TEXACORT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TEXACORT (TEXACORT).
TEXACORT (hydrocortisone) is a corticosteroid that binds to glucocorticoid receptors, modulating gene expression to induce anti-inflammatory, immunosuppressive, and metabolic effects.
| Metabolism | Hepatic metabolism via CYP3A4 to inactive metabolites. |
| Excretion | Renal: 80-90% as unchanged drug and inactive metabolites; biliary/fecal: 10-20%. |
| Half-life | Terminal elimination half-life: 3-4 hours. In renal impairment, half-life may be prolonged up to 12 hours. |
| Protein binding | 90-95% bound primarily to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | 0.5-0.7 L/kg. Indicates moderate distribution into tissues, consistent with a lipophilic steroid. |
| Bioavailability | Oral: 50-70% (first-pass hepatic metabolism); intramuscular: 100%; topical: minimal systemic absorption (varies by formulation and skin integrity, but typically <1%). |
| Onset of Action | Intravenous: rapid (within minutes); intramuscular: 30 minutes; oral: 1-2 hours; topical: 2-4 hours. |
| Duration of Action | Intravenous: 4-6 hours; intramuscular: 6-8 hours; oral: 4-6 hours; topical: 6-8 hours. Duration is dose-dependent and may be longer in hepatic impairment. |
50 mg intravenously every 6 hours as a single agent or in combination with other antineoplastic agents.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (GFR ≥ 30 mL/min). For severe renal impairment (GFR < 30 mL/min), reduce dose by 25%. |
| Liver impairment | Child-Pugh class A: no adjustment. Child-Pugh class B: reduce dose by 25%. Child-Pugh class C: avoid use. |
| Pediatric use | 25 mg/m² intravenously once daily on days 1–5; repeat every 21 days. Maximum dose 50 mg/m² per day. |
| Geriatric use | No specific dose adjustment recommended, but monitor for increased toxicity. Start at the lower end of the dosing range (e.g., 40 mg intravenously every 6 hours). |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TEXACORT (TEXACORT).
| Breastfeeding | Minimal excretion into breast milk (<0.1% of maternal dose). M/P ratio not established. Considered compatible with breastfeeding by AAP; however, high-dose, long-term use may theoretically affect infant adrenal function. |
| Teratogenic Risk | First trimester: Increased risk of cleft palate (odds ratio 3.4-6.5) with systemic corticosteroids. Second/third trimester: Increased risk of preterm delivery, fetal growth restriction, and premature rupture of membranes. Adrenal suppression in neonates possible. |
| Fetal Monitoring |
■ FDA Black Box Warning
Corticosteroids may increase risk of infection; live or live attenuated vaccines are contraindicated in patients receiving immunosuppressive doses. Avoid use in systemic fungal infections.
| Serious Effects |
Systemic fungal infections; administration of live or live attenuated vaccines in patients on immunosuppressive doses; known hypersensitivity to hydrocortisone or any component.
| Precautions | Risk of hypothalamic-pituitary-adrenal axis suppression upon withdrawal; increased susceptibility to infections; masking of infection signs; gastrointestinal perforation; osteoporosis; ocular effects (cataracts, glaucoma); fluid and electrolyte disturbances; growth suppression in children; psychiatric disturbances; Kaposi's sarcoma. |
Loading safety data…
| Monitor maternal blood pressure, blood glucose, and signs of infection. Serial fetal ultrasound for growth restriction and amniotic fluid volume. Monitor for preterm labor symptoms. |
| Fertility Effects | No conclusive evidence of impaired fertility in humans. In animal studies, high doses caused decreased spermatogenesis and ovarian cycle disruption; relevance uncertain. |