Aclobet-N

• Approved Indications:
• Treatment of inflamed dermatoses complicated by secondary bacterial and fungal infections.
• Superficial mixed infections involving susceptible bacteria and fungi such as dermatophytosis, candidiasis, and impetiginized eczema.
• Inflammatory skin conditions with suspected or confirmed superimposed bacterial (especially Gram-positive organisms) and fungal infections.
• Clinically Accepted Off-Label Uses:
• Resistant or recurrent cutaneous fungal infections with inflammatory components.
• Dermatitis with bacterial colonization not responding to monotherapy.

• Adults and Adolescents (≥12 years):
• Apply a thin layer to the affected skin area once or twice daily.
• Treatment duration generally limited to 2 weeks to reduce risk of corticosteroid-related adverse effects.
• Avoid prolonged or excessive use to prevent skin atrophy or resistance development.
• Pediatrics (<12 years):
• Use only if clearly indicated and under close medical supervision.
• Duration and frequency should be limited.
• Elderly:
• Use lowest effective frequency, monitor closely for side effects.
• Special Populations:
• No dosage adjustment needed for renal or hepatic impairment due to minimal systemic absorption.
• Administration Notes:
• For topical use only.
• Avoid contact with eyes, mucous membranes, and broken skin.
• Do not cover treated areas with occlusive dressings unless prescribed.

• Clobetasol Propionate: A potent topical corticosteroid that binds to glucocorticoid receptors, modulating gene expression to suppress pro-inflammatory mediators, thus exerting anti-inflammatory, immunosuppressive, and antipruritic effects by inhibiting cytokine release and leukocyte migration.
• Neomycin Sulphate: An aminoglycoside antibiotic that binds irreversibly to the 30S subunit of bacterial ribosomes, inhibiting protein synthesis and causing bacterial cell death, primarily effective against aerobic Gram-negative and some Gram-positive bacteria.
• Nystatin: A polyene antifungal agent that binds to ergosterol in fungal cell membranes, creating pores that lead to leakage of intracellular components and fungal cell death, effective against Candida species and some other yeasts.

The combination acts synergistically to reduce inflammation and control mixed bacterial and fungal infections in dermatological conditions.

• Absorption:
  Minimal systemic absorption under normal topical use. Absorption may increase with damaged skin or prolonged use.
• Distribution:
  Limited to local skin tissues; systemic distribution negligible.
• Metabolism:
  Clobetasol metabolized hepatically if systemically absorbed; neomycin and nystatin largely remain topical with negligible systemic metabolism.
• Elimination:
  Systemic elimination negligible; neomycin and nystatin excreted unchanged if absorbed.
• Half-life:
  Not clinically relevant for topical formulations.
• Onset:
  Clinical improvement usually observed within days of application.

• Pregnancy:
• Classified as Category C for corticosteroid component.
• Use only if benefits justify risks; minimal systemic absorption suggests low fetal risk with topical use.
• Lactation:
• Limited data; minimal systemic absorption suggests low risk, but caution advised to avoid nipple contact.
• Note: Use during pregnancy and breastfeeding only under medical supervision.

• Primary Class: Combination topical corticosteroid, antibiotic, and antifungal agent
• Subclass:
• Clobetasol Propionate: High-potency corticosteroid
• Neomycin Sulphate: Aminoglycoside antibiotic
• Nystatin: Polyene antifungal

• Known hypersensitivity to clobetasol, neomycin, nystatin, or excipients.
• Viral skin infections (e.g., herpes simplex, varicella).
• Tuberculous or syphilitic skin infections.
• Fungal infections not susceptible to nystatin.
• Perforated eardrum when used otically.
• Pre-existing skin atrophy or ulceration at the application site.

• Avoid prolonged use to prevent skin atrophy, striae, and systemic corticosteroid effects.
• Monitor for signs of allergic contact dermatitis, especially with neomycin due to sensitization risk.
• Use cautiously in patients with large affected areas or damaged skin to minimize systemic absorption.
• Risk of bacterial resistance with inappropriate or prolonged antibiotic use.
• Discontinue treatment if secondary infections worsen or hypersensitivity develops.
• Avoid occlusive dressings unless specifically directed.
• Not recommended for use on face, groin, or axilla unless directed by a physician.

• Common: Burning, itching, irritation, dryness at application site.
• Less common: Skin atrophy, telangiectasia, folliculitis, hypopigmentation.
• Rare: Allergic contact dermatitis, secondary infections, ototoxicity (rare, if used otically).
• Serious: Systemic corticosteroid effects with prolonged use (e.g., HPA axis suppression).

• Minimal systemic interactions due to topical administration.
• Concurrent use with other topical corticosteroids may increase risk of local adverse effects.
• Systemic absorption of neomycin may potentiate nephrotoxicity and ototoxicity with other nephrotoxic or ototoxic drugs if absorbed systemically (rare).
• Avoid concomitant use with other topical antibiotics unless prescribed.

• Current dermatology guidelines recommend limiting corticosteroid-antibiotic-antifungal combinations to short-term use (≤2 weeks).
• Emphasis on avoiding prolonged use due to resistance and side effect risks.
• Updated safety warnings emphasize neomycin allergy potential and need for cautious use in sensitized patients.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from light and moisture.
• Keep container tightly closed.
• Do not freeze.
• Keep out of reach of children.