Audicare Ear Drop (Ofloxacin USP 0.3% + Clotrimazole BP 1%

Audicare is a combination of Ofloxacin (antibacterial), Clotrimazole (antifungal), Beclometasone (anti-inflammatory), and Lidocaine (local anesthetic). Ofloxacin is a fluoroquinolone that exerts its antibacterial activity by inhibiting the DNA gyrase enzyme of bacteria. Clotrimazole is a synthetic imidazole derivative that shows fungicidal activity by inhibiting the biosynthesis of ergosterol which is an important ingredient required for fungal cell wall synthesis & thus it inhibits fungal growth. Beclometasone Dipropionate is a potent steroid that gives an anti-inflammatory effect by blocking the formation, release, and activity of prostaglandins, leukotrienes, and other inflammatory mediators. Lidocaine Hydrochloride is a topical local anesthetic that helps to reduce pain and stinging in the ear by inhibiting pain signal conduction.

Description

Audicare is a combination of four drugs: Ofloxacin (antibacterial), Clotrimazole (antifungal), Beclometasone (anti-inflammatory), and Lidocaine (local anesthetic). This ear drop has been specially formulated to maintain the natural environment of the external & middle ear. Ofloxacin is a fluoroquinolone that exerts its antibacterial activity by inhibiting the DNA gyrase enzyme of bacteria. Clotrimazole is a synthetic imidazole derivative that shows fungicidal activity by inhibiting the biosynthesis of ergosterol which is an important ingredient required for fungal cell wall synthesis & thus it inhibits fungal growth. Beclometasone Dipropionate is a potent steroid that gives an anti-inflammatory effect by blocking the formation, release, and activity of prostaglandins, leukotrienes, and other inflammatory mediators. Lidocaine Hydrochloride is a topical local anesthetic that helps to reduce pain and stinging in the ear by inhibiting pain signal conduction.

Presentation

Audicare Ear Drops: Each ml contains Ofloxacin USP 3 mg, Clotrimazole BP 10 mg, Beclometasone Dipropionate BP 0.25 mg, and Lidocaine Hydrochloride USP 20 mg.

Indications

Audicare 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.

Dosage & Administration

Adults & Children: Instill 2-5 drops into the affected ear 3-4 times daily for 7-14 days. * In the case of otitis externa with intact tympanic membrane, it can be used from the age of 6 months and older. * In case of chronic suppurative otitis media with perforated tympanic membrane, it should be used from the age of 12 years & older.

ADMINISTRATION PROCEDURE: To administer, position the head so that the ear faces upward – For adults and children older than 3 years: then gently pull the upper ear up and back. For children younger than 3 years: then gently pull the lower ear down and back.

Contrainidications

Audicare Ear Drop is contraindicated in patients with sensitivity to Ofloxacin or other quinolones, or to any of the components of this medication. It is contraindicated in viral infections of the ear.

Warning & Precautions

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 the overgrowth of nonsusceptible organisms.  If local irritation or sensitization occurs, discontinue this preparation and institute appropriate therapy.

Side effects

The systemic side effects are not common with this Audicare Ear Drops. The following adverse reactions may be observed when using this product: itching, burning, irritation, dryness, earache, headache, vertigo, dizziness, redness, folliculitis, hypertrichosis, acneform eruptions, and hypopigmentation.

Drug interaction

Use in special groups

Use in Pregnancy: Safety during pregnancy has not been established. Therefore, during use in pregnancy, the risk-benefit relationship should be considered carefully.
Use in Lactation: It is not known whether the active substances pass into breast milk when applied topically. Therefore, caution should be exercised when Audicare is administered to a nursing mother.

Packing

Audicare Ear Drops: Each LDPE dropper bottle contains 10 ml ear drops.