Troxegel

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TROXEGEL® (TROXEGEL®)

Composition:

Active ingredient: troxerutin;

1 g of gel contains 20 mg of troxerutin calculated as 100% substance;

Excipients: carbomer 934 P (carbopol 934 P), tromethamine (trometamol), disodium edetate (EDTA), benzalkonium chloride, purified water.

Pharmaceutical form. Gel.

Main physicochemical properties: transparent, jelly-like gel of yellow or yellow with a greenish tint, with a faint characteristic odor, homogeneous in 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 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 vascular endothelium against oxidative action of hydroxyl radicals. Troxerutin reduces increased capillary permeability and enhances venous tone. The cytoprotective effect is expressed through inhibition of neutrophil activation and adhesion, reduction of erythrocyte aggregation, increased erythrocyte resistance to deformation, and decreased release of inflammatory mediators.

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

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

Pharmacokinetics. The Troxegel® dosage form 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.

TroxeGel®, gel, is indicated for symptomatic treatment of the following conditions:

• venous insufficiency;
• prevaricose and varicose syndrome;
• superficial thrombophlebitis, phlebitis, and postphlebitic conditions;
• hemorrhoidal disease — as part of complex therapy;
• muscle cramps (spasmodic contraction of calf muscles).

Contraindications.

Hypersensitivity to troxerutin or to any other excipient of the medicinal product. TroxeGel® 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.

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

Special precautions.

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

Benzalkonium chloride contained in the medicinal product has an irritating effect and may cause skin reactions. Troxegele® gel should not be applied to the eyes or inflamed skin.

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

If symptoms do not improve during treatment with the medicinal product, consult a physician.

Use during pregnancy or breastfeeding.

There are no data regarding any adverse effects of the medicinal product when used during pregnancy or breastfeeding. However, use of Troxegele® gel is not recommended during the first trimester of pregnancy. This medicinal product should not be applied to the mammary glands of breastfeeding women, as it may enter the infant's body during breastfeeding.

Ability to influence reaction rate while driving or operating machinery. No effect.

Method of Administration and Dosage

For topical use only.

Apply the gel to the affected area as a thin, even layer, morning and evening, gently massaging until completely absorbed. If necessary, apply a compression or elastic bandage. The gel does not leave greasy stains on clothing. In more severe conditions, combination therapy is recommended. In chronic venous insufficiency, continue combination therapy until symptoms have completely resolved.

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 drug in children.

Overdose.

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

Side effects.

When using Troxegel® gel, skin irritation or allergic reactions may very rarely occur, including redness, itching, skin rashes, dermatitis, and angioneurotic edema. Usually, these symptoms quickly resolve after discontinuation of the medicinal product.

Reporting of suspected adverse reactions. All suspected adverse reactions and cases of lack of efficacy should be reported via the following link: https://aisf.dec.gov.ua.

Shelf life. 5 years.

Storage conditions.

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

Packaging. 40 g in a tube, 1 tube per carton.

Availability. Over-the-counter.

Manufacturer. JSC "Kyivmedpreparat".

Manufacturer's address and location of its business activity.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.