Troxerutin-ACOS, capsules 300 mg 50 pcs

Pharmacotherapeutic group

Venotonic and venoprotective agent

ATX code: C05CA

Pharmacodynamics:

The flavonoid (rutin derivative) has P-vitamin activity; it has venotonizing angioprotective anti-inflammatory and anti-edema effects; reduces capillary permeability and fragility.

Pharmacodynamic properties are associated with the participation of bioflavonoids of troxerutin in redox processes and hyaluronidase inhibition. Inhibiting hyaluronidase troxerutin stabilizes hyaluronic acid of cell membranes and reduces their permeability. It has antioxidant activity, which prevents oxidation of ascorbic acid adrenaline and lipids. It also reduces capillary permeability and fragility and prevents damage to the basal membrane of endothelial cells when it is exposed to various factors. Troxerutin reduces the exudative inflammation in the vascular wall by reducing the adhesion of platelets to its surface. It inhibits aggregation and increases the degree of red blood cell deformation.

In chronic venous insufficiency troxerutin reduces the feeling of heaviness and swelling in the legs reduces the intensity of pain and cramps improves tissue trophism. Troxerutin relieves symptoms associated with hemorrhoids (pain, exudation, itching, bleeding).

Interference in the permeability and resistance of capillary walls can slow down the progression of diabetic retinopathy. The effect of troxerutin on the rheological properties of the blood helps to prevent microthrombosis of the retinal vessels.

Pharmacokinetics:

Troxerutin is quickly absorbed when the drug is taken orally. The maximum concentration of troxerutin is established on average 175±046 hours after oral administration. Absorption is about 10-15%. Bioavailability of the drug increases with increasing dose. Half-life of the drug is 677±237 hours. Therapeutic concentration of the drug in plasma is maintained for 8 hours. In 30 hours after troxerutin intake there is a second maximum of drug concentration in plasma due to enterohepatic recirculation. It is partially metabolized in the liver to form glucuronide and trihydroethylquercitin. It is excreted mainly through the intestine (up to 65-70%) a smaller part (up to 25%) of the drug is excreted unchanged by the kidneys.

Indications

– Chronic venous insufficiency

– Post-phlebitic syndrome

– Trophic disorders in varicose leg disease and trophic ulcers

– As adjunctive treatment after sclerotherapy and/or removal of varicose veins of the lower extremities

– Post-traumatic edema and soft tissue hematomas.

– Hemorrhoids (for symptom relief).

– In the complex treatment of retinopathy in patients with diabetes mellitus arterial hypertension and atherosclerosis

Active ingredient

Composition

In one capsule:

The active ingredient: troxerutin – 300.0 mg.

Excipients: lactose monohydrate (milk sugar) – 39.5 mg, sodium carboxymethyl starch – 7.0 mg, magnesium stearate – 3.5 mg.

Solid gelatin capsules №0

Part of the capsule body: iron oxide red dye – 0.0071%; iron oxide yellow dye – 0.1227%; titanium dioxide – 2.0000%; gelatin – up to 100%.

Capsule cap composition: diamond blue dye – 0.0190 %; dye red charming – 0.0450 %; titanium dioxide – 3.0000 %; gelatin – up to 100 %.

How to take, the dosage

Ingestion with meals. The capsules are swallowed whole with plenty of water.

In the initial phase of treatment, 1 capsule (300 mg) 2 to 3 times daily until symptoms disappear. For maintenance treatment a dose of 1 capsule per day is recommended. The average course of treatment is 3-4 weeks. The necessity of longer treatment is determined individually.

In case of diabetic retinopathy Troxerutin is indicated in 2 capsules (300 mg) 3 times daily (daily dose 18 g).

Interaction

Special Instructions

If symptoms do not decrease while using the drug, consult a physician.

There is insufficient experience of using Troxerutin in children under 18 years of age.

The use of the drug Troxerutin has no effect on motor and mental reactions. The drug Troxerutin does not affect the ability to drive vehicles and operate machinery.

Contraindications

– Hypersensitivity to troxerutin or excipients included in the drug.

– Peptic ulcer and duodenal ulcer and chronic gastritis in the acute phase.

– Lactose intolerance lactase deficiency or glucose-galactose malabsorption syndrome.

– Pregnancy (first trimester) and lactation period.

– Childhood (under 18 years of age experience is insufficient).

– Chronic renal insufficiency.

Side effects

Allergic reactions:skin rash;

Central nervous system disorders:headache;

Gastrointestinal disorders: nausea vomiting stomach pain flatulence diarrhea erosive ulcerative lesions of the gastrointestinal tract;

Skin disorders: erythema and itching;

Other: flushes of blood to the face.

Overdose

Symptoms: nausea headache “rushes” of blood to the face.

Treated: it is necessary to flush the stomach take activated charcoal if necessary to start symptomatic treatment.

Pregnancy use

The teratogenicity and fetotoxicity of Troxerutin-containing drugs have not been reported in experimental studies. Studies on teratogenicity and fetotoxicity of Troxerutin in humans have not been conducted, but there are indications of a possible association between Troxerutin administration during pregnancy and abnormalities of the outer ear in children. The use of Troxerutin is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy the use of Troxerutin is possible only if the expected benefits to the mother exceed the potential risk to the child.

There are no data on the penetration of Troxerutin into breast milk. The drug Troxerutin should not be used during breastfeeding.

Similarities