Diosmin-Vertex, 600 mg 60 pcs

Pharmacotherapeutic group

Angioprotective agent

ATCode

C05CA03

Pharmacodynamics:

Diosmin is a benzpyrone derivative. It belongs to the group of bioflavonoids. It has phlebotonic action (reduces vein stretching (dose-dependent effect) reduces venous congestion) improves lymphatic drainage (increases tone and frequency of contraction of the lymph capillaries increases their functional density reduces lymphatic Improves microcirculation (increases capillary resistance (dose-dependent effect) decreases their permeability) decreases leukocyte adhesion to the venous wall and their migration into paravenous tissue improves oxygen diffusion and perfusion in the skin tissue It has anti-inflammatory effect. It enhances the vasoconstrictor effect of adrenaline noradrenaline blocks the production of free radicals synthesis of prostaglandins and thromboxane. It was shown that diosmin decreases the content in plasma of the enzymes responsible for the metabolism of mucopolysaccharides in the venous wall.

In clinical trials diosmin decreased the capacity of the venous bed and the volume of venous stasis (according to plethysmography) decreased average pressure in deep and superficial leg veins (according to ultrasonic Dopplerography) and increased systolic and diastolic blood pressure in patients with postoperative orthostatic hypotension.

Pharmacokinetics:

Intake

It is rapidly absorbed from the gastrointestinal tract is detectable in plasma 2 hours after administration. Bioavailability of diosmin after oral administration is approximately 40-579%. In the intestine diosmin is transformed by intestinal microflora into diosmethine hippuric acid and benzoic acid.

Distribution

The maximum concentration in plasma is reached 5 hours after intake. Diosmin is evenly distributed and accumulates in all layers of the wall of the hollow veins and subcutaneous veins of the lower extremities to a lesser extent in the kidneys, lungs and other tissues. The volume of distribution is 621 liters. Selective accumulation of diosmin and/or its metabolites in the venous vessels reaches a maximum by the ninth hour after administration and persists for 96 hours.

Metabolism

Diosmin is metabolized in the liver. The main metabolite is hydroxyphenylpropionic acid. Metabolites of diosmin are excreted mainly by the kidneys in the form of conjugates with glucuronic acid.

79% of ingested diosmin is excreted by the kidneys through the intestine – 11% with the bile – 24%. Enterohepatic circulation of diosmin is noted. After intake of radioactive isotope-labeled diosmin, approximately 86% is excreted by the kidneys and intestines within 48 hours.

Indications

As part of the complex therapy:

– to eliminate the symptoms of varicose veins of the lower extremities;

– to eliminate the symptoms of chronic lymphovenous insufficiency of the lower extremities: Feeling of heaviness or fatigue in the legs pain;

– for impaired microcirculation;

– to eliminate symptoms of acute hemorrhoids.

Active ingredient

Diosmin

Composition

One film-coated tablet contains:

the active ingredient: diosmin – 600.00 mg;

excipients: microcrystalline cellulose – 241.50 mg; talc – 18.00 mg; hyprolose (hydroxypropyl cellulose) – 13.50 mg; croscarmellose sodium – 13.50 mg; magnesium stearate – 9.00 mg; colloidal hydrophobic silica – 4.50 mg; film coating: [hypromellose, 16.20 mg; talc, 5.40 mg; titanium dioxide, 2.79 mg; macrogol 4000 (polyethylene glycol 4000), 2.43 mg; iron oxide red dye (iron oxide), 0.18 mg] or [dry film coating mixture, containing hypromellose (60%), talc (20%), titanium dioxide (10.33%), macrogol 4000 (polyethylene glycol 4000) (9%), iron oxide (iron oxide) dye (0.67%)] – 27.00 mg.

How to take, the dosage

The drug is intended to be taken orally Lymphatic venous insufficiency of the lower extremities Chronic lymphatic insufficiency is prescribed 1 tablet a day in the morning, preferably before meals. Usually the course of treatment is 2 months. Acute hemorrhoids and exacerbations of chronic hemorrhoids In acute hemorrhoids and exacerbations of chronic hemorrhoids, the drug is prescribed the first four days to 1 tablet 3 times a day with meals; in the next three days to 1 tablet 2 times a day with meals. In case of recurrence of symptoms the treatment course may be repeated on the recommendation of the doctor. Chronic hemorrhoids After relief of acute effects is recommended to continue taking the drug at 1 tablet 1 time per day for 1-2 months. If one or more doses of the drug are missed, it is necessary to continue using the drug as usual and in the usual dose. Before using the drug you should consult your doctor.

Interaction

Clinically significant effects of interaction of diosmin with other drugs are not described.

Special Instructions

The treatment of acute hemorrhoids is combined with other medications. In the absence of rapid clinical effect it is necessary to conduct additional examination and adjust the therapy.

In patients with venous circulation disorders (varicose veins of the lower extremities, chronic lymphovenous insufficiency of the lower extremities) the maximum effect of therapy is achieved by a combination of therapy and lifestyle changes: it is advisable to avoid long periods of standing upright and to reduce excessive body weight. In some cases improvement of blood circulation is promoted by wearing special stockings (compression stockings).

Please consult a physician if there is no reduction or if the symptoms worsen.

Do not exceed the maximum periods and recommended doses without consulting your doctor.

Influence on ability to operate vehicles and other machinery:

There are no data on adverse effects of the drug on ability to operate vehicles and other machinery.

Contraindications

– Hypersensitivity to the components of the drug;

– 1st trimester of pregnancy and breastfeeding (experience of use is limited);

– Age under 18 years.

Side effects

Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO):

very often ≥ 1/10;

often from ≥ 1/100 to < 1/10;

infrequently from ≥ 1/1000 to < 1/100;

rarely from ≥ 1/10000 to < 1/1000;

very rarely < 1/10000 including individual reports;

frequency is unknown – it is not possible to determine the frequency of occurrence from the available data.

Gastrointestinal tract:

often – nausea vomiting diarrhea dyspeptic disorders heartburn constipation; infrequent – colitis.

As for the central nervous system:

rarely – headache malaise dizziness.

Skin and subcutaneous fatty tissue:

rarely – skin rashes skin itching.

Allergic reactions:

rarely – urticaria;

frequency unknown – isolated swelling of the face of the lips of the eyelids; in exceptional cases – angioedema (Quincke’s edema).

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms

Symptoms of overdose have not been described. Given the wide therapeutic range of diosmin, the risk of intoxication in overdose appears to be small.

Treatment

A specific antidote is not known.

Pregnancy use

Pregnancy

Till now in clinical practice there have been no reports of any side effects when using the drug in pregnant women. Nevertheless, for safety reasons, it is not recommended to use the drug in the first trimester of pregnancy. Application during pregnancy in the II and III trimesters is possible only by prescription in cases when the expected benefits to the mother exceed the potential risk to the fetus.

In experimental studies there has been no teratogenic effect of diosmin on the fetus.

Breast-feeding period

The drug is not recommended during breast-feeding because there is no data on penetration of diosmin into the breast milk.

Similarities

Phlebodia 600, Venolek, Phlebofa