Betamethasone + Clotrimazole + Gentamicin

• Approved Indications:
• Treatment of inflammatory and infectious skin conditions where mixed bacterial and fungal infections are present or suspected.
• Superficial fungal infections complicated by secondary bacterial infections.
• Dermatitis, eczema, or other inflammatory dermatoses with superimposed infection.
• Otitis externa or skin infections responsive to topical corticosteroids, antifungals, and aminoglycoside antibiotics.
• Clinically Accepted Off-Label Uses:
• Management of localized skin infections in diabetic or immunocompromised patients under medical supervision.
• Treatment of mixed superficial infections in moist areas such as intertrigo.

• Formulation and Route:
• Topical cream or ointment applied directly to affected skin areas.
• Adults and Adolescents (≥12 years):
• Apply a thin layer to the affected area 2–3 times daily.
• Duration typically 7–14 days or as directed by a healthcare provider.
• Pediatrics (<12 years):
• Use only under medical supervision; safety not well established in younger children.
• Elderly:
• Use cautiously due to thinner skin and higher risk of adverse effects.
• Special Populations:
• Avoid application on large areas or broken skin to minimize systemic absorption.
• No specific dose adjustment for renal or hepatic impairment due to topical use.
• Administration Notes:
• Clean and dry the affected area before application.
• Avoid contact with eyes, mouth, and mucous membranes.
• Do not use occlusive dressings unless prescribed.

Betamethasone is a potent corticosteroid that reduces inflammation, immune responses, and allergic reactions by modulating gene expression through glucocorticoid receptor binding. Clotrimazole is an imidazole antifungal that inhibits ergosterol synthesis, disrupting fungal cell membrane integrity and function, leading to fungal cell death. Gentamicin is an aminoglycoside antibiotic that binds to bacterial 30S ribosomal subunits, inhibiting protein synthesis and causing bacterial cell death. Together, this combination controls inflammation and combats both fungal and bacterial infections effectively.

• Absorption: Minimal systemic absorption of all three agents when applied topically on intact skin; absorption may increase with damaged skin or large application areas.
• Distribution: Primarily localized at application site; negligible systemic distribution.
• Metabolism: Betamethasone metabolized hepatically if systemically absorbed; clotrimazole metabolized in liver; gentamicin not significantly metabolized.
• Elimination: Metabolites and unchanged drugs eliminated mainly via urine (gentamicin) and feces (clotrimazole).
• Half-Life: Systemic half-lives not clinically relevant due to minimal absorption.
• Onset: Symptom improvement typically within days of consistent application.

• Pregnancy: Category C – Use topical formulation with caution only if potential benefits outweigh risks. Avoid extensive or prolonged use.
• Lactation: Unknown excretion in breast milk; topical use on limited areas generally considered low risk; avoid nipple application.

• Combination topical corticosteroid + antifungal + aminoglycoside antibiotic.
• Betamethasone: potent glucocorticoid.
• Clotrimazole: imidazole antifungal.
• Gentamicin: aminoglycoside antibiotic.

• Hypersensitivity to betamethasone, clotrimazole, gentamicin, or excipients.
• Viral skin infections (e.g., herpes simplex, varicella).
• Tuberculous or syphilitic skin infections.
• Fungal infections without bacterial component if corticosteroid use is contraindicated.
• Application on open wounds or extensive damaged skin.

• Avoid prolonged use to prevent corticosteroid-induced skin atrophy and systemic effects.
• Monitor for secondary infections, especially bacterial superinfection resistant to gentamicin.
• Use cautiously in children, elderly, and patients with impaired skin barrier.
• Discontinue if irritation, worsening infection, or hypersensitivity occurs.
• Avoid contact with eyes and mucous membranes.

• Common:
• Local burning, itching, or stinging sensation.
• Dryness or irritation at application site.
• Less Common:
• Skin atrophy or thinning with prolonged corticosteroid use.
• Allergic contact dermatitis.
• Fungal resistance with improper use.
• Rare / Serious:
• Systemic corticosteroid effects (very rare).
• Ototoxicity or nephrotoxicity unlikely with topical use but possible with systemic exposure to gentamicin.

• Minimal systemic drug interactions expected due to topical administration.
• Concomitant use of other topical corticosteroids or antifungals may increase local adverse effects.
• Avoid combining with products that disrupt skin barrier integrity.

• Emphasis on limiting duration of use and monitoring to prevent resistance and adverse effects.
• Recommended as second-line therapy for mixed superficial infections complicated by inflammation.
• Guidance supports combination therapy for better symptom control and microbial eradication.

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