NEO-CORTEF
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NEO-CORTEF (NEO-CORTEF).
Neomycin is an aminoglycoside antibiotic that binds to the 30S ribosomal subunit, inhibiting bacterial protein synthesis. Hydrocortisone is a corticosteroid that binds to glucocorticoid receptors, modulating gene expression to suppress inflammation and immune response.
| Metabolism | Neomycin: Not significantly metabolized; excreted unchanged in urine. Hydrocortisone: Primarily hepatic via CYP3A4; metabolized to tetrahydrocortisone and other inactive metabolites. |
| Excretion | Renal (70-80% as free drug and metabolites), fecal (20-30% via bile). |
| Half-life | Terminal half-life 2-4 hours for neomycin; hydrocortisone half-life 1-2 hours. Clinical context: q6-8h dosing. |
| Protein binding | Neomycin: 0-30% (low); hydrocortisone: 90-95% (corticosteroid-binding globulin and albumin). |
| Volume of Distribution | Neomycin: 0.3 L/kg (confined to extracellular fluid); hydrocortisone: 0.4 L/kg (distributes into total body water). |
| Bioavailability | Topical/ophthalmic/aural: negligible systemic absorption (~1-5%); oral neomycin: 3% (mainly local effects). |
| Onset of Action | Topical: 2-7 days for anti-inflammatory effect; ophthalmic: 1-2 hours; aural: 2-3 days. |
| Duration of Action | Topical: 1-2 weeks of therapy often needed; ophthalmic: 4-8 hours per dose; aural: 3-7 days for symptom relief. |
Apply a thin layer to the affected area 3 to 4 times daily. Use the 0.5% strength for mild conditions and 1% for more severe conditions.
| Dosage form | OINTMENT |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Apply a thin layer to affected area 3 to 4 times daily. Use the lowest effective potency and shortest duration due to increased systemic absorption risk. Safety and efficacy in infants < 3 months not established. |
| Geriatric use | Use with caution due to increased risk of skin atrophy and systemic effects. Apply sparingly to limited areas, using the lowest effective potency for the shortest duration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NEO-CORTEF (NEO-CORTEF).
| Breastfeeding | Small amounts of hydrocortisone may be excreted in breast milk; negligible absorption from topical use. Neomycin is poorly absorbed orally; however, systemic absorption after topical application is minimal. Risk to infant is low with short-term, limited area use. M/P ratio not established. Avoid application to breast or nipple area. |
| Teratogenic Risk | NEO-CORTEF (neomycin and hydrocortisone) is pregnancy category C. Neomycin: Not teratogenic in animal studies but may cause fetal nephrotoxicity or ototoxicity if absorbed significantly. Hydrocortisone: Corticosteroids are associated with increased risk of orofacial clefts (first trimester), intrauterine growth restriction, and adrenal suppression in the neonate. Avoid topical use on large areas, broken skin, or prolonged use during pregnancy. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to neomycin, hydrocortisone, or any component of the formulation.","Viral infections of the cornea (e.g., epithelial herpes simplex keratitis), vaccinia, varicella.","Mycobacterial infections of the eye.","Fungal diseases of ocular structures.","Uncontrolled ocular hypertension/glaucoma.","Perforated tympanic membrane (for otic preparations)."]
| Precautions | ["Prolonged use may lead to ocular hypertension (IOP increase), glaucoma, cataract formation, or secondary ocular infections.","Neomycin may cause ototoxicity and nephrotoxicity if absorbed systemically, especially with prolonged use or in patients with renal impairment.","Avoid use in patients with epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, or fungal diseases of the eye.","Use with caution in patients with perforated tympanic membrane (for otic preparations) due to risk of ototoxicity."] |
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| Fetal Monitoring | Monitor maternal blood pressure, blood glucose, and signs of infection. In prolonged or high-dose use, assess fetal growth via ultrasound. Neonates should be monitored for signs of adrenal suppression (e.g., hypoglycemia, lethargy) if high-potency corticosteroids were used extensively. |
| Fertility Effects | No direct effect on fertility reported with topical corticosteroids or neomycin. Systemic corticosteroids may affect ovulation or sperm parameters at high doses; topical use unlikely to impact fertility. |