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. |
| Molecular Weight | 360.44 |
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 | Risk cannot be ruled out. Animal studies have shown teratogenic effects, but no adequate human studies. Use only if potential benefit outweighs risk. |
| 2nd trimester | May be used with caution. Monitor for maternal hyperglycemia and fetal growth restriction. |
| 3rd trimester | Prolonged use may cause adrenal suppression in the neonate. Avoid high doses; taper if used near term. |
Clinical note
Comprehensive clinical and safety monograph for STIE-CORT (STIE-CORT).
| Placental transfer | Crosses the placenta; metabolism by placental 11β-HSD2 reduces fetal exposure, but high doses may saturate the enzyme. |
| Breastfeeding | Enters breast milk in small amounts. Higher doses may suppress infant adrenal function. Use lowest effective dose; monitor infant for growth and development. |
■ FDA Black Box Warning
None.
| Serious Effects |
Systemic fungal infectionKnown hypersensitivity to any componentAdministration of live or live-attenuated vaccines
| Precautions | Systemic absorption with prolonged use, Adrenal suppression, Cushing's syndrome, Rebound effect upon discontinuation, Skin atrophy, Allergic contact dermatitis to the drug |
| Food/Dietary | No clinically significant food interactions. Avoid excessive alcohol intake as it may exacerbate skin dryness. |
| Clinical Pearls | STIE-CORT (hydrocortisone) is a low-potency topical corticosteroid. Avoid prolonged use on face, intertriginous areas, or under occlusion due to increased absorption and risk of atrophy. Not for use in bacterial, fungal, or viral infections unless appropriately treated. Monitor for systemic effects when used on large body surface areas or under occlusion in children. |
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| Lactation Rating |
| L2 - Safer |
| 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. |
| 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. |
| Patient Advice | Apply a thin layer to affected area only, usually 2-3 times daily as directed. · Do not cover with bandages or dressings unless instructed by your healthcare provider. · Avoid contact with eyes and mucous membranes. · Do not use for longer than prescribed; overuse can lead to skin thinning and other side effects. · Inform your doctor if symptoms persist or worsen after 2 weeks. |