Otipax

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT OTIPAX®

Composition:

Active substances: 16 g of solution contains 0.64 g of phenazone and 0.16 g of lidocaine hydrochloride monohydrate;

Excipients: sodium thiosulfate, anhydrous ethanol, glycerol, purified water.

Pharmaceutical form. Ear drops.

Main physicochemical properties: clear, colorless or slightly yellowish solution with a characteristic odor of alcohol.

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

Pharmacological properties.

Pharmacodynamics.

Otipax**®** is a combination of two active ingredients: 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 preparation 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 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, in:

• acute otitis media;
• postviral (postinfluenzal) vesicular otitis;
• barotraumatic otitis.

Contraindications.

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

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

Interaction with other medicinal products and other forms of interaction.

Currently, there are no data regarding the potential for 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 any destruction or perforation of the tympanic membrane, instillation of the medicine 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.

It should be noted that the medicine contains an active ingredient that may yield a positive result in anti-doping tests.

Use during pregnancy or breastfeeding

There are no expected adverse consequences of using the medicine 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, Otipax® may be used during pregnancy or breastfeeding following consultation with a physician.

Effect on ability to drive or operate machinery

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

Dosage and method of 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. The treatment course should not exceed 10 days. After this period, the treatment should be re-evaluated.

Method of administration

For otic use only.

To avoid discomfort caused by contact of the cold solution with the skin of the ear canal, warm the bottle in your hands before using the medicinal product.

• Unscrew the bottle cap.
• Remove the dropper from the polyethylene/paper blister.
• Screw the dropper onto the bottle.
• Remove the cap from the dropper.
• Turn the bottle upside down and gently squeeze the dropper to release 1 drop.
• Continue squeezing until 4 drops are delivered.
• Replace the white cap on the dropper.

Children.

There are no safety and efficacy data on the use of Otipax® in children under 1 month of age.

Use in children from 1 month of age should be performed after consultation with and upon recommendation by a physician.

Overdose.

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

Side effects.

The reported side effects are listed according to system organ classes.

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

Shelf life.

3 years.

30 days after first opening the bottle.

Storage conditions.

No special storage conditions required. Keep out of reach and sight of children.

Packaging.

16 g of solution in a dark glass bottle with a screw cap and tamper-evident seal. One bottle together with a separately packaged plastic dropper (blister made of polyethylene/paper) in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

BIODEX.

Manufacturer's name and address of the place of business.

Manufacturing address: 1 Avenue Blaise Pascal, 60000 Beauvais, France.