TROXERUTIN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TROXERUTIN Troxerutin

Composition:

Active substance: troxerutinum;

1 g of gel contains troxerutin 20 mg;

Excipients: carbomer, triethanolamine, disodium edetate, methylparahydroxybenzoate (E 218), propylene glycol, purified water.

Pharmaceutical form. 2% gel.

Main physicochemical properties: gel of yellow to light brown color, transparent or slightly opalescent, with a weak characteristic odor, of uniform consistency.

Pharmacotherapeutic group. Angioprotectors. Capillary stabilizing agents. Bioflavonoids. Troxerutin. ATC code C05CA04.

Pharmacological properties.

Pharmacodynamics.

The medicinal product Troxerutin, gel 2%, is a mixture of bioflavonoids containing not less than 95% troxerutin. Troxerutin selectively accumulates in the endothelial layer of venules and deeply penetrates into the subendothelial layer of the venous wall, where its concentration is higher than in adjacent tissues. The medicinal product prevents oxidative damage to cellular membranes.

The antioxidant effect is manifested by reduction and elimination of oxygen's oxidative properties, inhibition of lipid peroxidation, and protection of vascular endothelium from oxidative action of hydroxyl radicals. Troxerutin reduces increased capillary permeability and exerts a venotonic effect. The cytoprotective effect results from inhibition of neutrophil activation and adhesion, reduced erythrocyte aggregation, increased erythrocyte resistance to deformation, and decreased release of inflammatory mediators.

It improves venous-arterial reflux, prolongs the time of venous refill, and enhances microcirculation and microvascular perfusion.

The action of the medicinal product Troxerutin, gel 2%, is directed toward reduction of edema and pain, improvement of trophic conditions, and elimination of various pathological disorders associated with venous insufficiency.

Pharmacokinetics.

After topical application, the active ingredient of Troxerutin gel is readily released from the water-soluble gel base and penetrates into the dermis within approximately 30 minutes and into the subcutaneous fat tissue within 2–5 hours.

Clinical characteristics.

Indications.

Troxerutin, 2 % gel, is indicated for symptomatic treatment of the following conditions:

• venous insufficiency;
• prevaricose and varicose syndrome;
• superficial thrombophlebitis, phlebitis, and postphlebitic conditions;
• complex treatment of hemorrhoidal disease;
• muscle cramps (cramping of calf muscles).

Contraindications.

Hypersensitivity to troxerutin or to any excipient of the medicinal product. Troxerutin, 2 % gel, should not be applied to mucous membranes, open wounds, or areas of skin with eczema.

Interaction with other medicinal products and other forms of interaction.

The medicinal product enhances the effect of ascorbic acid on strengthening the vascular wall structure and reducing vascular wall permeability.

Special precautions for use.

Hypersensitivity reactions are more frequently observed in patients with skin and/or allergic disorders.

Prolonged use of the medicinal product is not recommended in patients with severe renal function impairment.

If symptoms of the disease do not decrease during treatment with the medicinal product, medical advice should be sought.

Use during pregnancy or breastfeeding.

There is no data on negative effects of the medicinal product when used during pregnancy or breastfeeding. However, the use of Troxerutin gel during the first trimester of pregnancy is not recommended.

Ability to influence reaction rate when driving or operating machinery.

Has no effect.

Method of Administration and Dosage

For topical use only.

Apply the gel evenly in a thin layer to the affected area twice daily (in the morning and evening), gently rubbing in with light massaging motions until completely absorbed. If necessary, a compression or elastic bandage may be applied. In chronic venous insufficiency, continue combined therapy until symptoms have completely resolved.

The dosage and duration of treatment should be determined by a physician, taking into account the severity and course of the disease.

Children

There are no contraindications regarding the use of the medicinal product in children.

Overdose

Cases of overdose have not been reported with topical application. In case of accidental ingestion of a large amount of the medicinal product, general measures for elimination of the drug should be taken (e.g., inducing vomiting), along with symptomatic treatment. If necessary, peritoneal dialysis should be performed.

Side effects.

When using Troxerutin gel, skin irritation or allergic reactions may very rarely occur, including redness, itching, rash, dermatitis, angioedema. Usually these symptoms quickly resolve after discontinuation of the medicinal product.

Shelf life.

3 years.

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

Storage conditions.

Store at a temperature not exceeding 25 °C. Do not freeze! Keep out of reach of children.

Packaging.

40 g or 100 g in tubes. One tube per cardboard box.

Supply category.

Over-the-counter.

Manufacturer/Applicant.

TOV "Ternopharm".

Manufacturer's address / Applicant's address.

4 Fabrychna Street, Ternopil, 46010, Ukraine.

Tel./Fax: (0352) 521-444, www.ternopharm.com.ua

Date of last review.