CORTENEMA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CORTENEMA (CORTENEMA).
Corticosteroid that binds to the glucocorticoid receptor, modulating gene expression to inhibit phospholipase A2, reduce prostaglandin and leukotriene synthesis, decrease cytokine production, and suppress inflammatory cell migration and activation in the colonic mucosa.
| Metabolism | Primarily hepatic via CYP3A4; systemic absorption occurs but limited due to topical administration; metabolites are inactive. |
| Excretion | Primarily hepatic metabolism with renal excretion of inactive metabolites; <5% unchanged in urine; biliary/fecal elimination of metabolites accounts for ~80% |
| Half-life | 1.8-3.5 hours (plasma); due to rectal administration and low systemic absorption, clinical effects persist longer than plasma levels suggest |
| Protein binding | 80-90% (primarily to corticosteroid-binding globulin and albumin) |
| Volume of Distribution | 0.5-1.4 L/kg (suggests extensive tissue distribution; not clinically adjusted for rectal use) |
| Bioavailability | Approximately 30-50% (rectal); systemic absorption limited by first-pass hepatic metabolism and local retention |
| Onset of Action | 2-5 days (rectal); clinical improvement in ulcerative colitis symptoms often noted within 3-5 days of daily administration |
| Duration of Action | 24-48 hours (after once-daily dosing); clinical effect may persist up to 7 days after discontinuation due to local tissue retention |
One enema (100 mg hydrocortisone in 60 mL) administered rectally once daily, preferably at bedtime, for 21 days or until clinical response.
| Dosage form | ENEMA |
| Renal impairment | No specific dose adjustment recommended; use with caution in severe renal impairment. |
| Liver impairment | No specific dose adjustment recommended; use with caution in severe hepatic impairment. |
| Pediatric use | Not recommended for pediatric use due to lack of safety and efficacy data. |
| Geriatric use | Use with caution; monitor for fluid retention, hypertension, and hyperglycemia due to increased risk of corticosteroid side effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CORTENEMA (CORTENEMA).
| Breastfeeding | Corticosteroids are excreted in human milk in small amounts. M/P ratio not specifically available for hydrocortisone enema. With limited systemic absorption from rectal use, concentrations in breast milk are expected to be low. However, caution is advised. No known adverse effects in nursing infants at therapeutic maternal doses. |
| Teratogenic Risk | CORTENEMA (hydrocortisone enema) is a corticosteroid. In animal studies, corticosteroids have been shown to be teratogenic. However, in humans, topical administration with minimal systemic absorption is considered low risk. There are no adequate and well-controlled studies in pregnant women. Use in first trimester: theoretical risk of cleft palate; second/third trimester: risk of fetal adrenal suppression if significant systemic absorption occurs. Because systemic absorption from rectal administration is limited, risk is likely low. |
■ FDA Black Box Warning
None
| Serious Effects |
Systemic fungal infections; known hypersensitivity to any component of the product; ileocolostomy or obstruction; extensive fistulas; acute surgical abdomen.
| Precautions | Systemic corticosteroid effects possible with prolonged use; adrenal suppression; increased risk of infections; masking of infection; gastrointestinal perforation; delayed wound healing; osteoporosis; growth suppression in children; ocular effects (cataracts, glaucoma). |
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| Fetal Monitoring | Monitor maternal adrenal suppression with prolonged use. Fetal monitoring not routinely required unless maternal systemic corticosteroid exposure is significant. In neonates exposed in utero, monitor for signs of adrenal suppression. |
| Fertility Effects | No specific studies on fertility effects with rectal hydrocortisone. Systemic corticosteroids may affect fertility (e.g., menstrual irregularities) but with limited absorption from enema, significant effect is unlikely. |