CORPHEDRA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CORPHEDRA (CORPHEDRA).
CorphEdra is a synthetic glucocorticoid that binds to the glucocorticoid receptor (GR), leading to transcriptional regulation of anti-inflammatory and immunosuppressive genes. It also activates the mineralocorticoid receptor (MR) with lower affinity, contributing to electrolyte and fluid balance effects.
| Metabolism | Primarily hepatic via CYP3A4; also undergoes 11β-hydroxysteroid dehydrogenase (11β-HSD) interconversion. Major metabolites: 6β-hydroxycorphEdra and tetrahydrocorphEdra. |
| Excretion | Renal: 70% unchanged; biliary/fecal: 20% as metabolites; 10% other |
| Half-life | 8-12 hours (terminal); clinical context: requires dosing every 12 hours; reduced clearance in elderly and renal impairment |
| Protein binding | 92% bound to albumin and alpha-1-acid glycoprotein |
| Volume of Distribution | 1.2 L/kg (0.8-1.5 L/kg); indicates extensive extravascular distribution |
| Bioavailability | Oral: 65% (first-pass effect); Intramuscular: 85%; Rectal: 50% |
| Onset of Action | Oral: 30-60 minutes; Intramuscular: 15-30 minutes; Intravenous: 1-2 minutes |
| Duration of Action | Oral: 6-8 hours; Intramuscular: 4-6 hours; Intravenous: 2-4 hours; clinical notes: shorter duration with higher doses due to metabolic saturation |
10-20 mg orally every 8 hours as needed for nasal congestion.
| Dosage form | SOLUTION |
| Renal impairment | GFR 30-59 mL/min: 10 mg every 8 hours. GFR 15-29 mL/min: 10 mg every 12 hours. GFR <15 mL/min: avoid use. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose by 50%. Child-Pugh Class C: avoid use. |
| Pediatric use | Children 2-5 years: 2.5 mg orally every 8 hours. Children 6-11 years: 5 mg orally every 8 hours. Children ≥12 years: 10 mg orally every 8 hours. |
| Geriatric use | Initiate at 5 mg orally every 8 hours; monitor for hypertension, tachycardia, and urinary retention. Avoid in patients with uncontrolled hypertension or prostatic hyperplasia. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CORPHEDRA (CORPHEDRA).
| Breastfeeding | Pseudoephedrine is excreted into breast milk in small amounts (M/P ratio approximately 2.6-3.0). Estimated infant dose is 0.4-0.7% of maternal weight-adjusted dose. A single dose may reduce milk production by 15-20%. Use with caution; monitor infant for irritability and sleep disturbance. American Academy of Pediatrics considers pseudoephedrine compatible with breastfeeding, but alternative decongestants (e.g., loratadine) may be preferred. |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. In animal reproduction studies, administration of pseudoephedrine (a component of CORPHEDRA) during organogenesis resulted in increased fetal resorptions and reduced fetal weights at doses 7 times the maximum recommended human dose. First trimester: Possible association with gastroschisis and small intestinal atresia based on retrospective studies. Second trimester: Limited data; theoretical risk of vasoconstriction reducing uteroplacental blood flow. Third trimester: Risk of uterine artery vasoconstriction and fetal tachycardia; avoid use near term due to potential for neonatal irritability, tremors, and transient ECG changes. |
■ FDA Black Box Warning
Long-term use may lead to hypothalamic-pituitary-adrenal (HPA) axis suppression and increased risk of infection. Abrupt withdrawal can cause acute adrenal insufficiency.
| Serious Effects |
Absolute: Hypersensitivity to CorphEdra or any component; systemic fungal infection. Relative: Active tuberculosis, peptic ulcer disease, recent myocardial infarction.
| Precautions | Increased risk of infections due to immunosuppression; monitor for adrenal insufficiency during stress; may cause osteoporosis with prolonged use; caution in patients with congestive heart failure, hypertension, or diabetes; avoid live vaccines. |
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| Fetal Monitoring | Maternal: Blood pressure, heart rate, and symptoms of palpitations or tremor. Fetal: Heart rate monitoring if used near term; consider fetal assessment in cases of maternal hypertensive response. Neonatal: Observe for transient tachycardia, irritability, and feeding difficulties in newborns exposed near delivery. |
| Fertility Effects | No human studies on fertility effects. In animal studies, pseudoephedrine at high doses caused decreased implantation and increased preimplantation loss. Pseudoephedrine may inhibit uterine contractility by its alpha-adrenergic effects, potentially affecting implantation. The clinical relevance is unknown. CORPHEDRA is not recommended for use in women attempting to conceive unless benefit outweighs potential risk. |