Storage:
active substances: phenazone, lidocaine hydrochloride;
1 g of drops contains phenazone in terms of 100% dry substance 0.04 g, lidocaine hydrochloride in terms of 100% anhydrous substance 0.01 g;
excipients: sodium thiosulfate, ethanol 96%, glycerin, purified water.
Medicinal form. Ear drops.
The main physical and chemical properties: transparent, 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 derivative of pyrazolone with analgesic and anti-inflammatory properties.
Lidocaine: a local anesthetic of the amide group. The combination of phenazone with lidocaine causes a synergistic analgesic/anti-inflammatory effect.
Pharmacokinetics.
Resorption of any component of the drug through the skin has not been studied. Resorption is almost absent.
Systemic absorption of this solution is not expected (in the absence of damage to the tympanic membrane).
The effect of the drug (reduction of pain in the tympanic membrane and reduction of inflammation) begins 5 minutes after instillation. The pain syndrome almost completely disappears after 15-30 minutes.
Clinical characteristics.
Indication.
Local symptomatic treatment of certain painful conditions of the middle ear with an intact eardrum in children aged 1 month and older and adults with:
· moderate otitis in the acute period;
phlyktenulosis viral otitis (post-influenza);
· barotraumatic otitis.
Contraindication.
Hypersensitivity to active substances, to any components of the drug or to amide local anesthetic drugs.
Perforation of the tympanic membrane of traumatic or infectious origin (see the section “Peculiarities of use”).
Interaction with other medicinal products and other types of interactions.
Currently, there are no data on the possibility of clinically significant interactions.
Features of application.
Before any use of the drug, the integrity of the eardrum should be checked (as a precaution). If there is destruction of the tympanic membrane, the introduction of the drug into the ear may lead to contact of the drug with the structures of the middle ear, causing adverse reactions in these tissues.
It should be taken into account that the drug contains an active component that can show a positive result in an anti-doping test.
Use during pregnancy or breastfeeding.
The consequences of the use of the drug 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 penetrate into breast milk. If necessary, Ototon® can be used during pregnancy or breastfeeding after consulting a doctor.
The ability to influence the speed of reaction when driving vehicles or other mechanisms.
The drug does not affect the ability to drive a vehicle or operate potentially dangerous mechanisms.
Method of application and dosage.
Children aged 1 month and older and adults instill 4 drops 2-3 times a day in 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 unpleasant sensations as a result of the contact of the skin of the auditory 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 instill 4 drops, slightly pressing the central part of the dropper. After use, tightly screw the white cap on the dropper and put the bottle in the package.
Children.
There are no data on the safety and effectiveness of the use of Ototon® in children under 1 month of age.
Apply to children aged 1 month and older after consultation and on the recommendation of a doctor.
Overdose.
When using the drug in the recommended dosage, overdose was not observed.
Adverse reactions.
Adverse reactions reported are listed by 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.
Expiry 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 higher than 25 ºС.
Keep out of the reach of children.
Packaging.
16 g in a bottle. 1 bottle in a pack.
Leave category. Without a prescription.
Producer.
“Farmak” JSC.
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