Ototon (phenazone, lidocaine hydrochloride) ear drops 16 g vial, №1

Description

Ototon 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 substance 0.01 g;
excipients: sodium thiosulfate, ethanol 96%, glycerin, purified water.

Dosage form
Ear drops.

Pharmacological properties
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 produces a synergistic analgesic / anti-inflammatory effect.
Systemic absorption of this solution is not expected (in the absence of damage to the tympanic membrane).
The action of the drug (reducing the soreness of the tympanic membrane and reducing inflammation) begins from the 5th minute after instillation. Pain syndrome almost completely disappears in 15-30 minutes.

Indications
Local symptomatic treatment of certain pain conditions of the middle ear with an intact tympanic membrane in children over 1 month old and in adults with:

• otitis media in the acute period;
• phlyctenular viral otitis media (post-influenza);
• barotraumatic otitis media.

Contraindications
Hypersensitivity to active ingredients, to any components of the drug, or to local anesthetic amide drugs.
Perforation of the tympanic membrane of traumatic or infectious origin.

Application features
Before any use of the drug, the integrity of the tympanic membrane should be checked (as a precautionary measure). If there is destruction of the tympanic membrane, the injection of the drug into the ear can lead to contact of the drug with the structures of the middle ear, causing adverse reactions in these tissues.
It should be borne in mind that the drug contains an active component that can show a positive result in an anti-doping test.

Children
There is no data on the safety and efficacy of Ototon in children under 1 month of age.
Apply to children over 1 month old after consultation and on the recommendation of a doctor.

Use during pregnancy or lactation
The consequences of using the drug Ototon during pregnancy are not expected, since the systemic exposure of phenazone and lidocaine is insignificant.
Under normal conditions of use, phenazone and lidocaine do not pass into breast milk. If necessary, it can be used during pregnancy or lactation after consulting a doctor.

The ability to influence the reaction rate when driving or driving other mechanisms
The drug does not affect the ability to drive vehicles or operate potentially dangerous machinery.

Method of administration and dosage
For children over 1 month old and for adults, instill 4 drops 2-3 times a day into the external auditory canal, in which pain is felt. The course of treatment should not exceed 10 days. Then you need to review the treatment.
In order to prevent discomfort as a result of contact of the skin of the ear canal with a cold solution, you should 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 drip 4 drops, lightly pressing on the central part of the dropper. After use, screw the white cap tightly onto the dropper and put the bottle in the package.

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

Side effects
Reported adverse reactions are listed according to organ system classes.
On the part of the organs of hearing and balance: local reactions – allergic reactions, including irritation, hyperemia of the external auditory canal, itching, skin rashes.

Shelf life
2 years.
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 original packaging at a temperature not exceeding 25 ºС.
Keep out of the reach of children.