CORTIFOAM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CORTIFOAM (CORTIFOAM).
Cortifoam (hydrocortisone acetate) is a corticosteroid that binds to glucocorticoid receptors, modulating gene expression to induce anti-inflammatory, antipruritic, and vasoconstrictive effects. It inhibits phospholipase A2, reducing prostaglandin and leukotriene synthesis, and suppresses immune cell migration and cytokine release.
| Metabolism | Primarily hepatic metabolism via CYP3A4; undergoes reduction and conjugation to inactive metabolites. |
| Excretion | Primarily renal (about 70-90% as metabolites) and fecal (about 10-30% as metabolites). |
| Half-life | Approximately 1.5-2 hours for hydrocortisone; clinically, effects persist longer due to local action. |
| Protein binding | 90-95% bound to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | 0.3-0.5 L/kg; reflects distribution into extracellular fluid and tissues. |
| Bioavailability | Rectal foam: approximately 30-50% systemic bioavailability; topical: minimal systemic absorption (~1-5%) with intact skin. |
| Onset of Action | Rectal: clinical effect within 2-3 days; topical: effect within 3-7 days. |
| Duration of Action | Rectal/topical: effect persists for several weeks with regular use; systemic effects short-lived. |
1 applicatorful (90 mg hydrocortisone acetate) rectally twice daily for 2-3 weeks, then every other day as needed.
| Dosage form | AEROSOL, METERED |
| Renal impairment | No specific adjustment required; systemic absorption is minimal. |
| Liver impairment | No specific adjustment required; use with caution in severe hepatic impairment due to potential corticosteroid effects. |
| Pediatric use | Safety and efficacy not established; use not recommended. |
| Geriatric use | No specific dose adjustment; use with caution due to increased risk of corticosteroid-related side effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CORTIFOAM (CORTIFOAM).
| Breastfeeding | Corticosteroids are excreted in breast milk in low amounts. The M/P ratio for hydrocortisone is approximately 0.25. Topical use is unlikely to cause significant exposure; however, caution is advised if applied to large areas or broken skin. |
| Teratogenic Risk | Corticosteroids are generally associated with an increased risk of cleft palate (first trimester) and fetal adrenal suppression (third trimester) when used systemically. Topical formulations like Cortifoam have minimal systemic absorption, but animal studies show some risk. Use only if benefit outweighs risk. |
■ FDA Black Box Warning
No FDA black box warning identified for topical or rectal use.
| Serious Effects |
["Hypersensitivity to hydrocortisone or any component","Untreated bacterial, fungal, or viral infections at application site","Perforated bowel or intestinal obstruction (for rectal foam)","Systemic fungal infections (except when used for replacement therapy)"]
| Precautions | ["Systemic absorption may cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression","Increased risk of local and systemic infections","Prolonged use may lead to skin atrophy, striae, or perioral dermatitis","Use caution in patients with diabetes, tuberculosis, or peptic ulcer disease","Avoid use in eyes, open wounds, or broken skin"] |
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| Fetal Monitoring |
| Monitor for signs of adrenal suppression in the mother (e.g., fatigue, hypotension) and fetal growth restriction if used long-term. Consider ultrasound for fetal growth in prolonged use. |
| Fertility Effects | No known adverse effects on fertility from topical corticosteroid use. Systemic corticosteroids have been associated with menstrual irregularities, but this is unlikely with Cortifoam. |