CORTAN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CORTAN (CORTAN).
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 to inactive metabolites. |
| Excretion | Renal: 80% as metabolites and unchanged drug; biliary/fecal: 20% |
| Half-life | Terminal elimination half-life 1.5–2 hours; clinical context: short duration requires multiple daily doses for sustained effect |
| Protein binding | 90–95% bound to albumin and corticosteroid-binding globulin (CBG) |
| Volume of Distribution | 0.4–0.7 L/kg; distributes into total body water, with higher volume in obesity |
| Bioavailability | Oral: 70–90%; intramuscular: 100% |
| Onset of Action | Oral: 30–60 minutes; intravenous: 15–30 minutes; intramuscular: 1–2 hours |
| Duration of Action | 8–12 hours depending on dose; clinical note: anti-inflammatory effects persist longer than analgesic effects |
5-60 mg orally once daily, titrated to the lowest effective dose. Maintenance: 5-20 mg daily.
| Dosage form | TABLET |
| Renal impairment | No adjustment needed; hydrocortisone is not significantly excreted renally. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B/C: reduce dose by 50% due to impaired clearance. |
| Pediatric use | Neonates: 1-2 mg/kg IV/IM every 6-8 hours. Children: 0.5-0.75 mg/kg/day orally in divided doses every 8 hours. |
| Geriatric use | Initiate at the low end of dosing range (5-10 mg daily) due to increased risk of osteoporosis and hyperglycemia; monitor bone density and glucose. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CORTAN (CORTAN).
| Breastfeeding | Cortisol is present in breast milk; M/P ratio unknown. No evidence of harm at maternal physiologic doses. Pharmacologic doses >20 mg/day may suppress infant adrenal function. Caution advised. |
| Teratogenic Risk | First trimester: Increased risk of orofacial clefts (odds ratio ~1.3-1.5). Second/third trimesters: Fetal adrenal suppression, intrauterine growth restriction, premature birth. Use only if benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
Corticosteroids can cause immunosuppression, increasing susceptibility to infections. Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses.
| Serious Effects |
Systemic fungal infections, known hypersensitivity to any component, and administration of live or live attenuated vaccines in immunosuppressed patients.
| Precautions | Monitor for hypercorticism (Cushing's syndrome), adrenal suppression, osteoporosis, glaucoma, and growth suppression in children. Use with caution in patients with diabetes, hypertension, or peptic ulcer disease. |
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| Monitor blood pressure, blood glucose, fundal height, fetal growth ultrasound every 4-6 weeks. Assess for signs of infection. Fetal heart rate monitoring as indicated. |
| Fertility Effects | No direct impairment. However, underlying disease (e.g., autoimmune) may affect fertility. Cessation of therapy for disease control may be required. |