Lidocaine hydrochloride, phenazone

Pharmacological properties

the droplex preparation is a combination of two active components: phenazone and lidocaine.

Phenazone is a derivative of pyrazolone with analgesic and anti-inflammatory properties. Lidocaine is a local anesthetic of the amide group. The combination of phenazone with lidocaine causes a synergistic analgesic / anti-inflammatory effect.

Pharmacokinetics The 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 eardrum).

The effect of the drug (reducing the pain of the eardrum and reducing inflammation) starts from the 5th minute after instillation. The pain syndrome almost completely disappears after 15-30 minutes.

Indications

Local symptomatic treatment of certain painful conditions of the middle ear with an intact eardrum in children aged 1 month and adults with:

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

Application

The drug is intended for use in the ear.

For children from 1 month of age and adults, r-r instill 4–3 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, treatment should be reviewed.

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 hands before using it.

The bottle must be closed after each use. Do not touch the edge of the pipette of the external auditory meatus to maintain sterility of the solution.

Children. There is no data on the safety and effectiveness of the drug in children under the age of 1 month. The drug is used in children aged 1 month after consultation and on the recommendation of a doctor.

Contraindications

Hypersensitivity to active substances, other components of the drug or amide local anesthetic drugs; perforation of the eardrum of traumatic or infectious origin.

Side effects

When using the drug, local reactions may develop: allergic reactions, including irritation, hyperemia of the external auditory canal, itching, skin rashes.

special instructions

Before using the drug, you should check the integrity of the eardrum (as a precaution). if there is a destruction of the eardrum, the introduction 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. in case of violation of the integrity of the eardrum, the use of the drug is contraindicated.

The drug contains an active component, which can lead to a positive result in the anti-doping test.

After instillation, tighten the cap tightly and hide the bottle in the package to protect the drug from light.

Use during pregnancy or lactation. The consequences of using the drug during pregnancy are not expected, since the systemic exposure of phenazone and lidocaine is negligible.

Under normal conditions of use, phenazone and lidocaine do not pass into breast milk. If necessary, the drug can be used during pregnancy and lactation after consulting a doctor.

The ability to influence the reaction rate when driving vehicles or other mechanisms. The drug does not affect the reaction rate when driving vehicles or other mechanisms.

Interactions

There is currently no evidence of the possibility of clinically significant interactions with other drugs and other types of interactions.

Overdose

When using the drug in the recommended dose, an overdose was not observed.

Storage conditions

At a temperature not exceeding 25 ° c. after opening the bottle, the drug can be used for 4 weeks.