Anauran^® (Drops) Instructions for Use

Marketing Authorization Holder

Zambon, S.p.A. (Italy)

ATC Code

S02AA30 (Combination of antimicrobial drugs)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Neomycin (Rec.INN registered by WHO)

Polymyxin B (Rec.INN registered by WHO)

Dosage Form

Anauran®

Ear drops 1000000 IU+375000 IU+4 g/100 ml: 25 ml bottle with dropper cap

Dosage Form, Packaging, and Composition

Ear drops transparent, colorless, odorless.

Excipients: benzalkonium chloride – 0.01 g, propylene glycol – 44 ml, glycerol – 26.5 mg, purified water – up to 100 ml.

25 ml – dark glass bottles (1) with dropper cap – cardboard boxes.

Clinical-Pharmacological Group

Drug with antimicrobial and local anesthetic action for topical use in ENT practice

Pharmacotherapeutic Group

Combined antibiotic (antibiotics: aminoglycoside + cyclic polypeptide + local anesthetic)

Pharmacological Action

Neomycin sulfate is a broad-spectrum aminoglycoside antibiotic.

It acts bactericidally against gram-positive (Staphylococcus spp., Streptococcus pneumoniae) and gram-negative (Escherichia coli, Shigella dysenteria, Shigella flexneri, Shigella boydii, Shigella sonnei, Proteus spp.) microorganisms; it has low activity against Streptococcus spp.

Polymyxin B is a polypeptide antibiotic.

Active against gram-negative microorganisms: Escherichia coli, Shigella dysenteria, Shigella flexneri, Shigella boydii, Shigella sonnei, Salmonella typhi, Salmonella paratyphi, Pseudomonas aeruginosa.

Not active against Proteus spp., Mycobacterium spp., gram-positive cocci, fungi.

It has a weak local irritant effect.

Lidocaine is a local anesthetic that quickly relieves pain and itching.

Pharmacokinetics

Pharmacokinetic studies have not been conducted because the drug is intended for topical use and systemic effects are unlikely.

Indications

• Acute and chronic external otitis;
• Acute otitis media at the stage before perforation;
• Chronic exudative otitis media;
• Postoperative purulent complications after radical mastoidectomy, tympanoplasty, antrotomy, fenestration.

ICD codes

Dosage Regimen

Administer topically into the external auditory canal using the supplied dropper.

For adults, instill 4-5 drops into the affected ear.

For children, instill 2-3 drops into the affected ear.

Apply this dosage 2-4 times daily for adults and 3-4 times daily for children.

Adjust the frequency of administration based on the severity of the condition.

Prior to instillation, warm the bottle by holding it in your hand for a few minutes to avoid vestibular discomfort.

Lie on your side with the affected ear upward.

Gently pull the auricle upward and backward to straighten the ear canal.

Instill the prescribed number of drops.

Maintain this position for several minutes to facilitate penetration.

A small piece of cotton wool may be placed loosely in the ear opening.

The total duration of treatment must not exceed 7 days.

Do not use the medication for prolonged periods.

Discontinue use if no clinical improvement is observed within the treatment week.

Do not share the dropper to prevent cross-contamination.

Avoid touching the dropper tip to the ear or any other surface.

Adverse Reactions

Local allergic reactions such as hyperemia, itching, and peeling of the skin of the external auditory canal are possible, which disappear without treatment after discontinuation of the drug.

Systemic effects are unlikely due to the low doses of the drug used.

However, with prolonged treatment, systemic side effects may occur, in particular, ototoxicity and nephrotoxicity due to the absorption of neomycin.

Contraindications

• Hypersensitivity to any of the components of the drug.

Use in Pregnancy and Lactation

During pregnancy and lactation, the drug should be used only in case of extreme necessity and under medical supervision.

Pediatric Use

In children under 1 year of age, the drug should be used only in case of extreme necessity and under medical supervision.

Special Precautions

Used exclusively for ear diseases.

In severe and persistent infections, local treatment should be supplemented with systemic antibiotic use.

Long-term use may lead to the development of superinfection with microorganisms resistant to the drug.

In children under 1 year of age, use only in case of extreme necessity and under medical supervision.

Drug Interactions

Incompatible with monomycin, streptomycin, gentamicin, amikacin, netilmicin (possible enhancement of the ototoxic effect of the above antibiotics).

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.