Instructions for Troxevasin capsules 300 mg blister No. 50
Composition
active ingredient: troxerutin;
1 capsule contains troxerutin 300 mg;
excipients: magnesium stearate, lactose monohydrate; quinoline yellow (E 104), sunset yellow (E 110), titanium dioxide (E 171), gelatin.
Dosage form
Capsules.
Main physicochemical properties: hard cylindrical gelatin capsules, No. 1, yellow (body – yellow; cap – yellow); capsule contents – powder from yellow to yellow-brown, the presence of conglomerates is allowed, which disintegrate when pressed.
Pharmacotherapeutic group
Angioprotectors. Capillary stabilizing agents. Bioflavonoids. Troxerutin. ATC code C05C A04.
Pharmacological properties
Pharmacodynamics
Troxevasin is a mixture of bioflavonoids containing at least 95% troxerutin; a capillary tonic and venotonic agent. It has anti-inflammatory and antioxidant effects, inhibits hyaluronidase. It prevents the oxidation of hyaluronic, ascorbic acid and adrenaline, inhibits lipid peroxidation. Troxerutin reduces increased capillary permeability and fragility, prevents damage to the basement membrane of endothelial cells by various factors and, in addition, has antioxidant, membrane-stabilizing, antihemorrhagic, anti-inflammatory, venotonic effects. It reduces edema, improves trophism, improves microcirculation and microvascular perfusion and reduces other symptoms associated with venous insufficiency or impaired lymphatic fluid outflow.
Pharmacokinetics
Maximum plasma concentrations are established 1–9 hours after oral administration. The decrease in plasma concentration is biexponential. Binding to plasma proteins is within 27–29%, in the largest quantities it accumulates in endothelial tissue. Does not penetrate the blood-brain barrier, penetrates the placental barrier in insignificant quantities, in minimal quantities it penetrates into breast milk. Metabolized by glucuronidation in the liver. Mainly excreted from the body with bile, in insignificant quantities - with urine.
Indication
Troxevasin, capsules, is used for the symptomatic treatment of the following diseases:
prevaricose and varicose syndrome, varicose ulcers;
superficial thrombophlebitis, phlebitis and post-phlebitic conditions;
chronic venous insufficiency;
hemorrhoids;
in the complex therapy of diabetic retinopathy;
swelling and pain due to injuries and varicose veins, varicose dermatitis;
combined treatment of contusions, sprains, dislocations, symptoms of muscle cramps (convulsive contraction of the calf muscles).
Contraindication
Troxevasin is contraindicated in patients with hypersensitivity to troxerutin or any excipient of the drug; with gastric and duodenal ulcers, with chronic gastritis (in the acute phase).
Interaction with other medicinal products and other types of interactions
The drug enhances the effect of ascorbic acid on strengthening the structure and reducing the permeability of the vascular wall.
Application features
The drug Troxevasin is ineffective for edema caused by diseases of the liver, kidneys, or cardiovascular system.
The drug should be prescribed with caution to patients with severe liver and gallbladder diseases.
Since the drug can irritate the gastric mucosa, Troxevasin should be used with meals.
The drug contains lactose, so it should not be used in patients with lactase deficiency, galactosemia or glucose/galactose malabsorption syndrome.
Due to the presence of a dye (E 110), treatment with the drug may cause an allergic reaction.
Use during pregnancy or breastfeeding
Pregnancy
There is no data on the negative effects of troxerutin on pregnant and breastfeeding women, but despite this, its use in the first trimester of pregnancy is not recommended. The drug can be used during pregnancy only under the close supervision of a doctor, as there is insufficient data on the use of troxerutin during pregnancy.
Breast-feeding
The drug penetrates into breast milk in minimal quantities, but there is no evidence that it has caused clinically significant reactions in newborns. The decision on the possibility of using the drug in this category of women is made by the doctor depending on the superiority of the benefit of treatment for the mother over the potential risk to the fetus or infant.
Ability to influence reaction speed when driving vehicles or other mechanisms
Troxevasin does not affect the ability to drive a car or operate other mechanisms.
Method of administration and doses
The usual dose is 2 capsules per day. Maintenance treatment is 1 capsule per day for 3–4 weeks. This treatment can be combined with the simultaneous use of Troxevasin, gel. The effectiveness of treatment with Troxevasin depends on the regularity of administration, the correct dosage and duration of therapy. Clinical experience shows that sometimes the desired effect is observed at doses exceeding 600 mg (2 capsules) per day.
Children
Experience with the use of the drug in the treatment of children (under 18 years of age) is limited, therefore the use of this medicine is not recommended.
Overdose
No cases of overdose have been observed.
Symptoms: Adverse reactions may worsen.
Treatment. Stop taking the drug. It is recommended to induce vomiting or perform gastric lavage and carry out symptomatic treatment. If necessary, peritoneal dialysis can be prescribed.
Adverse reactions
When treated with Troxevasin capsules, adverse reactions rarely occur.
Adverse reactions are classified according to frequency as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000); frequency unknown (cannot be estimated from the available data).
On the part of the immune system: very rarely - anaphylactic shock, anaphylactoid reactions, hypersensitivity reactions.
Skin and subcutaneous tissue disorders: rarely - rash; frequency unknown - allergic dermatitis (itching, urticaria).
On the part of the psyche: frequency unknown - sleep disorders.
From the nervous system: very rarely - dizziness, headache.
Vascular disorders: very rarely – ecchymosis.
Gastrointestinal: rarely - stomach pain, discomfort in the stomach area, dyspepsia, flatulence, diarrhea; frequency unknown - nausea, vomiting.
General disorders: very rarely - increased fatigue.
Reporting of suspected adverse reactions. All cases of suspected adverse reactions and lack of efficacy of the drug should be reported via the link: https://aisf.dec.gov.ua/.
Expiration date
5 years.
The drug should not be used after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 capsules in a blister; 5 or 10 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Balkanfarma-Razgrad JSC.
Location of the manufacturer and address of its place of business
68 April Uprising Blvd., Razgrad 7200, Bulgaria.
