Thiotriazolin

INSTRUCTIONS for medical use of the medicinal product THIOTRIAZOLINE

Composition:

Active substance: thiotriazolin;

1 ml of solution contains 10 mg of thiotriazolin calculated to 100% substance; 1 ml of solution contains 20 drops;

Excipients: sodium chloride, methylcellulose, purified water.

Pharmaceutical form. Eye drops.

Main physicochemical properties: slightly opalescent, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Ophthalmological agents. ATC code S01X A.

Pharmacological properties.

Pharmacodynamics.

The pharmacological effect of tiothiazolin is due to activation of the antioxidant enzyme system and inhibition of lipid peroxidation processes in ischemic areas of ocular tissues, reduction of severity of neurotrophic disorders, enhancement of intensity and rate of reparative processes, reduction of tissue inflammatory response, and improvement of blood flow in the ocular microcirculation. The drug promotes early recovery of corneal sensitivity, formation of more delicate opacity, significant reduction in the number of various complications, decreases manifestations of visual asthenopia, improves functional parameters of the ciliary muscle and central retinal regions, thereby enhancing ocular functional capacity.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Injuries and burns of the eyeball, inflammatory dystrophic diseases of the cornea, viral conjunctivitis. For prevention of eye inflammations and reduction of visual asthenopia symptoms in individuals working with personal computers.

Contraindications.

Hypersensitivity to the drug.

Interaction with other medicinal products and other forms of interactions.

Unknown.

Usage characteristics.

None.

Use during pregnancy or breastfeeding.

No contraindications.

Ability to affect reaction speed when driving or operating machinery.

Does not affect.

Dosage and Administration

The drug is administered from the first days of the disease as instillations of 2 drops 3–4 times a day into the conjunctival sac of the affected eye.

In severe cases, instillations should be combined with subconjunctival or peribulbar injections of 0.5 ml of a 1% solution once daily for 7–12 days. Instillations of Thiotoriazoline should be continued for 14–15 days. If necessary, the treatment course may be extended up to 30 days.

For individuals working with personal computers, the drug is administered as instillations of 2 drops immediately before starting work, followed by every 2 hours. The duration of use should be determined individually by a physician.

Since the drug must be stored at 4–8 °C after opening the bottle, it should be warmed to room temperature before use.

Children

There is no experience with use in children; therefore, the drug is not recommended for this age group.

Overdose

Overdose is impossible when recommended doses are followed.

Side effects.

The product is usually well tolerated. Reactions at the site of administration are possible. In cases of increased individual sensitivity, allergic reactions including itching and hyperemia may occur. Cases of rhinitis have been reported.

Shelf life.

4 years. The shelf life of the solution after opening the vial is 5 days when stored at a temperature between 4 °C and 8 °C.

Storage conditions.

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

Keep out of reach of children.

Incompatibility. Not known.

Packaging. 5 ml in a vial, 1 vial with a dropper cap in a carton.

Prescription status. Prescription only.

Manufacturer.

Limited Liability Company "Research Plant 'GNCLS'".

Limited Liability Company "FARMEKS GROUP".

Manufacturer's address and place of business.

8 Vorobiova Street, Kharkiv, Kharkiv region, 61057, Ukraine.

(Limited Liability Company "Research Plant 'GNCLS')

100 Shevchenka Street, Boryspil, Kyiv region, 08301, Ukraine.

(Limited Liability Company "FARMEKS GROUP")