Otoleptin^® (Drops) Instructions for Use

Marketing Authorization Holder

Intelbio LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

S02DA30 (Analgesics and anesthetics in combination)

Active Substances

Phenazone (Rec.INN registered by WHO)

Lidocaine (Rec.INN registered by WHO)

Dosage Form

Otoleptin®

Ear drops 10 mg/g+40 mg/g

Dosage Form, Packaging, and Composition

Ear drops

10 g – bottles – cardboard packs /with dropper/ – Over-the-Counter
15 g – bottles – cardboard packs /with dropper/ – Over-the-Counter
16 g – bottles – cardboard packs /with dropper/ – Over-the-Counter
20 g – bottles – cardboard packs /with dropper/ – Over-the-Counter
8 g – bottles – cardboard packs /with dropper/ – Over-the-Counter

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

• For local symptomatic treatment and pain relief in adults and children, including newborns.

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

ICD codes

Dosage Regimen

Instill 4 drops into the external auditory canal2-3 times per day.

Ensure the drops are at room temperature before use. Tilt the head to the side and gently pull the earlobe backward and upward to straighten the ear canal during administration.

The course of treatment must not exceed 10 days. If symptoms persist or worsen, discontinue use and consult a physician.

Adverse Reactions

Local reactions at the application site may occur, including allergic reactions, irritation, and hyperemia (redness).

Discontinue use immediately if any signs of a hypersensitivity reaction develop, such as severe itching, rash, or swelling. In such cases, seek medical attention promptly.

Drug Interactions

No specific drug interactions with other medicinal products have been reported to date.

Concurrent use with other ototoxic agents should be approached with caution. Inform your physician about all other medications you are taking, including prescription, over-the-counter, and herbal products.

Contraindications

• Hypersensitivity to phenazone, lidocaine, any other local anesthetics of the amide type, or any of the excipients.

• Mechanical damage to the tympanic membrane (perforation). The product is contraindicated in patients with a known or suspected perforated eardrum.

Overdose

Symptoms of overdose due to systemic absorption may include manifestations of lidocaine toxicity, such as central nervous system depression, dizziness, blurred vision, or cardiovascular effects.

In case of suspected overdose, discontinue treatment immediately and institute supportive and symptomatic measures. Seek immediate medical attention or contact a poison control center.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding according to indications and provided the tympanic membrane 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 tympanic membrane.

In case of use with a perforated tympanic membrane, 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 30°C (86°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.