Betnova-N

• Approved Indications:
• Topical treatment of inflammatory skin conditions with secondary bacterial infection or high risk of bacterial superinfection.
• Dermatitis, eczema, psoriasis, or other corticosteroid-responsive dermatoses complicated by superficial bacterial infections.
• Minor skin infections where anti-inflammatory and antibacterial effects are simultaneously required.
• Clinically Accepted Off-Label Uses:
• Treatment of weeping or exudative skin lesions with inflammation and bacterial colonization.
• Adjunctive therapy in localized infected wounds or burns under medical supervision.

• Formulation and Route:
• Topical cream or ointment applied directly to affected skin areas.
• Adults and Adolescents (≥12 years):
• Apply a thin layer 2–3 times daily to the affected area.
• Duration typically 7–14 days or as advised by a healthcare professional.
• Pediatrics (<12 years):
• Use only under medical supervision due to risk of systemic toxicity and sensitization.
• Elderly:
• Use cautiously with attention to skin fragility.
• Special Populations:
• Avoid use on large areas or broken skin to minimize systemic absorption and toxicity.
• No specific dose adjustments required for renal or hepatic impairment due to topical use.
• Administration Notes:
• Clean and dry affected area before application.
• Avoid contact with eyes, mucous membranes, and open wounds unless directed.

Betamethasone is a potent corticosteroid that suppresses inflammatory and immune responses by binding to intracellular glucocorticoid receptors, modulating gene expression to reduce cytokine production, inflammatory cell infiltration, and allergic reactions. Neomycin sulphate is an aminoglycoside antibiotic that binds irreversibly to bacterial 30S ribosomal subunits, inhibiting protein synthesis, which leads to bacterial cell death. The combination provides anti-inflammatory effects alongside broad-spectrum antibacterial action, helping to reduce inflammation while controlling bacterial infection.

• Absorption: Minimal systemic absorption when applied topically on intact skin; absorption may increase with prolonged use, damaged skin, or occlusion.
• Distribution: Localized primarily to skin at application site; negligible systemic distribution.
• Metabolism: Betamethasone metabolized hepatically if absorbed; neomycin poorly absorbed systemically, not metabolized significantly.
• Elimination: Betamethasone metabolites eliminated via urine and feces; neomycin excreted unchanged primarily by kidneys if systemic absorption occurs.
• Half-Life: Systemic half-life not clinically significant due to minimal absorption.
• Onset: Symptomatic relief generally observed within days of use.

• Pregnancy: Category C – Topical use only if potential benefits outweigh risks; avoid extensive or prolonged application.
• Lactation: Minimal systemic absorption suggests low risk; however, avoid application on breast area during breastfeeding to prevent infant exposure.

• Combination topical corticosteroid and aminoglycoside antibiotic.
• Betamethasone: potent glucocorticoid anti-inflammatory agent.
• Neomycin sulphate: aminoglycoside antibacterial agent.

• Known hypersensitivity to betamethasone, neomycin, or any excipients.
• Viral skin infections (e.g., herpes simplex, chickenpox).
• Tuberculous or fungal skin infections unless combined with appropriate therapy.
• Open wounds or extensive damaged skin (risk of systemic absorption and toxicity).
• History of aminoglycoside-induced ototoxicity or nephrotoxicity.

• Avoid prolonged or extensive use to prevent corticosteroid-induced skin atrophy and systemic effects.
• Risk of sensitization and allergic contact dermatitis with neomycin; discontinue if rash or irritation develops.
• Use cautiously in patients with impaired skin barrier function.
• Avoid occlusive dressings unless prescribed.
• Monitor for secondary infections, especially resistant bacteria.

• Common:
• Local irritation, burning, itching, or dryness at application site.
• Mild skin atrophy or thinning with prolonged corticosteroid use.
• Less Common:
• Allergic contact dermatitis or sensitization to neomycin.
• Folliculitis.
• Rare / Serious:
• Systemic corticosteroid side effects (very rare with topical use).
• Neomycin-associated ototoxicity or nephrotoxicity (extremely rare topical exposure).
• Secondary infections due to immunosuppression.

• Minimal systemic interactions expected due to topical use.
• Concurrent use with other topical corticosteroids or aminoglycosides increases risk of local adverse effects.
• Avoid combining with products that impair skin barrier or increase systemic absorption.

• Current guidelines emphasize limiting duration of corticosteroid-antibiotic combinations to reduce resistance and adverse effects.
• Recommended as second-line topical therapy for infected inflammatory dermatoses.
• Newer formulations aim to improve skin tolerability and patient adherence.

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