Ototon ear drops bottle 16 g

Instructions for Ototon ear drops bottle 16 g

Composition

active ingredients: phenazone, lidocaine hydrochloride;

1 g of drops contains phenazone in terms of 100% dry matter 0.04 g, lidocaine hydrochloride in terms of 100% anhydrous matter 0.01 g;

excipients: sodium thiosulfate, ethanol 96%, glycerin, purified water.

Dosage form

Ear drops.

Main physicochemical properties: clear, colorless or slightly yellowish liquid with the smell of alcohol.

Pharmacotherapeutic group

Means used in otology. ATX code S02D A30.

Pharmacological properties

Pharmacodynamics.

Ototon® is a combination of two active ingredients: phenazone and lidocaine.

Phenazone: a pyrazolone derivative with analgesic and anti-inflammatory properties.

Lidocaine: A local anesthetic of the amide group. The combination of phenazone with lidocaine provides a synergistic analgesic/anti-inflammatory effect.

Pharmacokinetics.

The absorption of any component of the drug through the skin has not been studied. Absorption is almost non-existent.

Systemic absorption of this solution is not expected (in the absence of damage to the eardrum).

The drug's effect (reducing eardrum pain and reducing inflammation) begins 5 minutes after instillation. The pain syndrome almost completely disappears after 15-30 minutes.

Indication

Local symptomatic treatment of certain painful conditions of the middle ear with an intact tympanic membrane in children from 1 month of age and adults with:

otitis media in the acute period;

phlyctenulous viral otitis (post-influenza);

barotraumatic otitis media.

Contraindication

Hypersensitivity to the active substances, to any of the components of the drug or to amide local anesthetic drugs.

Perforation of the eardrum of traumatic or infectious origin (see section "Special instructions for use").

Interaction with other medicinal products and other types of interactions

There are currently no data on the possibility of clinically significant interactions.

Application features

Before any use of the drug, the integrity of the eardrum should be checked (as a precaution). If there is destruction of the eardrum, administration of the drug into the ear may result in contact of the drug with the structures of the middle ear, causing adverse reactions in these tissues.

It should be noted that the drug contains a positive component that may show a positive result in an anti-doping test.

Use during pregnancy or breastfeeding

No consequences of using the drug during pregnancy are expected, since systemic exposure to phenazone and lidocaine is insignificant.

Under normal conditions of use, phenazone and lidocaine do not pass into breast milk. If necessary, Ototon® can be used during pregnancy or breastfeeding after consulting a doctor.

Ability to influence reaction speed when driving vehicles or other mechanisms

The drug does not affect the ability to drive or operate potentially dangerous machinery.

Method of administration and doses

Children from 1 month of age and adults should instill 4 drops 2-3 times a day into the external auditory canal where pain is felt. The course of treatment should not exceed 10 days. After which the treatment should be reviewed.

To prevent discomfort from contact of the skin of the ear canal with the cold solution, warm the bottle in your hand before using the medicine. Then unscrew the cap from the bottle and screw the dropper onto the bottle. Turn the bottle over and drop 4 drops, pressing lightly on the central part of the dropper. After use, tightly screw the white cap onto the dropper and put the bottle back into the packaging.

Children

There are no data on the safety and efficacy of Ototon® in children under 1 month of age.

Use in children aged 1 month and over after consultation and on the recommendation of a doctor.

Overdose

When using the drug at the recommended dosage, no overdose was observed.

Adverse reactions

Reported adverse reactions are listed according to system organ class.

From the organs of hearing and balance: local reactions - allergic reactions, including irritation, hyperemia of the external auditory canal, itching, skin rashes.

Expiration date

2 years.

The shelf life after opening the bottle is 1 month.

Do not use the drug after the expiration date indicated on the package.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 ºС.

Keep out of reach of children.

Packaging

16 g per bottle. 1 bottle per pack.

Vacation category

Without a prescription.

Producer

JSC "Farmak".

Location of the manufacturer and its business address

Ukraine, 04080, Kyiv, Kyrylivska St., 74.