Troximetazine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TROXIMETACIN

Composition:

Active substance: troxerutin;

1 g of gel contains troxerutin 20 mg;

Excipients: carbomers, triethanolamine, disodium edetate, benzalkonium chloride solution, purified water.

Pharmaceutical form. Gel.

Main physico-chemical properties: homogeneous transparent gel, yellow to yellow-green in color, free from air bubbles.

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

Pharmacological Properties.

Pharmacodynamics.

Troxerutin exerts angioprotective and phlebotonic effects. It selectively accumulates in the endothelial layer of veins and deeply penetrates the subendothelial layer of the venous wall, where its concentration is higher than in adjacent tissues. The drug 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. It prevents oxidation of hyaluronic acid, ascorbic acid, and adrenaline, and inhibits lipid peroxidation. Troxerutin reduces increased capillary permeability and enhances venous tone. It decreases capillary permeability and fragility, prevents damage to the basal membrane of endothelial cells, and additionally exerts membrane-stabilizing, antihemorrhagic, detoxifying, anti-allergic, and venotonic effects. The cytoprotective effect is manifested by inhibition of neutrophil activation and adhesion, reduction of erythrocyte aggregation, increased resistance of erythrocytes to deformation, and decreased release of inflammatory mediators.

The drug increases veno-arterial reflux, prolongs venous filling time, reduces blood inflow to the skin surface (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 dosage form of the drug 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.

For symptomatic treatment: venous insufficiency, prevaricose and varicose syndrome, superficial thrombophlebitis, phlebitis and postphlebitic conditions; for comprehensive treatment of hemorrhoidal disease; for treatment of edema and pain associated with varicose vein enlargement; for treatment of muscle spasms (cramping of calf muscles).

Contraindications.

Hypersensitivity to troxerutin or to any of the excipients. Troximetacin 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 capillary-protective effect of ascorbic acid.

Special precautions for use.

Prolonged use may cause hypersensitivity!

Benzalkonium chloride may cause skin reactions.

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

The medicinal product is not recommended for long-term use in patients with severe renal function impairment.

If symptoms do not improve during treatment, consult a physician.

Use during pregnancy or breastfeeding.

There are no clinical data on the use of this medicinal product in pregnant or breastfeeding women.

The use of Troxerutin gel during the first trimester of pregnancy is not recommended.

Ability to influence the speed of reactions while driving or operating machinery.

No effect.

Method of Administration and Dosage.

For external use on the skin only.

Apply a small amount of the gel evenly in a thin layer to the affected area both in the morning and evening, rubbing gently with massaging motions until completely absorbed. The dosage and duration of treatment are determined by a physician depending on the severity and course of the disease.

Children

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

Overdose.

With topical application, cases of overdose have not been reported. In case of accidental ingestion of a large amount of the medicinal product, general measures for drug elimination should be taken: induce vomiting, 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, and angioneurotic edema. These symptoms usually disappear after discontinuation of the medicinal product.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after medicinal product registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions through the national reporting system.

Shelf life. 5 years.

Shelf life after first opening of the tube: 1 month.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

40 g in a tube, in a cardboard box.

Pharmaceutical category.

Over-the-counter (without prescription).

Manufacturer.

VETPROM AD, Vpharma site / VETPROM AD, the Vpharma site.

Address of the manufacturer’s premises.

26 Otec Paisiy Street, Radomir 2400, Republic of Bulgaria.