INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AURIDEKSAN

Composition:

Active substance: decamethoxine;

1 ml of solution contains 0.5 mg of decamethoxine calculated as 100% substance;

Excipient: ethanol (70%).

Pharmaceutical form. Otic drops.

Main physicochemical properties: colorless clear liquid with a characteristic odor of alcohol.

Pharmacotherapeutic group. Otological preparations. Antimicrobial agents. ATC code S02AA.

Pharmacological properties.

Pharmacodynamics.

The drug exerts an antiseptic effect and has a broad spectrum of antimicrobial activity against gram-positive and gram-negative microorganisms (pyogenic cocci, including multidrug-resistant staphylococci, enterobacteria, Corynebacterium diphtheriae), protozoa, yeast-like fungi of the genus Candida, dermatophytes, and viruses. The agent acts bactericidally, sporicidally, and fungicidally on microorganisms. Auridexan increases bacterial sensitivity to antibiotics and potentiates the effect of conventional antimicrobial agents in combined therapy.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications. Treatment of bacterial and fungal acute and chronic external and middle non-perforative otitis.

Contraindications. Hypersensitivity to decamethoxine or ethanol.

Interaction with other medicinal products and other forms of interaction. Not studied.

Features of use.

The drug should not be used in case of individual hypersensitivity.

Use during pregnancy or breastfeeding. The drug may be used during pregnancy or breastfeeding only when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence reaction rate while driving or operating machinery. Does not affect.

Method of Administration and Dosage.

After opening the bottle, close it with the dropper cap.

For adults and children aged 12 years and older, instill 2–3 drops of Auridexan into each ear 3–4 times daily, warmed. The duration of treatment depends on the severity of the disease and the therapeutic effect achieved, and is determined individually by the physician.

Children. There is no experience with the use of decamethoxine in children under 12 years of age; therefore, the drug should not be prescribed to patients in this age group.

Overdose. Cases of overdose have not been reported.

Side effects.

Possible transient burning sensation upon application of the product, as well as local skin irritation reaction of the ear (external auditory canal, auricle) in case of increased individual sensitivity to decamethoxin.

Shelf life. 4 years.

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

Keep out of reach of children.

Packaging. 5 ml or 10 ml in a bottle with a dropper cap, in a carton.

Prescription status. Prescription only.

Manufacturer.

Limited Liability Company "Experimental Plant "GNCLS".

Limited Liability Company "FARMEKS GROUP".

Manufacturer's address and place of business.

Ukraine, 61057, Kharkiv region, city of Kharkiv, Vorobiova Street, building 8.

(Limited Liability Company "Experimental Plant "GNCLS")

Ukraine, 08301, Kyiv region, city of Boryspil, Shevchenka Street, building 100.

(Limited Liability Company "FARMEKS GROUP")