Детралекс®
Producer: Servier (Sevyer) France
Code of automatic telephone exchange: C05CA53
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agents: 500 mg of the cleared micronized flavonoidny fraction consisting of diosmin of 450 mg (90%) and flavonoids in terms of hesperidin of 50 mg (10%).
Excipients: gelatin, magnesium stearate, cellulose microcrystallic, sodium carboxymethylstarch, talc, the water purified. The cover is film: a macrogoal 6000, sodium a lauryl the sulfate, premix for a film cover of salmoncolored color consisting from: glitserola, magnesium of stearate, gipromelloza, ferrous oxide yellow, ferrous oxide red, dioxide titanium.
Description
Oval tablets, film coated, salmoncolored color.
Type of a tablet on a break: from pale yellow till yellow color of heterogeneous structure.
Pharmacological properties:
Pharmacodynamics. DETRALEX has venotoniziruyushchy and angioprotektivny properties.
Drug reduces distensibility of veins and venous stagnation, reduces permeability of capillaries and increases their resistance. Results of clinical trials confirm pharmacological activity of drug concerning indicators of a venous hemodynamics. Statistically reliable dozozavisimy effect of the drug DETRALEX was shown for the following venous pletizmografichesky parameters: venous capacity, venous distensibility, time of venous emptying. The optimum ratio doza-effect ″ is observed at reception of 2 tablets. DETRALEX raises a venous tone: by means of a venous occlusal pletizmografiya reduction of time of venous emptying was shown. At patients with signs of the expressed disturbance of microcirculation increase in the capillary resistance estimated by an angiostereometriya method after therapy by the drug DETRALEX is noted (statistically reliable), in comparison with placebo. The therapeutic effectiveness of the drug DETRALEX at treatment of chronic diseases of veins of the lower extremities is proved, and also at treatment of hemorrhoids.
Pharmacokinetics. The main release of drug happens to a stake. With urine it is on average removed near
14% of the accepted amount of drug. The elimination half-life makes 11 hours. Drug is exposed to active metabolism that is confirmed by presence of phenolic acids at urine.
Indications to use:
Therapy of symptoms of venous and lymphatic insufficiency:
- heavy feeling in legs;
- pain;
- "morning fatigue" of legs.
Symptomatic therapy of acute hemorrhoids.
Route of administration and doses:
Inside.
The recommended dose at venous and lymphatic insufficiency – 2 tablets a day: 1 tablet – in the middle of the day and 1 tablet – in the evening, during meal.
The recommended dose at acute hemorrhoids – 6 tablets a day: on 3 tablets in the morning and on 3 tablets in the evening within 4 days, then on 4 tablets a day: on 2 tablets in the morning and on 2 tablets in the evening during the next 3 days.
Features of use:
- At an exacerbation of hemorrhoids purpose of the drug DETRALEX does not replace specific treatment of other proctal disturbances. Duration of treatment should not exceed the terms specified in the section "Route of Administration and Doses". If symptoms do not disappear after the recommended therapy course, it is necessary to conduct proctologic examination and to reconsider the applied therapy.
- In the presence of disturbances of venous blood circulation the maximum effect of treatment is provided with a therapy combination to the healthy (balanced) way of life: it is desirable to avoid long stay in the sun, long stay standing, and also decrease in excess body weight. Foot walks and, in certain cases, wearing special stockings, promotes blood circulation improvement.
Influence on ability to drive the car and to perform the works demanding the high speed of mental and physical reactions
Does not influence.
Side effects:
During administration of drug DETRALEX it was reported about the following side effects in the form of the following gradation: very often (> 1/10); often (> 1/100, <1/10); moderately (> 1/1.000, <1/100); seldom (> 1/10.000, <1/1.000); extremely seldom (<1/10.000), including separate messages.
From a nervous system:
Seldom: dizziness, headache, febricula
From digestive tract:
Often: diarrhea, dyspepsia, nausea, vomiting
From integuments:
Seldom: rash, itch, urticaria.
Interaction with other medicines:
It was not noted.
Contraindications:
Hypersensitivity to active components or to the excipients which are a part of drug. Administration of drug is not recommended to the feeding women
PREGNANCY AND PERIOD OF FEEDING BY THE BREAST
Pregnancy
Experiments on animals did not reveal teratogenic effects. So far there were no messages on any side effects at beremennma drug use by women.
Feeding by a breast
Due to the lack of data on drug excretion in breast milk, administration of drug is not recommended to the feeding women.
Overdose:
Cases of overdose are not described.
At drug overdose immediately ask for medical care.
Storage conditions:
List B. Special storage conditions are not required. To store in places, unavailable to children.
PERIOD OF VALIDITY 4 years. Not to apply after the expiry date specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Tablets, film coated, 500 mg.
On 15 tablets in the blister (PVC / Is scarlet). On 2 or 4 blisters with the instruction on a medical use in a pack cardboard.
When packaging (packaging)/production at the Russian enterprise LLC Serdiks
On 15 tablets in the blister (PVC / Is scarlet). On 2 or 4 blisters with the instruction on a medical use in a pack cardboard.