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 |
| Molecular Weight | 207.27 |
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 | Avoid due to potential teratogenicity; no adequate human studies, but animal data suggest risk. |
| 2nd trimester | Avoid; may cause fetal tachycardia and uterine contractions. |
| 3rd trimester | Contraindicated as it may delay labor and cause fetal hypoxia. |
Clinical note
Comprehensive clinical and safety monograph for CORPHEDRA (CORPHEDRA).
| Placental transfer | Crosses placenta; achieves 70-90% of maternal plasma concentration. |
| Breastfeeding | Excreted in breast milk; may cause irritability and insomnia in infants. Use only if benefits outweigh risks. |
| Lactation Rating | L3 (Moderately Safe) |
■ 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 |
HypertensionSevere coronary artery diseaseAngle-closure glaucomaConcurrent MAOI therapyHypersensitivity to pseudoephedrine
| 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. |
| Food/Dietary | Avoid caffeine-containing foods and beverages as they may increase CNS stimulation. No significant food interactions beyond general caution with stimulants. |
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| 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. |
| 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. |
| Clinical Pearls | CORPHEDRA (pseudoephedrine/phenylephrine combination) should be used with caution in patients with hypertension, hyperthyroidism, diabetes, and prostate enlargement. Avoid in patients with severe coronary artery disease or those on MAOIs. Monitor for CNS stimulation and arrhythmias. |
| Patient Advice | Do not exceed recommended dose; may cause insomnia, nervousness, or increased blood pressure. · Avoid taking within 4-6 hours of bedtime to prevent sleep disturbances. · If you have high blood pressure, heart disease, or are on MAOIs, consult your doctor before use. · Stop use and seek medical attention if you experience chest pain, rapid heartbeat, or difficulty urinating. |