Indications

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 Offoxacin and
Clotrimazole.

Composition

This ear drop 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.

Pharmacology

it is a combination of an antibacterial, an antifungal, an anti-inffammatory and a topical local anesthetie agent. This ear drop has been specially formulated to maintain the natural environment of the external ear
eanal.

Offoxacin is a ffuoroquinolone that has a broad spectrum of activity against otic pathogens without ototoxicity. Hence Offoxacin is preferred to Aminoglycosides for any application within the middle ear space.
Ofloxacin exerts antibacteral activity by inhibiting DNA gyrase of bacteria. Offoxacin has been shown to be active against the following organisms responsible for otie infections: Gram-positive: Staphylococcus
aureus, Streptococeus 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 Staphylococdi. The antibacterial effect of Clotrimazole is advantageous to treat mixed bacterial-fungal infections.

Beelomethasone Dipropionate is a potent steroid as compared with other topical corticosteroids. Beclomethasone like other topical corticosteroids, has anti-inflammatory, antipruritie, and vasoconstrictive
properties. It induces phospholipase A2 and sequentially inhibits the release of arachidonie 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.

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Dosage & Administration

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 tympanie 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 pediatrie patients gently pull
the car lobe down & backward.

Contraindications

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

Side Effects

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

Pregnancy & Lactation

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.

Precautions & Warnings

. It afavorable response does not occur in one week, discontinue the use of Otoxin 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 ocours, discontinue Otoxin and institute appropriate therapy.
It otorrhea porsists after a full course of therapy, or it two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as
cholesteaoma, foreign body, or a tumor.
. Not for Ophthalmic use. Not for injection.

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Therapeutic Class

Anti-fungal or anti-bacterial ear drops

Storage Conditions

Keep away from light and moisture, store below 25"C.