OTOZAMBON Ear Drops (Solution)

What is OTOZAMBON

OTOZAMBON is a combination ear drop solution designed for the treatment of external ear infections, particularly otitis externa. It combines three active ingredients:

• Polymyxin B sulfate: an antibiotic effective against Gram-negative bacteria.
• Neomycin sulfate: a broad-spectrum aminoglycoside antibiotic that targets both Gram-positive and Gram-negative bacteria.
• Lidocaine hydrochloride: a local anesthetic used to relieve pain and discomfort.

This medication is typically used to alleviate symptoms such as ear pain, itching, and inflammation associated with bacterial infections of the outer ear. It is dispensed in a 25ml amber glass bottle for topical otic use only.

How to use OTOZAMBON

Proper administration of OTOZAMBON is critical for its effectiveness. Follow these instructions unless directed otherwise by a physician:

• Wash your hands thoroughly before using the drops.
• Warm the bottle slightly in your hand to avoid dizziness from cold liquid.
• Tilt the head to one side or lie down with the affected ear facing upward.
• Instill the prescribed number of drops into the ear canal (commonly 4–6 drops).
• Stay in the same position for a few minutes to allow the medication to penetrate deeply.
• Repeat for the other ear if required.
• Wipe off excess liquid gently and securely replace the bottle cap.

Use OTOZAMBON exactly as prescribed, typically 2 to 3 times daily for 7–10 days. Do not insert any object into the ear or use longer than advised.

Mode of Action OTOZAMBON

Each active ingredient in OTOZAMBON serves a unique therapeutic function:

• Polymyxin B sulfate: Binds to the bacterial cell membrane, increasing its permeability and causing cell death. Particularly active against Pseudomonas aeruginosa and other Gram-negative organisms.
• Neomycin sulfate: Inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, thereby preventing bacterial replication and survival.
• Lidocaine hydrochloride: Blocks sodium channels on nerve membranes, preventing the initiation and transmission of nerve impulses. This provides rapid and localized pain relief in the infected ear.

The combination ensures both antimicrobial and symptomatic relief (pain and discomfort), addressing the infection holistically.

OTOZAMBON Interactions OTOZAMBON

Although topical ear drops have limited systemic absorption, potential interactions should be considered, especially in patients using other otic or systemic medications:

• Concurrent use with other ototoxic drugs (e.g., loop diuretics, aminoglycosides) may increase the risk of hearing damage, especially if the tympanic membrane is perforated.
• Systemic absorption of neomycin may occur with prolonged use, posing a risk in patients with renal impairment or those on nephrotoxic medications.
• Lidocaine may interact with other local anesthetics or antiarrhythmic drugs if systemically absorbed.

Always inform your healthcare provider of all medications you are using, including over-the-counter products and herbal supplements.

Dosage of OTOZAMBON

The typical recommended dosage is as follows, but it must always be individualized based on the severity of the condition and the patient’s age:

• Adults and children over 1 year: 4–6 drops into the affected ear(s), 2 to 3 times daily.
• Duration of treatment is generally 7–10 days.
• Do not exceed the recommended duration to prevent microbial resistance and ototoxicity.

Always use the dropper provided and avoid contamination of the tip. Do not use if the solution changes color or develops particles.

Possible side effects of OTOZAMBON

Like all medications, OTOZAMBON may cause side effects. These are generally localized and mild but can occasionally be serious:

• Common: Mild stinging, burning, or irritation at the site of application.
• Less common: Allergic reactions including rash, itching, swelling, or redness.
• Rare: Ototoxicity (hearing loss or tinnitus), especially with prolonged use or perforated eardrum.
• Systemic: Very rare systemic absorption of neomycin or polymyxin B may lead to nephrotoxicity or neurotoxicity.

Discontinue use and seek medical advice if any severe or persistent adverse effects occur.

OTOZAMBON Contraindications OTOZAMBON

OTOZAMBON should not be used in the following conditions:

• Known hypersensitivity or allergy to any of the components (neomycin, polymyxin B, lidocaine, or excipients).
• Presence of tympanic membrane perforation unless explicitly prescribed by an ENT specialist.
• Viral or fungal ear infections (as this product is antibacterial and lacks antifungal/antiviral activity).
• Use in infants under 1 year old unless specifically advised by a healthcare provider.

Use with caution in patients with renal impairment, as aminoglycosides can be nephrotoxic when systemically absorbed.

Storage of OTOZAMBON

To ensure effectiveness and safety, OTOZAMBON should be stored correctly:

• Store at a temperature between 15°C and 25°C.
• Keep the bottle tightly closed when not in use.
• Protect from light and moisture; store in the original amber glass bottle.
• Keep out of reach of children.
• Do not freeze.
• Discard any unused medication 4 weeks after opening unless otherwise advised.

Always check the expiry date before use and consult a pharmacist if you notice changes in the product's appearance or smell.