Ofloxacin + Clotrimazole + Beclomethasone + Lidocaine

This combination is indicated for the treatment of mixed bacterial and fungal infections with associated inflammation and pain, particularly:

• Otitis externa (external ear infection): Caused by susceptible bacteria and fungi.
• Superficial skin infections: Where bacterial and fungal pathogens coexist with inflammation.
• Symptomatic relief of pain and itching: In infected and inflamed skin or ear canal.

Off-label uses (clinically accepted):

• Adjunct therapy for otomycosis with secondary bacterial infection.
• Inflammatory dermatoses complicated by mixed infections.

• Route: Topical application (ear drops or skin cream/ointment depending on formulation).
• Adults and adolescents (≥12 years):
• Ear drops: Instill 3–4 drops into the affected ear 2–3 times daily for 7–14 days.
• Skin application: Apply a thin layer 2–3 times daily to the affected area.
• Pediatrics (≥2 years): Use with caution and under medical supervision; dosing generally similar to adults but may be adjusted.
• Elderly: No specific dose adjustment required.
• Special populations:
• Renal or hepatic impairment: No dose adjustment necessary due to minimal systemic absorption.
• Avoid use if tympanic membrane perforation is suspected unless prescribed by a healthcare professional.
• Duration: Usually 7–14 days depending on clinical response. Avoid prolonged use to prevent adverse effects.
• Administration tips: Clean and dry the affected ear or skin area before applying medication. Avoid contamination of the dropper or applicator tip.

• Ofloxacin: A fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV enzymes, preventing bacterial DNA replication and transcription, leading to bacterial cell death.
• Clotrimazole: An antifungal agent that inhibits lanosterol 14-α-demethylase, an enzyme involved in ergosterol synthesis, disrupting fungal cell membrane integrity and causing cell death.
• Beclomethasone: A corticosteroid that binds to glucocorticoid receptors, modulating gene expression to suppress inflammation, reduce edema, and alleviate itching.
• Lidocaine: A local anesthetic that blocks voltage-gated sodium channels on nerve membranes, inhibiting nerve impulse conduction and providing rapid pain relief.

Together, these agents eradicate bacterial and fungal infections, reduce inflammation, and relieve pain and itching.

• Absorption: Minimal systemic absorption when applied topically.
• Distribution: Primarily localized to the site of application.
• Metabolism:
• Ofloxacin undergoes minimal metabolism; topical use limits systemic exposure.
• Clotrimazole is metabolized hepatically if systemically absorbed, but topical use results in negligible systemic levels.
• Beclomethasone is metabolized locally in skin and systemically in the liver if absorbed.
• Lidocaine is metabolized in the liver, but systemic absorption is negligible with topical use.
• Elimination: Mostly renal excretion for absorbed ofloxacin; negligible systemic elimination for topical use of other components.
• Onset: Lidocaine provides analgesia within minutes; antimicrobial and anti-inflammatory effects develop over days with consistent use.

• Pregnancy:
• Use only if clearly needed and benefits outweigh risks.
• Ofloxacin is FDA category C; fluoroquinolones generally avoided during pregnancy due to potential fetal risks.
• Clotrimazole topical use is considered low risk.
• Beclomethasone topical use in pregnancy is generally considered low risk but should be used cautiously.
• Lidocaine topical use is considered relatively safe.
• Lactation:
• Minimal systemic absorption suggests low risk to nursing infants.
• Use with caution; avoid applying on or near the breast to prevent infant exposure.
• Note: Limited human data; use under medical supervision.

• Combination topical antimicrobial and anti-inflammatory agent with local anesthetic.
• Components:
• Ofloxacin: Fluoroquinolone antibiotic
• Clotrimazole: Imidazole antifungal
• Beclomethasone: Topical corticosteroid
• Lidocaine: Local anesthetic

• Hypersensitivity to ofloxacin, clotrimazole, beclomethasone, lidocaine, or any formulation excipients.
• Known or suspected tympanic membrane perforation (unless specifically prescribed).
• Viral infections of the skin or ear (e.g., herpes simplex).
• Tuberculous infections of the ear or skin.
• Untreated fungal infections without appropriate antifungal therapy.

• Avoid prolonged use to prevent corticosteroid-induced skin thinning or secondary infections.
• Use with caution in patients with a history of hypersensitivity to any component.
• Discontinue if signs of hypersensitivity or worsening infection develop.
• Avoid contact with eyes and mucous membranes.
• Monitor for local irritation or allergic reactions.
• Not recommended for use in infants under 2 years unless prescribed.
• Avoid use if ear discharge or tympanic membrane perforation is suspected without medical advice.

• Common:
• Mild burning, stinging, itching, or irritation at the application site.
• Dryness or redness.
• Serious/Rare:
• Allergic reactions such as rash, urticaria, or anaphylaxis.
• Secondary infections due to immunosuppression from corticosteroid.
• Local skin atrophy or telangiectasia with prolonged use.
• Rare systemic toxicity from lidocaine if absorbed in large amounts.
• Onset: Usually occurs within minutes to days after starting therapy; dose-dependent.

• Minimal systemic absorption reduces the likelihood of systemic drug interactions.
• Avoid concomitant use with other ototoxic or topical corticosteroid agents.
• Clotrimazole may inhibit CYP3A4 enzymes moderately, but topical use is unlikely to cause significant interactions.
• Caution with other local anesthetics to avoid additive toxicity.
• Avoid alcohol consumption if irritation or systemic absorption is suspected.

• Current otitis externa management guidelines support combined antimicrobial and corticosteroid therapy for effective symptom control.
• Emphasis on limiting corticosteroid use duration to minimize side effects.
• No recent changes in approved indications or dosing protocols reported.
• Monitoring for antimicrobial resistance is advised with fluoroquinolone use.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from light, moisture, and excessive heat.
• Keep the container tightly closed.
• Do not freeze.
• Shake well before use if the product is a suspension.
• Keep out of reach of children.
• Discard unused medication after the prescribed course.