Otykain-zdorovya

INSTRUCTION for medical use of the medicinal product OTICAINE-ZDOROVYE (OTICAINE-ZDOROVYE)

Composition:

Active substances: phenazone, lidocaine;

1 g of the preparation contains 40 mg of phenazone and 10 mg of lidocaine hydrochloride;

Excipients: 96% ethanol, glycerol, sodium thiosulfate, purified water.

Pharmaceutical form. Ear drops, solution.

Main physico-chemical properties: clear solution ranging from colorless to yellowish with a characteristic alcoholic odor.

Pharmacotherapeutic group. Products used in otology. ATC code S02DA30.

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 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 nearly absent.

Systemic absorption of active ingredients is not expected (in the absence of tympanic membrane damage).

The drug's effect (reduction of tympanic membrane pain and inflammation) begins 5 minutes 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, such as:

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

Contraindications.

Hypersensitivity to the active substances, any component 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 forms of interaction.

Currently, there are no data regarding the possibility of clinically significant interactions.

Special precautions for use.

Before any application of the medicine, the integrity of the tympanic membrane should be checked (as a precautionary measure). If there is a destruction of the tympanic membrane, instillation of the medicine into the ear may lead to contact of the medicine with structures of the middle ear, causing adverse reactions in these tissues.

It should be taken into account that the medicine contains an active ingredient which may lead to a positive result in an anti-doping test.

Use during pregnancy or breastfeeding.

Adverse consequences of using the medicine during pregnancy are not expected, since 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 medicine may be used during pregnancy or breastfeeding after consultation with a physician.

Ability to influence reaction rate while driving or operating machinery.

The medicine does not affect the ability to drive or operate potentially hazardous machinery.

Dosage and Administration.

For children from 1 month of age and adults: instill 2–3 times daily 4 drops into the external auditory canal of the affected ear where pain is experienced. The treatment course should not exceed 10 days. After this period, treatment should be reevaluated.

Route of administration: for use in the ear.

To avoid discomfort caused by contact of the cold solution with the skin of the auditory canal, warm the bottle in your hand before applying the medication. Then unscrew the cap from the bottle and instill 4 drops using the dropper. After use, screw the dropper back onto the bottle and return the bottle into the packaging.

Children.

There are no safety and efficacy data available for use of the drug in infants under 1 month of age. Use in children from 1 month of age only after consultation and on recommendation of a physician.

Overdose.

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

Side effects.

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

Shelf life. 2 years.

Storage conditions.

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

The shelf life of the medication 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 and a glass pipette, in a carton.

Prescription status. Over-the-counter.

Manufacturer.

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.