NEO-CORT-DOME
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NEO-CORT-DOME (NEO-CORT-DOME).
Neomycin is an aminoglycoside antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. Hydrocortisone is a corticosteroid that exerts anti-inflammatory and immunosuppressive effects by binding to glucocorticoid receptors and modulating gene expression.
| Metabolism | Neomycin is minimally metabolized; primarily excreted unchanged in urine. Hydrocortisone is metabolized in the liver via reduction and conjugation. |
| Excretion | Renal excretion of hydrocortisone metabolites (primarily conjugated as glucuronides and sulfates) accounts for >90% of elimination; <5% biliary/fecal. |
| Half-life | 2–3 hours (terminal elimination half-life of hydrocortisone); clinically, duration of action is longer due to intracellular receptor binding. |
| Protein binding | 90–95% bound to corticosteroid-binding globulin (CBG) and albumin. |
| Volume of Distribution | 0.4–0.6 L/kg (hydrocortisone); indicates distribution into total body water. |
| Bioavailability | Topical: minimal systemic bioavailability (<1%) with intact skin, but may increase with damaged skin or occlusion; oral: ~96% (hydrocortisone). |
| Onset of Action | Topical: 2–4 hours for anti-inflammatory effect; systemic absorption minimal with intact skin. |
| Duration of Action | Topical: 24–36 hours with appropriate dosing frequency; clinical effect persists beyond plasma half-life due to receptor-mediated activity. |
Apply topically to affected area twice daily.
| Dosage form | SUSPENSION/DROPS |
| Renal impairment | No adjustment required. Minimal systemic absorption. |
| Liver impairment | No adjustment required. Minimal systemic absorption. |
| Pediatric use | Apply topically to affected area twice daily. Use lowest effective dose for shortest duration. |
| Geriatric use | Apply topically to affected area twice daily. Use lowest effective dose for shortest duration due to increased skin fragility. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NEO-CORT-DOME (NEO-CORT-DOME).
| Breastfeeding | Hydrocortisone is excreted in breast milk in low amounts; neomycin is poorly absorbed orally but may affect infant gut flora. No M/P ratio available. Caution advised; avoid prolonged application to large areas or broken skin. Use only if clearly needed. |
| Teratogenic Risk | Neo-Cort-Dome (neomycin, hydrocortisone) pregnancy category C. First trimester: no adequate human studies; animal studies show potential for fetal harm (neomycin: possible ototoxicity; hydrocortisone: cleft palate). Second/third trimester: prolonged maternal use of corticosteroids may cause fetal adrenal suppression; neomycin may be associated with fetal ototoxicity. Risk-benefit assessment required. |
■ FDA Black Box Warning
Neomycin is potentially nephrotoxic and ototoxic, especially when applied to large areas, broken skin, or under occlusive dressings. Absorption may occur, leading to systemic toxicity.
| Serious Effects |
["Hypersensitivity to neomycin, hydrocortisone, or any component","Perforated eardrum","Herpes simplex, vaccinia, varicella, or fungal infections of the skin"]
| Precautions | Prolonged use may lead to overgrowth of nonsusceptible organisms, including fungi. Systemic absorption of corticosteroids can cause reversible HPA axis suppression. Avoid use in eyes or mucous membranes. Monitor for signs of ototoxicity or nephrotoxicity with extensive use. |
Loading safety data…
| Fetal Monitoring | Monitor maternal adrenal suppression if used long-term or in high doses. For fetus/infant: assess for growth restriction (if high-dose corticosteroids), hearing deficits (neomycin). No specific fetal monitoring required for short-term topical use. |
| Fertility Effects | No known adverse effects on fertility from topical neomycin or low-dose hydrocortisone. High-dose systemic corticosteroids may disrupt menstrual cycles or spermatogenesis; however, topical use with minimal systemic absorption is unlikely to impact fertility. |