This ear drop is indicated for the treatment of superficial bacterial and fungal infections of the external auditory canal and middle ear caused by organisms sensitive to Ofloxacin and Clotrimazole.

This is a clear, pyrogen-free, preservative-free otic solution. Each ml contains:

• Ofloxacin BP 3 mg
• Clotrimazole BP 10 mg
• Beclomethasone Dipropionate BP 0.25 mg
• Lidocaine Hydrochloride BP 20 mg

This is a combination of an antibacterial, antifungal, anti-inflammatory, and local anesthetic agent designed to maintain the natural environment of the external ear canal.

Ofloxacin is a fluoroquinolone antibiotic with broad-spectrum activity against otic pathogens and no ototoxicity. It inhibits bacterial DNA gyrase and is effective against organisms such as Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Moraxella catarrhalis, Proteus mirabilis, and Pseudomonas aeruginosa.

Clotrimazole is a broad-spectrum imidazole antifungal agent effective against Candida, Microsporum, and Trichophyton. It inhibits ergosterol synthesis, disrupting fungal cell membrane integrity. It also shows activity against some bacteria like Streptococci and Staphylococci.

Beclomethasone Dipropionate is a potent corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It inhibits phospholipase A2 and reduces inflammatory mediators such as prostaglandins and leukotrienes.

Lidocaine Hydrochloride is a local anesthetic that reduces pain and stinging in the ear.

•  Adults & Children: Instill 2-5 drops three to four times daily into the affected ear for 7-14 days.
• Otitis Externa with intact tympanic membrane: From age 06 months & older.
• Chronic Suppurative Otitis Media with perforated tympanic membrane: 12 years & older.

Instruction to use: To apply, tilt head to one side so that the ear is facing up. Then gently pull the ear lobe up & backward in case of adults and children older than 3 years. In case of pediatric patients gently pull the ear lobe down & backward.

This ear drop is contraindicated in patients with hypersensitivity to Ofloxacin, other quinolones, or any of the components of the formulation. It is also contraindicated in viral infections of the ear.

Systemic side effects are uncommon with this ear drop. However, possible adverse reactions include itching, burning, irritation, dryness, ear pain, headache, vertigo, dizziness, redness, folliculitis, hypertrichosis, acneiform eruptions, and hypopigmentation.

Safety during pregnancy and lactation has not been established. It is not known whether the active substances pass into breast milk when used topically. The potential benefit should be weighed against possible risks to the fetus or nursing infant.

• If no improvement occurs within one week, discontinue use and perform culture tests for further management.
• Prolonged use may lead to overgrowth of non-susceptible organisms.
• If irritation or sensitization develops, discontinue use.
• Persistent or recurrent otorrhea requires further evaluation to exclude underlying conditions such as cholesteatoma, foreign body, or tumor. Not for ophthalmic use.
• Not for injection.

Anti-fungal or anti-bacterial ear drops

Keep away from light and moisture. Store below 25°C.