DELTA-CORTEF
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DELTA-CORTEF (DELTA-CORTEF).
Glucocorticoid; binds to glucocorticoid receptors, modulating gene expression to suppress inflammation, immune response, and adrenal function.
| Metabolism | Primarily hepatic via CYP3A4. |
| Excretion | Renal: approximately 80-90% as unchanged drug and metabolites (primarily 20β-dihydrocortisone and other inactive conjugates); biliary/fecal: <10%. |
| Half-life | Terminal elimination half-life: 1.5-2.5 hours (mean ~2 hours) for prednisolone; clinical context: short-acting glucocorticoid, requires multiple daily dosing for sustained anti-inflammatory effect, adrenocortical suppression lasts approximately 1.25-1.5 days after discontinuation. |
| Protein binding | Prednisolone: 65-91% bound to corticosteroid-binding globulin (CBG, transcortin) and albumin; binding is dose-dependent and saturable. |
| Volume of Distribution | Vd: 0.5-1.5 L/kg; reflects extensive tissue distribution and penetration into intracellular compartments. |
| Bioavailability | Oral: 70-90%; IM: 80-100%; intra-articular: locally high, systemic absorption slow and incomplete; rectal: 30-50%. |
| Onset of Action | IV: immediate (minutes); oral: 1-2 hours; IM: 1-2 hours; intra-articular: 2-4 hours. |
| Duration of Action | Duration of anti-inflammatory effect: 12-36 hours; duration of HPA axis suppression: 1.25-1.5 days; clinical note: single dose effect may last up to 36 hours; repeated dosing may prolong effect. |
Prednisolone (DELTA-CORTEF) typical adult dose: 5-60 mg orally once daily or in divided doses, depending on condition. For acute exacerbations: 20-60 mg orally daily. Route: oral. Frequency: once daily or divided.
| Dosage form | TABLET |
| Renal impairment | No specific GFR-based dose adjustment required. Use with caution in severe renal impairment due to fluid retention risk. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B or C: consider dose reduction by 50% due to reduced clearance. |
| Pediatric use | Children: 0.5-2 mg/kg/day orally in divided doses every 6-12 hours, up to 60 mg/day. For acute asthma: 1-2 mg/kg/day, max 60 mg/day. |
| Geriatric use | Elderly: start at lowest effective dose; monitor for osteoporosis, hyperglycemia, and fluid retention. Consider calcium and vitamin D supplementation. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DELTA-CORTEF (DELTA-CORTEF).
| Breastfeeding | Prednisolone (active metabolite) excreted in breast milk; M/P ratio ~0.1-0.3. Low risk at maternal doses <40 mg/day. Avoid breastfeeding during high-dose therapy. |
| Teratogenic Risk | First trimester: Increased risk of oral clefts (odds ratio ~3.4). Second/third trimester: Fetal adrenal suppression, growth restriction, preterm birth. Risk is dose-dependent and cumulative. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Systemic fungal infections","Hypersensitivity to prednisolone or any component","Live or live attenuated vaccines (relative)"]
| Precautions | ["Immunosuppression and increased infection risk","Hypothalamic-pituitary-adrenal (HPA) axis suppression","Cushing's syndrome with prolonged use","Osteoporosis","Gastrointestinal perforation","Psychiatric disturbances","Exacerbation of diabetes mellitus","Hypertension"] |
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| Monitor maternal blood pressure, glucose tolerance, signs of infection. Fetal ultrasound for growth restriction and amniotic fluid volume. Assess for adrenal insufficiency in neonates. |
| Fertility Effects | No direct impairment of fertility. Chronic use may disrupt menstrual cycles or ovulation due to hypothalamic-pituitary-adrenal axis suppression. |