Carbarutin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KARBARUTIN (CARBARUTIN)

Composition:

Active substances: troxerutin, carbazochrome;

1 ampoule (3 ml) of injection solution contains troxerutin 150 mg, carbazochrome 1.5 mg;

Excipients: sodium chloride; sodium hydroxide or diluted hydrochloric acid; water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear orange-colored solution.

Pharmacotherapeutic group.

Capillary-stabilizing agents. Troxerutin, combinations. ATC code C05CA54.

Pharmacological Properties

Pharmacodynamics

Carbarutin is a combination of troxerutin and carbazochrome intended for the treatment of vascular disorders and hemorrhagic syndromes associated with increased capillary wall fragility. It exerts anti-inflammatory and antioxidant effects and inhibits hyaluronidase. It prevents oxidation of hyaluronic acid, ascorbic acid, and adrenaline, and inhibits lipid peroxidation.

Troxerutin, also known as vitamin P4, is a bioflavonoid that reduces increased capillary permeability and fragility and prevents damage to the basal membrane of endothelial cells. In addition, it exerts antioxidant, membrane-stabilizing, antihemorrhagic, anti-inflammatory, and venotonic effects. It reduces edema, improves trophism, enhances microcirculation and microvascular perfusion, and alleviates other symptoms associated with venous insufficiency or impaired lymphatic drainage. It also potentiates the angioprotective effect of vitamin C, promotes and activates the synthesis of hyaluronic acid (a mucopolysaccharide responsible for vascular wall strength). Furthermore, it reduces the release of histamine—a potent vasodilator and pro-edematous agent.

Carbazochrome is an orthoquinone, an oxidation product of adrenaline lacking sympathomimetic activity due to the absence of a secondary amino group and an o-diphenolic group. It exerts a local vasoconstrictive effect on small blood vessels, thereby reducing the duration of bleeding. This effect is achieved without increasing arterial blood pressure or affecting cardiovascular function. Carbazochrome has also been shown to influence capillary permeability and strength, as well as vascular tone and constriction.

The combination of troxerutin and carbazochrome is justified by mutual enhancement of pharmacological and therapeutic effects aimed at hemostasis and vasoprotection.

In a chronic toxicity study of the oral formulation of the combination in rats (at a dose of ½ tablet/kg/day) and dogs (at doses of ½ and ¼ tablet/kg/day), the product was well tolerated throughout the entire treatment period. No signs of general or gastrointestinal toxicity, behavioral changes, or changes in body weight were observed. In reproductive toxicity studies (embryo- and fetotoxicity, teratogenicity), no significant differences were found between the test and control groups.

Pharmacokinetics

Pharmacokinetic studies have not been conducted.

Clinical characteristics.

Indications.

• Symptoms of venous insufficiency.
• Increased capillary fragility.

Contraindications.

Hypersensitivity to the active substances or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

The medicinal product enhances the effect of vitamin C on strengthening the vascular wall structure and reducing its permeability.

Data on interactions with other drugs and other types of interactions are lacking.

Special precautions for use.

The efficacy and safety for mesotherapy (for intradermal and subcutaneous administration) have not been established. The medicinal product is not intended for mesotherapy.

The medicinal product is ineffective in treating lower limb edema caused by liver, kidney, or cardiovascular diseases.

The medicinal product should be used with caution in patients with severe liver or gallbladder disorders.

The medicinal product contains 24.004 mg/dose of sodium chloride. Caution is advised when administering to patients on a sodium-controlled diet.

Use during pregnancy or breastfeeding.

Safety and efficacy during pregnancy or breastfeeding have not been established. The medicinal product should not be used during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

The medicinal product does not affect the reaction rate when driving or operating machinery.

Method of Administration and Dosage.

Adults

The medicinal product should be administered intramuscularly at a dose of 1–3 ampoules per day. The duration of treatment and dosage regimen should be determined individually.

The contents of the ampoule must not be mixed with solutions containing ascorbic acid.

Children

Safety and efficacy have not been established. The medicinal product should not be used in children.

Overdose.

Cases of overdose have not been reported. Overdose may enhance the manifestations of adverse reactions. In case of overdose, symptomatic and supportive therapy should be administered.

Adverse reactions.

Hypersensitivity reactions may occur during the use of the medicinal product.

Local and generalized erythema have been reported following intradermal and subcutaneous administration (mesotherapy).

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after medicinal product registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

5 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Incompatibility.

The contents of the ampoule should not be mixed with solutions containing ascorbic acid.

Packaging.

5 ampoules in a blister pack, 2 blister packs in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Mefar Ilac San. A.S. / Mefar Ilac San. A.S.

Manufacturer's address and location of its business operations.

Ramazanoglu Mah. Ensar Cad. No: 20, 34906 Kurtkoy – Pendik/Istanbul, Turkey /
Ramazanoglu Mah. Ensar Cad. No: 20, 34906 Kurtkoy – Pendik/Istanbul, Turkey.

Marketing Authorization Holder.

LLC "WORLD MEDICINE", Ukraine /
WORLD MEDICINE, LLC, Ukraine.