Otics

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT OTIKS (OTIX)

Composition:

Active substances: phenazone, lidocaine hydrochloride;

1 g of ear drops, solution, contains phenazone 40 mg and lidocaine hydrochloride 10 mg;

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

Pharmaceutical form. Ear drops, solution.

Main physicochemical properties: clear colorless or light amber liquid with an alcoholic odor.

Pharmacotherapeutic group. Agents used in otology.

ATC code S02D A30.

Pharmacological properties.

Pharmacodynamics.

Otyks 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.

Absorption of any component of the drug through the skin has not been studied. Absorption is negligible.

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

The effect of the drug (reduction of tympanic membrane pain and inflammation) begins within 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 for:

• acute otitis media;
• post-viral flaccid bullous otitis (post-influenzal);
• barotraumatic otitis.

Contraindications.

Hypersensitivity to the active substances or to any of the excipients of the medicinal product or to amide-type local anesthetics.

Perforation of the tympanic membrane of traumatic or infectious origin (see section "Special precautions").

Interaction with other medicinal products and other forms of interaction.

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

Special precautions for use

Before applying the medication, the integrity of the tympanic membrane should be checked (as a precautionary measure). If there is a perforation of the tympanic membrane, instillation of the medication into the ear may result in contact of the drug with structures of the middle ear, potentially causing adverse reactions in these tissues.

It should be noted that the medication contains an active ingredient which may lead to a positive result in anti-doping tests.

Use during pregnancy or breastfeeding

Adverse effects of the medication 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, Otix may be used during pregnancy or breastfeeding after consultation with a physician.

Ability to affect reaction speed when driving or operating machinery

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

Method of administration and dosage.

For children from 1 month of age and adults, instill 4 drops into the external auditory canal of the ear experiencing pain, 2–3 times daily. The treatment course should not exceed 10 days, after which a reassessment of treatment is required.

Method of administration

For otic use.

To avoid discomfort caused by contact between the skin of the ear canal and cold solution, warm the bottle in your hand prior to administering the medication. Then unscrew the cap from the bottle. Invert the bottle and instill 4 drops by gently pressing the central part of the dropper. After use, tightly replace the cap on the dropper and return the bottle to its packaging.

Children.

There are no data on the safety and efficacy of Otix medication in children under 1 month of age.

Use in children from 1 month of age only after consultation with and under the recommendation of a physician.

Overdose.

No cases of overdose have been observed when the drug is used at the recommended dosage.

Adverse reactions.

Reported adverse reactions are listed below by system organ classes.

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

Shelf life. 3 years.

Shelf life after first opening of the container – 6 months.

Storage conditions.

Store in the original packaging, protected from light, in a place inaccessible to children, at a temperature not exceeding 25 °C.

Packaging.

Ear drops, solution, 15 g in a bottle. One bottle per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

LLC "Arpimed"

Manufacturer's address and site of operations.

Building 19, 2nd microdistrict, city of Abovyan, Kotayk region, Republic of Armenia.