Otipain (Drops) Instructions for Use

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

YUGPHARM, 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

Otipain

Ear drops 10 mg/g+40 mg/g

Dosage Form, Packaging, and Composition

Ear drops

15 ml – dropper bottles – cardboard packs – Over-the-Counter

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 pain relief in adults and children, including newborns.
• Apply for conditions such as acute otitis media during the inflammation period.
• Use for otitis occurring as a complication after influenza.
• Employ for the management of 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.

Gently pull the auricle backwards and upwards in adults and backwards and downwards in children to straighten the ear canal.

Remain in the lateral position for several minutes after instillation to ensure the solution penetrates deeply.

If necessary, place a small cotton wool plug into the meatus.

Limit the total duration of treatment to a maximum of 10 days.

Do not exceed the recommended dosage and duration of therapy.

If symptoms persist or worsen after a few days of treatment, discontinue use and consult a physician.

Adverse Reactions

Local reactions may occur at the application site.

Reported effects include allergic reactions, irritation, and hyperemia.

Drug Interactions

No specific drug interactions have been reported for this topical preparation.

Exercise caution when using with other ototoxic agents if tympanic membrane perforation is suspected.

Inform your physician about all concomitant medications.

Contraindications

• Do not use in patients with known hypersensitivity to phenazone, lidocaine, or any other component of the drug.
• Strictly contraindicated in cases of mechanical damage to the eardrum or suspected perforation.

Overdose

Overdose from topical otic administration is unlikely due to minimal systemic absorption.

In case of accidental ingestion, seek immediate medical attention and manage symptomatically.

Symptoms of lidocaine systemic toxicity may include CNS effects and cardiovascular depression.

Use in Pregnancy and Lactation

Can be used during pregnancy and breastfeeding 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.

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

Information for athletes: contains an active component that may 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.