Droplex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DROPLEKS (DROPLEKS)

Composition:

Active substances: phenazone, lidocaine;

1 ml of the preparation contains 45.5 mg of phenazone and 11.4 mg of lidocaine hydrochloride;

Excipients: sodium thiosulfate, glycerin, 96% ethanol, sodium hydroxide, purified water.

Pharmaceutical form. Ear drops, solution.

Main physicochemical properties: clear, colorless or slightly yellowish solution.

Pharmacotherapeutic group. Preparations used in otology. Analgesics and anesthetics in combination. ATC code S02DA30.

Pharmacological properties.

Pharmacodynamics.

The drug is a combination of two active components: 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 and lidocaine provides a synergistic analgesic/anti-inflammatory effect.

Pharmacokinetics.

Absorption of any component of the drug through the skin has not been studied. Absorption is negligible. Systemic absorption of this solution is not expected (in the absence of tympanic membrane damage).

The effect of the drug (reduction of tympanic membrane pain and inflammation) begins from the 5th minute after instillation. Pain syndrome almost completely disappears within 15–30 minutes.

Clinical characteristics.

Indications.

Local symptomatic treatment of certain painful conditions of the middle ear with intact tympanic membrane in children from 1 month of age and adults for:

• acute otitis media;
• vesicular viral otitis (post-influenza);
• barotraumatic otitis.

Contraindications.

• Hypersensitivity to the active substances, to other components of the medicinal product, or to amide-type local anesthetics.
• Perforation of the tympanic membrane of traumatic or infectious origin.

Interaction with other medicinal products and other types of interactions.

Currently, there are no data regarding the potential for clinically significant interactions with other medicinal products or other types of interactions.

Special precautions for use

Before applying the medicinal product, the integrity of the tympanic membrane should be checked (as a precautionary measure). If there is a destruction of the tympanic membrane, administration of the product into the ear may result in contact of the active substances with the structures of the middle ear, potentially causing adverse reactions in these tissues.

The product contains an active ingredient that may lead to a positive result in an anti-doping test.

Use during pregnancy or breastfeeding.

There are no expected consequences of using the product during pregnancy, as systemic exposure to phenazone and lidocaine is negligible.

Under normal conditions of use, phenazone and lidocaine do not penetrate into breast milk. If necessary, the product may be used during pregnancy or breastfeeding after consultation with a physician.

Ability to influence reaction speed when driving vehicles or operating machinery.

The medicinal product does not affect the speed of reaction when driving vehicles or operating machinery.

Method of Administration and Dosage

The medication is intended for administration into the external auditory canal.

For children aged 1 month and older, and adults: instill the solution into the external auditory canal of the affected ear 2–3 times daily, 4 drops each time. The treatment course should not exceed 10 days. After this period, the treatment should be reviewed.

To avoid discomfort caused by contact of the cold solution with the skin of the auditory canal, warm the bottle in your hands before use.

The bottle should be closed after each use. Avoid touching the tip of the dropper to the external auditory canal to maintain the sterility of the solution.

Children.

There is no data regarding the safety and efficacy of using the medication in infants under 1 month of age.

The medication should be used in children aged 1 month and older only after consultation with and upon recommendation by a physician.

Overdose.

Overdose has not been observed when the medication is used at the recommended dosage.

Adverse reactions.

The adverse reactions reported are listed according to system organ classes.

Auditory and vestibular disorders: local reactions: allergic reactions including irritation, hyperemia of the external auditory canal, itching, skin rashes.

Shelf life.

3 years.

After opening the bottle, the preparation can be used for up to 4 weeks.

Storage conditions.

Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

15 ml of solution in a polymer dropper bottle. One dropper bottle per cardboard box.

Pharmaceutical supply category.

Over-the-counter (without prescription).

Manufacturer.

K.O. "Rompharm Company S.R.L."/S.C. "Rompharm Company S.R.L."

Manufacturer's location and address of its place of business.

Otopeni city, Eroilor str. № 1A, 075100, jud. Ilfov, Romania / Romania, Otopeni city, Eroilor str. № 1A, 075100, jud. Ilfov.

Marketing authorization holder.

LLC "WORLD MEDICINE", Ukraine.

WORLD MEDICINE, LLC, Ukraine.