OTO-4

• Fungal eye infections

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

N/A

This ear drop is contraindicated in patients with sensitive to Ofloxacin or other quinolone, or to any of the components of this medications. It is contra-indicated in viral infections of the ear.

It is a combination of an antibacterial, an antifungal, an anti-inflammatory and a topical local anesthetic agent. This ear drop has been specially formulated to maintain the natural environment of the external ear canal.Ofloxacin is a fluoroquinolone that has a broad spectrum of activity against otic pathogens without ototoxicity. Hence Ofloxacin is preferred to Aminoglycosides for any application within the middle ear space. Ofloxacin exerts antibacterial activity by inhibiting DNA gyrase of bacteria. Ofloxacin has been shown to be active against the following organisms responsible for otic infections: Gram-positive: Staphylococcus aureus, Streptococcus pneumoniae. Gram-negative: Escherichia coli, Haemophilus influenzae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa.Clotrimazole is a synthetic imidazole derivative, which is a broad-spectrum antifungal agent that exerts fungicidal activity against fungi responsible for superficial mycotic infections affecting the outer or middle ear including Candida, Microsporum & Trichophyton. Clotrimazole inhibits Cytochrome P-450 synthesis of Ergosterol, which decreases fungal cell wall integrity thus inhibits fungal growth. Clotrimazole also has activity against certain bacteria such as Streptococci and Staphylococci. The antibacterial effect of Clotrimazole is advantageous to treat mixed bacterial-fungal infections.Beclomethasone Dipropionate is a potent steroid as compared with other topical corticosteroids. Beclomethasone like other topical corticosteroids, has anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces phospholipase A2 and sequentially inhibits the release of arachidonic acid, thereby depressing the formation, release, and activity of prostaglandins, leukotrienes, and other inflammatory mediators.Lidocaine Hydrochloride is a topical local anesthetic which helps to reduce pain and stinging in the ear.

The systemic side-effects are not common with this ear drops. The following adverse reactions may be observed when using this product: itching, burning, irritation, dryness, earache, headache, vertigo, dizziness, redness, folliculitis, hypertrichosis, acne form eruptions and hypopigmentation.

Safety during pregnancy or lactation has not been established. It is not known whether the active substances pass into breast milk when applied topically. Therefore, the potential benefit of this product during pregnancy or lactation, should be weighed against possible hazard to the fetus or the nursing infant.

If a favorable response does not occur in one week, discontinue the use of this preparation and obtain cultures to guide further treatment. As with other anti-infective preparations, prolonged use may result in overgrowth of nonsusceptible organisms. If local irritation or sensitization occurs, discontinue this preparation and institute appropriate therapy. If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor. Not for Ophthalmic use. Not for injection.