Flebopress^® (Capsules) Instructions for Use

Marketing Authorization Holder

Ozon, LLC (Russia)

Manufactured By

Ozon Pharm, LLC (Russia)

Or

Ozon, LLC (Russia)

ATC Code

C05CA04 (Troxerutin)

Active Substance

Troxerutin (Rec.INN registered by WHO)

Dosage Form

Flebopress®

Capsules 300 mg: 10, 20, 30, 50, 60, 90, 100, 150, 180, 270 or 300 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 0 with a light yellow body with a brownish tint and a light purple cap, opaque; the capsule contents are a granulated powder or a mixture of powder and granules ranging from yellow to greenish-yellow in color, compaction of the capsule contents into lumps is allowed.

Excipients : lactose monohydrate (milk sugar) – 39.5 mg, sodium carboxymethyl starch – 7 mg, magnesium stearate – 3.5 mg.

Capsule body composition: iron oxide red dye – 0.0071%, iron oxide yellow dye – 0.1227%, titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: brilliant blue dye – 0.019%, allura red AC dye – 0.045%, titanium dioxide – 3%, gelatin – up to 100%.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
10 pcs. – contour cell packaging (10) – cardboard packs.
30 pcs. – contour cell packaging (1) – cardboard packs.
30 pcs. – contour cell packaging (2) – cardboard packs.
30 pcs. – contour cell packaging (3) – cardboard packs.
30 pcs. – contour cell packaging (5) – cardboard packs.
30 pcs. – contour cell packaging (6) – cardboard packs.
30 pcs. – contour cell packaging (9) – cardboard packs.
30 pcs. – contour cell packaging (10) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
60 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

Clinical-Pharmacological Group

Drug used for disorders of venous circulation. Angioprotector

Pharmacotherapeutic Group

Venotonic and venoprotective agent

Pharmacological Action

A drug for the treatment of chronic venous insufficiency, a semi-synthetic bioflavonoid (a derivative of rutin) of the benzopyran class, has P-vitamin activity, and has a venotonic, angioprotective, anti-inflammatory, and anti-edema effect, reduces capillary permeability and fragility.

Its pharmacodynamic properties are associated with the participation of the bioflavonoids of troxerutin in redox processes and the inhibition of hyaluronidase. By suppressing hyaluronidase, Troxerutin stabilizes hyaluronic acid in cell membranes and reduces their permeability. It has antioxidant activity, thereby preventing the oxidation of ascorbic acid, adrenaline, and lipids. Furthermore, it reduces capillary permeability and fragility, preventing damage to the basement membrane of endothelial cells when exposed to various factors. Troxerutin increases the density of the vascular wall, reduces the exudation of the liquid part of plasma and the diapedesis of blood cells. It reduces exudative inflammation in the vascular wall by decreasing platelet adhesion to its surface. It inhibits aggregation and increases the degree of erythrocyte deformation.

The use of troxerutin is possible both in the initial and late stages of treatment for chronic venous insufficiency, and it can be used as one of the components of complex therapy. Troxerutin reduces swelling and the feeling of heaviness in the legs, decreases the intensity of pain and cramps, and improves tissue trophism.

Troxerutin alleviates symptoms associated with hemorrhoids (pain, exudation, itching, bleeding).

Due to its effect on the permeability and resistance of capillary walls, Troxerutin helps slow the progression of diabetic retinopathy.

The effect of troxerutin on the rheological properties of blood helps prevent the development of microthrombosis of retinal vessels.

Pharmacokinetics

Troxerutin is rapidly absorbed after oral administration. The C_max of troxerutin in blood plasma is reached on average 1.75±0.46 hours after oral intake. Absorption is approximately 10-15%. Bioavailability increases with increasing dose. T_1/2 is 6.77±2.37 hours. The therapeutic concentration of the drug in blood plasma is maintained for 8 hours. A second peak in the plasma concentration of the drug is observed 30 hours after troxerutin intake, due to enterohepatic recirculation. It is partially metabolized in the liver to form a glucuronide and trihydroxyethylquercetin. It is excreted mainly through the intestines (up to 65-70%), a smaller part (up to 25%) of the drug is excreted unchanged by the kidneys.

Indications

As part of complex therapy for the following diseases: chronic venous insufficiency; trophic disorders in chronic venous insufficiency and trophic ulcers; varicose veins; superficial thrombophlebitis, periphlebitis; post-thrombotic syndrome; post-traumatic edema and soft tissue hematomas; as an auxiliary treatment after sclerotherapy and/or removal of varicose veins of the lower extremities; hemorrhoids (to alleviate symptoms); diabetic angiopathy, retinopathy.

ICD codes

Dosage Regimen

Administer orally with meals.

For the treatment of chronic venous insufficiency and associated conditions, the typical daily dose is 600 mg to 900 mg.

Divide the total daily dose into two or three separate administrations.

The standard treatment duration is 2 to 4 weeks.

For severe symptoms or upon physician’s recommendation, the initial dose may be set at 900 mg per day.

Reduce the dose to 600 mg per day after 2 to 4 weeks as symptoms improve for maintenance therapy.

The maximum single dose is 300 mg (one capsule).

The maximum daily dose should not exceed 900 mg (three capsules).

For the symptomatic relief of hemorrhoids, adhere to the same dosage range and administration schedule.

In cases of diabetic retinopathy, follow the physician’s prescribed dosage, which may require a longer course of treatment.

Do not exceed the recommended daily dose.

Do not use in children and adolescents under 18 years of age.

If a dose is missed, take it as soon as remembered, but do not double the dose to make up for a missed one.

Discontinue use and consult a physician if no improvement is observed after 2 weeks of treatment.

Adverse Reactions

Immune system disorders hypersensitivity reactions.

Nervous system disorders headache.

Vascular disorders flushing.

Gastrointestinal disorders nausea, vomiting, stomach pain, flatulence, diarrhea, erosive and ulcerative lesions of the gastrointestinal tract.

Skin and subcutaneous tissue disorders erythema, skin itching, skin rash.

Contraindications

Hypersensitivity to troxerutin; peptic ulcer of the stomach and duodenum, chronic gastritis in the acute phase; first trimester of pregnancy; breastfeeding period; children under 18 years of age.

With caution

In patients with chronic renal failure (with long-term use).

Use in Pregnancy and Lactation

Use in the first trimester of pregnancy is contraindicated. The possibility of use in the second and third trimesters of pregnancy is determined by the doctor and is only possible if the intended benefit to the mother outweighs the potential risk to the fetus.

Data on the penetration of troxerutin into breast milk are not available. Use during breastfeeding is contraindicated.

Use in Renal Impairment

In patients with chronic renal failure (with long-term use).

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

When treating superficial thrombophlebitis or deep vein thrombosis, the use of troxerutin does not exclude the need for anti-inflammatory and antithrombotic therapy.

Troxerutin is not effective for edema caused by concomitant diseases of the liver, kidneys, and heart.

Drug Interactions

With simultaneous use, it enhances the effect of ascorbic acid on vascular wall resistance and permeability.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.