CORTEF
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CORTEF (CORTEF).
Corticosteroid that binds to the glucocorticoid receptor, leading to altered gene expression and inhibition of inflammatory mediators such as prostaglandins and leukotrienes.
| Metabolism | Hepatic via CYP3A4 |
| Excretion | Renal (primarily as inactive metabolites, <5% unchanged); biliary/fecal (minor). |
| Half-life | Plasma terminal half-life: 1.5–2.5 hours (cortisol); duration of action: 8–12 hours due to intracellular effects. |
| Protein binding | 90% bound to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | 0.4–1.0 L/kg (distributes readily into tissues). |
| Bioavailability | Oral: ~60–70% (first-pass metabolism); IM: 100%. |
| Onset of Action | Intravenous: rapid (minutes); oral: 1–2 hours; intramuscular: 2–4 hours. |
| Duration of Action | 8–12 hours (HPA axis suppression lasts longer with chronic use). |
Hydrocortisone (Cortef) 10-30 mg orally 2-4 times daily; for anti-inflammatory effect: 20-240 mg orally daily in divided doses; for physiologic replacement: 20-30 mg orally daily in divided doses (e.g., 10 mg morning, 5 mg afternoon).
| Dosage form | INJECTABLE |
| Renal impairment | No specific GFR-based dose adjustment required; however, monitor for fluid retention in severe renal impairment. |
| Liver impairment | Child-Pugh Class A: no adjustment; Child-Pugh Class B: reduce dose by 50%; Child-Pugh Class C: reduce dose by 75% (due to decreased clearance of corticosteroids). |
| Pediatric use | Children: 0.5-0.75 mg/kg/day orally in divided doses every 6-8 hours; maximum 2-3 mg/kg/day; for physiologic replacement: 8-12 mg/m²/day orally in divided doses. |
| Geriatric use | Use lowest effective dose; monitor for osteoporosis, hyperglycemia, hypertension, and increased susceptibility to infections; consider dose reduction due to age-related decreased renal or hepatic function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CORTEF (CORTEF).
| Breastfeeding | Hydrocortisone is excreted into breast milk in small amounts; M/P ratio is approximately 0.25-0.5. At maternal doses up to 80 mg/day, the infant dose is estimated to be <10% of the maternal dose and unlikely to cause adrenal suppression. Use with caution; monitor infant for signs of adrenal suppression (e.g., poor feeding, hypoglycemia). |
| Teratogenic Risk | Corticosteroids including hydrocortisone (Cortef) are generally considered to have a low teratogenic risk in humans. First trimester exposure: No consistent association with major congenital malformations; a small increased risk of oral clefts has been reported in some studies (absolute risk increase ~0.1%). Second/third trimester exposure: Potential for fetal adrenal suppression, intrauterine growth restriction (IUGR), and preterm birth; chronic high doses may increase risk of preterm premature rupture of membranes (PPROM). |
■ FDA Black Box Warning
None
| Serious Effects |
["Systemic fungal infections","Hypersensitivity to corticosteroids","Administration of live or live attenuated vaccines"]
| Precautions | ["Immunosuppression and increased risk of infection","Adrenal suppression with prolonged use","Cushing's syndrome with high doses","Osteoporosis with long-term use","Growth suppression in children","Increased intraocular pressure and glaucoma","Exacerbation of diabetes mellitus","Withdrawal syndrome upon abrupt discontinuation"] |
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| Fetal Monitoring | Maternal: Blood pressure, blood glucose, signs of infection, weight gain, bone density if long-term use. Fetal: Ultrasound for growth restriction (every 4-6 weeks) if chronic use; monitor for preterm labor. Neonatal: Assess for adrenal suppression if maternal dose >20 mg/day for >3 weeks before delivery. |
| Fertility Effects | High-dose or prolonged corticosteroid use may cause menstrual irregularities and suppress ovulation, potentially impairing fertility. However, at typical replacement doses (e.g., for adrenal insufficiency), fertility is not significantly affected. Reversible upon dose reduction or discontinuation. |