Diosmin - instructions for use, doses, side effects, contraindications

Excipients: cellulose microcrystalline - 241.50 mg; talcum - 18.00 mg; giprolose (hydroxypropyl cellulose) - 13.50 mg; croscarmellose sodium - 13.50 mg; magnesium stearate - 9.00 mg; silicon dioxide colloidal hydrophobic - 4.50 mg; film sheath: [hypromellose 16.20 mg, talc 5.40 mg, titanium dioxide 2.79 mg, macrogol 4000 (polyethylene glycol 4000) 2.43 mg, ferric oxide red oxide (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 dye oxide red (iron oxide) (0 , 67%)] - 27.00 mg.

Description:

Oval biconvex tablets covered with a pink film cover. On the cross-section the nucleus is grayish-yellow or light-yellow in color.

Pharmacotherapeutic group:Angioprotective agent

ATX: & nbsp

C.05.C.A.03 Diosmin

Pharmacodynamics:

Diosmin is a benzopyrone derivative. Refers to the group of bioflavonoids. It has a phlebotonizing effect (reduces vein dilatation, increases vein tone (dose-dependent effect), reduces venous congestion), improves lymphatic drainage (increases tone and frequency of lymphatic capillary contraction, increases their functional density, reduces lymphatic pressure), improves microcirculation (increases resistance of capillaries ( dose-dependent effect), reduces their permeability), reduces the adhesion of leukocytes to the venous wall and their migration to parainous tissues, improves diffusion of oxygen and perfusion in skin tissue, and has an anti-inflammatory effect. Strengthens the vasoconstrictive effect of adrenaline, norepinephrine, blocks the production of free radicals, the synthesis of prostaglandins and thromboxane. It was shown that diosmin reduces the content of plasma enzymes responsible for the metabolism of mucopolysaccharides in the venous wall.

In clinical trials diosmin reduced the capacity of the venous bed and the volume of venous stasis (according to plethysmography),reduced the average pressure in the deep and superficial veins of the legs (according to ultrasound dopplerography) and increased systolic and diastolic blood pressure in patients with postoperative orthostatic hypotension.

Pharmacokinetics:

Suction

Quickly absorbed from the gastrointestinal tract, detected in the blood plasma 2 hours after ingestion. Bioavailability of diosmine after oral administration is approximately 40-57.9%. In the intestine diosmin It is transformed by intestinal microflora into diosmetin, hippuric and benzoic acid.

Distribution

The maximum concentration in the blood plasma is reached after 5 hours after administration. Diosmin evenly distributed and accumulated in all layers of the wall of the hollow veins and subcutaneous veins of the lower limbs, to a lesser extent - in the kidneys, liver, lungs and other tissues. The volume of distribution is 62.1 liters. The selective accumulation of diosmin and / or its metabolites in venous vessels reaches a maximum by the ninth hour after administration and lasts for 96 hours.

Metabolism

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

Excretion

79% of the received diosmina is excreted by the kidneys, 11% through the intestine, and 2.4% by the bile. The enterohepatic circulation of the diosmin is noted. After receiving a diosmin labeled with a radioactive isotope, approximately 86% is excreted by the kidneys and intestines within 48 hours.

Indications:

As part of complex therapy:

- to eliminate the symptoms of varicose veins of the lower limbs;

- for elimination of symptoms of chronic lymphovenous insufficiency of the lower extremities: a feeling of heaviness or fatigue in the legs, pain;

- when microcirculation is impaired;

- to eliminate the symptoms of acute hemorrhoids.

Contraindications:

- Hypersensitivity to the components of the drug;

- 1 trimester of pregnancy and the period of breastfeeding (experience of use is limited);

- age to 18 years.

Pregnancy and lactation:

Pregnancy

So far, in clinical practice, there have been no reports of any side effects when the drug is used in pregnant women. However, for safety reasons, it is not recommended to use the drug in the first trimester of pregnancy. Use during pregnancy in II and III trimesters are possible only according to the prescription of the doctor in those cases when the expected benefit for the mother exceeds the potential risk to the fetus.

