STIE-CORT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for STIE-CORT (STIE-CORT).
Glucocorticoid receptor agonist; modulates gene expression leading to anti-inflammatory and immunosuppressive effects.
| Metabolism | Hepatic metabolism via CYP3A4; primarily excreted in urine and feces. |
| Excretion | Renal: 60-70% as metabolites; biliary/fecal: 20-30% as metabolites; unchanged drug: <5%. |
| Half-life | Terminal elimination half-life is 1.5-2 hours (intravenous) and 2-3 hours (oral), reflecting rapid clearance; clinical context: supports twice-daily dosing for systemic effects. |
| Protein binding | 70-80% bound to albumin and corticosteroid-binding globulin (CBG). |
| Volume of Distribution | Vd is 0.8-1.0 L/kg, indicating distribution into total body water and moderate tissue binding. |
| Bioavailability | Oral: 50-70% (first-pass metabolism reduces systemic exposure); intramuscular: 100% (relative to intravenous). |
| Onset of Action | Intravenous: 2-5 minutes; intramuscular: 15-30 minutes; oral: 1-2 hours; topical: 1-2 hours (local anti-inflammatory effect). |
| Duration of Action | Duration is 6-12 hours for systemic effects (clinical note: shorter duration than prednisolone); topical duration: 4-6 hours after single application. |
Topical: Apply a thin film to affected area twice daily. Maximum 2-week continuous use. In severe cases, apply up to 4 times daily. Do not exceed 50 g/week.
| Dosage form | LOTION |
| Renal impairment | No dose adjustment required for topical use. For systemic absorption (prolonged use on large areas), consider monitoring for adrenal suppression in severe renal impairment (eGFR <30 mL/min/1.73m²). |
| Liver impairment | No dose adjustment required. In severe hepatic impairment (Child-Pugh C), avoid prolonged use on large areas due to risk of systemic effects. |
| Pediatric use | Children ≥1 year: Apply thin film to affected area twice daily. Maximum 2-week course. Do not use under occlusion. Weigh risk-benefit in children <2 years; use lowest potency for shortest duration. |
| Geriatric use | Use lowest effective dose for shortest duration. Avoid occlusive dressings. Monitor for skin atrophy and adrenal suppression, especially with prolonged use. Consider renal function (eGFR) if applying to large body surface areas. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for STIE-CORT (STIE-CORT).
| Breastfeeding | Hydrocortisone is excreted into breast milk in low amounts. M/P ratio is approximately 0.2-0.5 for systemic hydrocortisone. Topical use on small areas with intact skin is considered compatible with breastfeeding. Avoid application to breast or nipples. |
| Teratogenic Risk | First trimester: Corticosteroids are associated with a small increased risk of cleft palate (odds ratio 1.3-3.4). Second and third trimesters: Chronic use may cause fetal adrenal suppression, intrauterine growth restriction, and preterm birth. No specific data for STIE-CORT (hydrocortisone) alone; risk is low for short-term, low-potency topical use. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to any component","Untreated bacterial, viral, or fungal infections","Perioral dermatitis","Rosacea"]
| Precautions | ["Systemic absorption with prolonged use","Adrenal suppression","Cushing's syndrome","Rebound effect upon discontinuation","Skin atrophy","Allergic contact dermatitis to the drug"] |
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| Fetal Monitoring | Monitor maternal blood pressure, blood glucose, and signs of infection. For prolonged high-dose use, monitor fetal growth via ultrasound and assess for adrenal suppression in the neonate after delivery. |
| Fertility Effects | No known direct effects of topical hydrocortisone on fertility. High-dose systemic corticosteroids may disrupt menstrual cycles and reduce sperm count, but topical use at recommended doses is unlikely to affect fertility. |