Hydrocortisone Acetate + Neomycin Sulphate

• Topical Skin Disorders
• Inflammatory dermatoses: Eczema, dermatitis, and psoriasis with secondary bacterial infection
• Pruritus and mild allergic reactions: Reduces itching and inflammation
• Bacterial Skin Infections
• Effective against superficial skin infections caused by susceptible Gram-positive and Gram-negative bacteria
• Off-label / Clinically Accepted Uses
• Minor cuts, abrasions, and infected dermatoses
• Post-surgical wound care for superficial infections in combination with anti-inflammatory management

• Topical Administration Only
• Apply a thin layer 1–3 times daily to affected area
• Duration: up to 7–14 days, or as directed by a healthcare professional
• Reassess if no improvement within 7 days
• Special Populations
• Use caution in children due to increased risk of systemic corticosteroid absorption
• Avoid application on extensive or severely damaged skin unless medically indicated
• Administration Instructions
• Clean and dry affected area before application
• Wash hands after application to prevent accidental contact with eyes or mucous membranes

Hydrocortisone acetate is a corticosteroid that binds to glucocorticoid receptors, modulating gene transcription to inhibit pro-inflammatory cytokine production, leukocyte infiltration, and vascular permeability. Neomycin sulphate is an aminoglycoside antibiotic that binds to bacterial 30S ribosomal subunits, disrupting protein synthesis and leading to bacterial cell death. The combination provides both anti-inflammatory and antibacterial effects, reducing inflammation, itching, and bacterial colonization on affected skin.

• Absorption: Minimal systemic absorption through intact skin; increased absorption via damaged or inflamed skin
• Distribution: Primarily local; systemic exposure of hydrocortisone may occur if applied to large areas
• Metabolism: Hydrocortisone acetate is metabolized in the liver to active hydrocortisone; neomycin is poorly absorbed systemically
• Excretion: Hydrocortisone metabolites are excreted via urine; unabsorbed neomycin is excreted in feces
• Onset: Anti-inflammatory effects within hours; antibacterial effect within 24–48 hours
• Duration: Anti-inflammatory effect lasts 8–12 hours; antibacterial effect persists with continued application

• Pregnancy: Topical corticosteroid considered Category C; avoid prolonged or large-area use
• Lactation: Limited data; caution advised if applied near breast tissue
• Minimize systemic exposure to reduce potential risk to fetus or infant

• Primary therapeutic class: Topical corticosteroid + topical aminoglycoside antibiotic
• Subclass: Anti-inflammatory and antibacterial combination

• Known hypersensitivity to hydrocortisone, neomycin, or formulation excipients
• Viral, fungal, or mycobacterial skin infections without concurrent appropriate therapy
• Open wounds with risk of systemic absorption of corticosteroid or aminoglycoside

• High-risk groups: Pediatric, elderly, pregnant, or lactating patients
• Systemic absorption risk: Avoid prolonged use on large or damaged areas to prevent corticosteroid or neomycin toxicity
• Nephrotoxicity/ototoxicity risk: Rare systemic absorption of neomycin can cause renal or auditory issues
• Monitoring: Watch for signs of local irritation, secondary infections, or hypersensitivity reactions

• Local: Burning, stinging, erythema, dryness, or itching
• Dermatologic: Skin thinning, striae, telangiectasia with prolonged corticosteroid use
• Allergic: Contact dermatitis or hypersensitivity reactions
• Rare/Serious: Secondary infections, systemic corticosteroid effects, nephrotoxicity or ototoxicity (rare)

• Other topical corticosteroids: Increased risk of local or systemic corticosteroid effects
• Other nephrotoxic or ototoxic drugs: Rare risk if significant systemic absorption of neomycin occurs
• Minimal systemic CYP450 interactions expected

• Recommendations emphasize short-term use to limit local and systemic adverse effects
• Avoid prolonged use in children and pregnant women
• Labeling updated to highlight risk of hypersensitivity to neomycin and potential corticosteroid-related skin thinning
• Use only thin layers and avoid occlusive dressings unless directed

• Store at 20°C to 25°C (room temperature)
• Protect from light, moisture, and heat
• Keep container tightly closed and out of reach of children
• Avoid freezing and contamination