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. |
| Molecular Weight | 416.5 |
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 | Avoid unless clearly needed; topical corticosteroids may be associated with cleft palate. Risk cannot be ruled out. |
| 2nd trimester | Use only if potential benefit justifies risk; prolonged use may cause fetal growth restriction. |
| 3rd trimester | Avoid prolonged use; may cause neonatal adrenal suppression or low birth weight. |
Clinical note
Comprehensive clinical and safety monograph for NEO-CORT-DOME (NEO-CORT-DOME).
| Placental transfer | Placental transfer occurs with systemic absorption. Topical use results in low systemic exposure unless applied over large areas or under occlusion. |
| Breastfeeding | Excretion into breast milk is negligible with topical application; avoid application to breast area to prevent infant ingestion. Short-term use of low potency is considered compatible. |
■ 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 any componentUntreated bacterial, fungal, viral, or parasitic infectionsPerioral dermatitisRosacea
| 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. |
| Food/Dietary | No known food interactions with topical NEO-CORT-DOME. Avoid ingestion. |
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| Lactation Rating |
| L2 (Probably Compatible) |
| 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. |
| 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. |
| Clinical Pearls | NEO-CORT-DOME combines neomycin (aminoglycoside antibiotic) and hydrocortisone (topical corticosteroid). Use for short-term treatment of inflammatory skin conditions with secondary bacterial infection. Avoid prolonged use (limit to 1-2 weeks) due to risk of skin atrophy, systemic absorption, and neomycin sensitization. Do not use on large body surface areas, broken skin, or with occlusive dressings. Monitor for ototoxicity if applied to extensively damaged skin. |
| Patient Advice | Apply a thin layer to affected area twice daily as directed. · Do not use on open wounds, burns, or infected areas without bacterial confirmation. · Avoid covering the area with bandages or dressings unless instructed by your doctor. · Stop use and inform your doctor if irritation, rash, or worsening occurs. · Do not use for more than 2 weeks unless specifically prescribed. · Keep away from eyes, mouth, and mucous membranes. · Wash hands after application to avoid spreading infection. |