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. |
| Molecular Weight | 362.46 |
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 | Use only if clearly needed; associated with orofacial clefts (risk ~0.3%) and intrauterine growth restriction. Consider alternative if possible. |
| 2nd trimester | Use only if benefit outweighs risk; may cause fetal adrenal suppression, but teratogenic risk lower than in first trimester. |
| 3rd trimester | Use with caution; prolonged use may lead to neonatal adrenal suppression, hypoglycemia, and growth retardation. Monitor neonate after delivery. |
Clinical note
Comprehensive clinical and safety monograph for SOLU-CORTEF (SOLU-CORTEF).
| Placental transfer | Hydrocortisone crosses the placenta; however, placental 11β-HSD2 converts most cortisol to inactive cortisone, limiting fetal exposure. High maternal doses can saturate this enzyme, increasing fetal transfer. |
| Breastfeeding | Hydrocortisone (active form) distributes into breast milk in low concentrations; minimal risk to infant at maternal doses up to 50 mg/day. Avoid high-dose or prolonged systemic therapy. For short-term use, consider waiting 4 hours after dose before nursing to reduce exposure. |
■ 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 infectionKnown hypersensitivity to hydrocortisone or any componentAdministration of live or live-attenuated vaccines concurrent with immunosuppressive doses
| 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 |
| Food/Dietary |
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| Lactation Rating | L2 (Probably Compatible) |
| 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. |
| 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. |
| Avoid grapefruit and grapefruit juice as they may increase corticosteroid levels. Limit sodium intake to reduce fluid retention and hypertension. Maintain adequate potassium intake (e.g., bananas, oranges) as hypokalemia can occur. Avoid alcohol due to increased risk of GI ulceration. |
| Clinical Pearls | Solu-Cortef (hydrocortisone sodium succinate) is a water-soluble corticosteroid for IV/IM use. For acute adrenal crisis, administer 100 mg IV bolus followed by 100 mg IV infusion over 24h. Taper dose gradually to avoid adrenal insufficiency. Monitor for hyperglycemia, hypokalemia, and immunosuppression. In septic shock, consider stress-dose steroids only if refractory to fluids and vasopressors. Avoid abrupt withdrawal after prolonged use. |
| Patient Advice | Report any signs of infection (fever, sore throat) or unusual bruising/bleeding. · Do not stop taking this medication suddenly; dose must be tapered under medical supervision. · May cause increased blood sugar; monitor if diabetic. · Avoid live vaccines during treatment. · Inform all healthcare providers that you are taking corticosteroids. |