SYNACORT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SYNACORT (SYNACORT).
Synthetic corticosteroid with potent glucocorticoid activity; binds to glucocorticoid receptors, modulating gene expression to suppress inflammation, immune response, and adrenal function.
| Metabolism | Primarily hepatic via CYP3A4; also undergoes metabolism in extrahepatic tissues. |
| Excretion | Primarily renal (80% as metabolites, 20% unchanged); minor biliary/fecal (<5%). |
| Half-life | Terminal elimination half-life is 2.5–3.5 hours; clinically, this short half-life requires multiple daily dosing for sustained effects. |
| Protein binding | Approximately 95% bound, primarily to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | Vd = 0.5–0.7 L/kg; distributes into total body water with higher concentrations in tissues rich in glucocorticoid receptors. |
| Bioavailability | Oral: 70–80%; Intramuscular: 90–100%. |
| Onset of Action | Intravenous: 5–15 minutes; Intramuscular: 30–60 minutes; Oral: 1–2 hours. |
| Duration of Action | Duration of clinical effect: 8–12 hours (hormonal effects may persist longer due to genomic actions). |
100 mg intravenously every 8 hours for 24 hours, then 50 mg intravenously every 8 hours for 48 hours, followed by 25 mg intravenously every 8 hours for 72 hours.
| Dosage form | CREAM |
| Renal impairment | No adjustment required for GFR ≥10 mL/min. For GFR <10 mL/min, administer 75% of usual dose. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50%; Child-Pugh C: use with caution, consider alternative agent. |
| Pediatric use | 1-2 mg/kg intravenously every 8 hours, not to exceed adult dose. |
| Geriatric use | No specific adjustment, but monitor for fluid retention and electrolyte imbalances; consider lower initial doses due to increased risk of adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SYNACORT (SYNACORT).
| Breastfeeding | Hydrocortisone is excreted into breast milk at low concentrations (M/P ratio approximately 0.25-0.5). At physiologic doses, it is considered compatible with breastfeeding. High maternal doses (>40 mg/day) may lead to detectable infant levels; monitor for growth or adrenal suppression. Use lowest effective dose. |
| Teratogenic Risk | SYNACORT (hydrocortisone) is a corticosteroid. First trimester: Increased risk of orofacial clefts (odds ratio ~1.3-1.7) with systemic use. Second/third trimesters: Chronic use may cause fetal adrenal suppression, intrauterine growth restriction, and preterm birth. Topical use has minimal systemic absorption but high potency or prolonged use may pose risks. |
■ FDA Black Box Warning
None
| Serious Effects |
Systemic fungal infections; known hypersensitivity to hydrocortisone or any component of the formulation; administration of live or live attenuated vaccines in patients receiving immunosuppressive doses; idiopathic thrombocytopenic purpura (IM administration).
| Precautions | Increased risk of infections due to immunosuppression; adrenal suppression; Cushing's syndrome with chronic use; osteoporosis; gastrointestinal perforation; altered mental status; increased intraocular pressure; growth suppression in children; fetal harm in pregnancy; use with caution in patients with hypertension, congestive heart failure, or renal insufficiency; monitor for hypokalemia and hyperglycemia. |
Loading safety data…
| Fetal Monitoring | Monitor maternal blood glucose, blood pressure, and signs of infection. Fetal: Ultrasound for growth restriction if chronic therapy. Newborn: Observe for adrenal insufficiency if maternal use in late pregnancy. |
| Fertility Effects | High doses may disrupt menstrual cycles and fertility due to hypothalamic-pituitary-adrenal axis suppression. Normalization of Cushing's state can restore fertility. |