Troxerutin-darnitsa

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TROXERUTIN-DARNITSA (TROXERUTIN-DARNITSA)

Composition:

Active substance: troxerutin;

1 g of gel contains 20 mg of troxerutin;

Excipients: methylparahydroxybenzoate (E 218), propylene glycol, carbomer 980, tromethamine, disodium edetate, purified water.

Medicinal form. Gel.

Main physico-chemical properties: Transparent yellow gel with a faint characteristic odor. Should be homogeneous in appearance.

Pharmacotherapeutic group. Angioprotectives. Capillary-stabilizing agents. Troxerutin. ATC code C05CA04.

Pharmacological properties.

Pharmacodynamics.

Troxerutin-Darnytsia exerts angioprotective and phlebotonic effects.

The primary site of accumulation of the drug is the endothelial layer of venules. The drug 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 cellular membranes. The antioxidant effect is manifested by reducing and eliminating the oxidative properties of oxygen, inhibiting lipid peroxidation, and protecting the vascular endothelium from the oxidative action of hydroxyl radicals. Troxerutin-Darnytsia reduces increased capillary permeability and enhances venous tone.

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

The action of the drug is directed toward reducing edema and pain, improving trophicity, and eliminating various pathological disorders associated with venous insufficiency.

Pharmacokinetics.

When Troxerutin-Darnytsia is applied to the affected area, the active substance rapidly penetrates through the epidermis, appears in the dermis within 30 minutes, and reaches the subcutaneous fat tissue within 2–5 hours.

Clinical characteristics.

Indications.

For symptomatic treatment: venous insufficiency, prevaricose and varicose syndrome, superficial thrombophlebitis, phlebitis and postphlebitic conditions; for complex treatment of hemorrhoidal disease; edema and pain due to trauma and varicose vein enlargement; muscle cramps (calf muscle spasms).

Contraindications.

Hypersensitivity to troxerutin or to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Enhances the capillary-protective effect of ascorbic acid.

Special precautions for use.

The gel should not be applied to open wounds, eczematous skin areas, eyes, or mucous membranes. Prolonged use may cause hypersensitivity.

In patients with pronounced renal function impairment, prolonged use of the medicinal product is not recommended.

If symptoms of the disease do not diminish during treatment with the medicinal product, consult a physician.

Use during pregnancy or breastfeeding.

There are no data regarding negative effects of the medicinal product when used during pregnancy or breastfeeding. Therefore, use is permitted only upon prescription by a physician who has evaluated the benefit to the woman versus the risk to the fetus (child).

Ability to affect reaction speed when driving or operating machinery.

Does not affect.

Method of administration and dosage.

Externally: apply the gel in the morning and evening to the affected area of the skin, gently rubbing in with light movements until complete absorption of the medicinal agent. In severe cases, combination therapy with troxerutin capsules is recommended. In chronic venous insufficiency, apply combination therapy until complete disappearance of symptoms. The dosage and duration of treatment are determined individually 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 elimination of the drug should be taken: induce vomiting, administer symptomatic treatment. If indicated, perform peritoneal dialysis.

Adverse reactions.

When using Troxerutin-Darnytsia gel, the following adverse reactions may very rarely occur:

Immune system disorders: angioneurotic edema;

Skin and subcutaneous tissue disorders: skin irritation, redness, erythema, itching, skin rash, dermatitis.

These symptoms usually resolve quickly after discontinuation of the medicinal product. The medicinal product contains methylparahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze. Keep out of reach of children.

Packaging.

30 g or 50 g in a tube, 1 tube per carton.

Supply category. Over-the-counter.

Manufacturer. JSC "Pharmaceutical company "Darnytsia".

Manufacturer's address and place of business.

13, Borispilska Street, Kyiv, 02093, Ukraine.