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). |
| Molecular Weight | 362.46 |
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 | Corticosteroids including hydrocortisone are associated with a small increased risk of oral clefts (absolute risk <0.1%). Use only if clearly needed. |
| 2nd trimester | May be used for maternal conditions such as asthma exacerbation or collagen vascular disease. Monitor for preterm labor and intrauterine growth restriction. |
| 3rd trimester | High doses near term may cause neonatal adrenal suppression. Use lowest effective dose. |
Clinical note
Comprehensive clinical and safety monograph for CORTEF (CORTEF).
| Placental transfer | Hydrocortisone crosses the placenta with a maternal to fetal ratio of about 0.5. Approximately 67% is metabolized by placental 11β-HSD2. |
| Breastfeeding | Hydrocortisone is excreted in breast milk in small amounts. Doses up to 20 mg/day are generally considered compatible with breastfeeding. Use lowest effective dose and monitor infant for growth and development. |
■ FDA Black Box Warning
None
| Serious Effects |
Systemic fungal infectionsAdministration of live or live-attenuated vaccines in patients receiving immunosuppressive dosesKnown hypersensitivity to hydrocortisone or any component
| 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 |
| Food/Dietary | Avoid grapefruit and grapefruit juice as they may alter drug metabolism. Limit sodium intake to reduce fluid retention and hypertension. Increase dietary potassium (bananas, oranges, spinach) to counteract hypokalemia. Take with food to minimize gastrointestinal irritation. |
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| Lactation Rating | L2 (Safer) |
| 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). |
| 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. |
| Clinical Pearls | Cortef (hydrocortisone) is a short-acting glucocorticoid used for replacement therapy in adrenal insufficiency. For stress dosing, oral hydrocortisone should be doubled or tripled during minor illness. Avoid abrupt discontinuation; taper dose gradually to prevent adrenal crisis. Monitor for signs of hypercortisolism, glucose intolerance, and osteoporosis with chronic use. |
| Patient Advice | Take with food or milk to reduce stomach upset. · Do not stop taking this medication suddenly; follow your doctor's tapering instructions. · Carry a medical alert card or wear a bracelet indicating you take corticosteroids. · Inform all healthcare providers that you are taking hydrocortisone. · Report any signs of infection (fever, sore throat), unusual weight gain, or mood changes. · Avoid live vaccines while on this medication. · Do not take without a prescription or share with others. |