STERANE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for STERANE (STERANE).
Sterane (prednisolone) is a glucocorticoid that binds to the glucocorticoid receptor, leading to modulation of gene expression and suppression of inflammation by inhibiting phospholipase A2, reducing prostaglandin and leukotriene synthesis, and decreasing cytokine production.
| Metabolism | Primarily hepatic via CYP3A4; prednisolone is the active metabolite of prednisone. |
| Excretion | Renal (approximately 70% as unchanged drug and glucuronide conjugate), biliary/fecal (approximately 30%) |
| Half-life | Terminal elimination half-life is approximately 2.5 hours (range 2-3 hours) in adults with normal renal function; clinically, this supports twice-daily dosing |
| Protein binding | Approximately 95% bound, primarily to albumin and corticosteroid-binding globulin |
| Volume of Distribution | 0.5-1.0 L/kg; reflects moderate tissue penetration and distribution into extracellular fluid |
| Bioavailability | Oral: approximately 80% (range 70-90%) |
| Onset of Action | Oral: 30-60 minutes; Intravenous: 5-10 minutes |
| Duration of Action | Oral: 6-8 hours; Intravenous: 4-6 hours; clinical note: duration may be prolonged in hepatic impairment |
100 mg orally every 12 hours
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for GFR >30 mL/min. For GFR 10-30 mL/min: 100 mg every 24 hours. For GFR <10 mL/min: 100 mg every 48 hours. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: 50% of normal dose. Child-Pugh Class C: avoid use. |
| Pediatric use | 1.5 mg/kg orally every 12 hours, maximum 100 mg per dose. |
| Geriatric use | Start at 50 mg every 12 hours, titrate based on renal function and tolerability. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for STERANE (STERANE).
| Breastfeeding | Enters breast milk in low concentrations (M/P ratio ~0.5); risk of adrenal suppression unclear. Consider risk-benefit; use lowest effective dose. |
| Teratogenic Risk | First trimester: Cleft palate risk increased (odds ratio 3.35); second and third trimester: Intrauterine growth restriction, adrenal suppression, premature birth. Overall FDA category C (animal teratogenicity, human data limited). |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Systemic fungal infections","Known hypersensitivity to prednisolone or any component","Administration of live or live-attenuated vaccines (relative contraindication)"]
| Precautions | ["Immunosuppression and increased risk of infections","Adrenal suppression with prolonged use","Osteoporosis with long-term therapy","Gastrointestinal perforation risk (especially in patients with GI disease)","Exacerbation of systemic fungal infections","Kaposi's sarcoma has been reported","Neuropsychiatric reactions (e.g., euphoria, psychosis)","Corticosteroid-induced myopathy","Growth suppression in children","Ocular effects (e.g., glaucoma, cataracts)"] |
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| Monitor maternal blood glucose, blood pressure, weight gain; fetal growth ultrasound every 4-6 weeks in 2nd/3rd trimester; assess for neonatal adrenal insufficiency at birth. |
| Fertility Effects | May impair ovulation (dose-dependent) with prolonged use; reversible upon discontinuation. No evidence of permanent infertility. |