase systemic absorption."] |
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| Fetal Monitoring | No specific monitoring required for brief, low-potency topical use. For prolonged or high-potency use, monitor fetal growth (ultrasound) and maternal blood glucose. In neonates, monitor for signs of adrenal suppression if maternal use was extensive and protracted. |
| Fertility Effects | No significant effect on fertility reported with topical corticosteroids. Systemic corticosteroids may impair spermatogenesis and ovulatory function, but topical use is not expected to impact fertility. |