Instructions Carbarutin solution for injection ampoule 3 ml No. 10
Composition
active ingredients: troxerutin, carbazochrome;
1 ampoule (3 ml) of solution for injection contains troxerutin 150 mg, carbazochrome 1.5 mg;
Excipients: sodium chloride; sodium hydroxide or diluted hydrochloric acid; water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear orange solution.
Pharmacotherapeutic group
Capillary stabilizing agents. Troxerutin, combinations. ATX code C05C A54.
Pharmacological properties
Pharmacodynamics
Carbarutin is a combination of troxerutin and carbazochrome, which is aimed at the treatment of vascular diseases and hemorrhagic syndromes with increased weakness of the capillary walls. It has anti-inflammatory and antioxidant effects, inhibits hyaluronidase. Prevents the oxidation of hyaluronic, ascorbic acid and adrenaline, inhibits lipid peroxidation.
Troxerutin, also known as vitamin P4, is a bioflavonoid that reduces increased capillary permeability and fragility and prevents damage to the basement membrane of endothelial cells. In addition, it has antioxidant, membrane-stabilizing, antihemorrhagic, anti-inflammatory, venotonic effects. Reduces edema, improves trophism, improves microcirculation and microvascular perfusion and alleviates other symptoms associated with venous insufficiency or impaired lymphatic drainage. It also enhances the angioprotective effect of vitamin C and performs and activates the synthesis of hyaluronic acid (a mucopolysaccharide responsible for the strength of vascular walls). In addition, it reduces the release of histamine - a powerful vasodilator and pro-edematous agent.
Carbazochrome is an orthoquinone, an oxidation product of adrenaline without sympathomimetic activity due to the absence of secondary amino and o-diphenol groups. It has a local vasoconstrictor effect on small vessels, which leads to a decrease in the duration of bleeding. This effect is achieved without increasing blood pressure and affecting cardiovascular activity. It has also been established that carbazochrome affects the permeability and strength of capillaries and the tone and narrowing of blood vessels.
The combination of troxerutin and carbazochrome has found its justification in the mutual enhancement of pharmacological and therapeutic effects for the purpose of hemostasis and vasoprotection.
In a chronic toxicity study of the oral form of the combination in rats (at a dose of
½ tablet/kg/day) and dogs (at a dose of ½ and ¼ tablet/kg/day) it was well tolerated throughout the entire treatment period. No signs of general or gastrointestinal toxicity, changes in behavior or body weight were detected. In reproductive toxicity studies (embryo- and fetotoxicity, teratogenicity) no significant differences were found between the main and control groups.
Pharmacokinetics
Pharmacokinetic studies have not been conducted.
Indication
– Symptoms of venous insufficiency.
– Increased capillary fragility.
Contraindication
Hypersensitivity to the active substances or to other components of the drug.
Interaction with other medicinal products and other types of interactions
The drug enhances the effect of vitamin C on strengthening the structure and reducing the permeability of the vascular wall.
There are no data on the interaction of the drug with other drugs or other types of interactions.
Application features
Efficacy and safety for mesotherapy (for intradermal and subcutaneous use) have not been established. The product is not intended for mesotherapy.
The drug is ineffective for edema of the lower extremities caused by diseases of the liver, kidneys, or cardiovascular system.
The drug should be used with caution in patients with severe liver and gallbladder diseases.
The product contains 24.004 mg/dose of sodium chloride. Caution should be exercised when used in patients on a controlled sodium diet.
Use during pregnancy or breastfeeding
Safety and efficacy have not been established. The drug should not be used during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving vehicles or other mechanisms.
Method of administration and doses
Adults.
The drug is administered intramuscularly at a dose of 1–3 ampoules per day. The duration of treatment and dosage regimen are determined individually.
The contents of the ampoule should not be mixed with solutions containing ascorbic acid.
Children
Safety and efficacy have not been established. The drug should not be used in children.
Overdose
No cases of overdose have been reported. Adverse reactions may be exacerbated. In case of overdose, symptomatic and supportive treatment should be provided.
Adverse reactions
When using the drug, the development of hypersensitivity reactions is possible.
Local and generalized erythema have been reported with intradermal and subcutaneous administration (mesotherapy).
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Incompatibility.
The contents of the ampoule should not be mixed with solutions containing ascorbic acid.
Packaging
5 ampoules in a contour blister pack, 2 contour blister packs in a cardboard box.
Vacation category
According to the recipe.
Producer
Mefar Ilach San. A.Sh. / Mefar Ilac San. AS
Location of the manufacturer and its business address
Ramazanoglu Mach. Ansar Jad. No. 20, 34906 Kurtkoy – Pendik/Istanbul, Turkey / Ramazanoglu Mah. Ensar Cad. No: 20, 34906 Kurtkoy – Pendik/Istanbul, Turkey.
Applicant
WORLD MEDICINE LTD / WORLD MEDICINE LTD.
