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. |
| Molecular Weight | 360.44 |
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 | Corticosteroids like TEXACORT are generally avoided in first trimester unless benefits outweigh risks due to potential teratogenicity (cleft palate). |
| 2nd trimester | Use with caution; associated with increased risk of intrauterine growth restriction and adrenal suppression in fetus. |
| 3rd trimester | Use with caution; may cause neonatal adrenal suppression if late pregnancy use. |
Clinical note
Comprehensive clinical and safety monograph for TEXACORT (TEXACORT).
| Placental transfer | TEXACORT crosses the placenta; degree of transfer depends on dose and formulation. |
| Breastfeeding | TEXACORT is excreted into breast milk in low amounts; when used at therapeutic doses, it is generally considered compatible with breastfeeding. Monitor infant for adrenal suppression. |
■ 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 infectionsHypersensitivity to 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. |
| Food/Dietary | No clinically significant food interactions. Grapefruit juice does not affect topical corticosteroids. Maintain a balanced diet to support skin healing. |
Loading safety data…
| Lactation Rating |
| L3 - Moderate Safety |
| 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 | 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. |
| Clinical Pearls | TEXACORT (hydrocortisone acetate 2.5%) is a low-potency topical corticosteroid used for mild to moderate inflammatory dermatoses. Do not use for prolonged periods without monitoring for skin atrophy, especially on the face or intertriginous areas. Avoid application to broken skin or infected lesions unless appropriate antimicrobial therapy is added. Do not exceed 50 g/week to minimize systemic absorption. |
| Patient Advice | Apply a thin layer to affected skin only; do not cover with bandages unless directed by your doctor. · Wash hands after application unless treating hands; avoid contact with eyes, mouth, and open wounds. · Do not use for more than 2 weeks without physician reevaluation. · Report any signs of skin infection, allergic reaction, or worsening of condition. · Do not use for diaper rash or on children's skin without medical advice. |