TROXERUTIN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TROXERUTIN (Troxerutin)

Composition:

Active ingredient: 1 g of gel contains: troxerutin – 20 mg;

Excipients: methyl p-hydroxybenzoate (E 218), carbomer, ammonia solution 15%, disodium edetate, purified water.

Pharmaceutical form. Gel.

Main physicochemical characteristics: light yellow or yellow gel, transparent, of uniform consistency.

Pharmacotherapeutic group.

Angioprotectors. Capillary-stabilizing agents. Troxerutin.

ATC code C05CA04.

Pharmacological properties.

Pharmacodynamics.

Troxerutin exerts angioprotective and phlebotonic effects. Troxerutin selectively accumulates in the endothelial layer of veins 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 cell membranes. The antioxidant effect is manifested by reduction and elimination of oxygen's oxidative properties, inhibition of lipid peroxidation, and protection of the vascular endothelium from the oxidative action of hydroxyl radicals. Troxerutin reduces increased capillary permeability and exerts a venotonic effect.

The cytoprotective effect is manifested by inhibition of neutrophil activation and adhesion, reduction of erythrocyte aggregation and increased resistance of erythrocytes to deformation, and reduction of inflammatory mediator release.

The drug increases veno-arterial reflux, prolongs venous filling time, reduces blood flow to the skin (in the supine position), and improves microcirculation and microvascular perfusion.

The drug's action is directed toward reducing edema and pain, improving trophism, and eliminating various pathological disorders associated with venous insufficiency.

Pharmacokinetics.

The pharmaceutical form of the drug Troxerutin ensures complete absorption of the active substance through the stratum corneum of the epidermis and penetration into blood vessels in the subcutaneous tissue.

Clinical characteristics.

Indications.

Troxerutin is indicated for the symptomatic treatment of the following conditions:

• venous insufficiency;
• pre-varicose and varicose syndrome;
• superficial thrombophlebitis, phlebitis, and post-phlebitic conditions;
• complex treatment of hemorrhoidal disease;
• edema and pain associated with varicose veins;
• muscle cramps (spasmodic contraction of calf muscles).

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Enhances the effect of ascorbic acid on the structure and permeability of the vascular wall.

Special precautions for use.

Prolonged use may cause hypersensitivity! Hypersensitivity reactions are more frequently observed in patients with skin and/or allergic disorders.

Troxe Rutin gel should not be applied to the eyes or on inflamed skin.

Patients with severe renal function impairment should not use the drug for prolonged periods. If symptoms do not improve during treatment, medical advice should be sought.

Use during pregnancy or breastfeeding.

There is no data regarding negative effects of the drug when used during pregnancy or breastfeeding. However, use of Troxe Rutin gel during the first trimester of pregnancy is not recommended.

Ability to influence reaction rate when driving or operating machinery.

No influence.

Method of Administration and Dosage

For topical use only.

Apply the gel in a thin, even layer to the affected area of skin twice daily (in the morning and evening), gently massaging until completely absorbed. If necessary, a tight or elastic bandage may be applied. The gel is odorless and does not leave greasy stains on clothing. In severe cases, combination therapy with Troxerutin capsules is recommended. In chronic venous insufficiency, continue combination therapy until symptoms have completely resolved.

Dosage and duration of treatment should be determined by a physician, depending on the severity and course of the disease.

Children

There are no contraindications for the use of this medication in children.

Overdose

No cases of overdose have been reported with topical application. In case of accidental ingestion of a large amount of the medication, general measures for elimination of the drug should be taken: induce vomiting and administer symptomatic treatment. If necessary, perform peritoneal dialysis.

Side effects.

In individual cases, hypersensitivity reactions may occur, including skin irritation, erythema, itching, skin rashes, dermatitis, angioneurotic edema. Usually these symptoms disappear after discontinuation of the drug. The formulation includes methylparahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).

Shelf life. 2 years.

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

Storage conditions.

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

Keep out of reach of children.

Packaging.

35 g of gel in tubes № 1; in a cardboard box.

Supply category.

Over-the-counter.

Manufacturer.

PJSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's address and location of business activity.

1, Gordienkivska Street, Kharkiv, Kharkiv region, 61010, Ukraine.