NEO-DELTA-CORTEF
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NEO-DELTA-CORTEF (NEO-DELTA-CORTEF).
Corticosteroid with potent anti-inflammatory, immunosuppressive, and antiallergic effects. Binds to glucocorticoid receptors, modulating gene expression to inhibit phospholipase A2, reduce prostaglandin and leukotriene synthesis, and suppress cytokine production.
| Metabolism | Primarily hepatic via CYP3A4; undergoes reduction, hydrolysis, and conjugation; metabolites excreted in urine and bile. |
| Excretion | Renal: 70-80% as metabolites; biliary: 10-15%; fecal: <5% |
| Half-life | Prednisolone: 2-4 hours; clinical context: adrenal suppression lasts 24-36 hours, requiring tapering |
| Protein binding | Prednisolone: 70-90% bound to corticosteroid-binding globulin (CBG) and albumin; prednisone: 70% bound to CBG |
| Volume of Distribution | Prednisolone: 0.4-1.0 L/kg; clinically indicates extensive distribution into tissues |
| Bioavailability | Oral: 70-90% (prednisone converted to prednisolone); IM: 100% |
| Onset of Action | IV: 1-2 minutes; IM: 1-2 hours; oral: 1-2 hours; topical: rapid (minutes) for anti-inflammatory effect |
| Duration of Action | IV: 2-4 hours; oral: 12-36 hours (due to HPA axis suppression); topical: 2-4 hours per application; clinical note: duration depends on dose and duration of therapy |
1-2 drops into the conjunctival sac every 1-2 hours during the day and every 2 hours at night initially, then reduce frequency as inflammation subsides.
| Dosage form | OINTMENT |
| Renal impairment | No dosage adjustment required for renal impairment. |
| Liver impairment | No specific dosage adjustment recommended; use with caution in severe hepatic impairment. |
| Pediatric use | 1 drop into the conjunctival sac every 1-2 hours; use lowest effective dose for shortest duration. |
| Geriatric use | No specific dose adjustment; monitor for increased intraocular pressure and corticosteroid adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NEO-DELTA-CORTEF (NEO-DELTA-CORTEF).
| Breastfeeding | Enters breast milk. M/P ratio not established for neomycin/polymyxin B combination; prednisolone M/P ratio ~0.1. Generally considered compatible during lactation at typical doses, but avoid applying to breast area to minimize infant ingestion. Monitor infant for signs of adrenal suppression if maternal systemic absorption is high. |
| Teratogenic Risk | First trimester: Increased risk of cleft palate (approximately 3-5 fold increase, absolute risk 0.1-0.2%). Second and third trimesters: Risk of intrauterine growth restriction, adrenal suppression, and potential hypothalamic-pituitary-adrenal axis suppression in neonate. Chronic use may lead to oligohydramnios due to fetal renal effects. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to any component.","Active ocular infections (fungal, viral including herpes simplex, bacterial) without concurrent antimicrobial therapy.","Corneal epithelial defects or ulcers."]
| Precautions | ["Increased intraocular pressure (IOP) with prolonged use; monitor IOP.","Corneal thinning and perforation risk, especially in keratitis.","Cataract formation with long-term use.","Suppression of local immune response; risk of secondary infections (e.g., fungal, viral).","Systemic absorption possible with extensive use; adrenal suppression unlikely but caution in large doses."] |
Loading safety data…
| Fetal Monitoring | Monitor maternal blood pressure and glucose levels due to corticosteroid effects. Assess fetal growth via ultrasound if used chronically. Newborns exposed in utero should be monitored for adrenal insufficiency, hypocalcemia, and signs of infection. |
| Fertility Effects | No direct evidence of impaired fertility. High-dose corticosteroids may disrupt menstrual cycle and ovulation transiently. Neomycin and polymyxin B are not known to affect fertility. |