SOLU-CORTEF
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SOLU-CORTEF (SOLU-CORTEF).
Solu-Cortef (hydrocortisone sodium succinate) is a corticosteroid that binds to the glucocorticoid receptor, leading to modulation of gene expression and suppression of inflammatory mediators, including prostaglandins and leukotrienes. It also inhibits immune cell migration and activation.
| Metabolism | Primarily hepatic metabolism via CYP3A4; also undergoes renal metabolism. Hydrocortisone is metabolized to tetrahydrocortisone and tetrahydrocortisol, conjugated with glucuronic acid, and excreted renally. |
| Excretion | Renal: ~80% as metabolites (mainly 17-hydroxycorticosteroids) and <5% unchanged. Biliary/fecal: minimal (<5%). |
| Half-life | Terminal elimination half-life: 1.5-2 hours (hydrocortisone); clinical duration of action is longer due to genomic effects (6-8 hours). |
| Protein binding | ~90-95% bound to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | 0.4-0.6 L/kg (hydrocortisone); distributes into total body water. |
| Bioavailability | Not applicable for IV/Solu-Cortef (100% bioavailable IV). Oral hydrocortisone: ~96%. |
| Onset of Action | IV: rapid (minutes); IM: 1-2 hours; oral: <1 hour (no oral formulation of SOLU-CORTEF; hydrocortisone oral onset ~1 hour). |
| Duration of Action | IV: 6-8 hours (anti-inflammatory effect); IM: 8-12 hours; duration depends on dose and condition. |
100-1000 mg intravenous (IV) or intramuscular (IM), then 100-500 mg IV or IM every 2-6 hours as needed.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment required for renal impairment. |
| Liver impairment | No specific dose adjustment required for hepatic impairment; however, use with caution in severe hepatic impairment. |
| Pediatric use | 0.5-1.7 mg/kg/day IV or IM divided every 6-8 hours, or 1-2 mg/kg IV as a single dose for acute conditions. |
| Geriatric use | Use lowest effective dose due to increased risk of osteoporosis, fluid retention, and immunosuppression; monitor for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SOLU-CORTEF (SOLU-CORTEF).
| Breastfeeding | Hydrocortisone (active form) distributed into breast milk; M/P ratio approximately 0.25–0.5. No reports of adverse effects in infants at maternal doses ≤80 mg/day. Avoid high-dose or prolonged use; monitor infant for growth and adrenal suppression. |
| Teratogenic Risk | First trimester: Increased risk of cleft palate (odds ratio 3.4–6.9). Second trimester: Fetal growth restriction, adrenal suppression. Third trimester: Premature labor, neonatal adrenal insufficiency. Overall risk category C (FDA) – benefits may outweigh risks in life-threatening conditions. |
■ FDA Black Box Warning
Corticosteroids have been reported to cause increased risk of infection, masking of infection, and reactivation of latent infections. Avoid live virus vaccines in patients receiving immunosuppressive doses. Prolonged use may lead to adrenal suppression and withdrawal reactions.
| Serious Effects |
["Systemic fungal infections","Hypersensitivity to hydrocortisone or any component of the formulation","Administration of live or live-attenuated vaccines in patients receiving immunosuppressive doses","Idiopathic thrombocytopenic purpura (relative, use with caution)"]
| Precautions | ["Increased susceptibility to infections and masking of clinical signs of infection","Adrenal suppression with prolonged use; taper doses when discontinuing","Osteoporosis with long-term use, especially in postmenopausal women","Increased risk of gastrointestinal perforation in patients with certain GI disorders","Cushing's syndrome with chronic high-dose therapy","Myopathy, particularly with high doses and concurrent use of neuromuscular blocking agents","Potential for growth suppression in children","Exacerbation of hypertension, congestive heart failure, and electrolyte disturbances","Capillary fragility and increased intracranial pressure","Psychiatric reactions including euphoria, insomnia, and severe depression"] |
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| Fetal Monitoring |
| Monitor maternal blood glucose (risk of hyperglycemia), blood pressure (hypertension), and signs of infection (immunosuppression). Fetal: Ultrasound for growth restriction if used long-term; monitor for preterm labor. Neonatal: Observe for signs of adrenal insufficiency (hypoglycemia, hypotonia) after delivery. |
| Fertility Effects | High doses may suppress gonadotropin release, causing menstrual irregularities and transient infertility. Effect is dose-dependent and reversible upon dose reduction or discontinuation. |