PENECORT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PENECORT (PENECORT).
PENECORT is a corticosteroid that binds to glucocorticoid receptors, modulating gene expression and suppressing inflammation, immune responses, and adrenal function.
| Metabolism | Hepatic CYP3A4-mediated metabolism. |
| Excretion | Renal: 60-70% as metabolites, 5-10% unchanged; Biliary/fecal: 20-30% as metabolites. |
| Half-life | Terminal elimination half-life: 3-4 hours in adults; prolonged in hepatic impairment (up to 8 hours). |
| Protein binding | 90-95% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.4-0.8 L/kg; distributes widely into tissues, including CSF. |
| Bioavailability | Oral: 70-85%; Intramuscular: 90-100%; Topical: 1-5% (varies with formulation and skin condition). |
| Onset of Action | Oral: 1-2 hours; Intramuscular: 30-60 minutes; Intravenous: 5-10 minutes; Topical: 1-3 days for anti-inflammatory effect. |
| Duration of Action | Oral: 12-24 hours; Intramuscular: 24-48 hours; Intravenous: 6-12 hours; Topical: 2-4 weeks for psoriasis (with continuous use). |
| Molecular Weight | 416.5 |
2.5-5 mg orally once daily; maximum 10 mg/day. Intramuscular: 20-40 mg every 2-4 weeks.
| Dosage form | SOLUTION |
| Renal impairment | eGFR <30 mL/min: reduce dose by 50% and monitor for fluid retention. eGFR <15 mL/min: avoid use. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: contraindicated. |
| Pediatric use | 0.1-0.2 mg/kg orally once daily (max 5 mg/day). Titrate to lowest effective dose. |
| Geriatric use | Start at lowest dose (2.5 mg daily), increase slowly due to increased risk of osteoporosis, hypertension, and hyperglycemia. |
| 1st trimester | Risk cannot be ruled out. Animal studies indicate fetal abnormalities, but human data insufficient. Use only if benefit outweighs risk. |
| 2nd trimester | May cause fetal growth restriction and adrenal suppression with prolonged use. Use lowest effective dose for shortest duration. |
| 3rd trimester | Potential for neonatal adrenal suppression if used near term. Avoid systemic use in late pregnancy. |
Clinical note
Comprehensive clinical and safety monograph for PENECORT (PENECORT).
| Placental transfer | Crosses placenta; degree of transfer varies with formulation and dose. Active transport by P-glycoprotein limits fetal exposure for some corticosteroids. |
| Breastfeeding | Excreted in breast milk in low amounts. At therapeutic doses, unlikely to cause adverse effects in infant. Monitor for growth suppression if high-dose or prolonged use. |
■ FDA Black Box Warning
None.
| Serious Effects |
Systemic fungal infectionHypersensitivity to any componentIntrathecal administration
| Precautions | Adrenal suppression, increased infection risk, osteoporosis, glaucoma, growth suppression in children, and Cushing's syndrome with long-term use. |
| Food/Dietary | No known food interactions with topical hydrocortisone. Systemic absorption minimal with topical use; no dietary restrictions required. |
| Clinical Pearls | PENECORT (hydrocortisone) is a topical corticosteroid. Use the lowest potency for shortest duration to avoid skin atrophy and systemic absorption. Avoid occlusion unless directed. Do not use on open wounds, infected lesions, or for acne. Monitor for HPA axis suppression with prolonged use on large surface areas. |
Loading safety data…
| Lactation Rating | L3 - Moderate Safety |
| Teratogenic Risk | PENECORT (hydrocortisone) is a corticosteroid. First trimester: Increased risk of cleft palate (odds ratio 1.3-1.7). Second/third trimester: Fetal adrenal suppression, growth restriction, preterm delivery with chronic use. Avoid high doses. |
| Fetal Monitoring | Maternal: Blood pressure, glucose, signs of infection, adrenal insufficiency. Fetal: Ultrasound for growth restriction (serial), amniotic fluid volume, fetal movement counts. Neonatal: Assess for hypoglycemia, adrenal suppression. |
| Fertility Effects | May disrupt menstrual cycle and ovulation at high doses due to hypothalamic-pituitary-adrenal axis suppression. Generally reversible upon dose reduction or discontinuation. |
| Patient Advice | Apply a thin layer to affected skin only, avoiding eyes and mucous membranes. · Do not bandage, wrap, or cover the area unless instructed by your doctor. · Wash hands before and after applying, unless treating hands. · Do not use for more than 2 weeks unless directed. · Avoid using on diaper area in children unless instructed. · Stop use and contact doctor if condition worsens or does not improve within 1 week. |