HYDROCORTONE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HYDROCORTONE (HYDROCORTONE).
Hydrocortisone is a corticosteroid that binds to the glucocorticoid receptor, leading to anti-inflammatory and immunosuppressive effects by inhibiting phospholipase A2, reducing prostaglandin and leukotriene synthesis, and suppressing cytokine production.
| Metabolism | Hepatic via CYP3A4 and other microsomal enzymes; primarily metabolized by 11-beta-hydroxysteroid dehydrogenase and 5-alpha-reductase. |
| Excretion | Renal (primarily as inactive metabolites; <5% unchanged) and biliary/fecal (minor). |
| Half-life | Terminal elimination half-life: 1.5–2.5 hours (plasma), but biological half-life (duration of HPA axis suppression) is 8–12 hours. |
| Protein binding | ~90% bound to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | 0.3–0.5 L/kg; distributes widely into tissues, with high penetration into CSF. |
| Bioavailability | Oral: ~96% (rapid and complete); IM: 100% (by definition). |
| Onset of Action | IV: immediate (minutes); IM: 1–2 hours; oral: 1–2 hours; topical: variable (hours to days). |
| Duration of Action | Duration of HPA suppression: 8–12 hours after a single dose; clinical anti-inflammatory effects persist 24–48 hours. |
100-500 mg intravenously every 2-6 hours for initial management of adrenal insufficiency; oral maintenance: 20-30 mg daily in divided doses (e.g., 10 mg morning, 5 mg afternoon).
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for renal impairment. Not removed by hemodialysis. |
| Liver impairment | Child-Pugh Class A: no adjustment; Class B: reduce dose by 50%; Class C: reduce dose by 60% or consider alternative. |
| Pediatric use | Adrenal insufficiency: oral 8-10 mg/m²/day in 3 divided doses; IV/IM: 1-2 mg/kg/dose every 6-8 hours. Status asthmaticus: IV 4-8 mg/kg/day divided every 6 hours. |
| Geriatric use | Start at lowest effective dose (e.g., 10-15 mg/day oral). Monitor for hyperglycemia, hypertension, osteoporosis. Use lower initial doses due to increased risk of adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HYDROCORTONE (HYDROCORTONE).
| Breastfeeding | HYDROCORTONE is excreted into breast milk in low concentrations. M/P ratio is approximately 0.25 for hydrocortisone. Doses up to 40 mg daily are considered compatible with breastfeeding; higher doses may require monitoring for infant adrenal suppression. Use lowest effective dose. |
| Teratogenic Risk | Corticosteroids including HYDROCORTONE are associated with a small increased risk of cleft palate (first trimester), fetal growth restriction, and adrenal suppression in neonates with prolonged maternal use. Second/third trimester use may cause fetal adrenal suppression but no specific malformation pattern. Risk must be weighed against maternal benefit. |
■ FDA Black Box Warning
None
| Serious Effects |
Systemic fungal infections, administration of live virus vaccines, idiopathic thrombocytopenic purpura (IM use), hypersensitivity to hydrocortisone.
| Precautions | Adrenal suppression, increased susceptibility to infections, masking of infection, Cushing's syndrome, osteoporosis, cataracts, glaucoma, hypertension, hypokalemia, growth retardation in children, and neuropsychiatric effects. |
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| Fetal Monitoring | Monitor maternal blood pressure, blood glucose (especially in diabetics), and signs of infection. Fetal growth should be assessed via ultrasound if prolonged use. Neonates exposed in utero should be monitored for adrenal insufficiency (e.g., hypoglycemia, hypotension) after birth. |
| Fertility Effects | Chronic high-dose corticosteroids may suppress endogenous cortisol, leading to oligomenorrhea or amenorrhea due to hypothalamic-pituitary-adrenal axis suppression. Effects are usually reversible upon dose reduction or discontinuation. No direct negative impact on fertility at typical therapeutic doses. |