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. |
| Molecular Weight | 404.5 |
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 | Systemic absorption after topical application is low; however, corticosteroids are associated with a small increased risk of cleft palate when used systemically in first trimester. Based on available data, no major teratogenic risk has been reported with topical hydrocortisone acetate. Use only if clearly needed. |
| 2nd trimester | Topical corticosteroids are generally considered safe in second trimester when used as directed. No evidence of fetal harm with short-term use of hydrocortisone acetate foam. |
| 3rd trimester | Use in third trimester may be associated with intrauterine growth restriction if high doses or prolonged use; however, typical topical use of hydrocortisone acetate results in minimal systemic absorption. Benefit of treating maternal condition may outweigh theoretical risk. |
Clinical note
Comprehensive clinical and safety monograph for CORTIFOAM (CORTIFOAM).
| Placental transfer | Low placental transfer; hydrocortisone acetate is rapidly metabolized to inactive metabolites. Minimal fetal exposure after maternal topical use. |
■ FDA Black Box Warning
No FDA black box warning identified for topical or rectal use.
| Serious Effects |
Hypersensitivity to hydrocortisone acetate or any component of the formulationSystemic fungal infections (untreated)Administration by any non-rectal route
| 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 |
| Food/Dietary | No specific food interactions are known for Cortifoam. However, patients with ulcerative colitis may benefit from a low-residue diet during flares to reduce bowel irritation. Avoid alcohol and caffeine as they may exacerbate diarrhea. Limit lactose if intolerant. Maintain adequate fluid intake. There are no known direct pharmacokinetic interactions with food. |
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| Breastfeeding |
| After topical application of hydrocortisone acetate foam, systemic absorption is minimal. No reports of adverse effects in breastfed infants. However, avoid application to breast area prior to nursing. Use smallest effective dose for shortest duration. |
| Lactation Rating | L2 (Safer) |
| 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. |
| 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. |
| Clinical Pearls | Cortifoam (hydrocortisone acetate) is a topical corticosteroid foam for rectal use, primarily indicated for ulcerative colitis. Its foam formulation allows for better dispersion and retention in the rectum and sigmoid colon compared to enemas. For optimal efficacy, instruct patients to evacuate bowel before administration and retain foam for at least 30 minutes, preferably overnight. Systemic absorption is minimal but may increase with prolonged use or extensive mucosal damage. Monitor for adrenal suppression if used long-term or with other corticosteroids. Do not use in patients with intestinal obstruction, abscess, or perforation. |
| Patient Advice | Use exactly as prescribed; do not use more often or longer than directed. · Shake the canister well before each use. · Evacuate your bowels before applying the foam. · Insert the applicator gently into the rectum and press the plunger to release the foam. · Remain lying down for at least 30 minutes after application to allow the foam to spread. · Do not use if you have a bowel blockage, severe infection, or recent bowel surgery. · Tell your doctor if you have diabetes, high blood pressure, or a history of tuberculosis. · Contact your doctor if symptoms worsen or do not improve within 2-3 weeks. · Avoid getting the foam on your face, eyes, or broken skin. · Do not share your medication with others. |