CORTRIL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CORTRIL (CORTRIL).
Cortril (hydrocortisone) is a corticosteroid that binds to the glucocorticoid receptor, leading to inhibition of inflammatory mediators and suppression of immune response.
| Metabolism | Hepatic via CYP3A4 |
| Excretion | Renal (95% as free cortisol and metabolites, primarily tetrahydrocortisol and glucuronide conjugates). Biliary/fecal excretion is minimal (<5%). |
| Half-life | Terminal elimination half-life: 1.5–2.5 hours. Clinically, the biologic half-life (duration of ACTH suppression) is longer (8–12 hours). |
| Protein binding | 90–95% bound primarily to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | Vd: 0.3–0.4 L/kg (for free cortisol). Higher in obese patients. Reflects distribution into total body water. |
| Bioavailability | Oral: 25–40% (due to extensive first-pass metabolism). IM: 85–100%; IV: 100%; Topical: low systemic absorption (<5% on intact skin, higher on inflamed skin). |
| Onset of Action | Oral: 1–2 hours; IV: immediate; IM: 1–2 hours; Topical: hours to days. Oral peak effect at 2–4 hours. |
| Duration of Action | Duration of action: 6–8 hours for oral/IV (biologic half-life). Physiologic effects persist longer due to gene-mediated actions. Topical effects are sustained with regular application. |
| Molecular Weight | 362.46 |
Hydrocortisone (Cortril) for adrenal insufficiency: 20-30 mg orally daily divided into two or three doses. For acute conditions, IV or IM hydrocortisone sodium succinate 100 mg every 8 hours.
| Dosage form | TABLET |
| Renal impairment | No specific dose adjustment required in renal impairment. However, monitor for fluid retention and electrolyte disturbances. |
| Liver impairment | Severe hepatic impairment (Child-Pugh C): Reduce dose by 50%. Use with caution in moderate impairment (Child-Pugh B). |
| Pediatric use | Adrenal insufficiency: 0.5-1 mg/kg/day orally divided every 6-8 hours. Stress doses: 1-2 mg/kg IV every 6 hours. |
| Geriatric use | Start at lower end of dosing range (e.g., 10-20 mg daily oral). Monitor for osteoporosis, hyperglycemia, and immunosuppression closely. |
| 1st trimester | Avoid systemic use in first trimester unless essential. Increased risk of orofacial clefts (odds ratio 2-3) from epidemiologic studies. Consider topical or inhaled forms if possible. |
| 2nd trimester | Use only if clearly needed. May cause fetal adrenal suppression with prolonged high-dose therapy. Monitor fetal growth. |
| 3rd trimester | Use with caution; high doses may cause neonatal adrenal suppression, growth restriction, and premature labor. Taper prior to delivery if possible. |
Clinical note
Comprehensive clinical and safety monograph for CORTRIL (CORTRIL).
| Placental transfer | Hydrocortisone crosses the placenta; however, the placenta converts cortisol to cortisone via 11β-HSD2, reducing fetal exposure. At therapeutic maternal doses, fetal levels are approximately 10-33% of maternal levels. High doses overwhelm placental barrier. |
| Breastfeeding | Cortril (hydrocortisone) is excreted into breast milk in low amounts (estimated 0.15-0.6% of maternal dose). At maternal doses up to 80 mg/day, infant exposure is negligible. However, high-dose maternal therapy (>80 mg/day) may theoretically affect infant adrenal function. Use lowest effective dose and monitor infant for growth and development. |
■ FDA Black Box Warning
None
| Serious Effects |
Systemic fungal infectionHypersensitivity to hydrocortisone or any componentAdministration of live or live-attenuated vaccines with immunosuppressive doses
| Precautions | Immunosuppression and increased risk of infections, Adrenal suppression with prolonged use, Osteoporosis, Gastrointestinal perforation, Growth suppression in children, Cushing's syndrome, Psychiatric disturbances |
| Food/Dietary | Avoid grapefruit and grapefruit juice as they may increase hydrocortisone levels. Limit high-sodium foods to reduce edema. Maintain adequate calcium and vitamin D intake to prevent osteoporosis. Use with caution with alcohol due to increased GI irritation risk. |
Loading safety data…
| Lactation Rating | L2 (Probably Compatible) |
| Teratogenic Risk | First trimester: Cleft palate risk increased (OR 3.4) with systemic exposure >10 mg/day; second and third trimesters: Fetal adrenal suppression, intrauterine growth restriction, oligohydramnios with prolonged high doses. |
| Fetal Monitoring | Maternal: Blood pressure, blood glucose, weight, signs of infection; Fetal: Serial ultrasound for growth and amniotic fluid volume; Neonatal: Observe for adrenal suppression if high-dose used near term. |
| Fertility Effects | May reduce fertility via suppression of gonadotropins and menstrual irregularities; reversible upon dose reduction or discontinuation. |
| Clinical Pearls |
| Hydrocortisone (Cortril) is a short-acting glucocorticoid with mineralocorticoid activity. For stress dosing in adrenal insufficiency, double or triple the usual oral dose during minor illness; for major stress, switch to parenteral hydrocortisone 100 mg IV q8h. Monitor for hyperglycemia, hypokalemia, and osteoporosis with long-term use. Taper dose gradually to avoid adrenal crisis. Do not use intrathecally; contains benzyl alcohol in parenteral forms. |
| Patient Advice | Take with food to reduce gastric irritation. · Do not stop suddenly; follow dose-tapering plan. · Wear medical alert bracelet for adrenal insufficiency. · Report signs of infection, hyperglycemia (excessive thirst, urination), or mood changes. · Avoid live vaccines during therapy. |