OXOLIN-DARNITSA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT OXOLIN-DARNITSA (OXOLIN-Darnitsa)

Composition:

Active substance: 1 g of ointment contains 2.5 mg of oxolin;

Excipients: benzoic acid (E 210), poloxamer, macrogol cetyl stearyl ether, cetyl stearyl alcohol, liquid paraffin, hard paraffin, propylene glycol.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: homogeneous ointment of white or white with a yellowish tint color.

Pharmacotherapeutic group. Agents acting on the sense organs. Antiviral agents. ATC code S01AD.

Pharmacological Properties.

Pharmacodynamics.

Oxolin-Darnytsia is an antiviral agent for topical use. It has virucidal activity by blocking the binding sites of the influenza virus (mainly type A2) on the surface of the cell membrane, thus protecting cells from viral penetration. Viruses sensitive to oxolin also include Herpes simplex virus, varicella-zoster virus, adenoviruses, viruses of infectious warts, and molluscum contagiosum virus.

Pharmacokinetics.

The drug is non-toxic; no systemic effects have been observed with local application, and it does not accumulate in the body. When applied to the mucous membrane, 20% of the drug is absorbed and is excreted mainly by the kidneys within 24 hours.

Clinical characteristics.

Indications.

Prevention of influenza, treatment of viral rhinitis.

Contraindications.

Individual hypersensitivity to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Concomitant intranasal use with adrenomimetic agents may lead to drying of the nasal mucosa.

Special precautions.

Use during pregnancy or breastfeeding.

There are no data on the safety and efficacy of the medicinal product during pregnancy and breastfeeding. The medicinal product is not recommended for use during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Oxolin does not affect the speed of neuromuscular conduction; therefore, it can be used at recommended doses by individuals who drive vehicles or operate complex machinery.

Method of Administration and Dosage

Influenza prophylaxis: apply the ointment to the nasal mucosa daily 2–3 times a day for 25 days or during contact with infected individuals.

Treatment of viral rhinitis: apply the ointment to the nasal mucosa daily 2–3 times a day for 3–4 days.

Children

Data on the safety and efficacy of the medicinal product in children are lacking.

Overdose.

There have been no reports of overdose to date.

Symptoms: possible burning sensation on the nasal mucosa and rhinorrhea.

Treatment: discontinue use of the ointment; remove any residual product by washing with warm water.

Side effects.

At the site of ointment application, a burning sensation may occur, which quickly passes; rhinorrhea; blue discoloration of the mucous membrane.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 8 °C.

Keep out of reach of children.

Packaging. 10 g in a tube; 1 tube in a carton.

Availability category. Over-the-counter.

Manufacturer.

JSC "Pharmaceutical company "Darnytsia".

Manufacturer's address and place of business.

Ukraine, 02093, Kyiv, Borispilska Street, 13.