Otofizin (Drops) Instructions for Use

Marketing Authorization Holder

Vita Line, LLC (Russia)

Manufactured By

Rubicon, LLC (Republic of Belarus)

ATC Code

S02DA30 (Analgesics and anesthetics in combination)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Phenazone (Rec.INN registered by WHO)

Dosage Form

Otofizin

Ear drops 10 mg+40 mg/1 g: bottle 20 g with dropper cap included

Dosage Form, Packaging, and Composition

Ear drops as a clear, colorless or yellowish solution with an odor of alcohol.

Excipients : sodium thiosulfate – 1 mg, ethanol (ethyl alcohol) 96% – 217 mg, glycerol – 627 mg, purified water – 104.3 mg.

20 g – dark glass bottles (1) complete with a dropper cap – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory and local anesthetic action for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of ear diseases; other drugs for the treatment of ear diseases; analgesics and anesthetics

Pharmacological Action

A combined drug that has anti-inflammatory, local anesthetic, and analgesic effects.

Indications

• Use for local symptomatic treatment and anesthesia in adults and children, including newborns.

• Apply for conditions such as acute otitis media during the inflammation period, otitis as a complication after influenza, and barotraumatic otitis.

ICD codes

Dosage Regimen

Instill the solution into the external auditory canal while the patient is lying on their side.

Administer 4 drops into the affected ear, 2-3 times per day.

Remain in the lateral position for several minutes to ensure the solution penetrates the ear canal.

If required, gently insert a small cotton wool plug into the ear after instillation.

Limit the course of treatment to a maximum of 10 days.

Do not exceed the recommended dosage or duration of therapy.

Discontinue treatment and consult a physician if symptoms persist or worsen after a few days of use.

Adverse Reactions

Primarily local reactions may occur at the application site.

These include allergic reactions, irritation, and hyperemia.

Drug Interactions

Exercise caution due to the potential for interactions with other medicinal products.

Avoid concurrent use with other local anesthetics or anti-inflammatory agents applied to the same site, as effects may be additive.

The ethanol content may interact with disulfiram or metronidazole.

Contraindications

• Do not use in patients with known hypersensitivity to lidocaine, phenazone, or any of the excipients.

• Contraindicated in cases of mechanical damage to the eardrum or suspected tympanic membrane perforation.

Overdose

Symptoms of overdose are unlikely with topical application to the intact ear but may occur if the product is absorbed systemically, especially through a perforated tympanic membrane.

Potential symptoms include central nervous system effects such as dizziness or sedation, and cardiovascular effects.

In case of suspected overdose, discontinue use immediately and institute supportive therapy.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible according to indications and provided the eardrum is intact.

Pediatric Use

Can be used in infants.

Special Precautions

Before starting to use the drug, it is necessary to ensure the integrity of the eardrum.

In case of use with a perforated eardrum, the drug may come into contact with the middle ear organs and lead to complications.

Information for athletes: contains an active component that can give a positive reaction during doping control.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.