CORTROSYN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CORTROSYN (CORTROSYN).
Corticotropin (ACTH) stimulates the adrenal cortex to release cortisol, corticosterone, and aldosterone; used diagnostically to assess adrenal function.
| Metabolism | ACTH is metabolized by proteolytic enzymes in plasma and tissues; half-life approximately 15 minutes. |
| Excretion | Primarily renal (90% as metabolites, 10% unchanged); negligible biliary/fecal. |
| Half-life | Terminal half-life approximately 1.5 hours (dose-dependent: 1.1-2.2 h). Rapid clearance limits duration of action. |
| Protein binding | Binding to corticosteroid-binding globulin (CBG) ~80%. |
| Volume of Distribution | 0.2-0.4 L/kg (primarily confined to extracellular fluid). |
| Bioavailability | IM: virtually 100%; SubQ: ~80% (relative to IV). |
| Onset of Action | IV: <1 minute; IM: 15-30 minutes; SubQ: 30-60 minutes. |
| Duration of Action | 2-4 hours (adrenal stimulation); effect wanes as drug cleared. |
For diagnostic testing of adrenal function: 250 mcg intramuscularly or intravenously as a single dose. For infants and children: 125 mcg intramuscularly or intravenously as a single dose.
| Dosage form | INJECTABLE |
| Renal impairment | No adjustment required for renal impairment as drug is rapidly metabolized, but caution in severe renal disease due to possible fluid retention. |
| Liver impairment | No specific dosing adjustment required for hepatic impairment based on Child-Pugh classification, but use with caution due to altered metabolism. |
| Pediatric use | Neonates and infants: 125 mcg intramuscularly or intravenously. Children 2 years and older: 250 mcg intramuscularly or intravenously. |
| Geriatric use | No specific dose adjustment required, but monitor for fluid overload and hypertension due to increased sensitivity to corticosteroids. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CORTROSYN (CORTROSYN).
| Breastfeeding | Excretion into breast milk is unknown. Cortrosyn is a synthetic ACTH analog with a short half-life (15 minutes). Due to low oral bioavailability, infant exposure from breastfeeding is minimal. M/P ratio not available. |
| Teratogenic Risk | Corticotropin (cosyntropin) is considered to have a low teratogenic risk. Corticosteroids used in pregnancy have been associated with an increased risk of cleft palate in animal studies, but human data for cosyntropin are lacking. Increased fetal exposure to maternal cortisol is possible. Use only if clearly needed and monitor for fetal growth restriction. |
■ FDA Black Box Warning
Increased risk of infections; live or live attenuated vaccines should not be given during therapy.
| Serious Effects |
["Hypersensitivity to corticotropin or any component","Systemic fungal infections","Administration of live or live attenuated vaccines","Recent vaccination with live virus","Ocular herpes simplex"]
| Precautions | ["Increased risk of infections due to immunosuppression","May cause adrenal suppression with prolonged use","May mask signs of infection","May cause Cushing's syndrome","May cause hypertension, fluid retention, and electrolyte disturbances","Use with caution in patients with diabetes, osteoporosis, peptic ulcer disease, or psychiatric disorders"] |
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| Fetal Monitoring | Monitor maternal blood pressure, blood glucose, and electrolytes. Assess fetal growth via ultrasound if prolonged use. Evaluate for signs of fluid retention or infection. |
| Fertility Effects | No direct effects on fertility have been reported. Adrenal suppression from chronic use may affect reproductive function, but this is not relevant for single-dose use. |