Otoxin Ear Drop

Indications

This ear drop is specifically designed to treat superficial bacterial and fungal infections affecting the external auditory canal and middle ear, caused by organisms susceptible to Ofloxacin and Clotrimazole.
Use medication only as directed by a registered physician.

Composition

This clear, pyrogen-free, preservative-free otic solution contains the following per ml:

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

Pharmacology

This formulation combines an antibacterial, antifungal, anti-inflammatory, and local anesthetic agent. It is crafted to maintain the natural balance of the external ear canal.

• Ofloxacin, a fluoroquinolone, offers a broad-spectrum antibacterial activity without ototoxicity. It inhibits bacterial DNA gyrase and is effective against pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, and Pseudomonas aeruginosa.
• Clotrimazole, a synthetic imidazole, acts as a broad-spectrum antifungal, combating infections from fungi like Candida, Microsporum, and Trichophyton. It also inhibits certain bacteria such as Streptococci and Staphylococci, making it useful for mixed bacterial-fungal infections.
• Beclomethasone Dipropionate is a potent corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It suppresses the release of inflammatory mediators by inhibiting phospholipase A2 and prostaglandin formation.
• Lidocaine Hydrochloride provides rapid local anesthesia, relieving pain and discomfort in the ear.

Dosage & Administration

• Adults & Children: Apply 2-5 drops in the affected ear 3-4 times daily for 7-14 days.
• Otitis Externa: For patients aged 6 months and older.
• Chronic Suppurative Otitis Media: For patients 12 years and older with a perforated tympanic membrane.

Application Instructions

Tilt the head to one side with the ear facing upward.

• For adults and children over 3 years: Gently pull the ear lobe up and back.
• For younger children: Pull the ear lobe down and back.

Use medication only as directed by a registered physician.

Contraindications

Do not use in individuals allergic to Ofloxacin, other quinolones, or any of the ingredients. It is also contraindicated in viral ear infections.

Side Effects

While systemic side effects are rare, localized reactions such as itching, irritation, burning, headache, vertigo, dizziness, and redness may occur.

Pregnancy & Lactation

The safety of this product during pregnancy or breastfeeding is not established. It is unknown whether the active ingredients pass into breast milk. Weigh the benefits against potential risks when considering use during pregnancy or lactation.

Precautions & Warnings

• Discontinue use if no improvement is seen after one week and consider alternative treatments.
• Prolonged use may lead to the overgrowth of non-susceptible organisms.
• In case of local irritation or sensitization, stop using the ear drops and initiate appropriate therapy.
• If symptoms persist or reoccur frequently, further medical evaluation is necessary to rule out underlying conditions such as cholesteatoma or foreign bodies.
• This product is not intended for ophthalmic use or injection.

Therapeutic Class

Antifungal and antibacterial ear drops.

Storage Instructions

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