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. |
| Molecular Weight | 362.46 |
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 | Corticosteroids are generally avoided in first trimester unless benefit outweighs risk. Topical hydrocortisone (low potency) may be used sparingly. Systemic use associated with orofacial clefts (odds ratio ~3.4). |
| 2nd trimester | Use cautiously; increased risk of gestational diabetes, hypertension, and fetal growth restriction with prolonged systemic use. Topical low-potency agents preferred. |
| 3rd trimester | Use only if clearly needed; systemic corticosteroids may cause adrenal suppression in neonate. Avoid high-potency topical agents on large areas or occluded skin. |
Clinical note
Comprehensive clinical and safety monograph for CORT-DOME (CORT-DOME).
| Placental transfer | Hydrocortisone crosses the placenta; placental metabolism reduces fetal exposure to about 10-15% of maternal levels. High doses may exceed placental capacity. |
| Breastfeeding | Topical hydrocortisone is considered compatible with breastfeeding; systemic absorption minimal. Avoid application to breast or nipple area to prevent infant ingestion. With systemic administration, use lowest effective dose; monitor infant for growth and adrenal suppression. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to hydrocortisone or any componentUntreated bacterial, fungal, or viral skin infections (for topical use)Intranasal application (not applicable)Systemic fungal infections (for systemic use)
| 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. |
| Food/Dietary | No known significant food interactions. Avoid alcohol if causing flushing or irritation of skin condition. |
Loading safety data…
| Lactation Rating | L2: Safer (topical). L3: Moderately Safe (systemic short-term). |
| 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. |
| 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. |
| Clinical Pearls | CORT-DOME (hydrocortisone acetate) is a topical corticosteroid with mild potency. Avoid prolonged use on face, groin, or axillae to prevent skin atrophy. Use for no longer than 2 weeks on intertriginous areas. Not for use on broken skin or infected lesions unless concurrent antifungal/antibacterial therapy is provided. |
| Patient Advice | Apply a thin layer to affected area only. Do not use on face or groin without physician approval. Avoid contact with eyes. Do not bandage or cover unless directed. Wash hands after application unless treating hands. Notify your doctor if no improvement in 2 weeks or if condition worsens. |