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). |
| Molecular Weight | 362.46 |
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 | Corticosteroids such as SYNACORT (hydrocortisone) are generally considered safe in the first trimester when used at physiologic replacement doses. High doses may be associated with a small increased risk of oral clefts; use only if clearly needed. |
| 2nd trimester | Use in the second trimester is generally considered safe at physiologic doses. High doses may increase risk of preterm labor and fetal growth restriction; monitor fetal growth. |
| 3rd trimester | Use in the third trimester may cause neonatal adrenal suppression if high doses are given near term. Taper doses before delivery if possible. Monitor neonate for adrenal insufficiency. |
Clinical note
Comprehensive clinical and safety monograph for SYNACORT (SYNACORT).
| Placental transfer | Hydrocortisone crosses the placenta. The degree of transfer is moderate; approximately 50-70% of maternal levels reach the fetus, depending on placental metabolism. High doses can suppress fetal adrenal function. |
| Breastfeeding |
■ FDA Black Box Warning
None
| Serious Effects |
Systemic fungal infectionsIdiopathic thrombocytopenic purpura (ITP) (contraindicated for high-dose therapy)Hypersensitivity to hydrocortisone or any componentAdministration of live virus vaccines (due to immunosuppression)
| 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. |
| Food/Dietary | Avoid excessive intake of grapefruit and grapefruit juice as they may increase hydrocortisone levels. Limit sodium intake to reduce fluid retention. Maintain adequate potassium intake (e.g., bananas, oranges) as corticosteroids can cause hypokalemia. |
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| Hydrocortisone is excreted into breast milk in small amounts. At maternal doses up to 80 mg daily, breastfed infants receive less than 10% of the maternal weight-adjusted dose and are unlikely to experience adverse effects. Use with caution at high doses; monitor infant for growth and adrenal suppression. |
| Lactation Rating | L2 (Safe - Limited data suggest no significant risk) |
| 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. |
| 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. |
| Clinical Pearls | SYNACORT (hydrocortisone) is a corticosteroid used for anti-inflammatory and immunosuppressive effects. Monitor for adrenal suppression with prolonged use; taper dose gradually to avoid withdrawal. Use lowest effective dose for shortest duration. In acute stress (e.g., surgery, trauma), increase dose to prevent adrenal crisis. Avoid live vaccines during therapy. |
| Patient Advice | Take exactly as prescribed; do not stop abruptly without consulting your doctor. · Report any unusual weight gain, swelling, or mood changes. · Avoid close contact with people who have infections; notify doctor if exposed to chickenpox or measles. · Carry a steroid warning card if on long-term therapy. · Do not receive live vaccines while taking this medication. |