Maxicold^® Ototita (Drops) Instructions for Use

Marketing Authorization Holder

Otisipharm, JSC (Russia)

Manufactured By

Lekko, CJS (Russia)

ATC Code

S02DA30 (Analgesics and anesthetics in combination)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Phenazone (Rec.INN registered by WHO)

Dosage Form

Maxicold® Ototita

Ear drops 40 mg+10 mg/1 g: bottle 15 ml

Dosage Form, Packaging, and Composition

Ear drops are a transparent colorless or yellowish liquid with a characteristic odor.

Excipients: sodium thiosulfate (sodium thiosulfate pentahydrate) – 1 ml, ethanol (ethyl alcohol 95%) – 221.8 mg, purified water – 18.2 mg, sodium hydroxide solution 1M – to pH 5.5 ± 0.2, glycerol – to 1 g.

15 ml – dropper bottles (1) with a dosing nozzle – cardboard packs.
15 ml – dark glass bottle (1) 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 pain relief 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.

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

Limit the total course of treatment to a maximum of 10 days; do not exceed this duration.

Adverse Reactions

Primarily local reactions at the application site.

Observe for signs of allergic reactions, local irritation, or hyperemia (redness).

Contraindications

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

• Strictly contraindicated in cases of mechanical damage to the eardrum or suspected perforation.

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.

If used 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.