Oticain-Zdorovye ear drops solution bottle with dropper cap 16 g

Instructions for Oticain-Zdorovye ear drops solution bottle with dropper cap 16 g

Composition

active ingredients: phenazone, lidocaine;

1 g of the drug contains phenazone 40 mg, lidocaine hydrochloride 10 mg;

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

Dosage form

Ear drops, solution.

Main physicochemical properties: transparent solution from colorless to yellowish with an alcoholic odor.

Pharmacotherapeutic group

Means used in otology. ATX code S02D A30.

Pharmacological properties

Pharmacodynamics.

The drug 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 active components 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, any components of the drug or to amide local anesthetics. Perforation of the eardrum of traumatic or infectious origin.

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 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, the drug 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 which the treatment should be reviewed.

Method of application: for use in the ear.

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, drop 4 drops using the dropper. After use, screw the dropper onto the bottle and put the bottle in the package.

Children.

There are no data on the safety and efficacy of the drug in children under 1 month of age. Use in children over 1 month of age after consultation and on the recommendation of a doctor.

Overdose

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

Side effects

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.

Storage conditions

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

The shelf life of the drug after opening the bottle is no more than 4 weeks.

Keep out of reach of children.

Packaging

8 g or 16 g in a bottle with a dropper cap with a glass pipette in a box.

Vacation category

Without a prescription.

Producer

Limited Liability Company "Pharmaceutical Company "Zdorovya".

Address

Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenko street, building 22.