In experimental studies, there was no teratogenic effect of diosmina on the fetus.

Breastfeeding period

During breastfeeding, taking the drug is not recommended, since there is no data on the penetration of diosmin into breast milk.

Dosing and Administration:

Use the drug only according to the indications, the method of administration and the doses indicated in the instructions.

Before using the drug should consult a doctor. A drug Diosmin is intended for oral administration.

With varicose veins of the lower extremities and chronic lymphovenous insufficiency appoint 1 tablet per day in the morning on an empty stomach. The duration of therapy is usually 2 months.

In severe forms of chronic lymphovenous insufficiency (swelling, pain, cramps, and so on), treatment may be longer (the total duration of continuous therapy should not exceed 3-4 months).

Course of drug treatment Diosmin repeat after 2-3 months.

For the treatment of chronic lymphovenous insufficiency during II and III trimester of pregnancy drug is used for 1 tablet 1 time per day. The duration of therapy is not more than 30 days. The drug should be discontinued 2-3 weeks before delivery.

With an exacerbation of hemorrhoids the drug is prescribed for 2-3 tablets per day during meals for 7 days. Further, if necessary, you can continue taking the drug 1 tablet 1 time per day for 1-2 months.

With violations of microcirculation

The drug is prescribed 1 tablet per day in the morning on an empty stomach. The duration of therapy is usually 1-2 months.

If you miss one or more of the medications, you must continue to use the drug in the usual mode and in a regular dose.

Side effects:

Classification of the incidence of adverse events according to recommendations 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 messages;

the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

From the gastrointestinal tract:

often - nausea, vomiting, diarrhea, dyspeptic disorders, heartburn, constipation; infrequently - colitis.

From the central nervous system:

rarely - headache, malaise, dizziness.

From the skin and subcutaneous fat:

rarely - skin rashes, itchy skin.

Allergic reactions:

rarely - hives;

frequency unknown - isolated edema of the face, lips, eyelids; in exceptional cases - angioedema (Quincke's edema).

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

Overdose:

Symptoms

Symptoms of overdose are not described. Given the wide therapeutic range of diosmosis, the risk of intoxication with an overdose is insignificant.

Treatment

The specific antidote is unknown.

Interaction:

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

Special instructions:

Treatment of acute hemorrhoids is carried out in conjunction with other drugs. In the absence of a rapid clinical effect, it is necessary to conduct an additional examination and adjust the therapy.

If there is a violation of the venous circulation (varicose veins of the lower extremities, chronic lymphovenous insufficiency of the lower extremities), the maximum effect of treatment is provided by combining therapy with lifestyle changes: it is desirable to avoid prolonged stay in an upright position, to reduce excess body weight. In some cases, the improvement of blood circulation is facilitated by wearing special stockings (compression jersey).

If there is no reduction or if symptoms of the disease worsen, consult a doctor.

Do not exceed the maximum periods and recommended doses of the drug without consulting a doctor.

Effect on the ability to drive transp. cf. and fur:

There is no evidence of a negative effect of the drug on the ability to drive vehicles and other mechanisms.

Form release / dosage:

Film-coated tablets, 600 mg.

Packaging:

10, 15 or 30 tablets in a planar cell packaging made of a polyvinylchloride film and aluminum foil.

15, 30 or 90 tablets in a can of high-density polyethylene.

1, 3 or 6 contour cell packs of 10 tablets, 1, 2, 4 or 6 contour cell packs of 15 tablets, 1,2 or 3 contourcell packs of 30 tablets or one pot together with instructions for use in a pack of cardboard.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004278

Date of registration:28.04.2017

Expiration Date:28.04.2022

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Information update date: & nbsp23.05.2017

Illustrated instructions

Instructions

Diosmin (Diosmin)