Otipax ear drops 16 g

Instructions for use Otipax ear drops 16 g

Composition

active ingredients: 16 g of solution contain phenazone 0.64 g and lidocaine hydrochloride 0.16 g;

Excipients: sodium thiosulfate, anhydrous ethanol, glycerin, purified water.

Dosage form

Ear drops.

Main physicochemical properties: transparent colorless or slightly yellowish solution with the smell of alcohol.

Pharmacotherapeutic group

Means used in otology. Analgesics and anesthetics in combination. ATX code S02D A30.

Pharmacological properties

Pharmacodynamics.

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

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

Contraindication

Hypersensitivity to the active substances, any 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

To date, there is 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 an active ingredient 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 penetrate into breast milk. If necessary, Otipax 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 of the ear in which pain is felt. The course of treatment should not exceed 10 days. After this period of use, the treatment should be reviewed.

Method of application

For use in the ear.

In order to prevent unpleasant sensations as a result of contact of the skin of the ear canal with the cold solution, the bottle should be warmed in the hands before using the medicine.

Children

There are no data on the safety and efficacy of Otipax 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

No overdose was observed when using the drug at the recommended dosage.

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

3 years.

30 days after first opening the bottle.

Storage conditions

Does not require any special storage conditions. Keep out of the reach of children.

Packaging

16 g of solution in a dark glass bottle with a screw cap with tamper-evident lid. 1 bottle with a separately packaged plastic dropper (polyethylene/paper blister) in a cardboard box.

Vacation category

Without a prescription.

Producer

BIOCODEX.

Location of the manufacturer and its business address

Production address: 1 Avenue Blaise Pascal, 60000 Beauvais, France.