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Composition:


active ingredient: diosmin;


1 tablet contains 1000 mg of micronized diosmin;


excipients: polyvinyl alcohol, sodium croscarmellose, magnesium stearate.


Dosage form. Pills.


Basic physical and chemical properties: from pale greenish or grayish-yellow to pale greenish or grayish-brown marble, slightly biconvex Oval tablets.


Pharmacotherapeutic group.


Angioprotectors. Bioflavonoids. Capillary stabilizing agents. Diosmin. ATX code C05C A03.


Pharmacological properties.


Mechanism of action


Venotonic activity


Diosmin reduces venous extensibility and reduces venous congestion. Diosmin increases the tone of the veins and, consequently, reduces the capacity, extensibility and stagnation of blood: venous occlusal Mercury plethysmography indicates a reduction in the time of emptying the veins.


The end effect is a reduction in venous hypertension in patients with venous diseases.


Microcirculatory activity


Diosmin reduces capillary permeability and increases capillary resistance. It also has an anti-inflammatory effect, affecting the synthesis of prostaglandins. Controlled double-blind clinical trials show a statistically significant difference between diosmin and placebo. In patients with Capillary fragility, treatment with diosmin increases capillary resistance and reduces clinical manifestations. After administration of 1 g of diosmin daily, compared to placebo, there was also a decrease in capillary permeability, which was determined using technetium-labeled albumin or plethysmography.


Pharmacodynamic effects


The pharmacological activity of diosmin in humans was confirmed in controlled double-blind clinical studies, as well as using objective and quantitative methods to study the effect of the active substance on venous hemodynamics.


Effects on the lymphatic system


Diosmin stimulates lymphatic activity, improving interstitial drainage and increasing lymphatic flow. Administration of 1 g of diosmin daily reduces the diameter of the lymphatic capillary and intra-lymphatic pressure, improving the number of functioning lymphatic capillaries in patients with severe chronic venous insufficiency without ulcers.


Clinical efficacy and safety


Controlled double-blind clinical studies demonstrate the therapeutic activity of the drug for the treatment of signs and symptoms of established chronic venous disease and for the treatment of acute hemorrhoidal disease.


Pharmacokinetics.


Suction


After oral administration, diosmin is rapidly hydrolyzed in the intestine by the intestinal flora and absorbed as its aglycone derivative, diosmetin. The oral bioavailability of micronized diosmin is approximately 60 %.


Distribution


The volume of distribution of diosmetin is 62.1 liters, which indicates a wide distribution in tissues.


Biotransformation


Diosmetin is intensively metabolized to phenolic acids or their glycine conjugate derivatives, which are excreted in the urine. In humans, the predominant metabolite found in the urine is m-hydroxy-phenylpropionic acid, which is mainly excreted in conjugated form. Metabolites found in smaller amounts include phenolic acids corresponding to 3-hydroxy-4-methoxybenzoic acid and 3-methoxy-4-hydroxyphenylacetic acid.


Output


Elimination of micronized diosmin occurs relatively quickly, as approximately 34% of the radioactive dose of 14C-diosmin is excreted in the urine and faeces within the first 24 hours and approaches 86% within the first 48 hours. Approximately half of the dose is excreted in the faeces as unchanged diosmin or diosmetin, while these two compounds are not excreted in the urine.


The Half-Life of diosmetin showed an average of 31.5 hours, ranging from 26 to 43 hours.


Clinical characteristics.


Indications.


Symptomatic treatment of chronic venolymphatic insufficiency (heaviness in the legs, pain, night cramps, edema, trophic disorders, including varicose ulcers).


Symptomatic treatment of hemorrhoids.


Contraindications.


Hypersensitivity to the active substance or any excipient.


Interactions with other drugs and other types of interactions.


Interaction studies have not been conducted. Despite extensive post-marketing experience with diosmin, interactions with other drugs have not yet been reported.


Application features.


The use of this drug in acute hemorrhoids does not replace specific therapy and does not interfere with the treatment of other proctological diseases. If the symptoms do not disappear quickly during a short course of treatment, a proctological examination should be performed and therapy should be reviewed.


In case of venous circulatory disorders a combination of therapy with compliance with the following lifestyle recommendations is more effective:


* avoid too long exposure to the sun, prolonged immobility on your feet;


* avoid being overweight;


* you should walk and in some cases wear special stockings to improve blood circulation.


Special attention should be paid if the patient's condition worsens during treatment. This can manifest as skin inflammation, vein inflammation, subcutaneous compaction, severe pain, skin ulcers, or atypical symptoms (such as instant swelling of one or both legs).


Phlebaven® 1000 is ineffective in reducing edema of the lower extremities caused by heart, liver or kidney diseases.


Use during pregnancy or lactation.


Pregnancy


In pregnant women, Phlebaven® 1000 should be used with caution. Consult your doctor before use.


Studies have not revealed a teratogenic effect of the drug; no side effects have been reported.


Breast-feeding


Due to the lack of data on its penetration into breast milk, use during breast-feeding should be avoided.


Fertility


Studies of reproductive toxicity in animals have shown no effect on fertility.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


Studies of the effect of diosmin on the ability to drive vehicles or work with other mechanisms have not been conducted. However, according to the general safety profile, diosmin does not affect or has little effect on this ability.


Dosage and administration.


For oral administration.


Assigned to adults. Tablets should be taken with a meal.


Chronic venolymphatic insufficiency


The recommended dose is 1 tablet per day in the morning. The duration of treatment is not less than 4-5 weeks.


Hemorrhoidal disease


Treatment of episodes of acute hemorrhoids: 3 tablets per day for 4 days, then 2 tablets per day for the next 3 days. The daily number of tablets is divided into 2-3 doses. Maintenance therapy-1 tablet per day.


The duration of treatment is determined by the doctor depending on the indications for use and the course of the disease (see the section "application features").


Children.


There are no data on the use of Phlebaven® 1000 in children.


Overdose.


No overdose cases have been reported.


Tags: Diosmin