Beclomethasone Dipropionate + Chloramphenicol + Clotrimazole + Lidocaine

This fixed-dose topical combination is indicated for the treatment of inflammatory dermatoses complicated by bacterial and/or fungal infections, particularly where symptomatic relief such as pain or itching is also required.

Approved and Common Clinical Uses:

• Tinea corporis, cruris, and pedis with secondary inflammation
• Cutaneous candidiasis (moniliasis)
• Infected eczema and intertrigo
• Otitis externa caused by susceptible fungi and/or bacteria
• Mixed infections involving Candida albicans, Staphylococcus aureus, or dermatophytes
• Infected allergic contact or irritant dermatitis
• Infected psoriasis (localized, non-extensive)
• Relief of pain, itching, redness, and inflammation associated with superficial skin infections

Adults and Elderly:

• Apply a thin layer to the affected area 2–3 times daily, gently massaging it into the skin.
• For otic use (ear infections), instill 2–3 drops into the affected ear canal 2 to 3 times daily.
• Duration: Limit use to 7–10 days; reassess if no improvement.

Pediatric Population:

• Children >2 years: Apply twice daily under physician supervision.
• Avoid in infants <2 years unless specifically prescribed.

Special Groups:

• Renal/Hepatic impairment: No dosage adjustment typically required due to limited systemic absorption. Caution with prolonged use.

Route of Administration: Topical (cutaneous or otic). Not for ophthalmic, oral, or intravaginal use.

Each active ingredient contributes a specific action:

• Beclomethasone Dipropionate: A high-potency corticosteroid that inhibits inflammatory mediators such as prostaglandins and leukotrienes by suppressing phospholipase A2 activity. This reduces local inflammation, erythema, and pruritus.
• Chloramphenicol: A broad-spectrum bacteriostatic antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, effective against Staphylococcus aureus and other skin pathogens.
• Clotrimazole: An imidazole antifungal that inhibits ergosterol synthesis in fungal cell membranes, leading to increased permeability and cell death, particularly effective against Candida and dermatophytes.
• Lidocaine: A local anesthetic that blocks voltage-gated sodium channels in neuronal membranes, inhibiting pain signal propagation to provide rapid symptom relief.

Due to its topical use, systemic absorption is generally low. However, absorption may increase with damaged skin, prolonged use, or occlusive dressing.

• Absorption:
• Beclomethasone: Minimal through intact skin; enhanced if used on broken skin or with occlusion.
• Chloramphenicol: Minimal unless applied over large, open wounds.
• Clotrimazole: Systemic absorption is <0.5%.
• Lidocaine: May be absorbed in varying degrees; more so on mucous membranes or inflamed skin.
• Distribution: If absorbed, systemic distribution may occur, but typically minimal.
• Metabolism:
• Beclomethasone and Clotrimazole: Metabolized in the liver.
• Chloramphenicol: Undergoes hepatic glucuronidation.
• Lidocaine: Metabolized via CYP1A2 and CYP3A4.
• Excretion: Primarily renal; Lidocaine and Chloramphenicol may also undergo biliary elimination.

• Pregnancy:
• Beclomethasone: Category C (FDA) — potential fetal risks; avoid prolonged use during pregnancy.
• Chloramphenicol: Contraindicated systemically in late pregnancy; avoid topical use over large areas.
• Clotrimazole: Topical use generally considered safe.
• Lidocaine: Use with caution; topical use in small quantities is generally considered low risk.
• Lactation:
• Avoid application to the breast area to prevent infant exposure.
• Systemic absorption from topical use is minimal, but caution is recommended.
• Monitor infants for potential effects if applied on large areas or under occlusion.

• Primary Class: Topical Anti-infective with Corticosteroid
• Subclasses:
• Corticosteroid: Beclomethasone Dipropionate (high potency)
• Antibiotic: Chloramphenicol (broad-spectrum, bacteriostatic)
• Antifungal: Clotrimazole (imidazole class)
• Local Anesthetic: Lidocaine (amide-type)

• Hypersensitivity to any component of the formulation
• Viral infections of the skin (e.g., herpes simplex, varicella)
• Tuberculosis or syphilitic lesions in the area of application
• Ophthalmic use (not for eyes)
• Perforated tympanic membrane (when used in ear)
• Application over deep or extensive wounds
• Use in children under 2 years without medical supervision

• Prolonged use may cause systemic corticosteroid effects including adrenal suppression, especially in children.
• Avoid occlusive dressings unless prescribed, to minimize systemic absorption.
• Risk of ototoxicity with Chloramphenicol and Lidocaine if tympanic membrane is perforated.
• Superinfection: Prolonged use may lead to bacterial or fungal overgrowth.
• Use with caution in pregnancy and lactation.
• Discontinue if hypersensitivity, irritation, or worsening of infection occurs.

Common Local Reactions:

• Burning or stinging
• Itching
• Dryness or peeling
• Erythema or local irritation

Less Common:

• Skin thinning or atrophy (with prolonged corticosteroid use)
• Folliculitis
• Striae (stretch marks)
• Telangiectasia

Rare but Serious:

• Contact dermatitis
• Allergic reactions (rash, swelling)
• Secondary infection (fungal or bacterial)
• Ototoxicity (when used in ears with damaged tympanic membrane)
• Adrenal suppression with excessive use

• Lidocaine: Increased CNS depressant effects with other anesthetics or antiarrhythmic drugs (if absorbed).
• Chloramphenicol: Risk of hematologic toxicity if significantly absorbed and used concurrently with systemic drugs such as phenytoin, warfarin, or sulfonylureas.
• Topical Interactions: Avoid simultaneous use with other topical steroids, antibiotics, or antifungals unless advised, to prevent irritation or reduced efficacy.

Enzyme Involvement:

• Lidocaine is metabolized via CYP1A2 and CYP3A4.
• Chloramphenicol undergoes hepatic glucuronidation.

• No major changes in regulatory status or indication by FDA, EMA, or WHO in the past 12 months.
• Clinical recommendations emphasize short-term use, avoiding unsupervised application, and discouraging self-medication in fungal-only infections.

• Store at 15°C to 25°C (room temperature)
• Protect from light and moisture
• Do not freeze
• Keep container tightly closed when not in use
• For ear drops: Shake well before use if suspension
• Use within 30 days of opening (for otic formulations or creams in tubes)