Detralex®
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2019-09-19
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Clinical Pharmacology
Detralex® has venotonic and angioprotective properties. The drug reduces the tensile properties of the veins and venous congestion, reduces capillary permeability and increases their resistance. The results of clinical studies confirm the pharmacological activity of the drug in relation to venous hemodynamic parameters.
The statistically significant dose-dependent effect of Detralex® was demonstrated for the following venous plethysmographic parameters: venous capacity, venous distensibility, venous emptying time. The optimal dose-effect ratio is observed when taking 1000 mg / day.
Detralex® increases venous tone: using venous occlusive plethysmography, a decrease in venous emptying time has been shown. In patients with signs of marked impairment of microcirculation after treatment with Detralex®, there is a (statistically significant, compared with placebo) increase in capillary resistance, assessed by angiostereometry.
The therapeutic efficacy of Detralex® has been proven in the treatment of chronic diseases of the veins of the lower extremities, as well as in the treatment of hemorrhoids.
Detralex® reduces undesirable side effects of invasive methods of treating chronic vein diseases (reduces the incidence of undesirable side effects in the surgical and endovascular treatment of varicose veins: significantly reduces the intensity of postoperative pain, swelling and severity of hemorrhages after endovascular and surgical treatment).
Pharmacokinetics
The main excretion of the drug occurs with feces. With urine, on average, about 14% of the accepted amount of the drug is excreted. T1 / 2 is 11 hours.
The drug is subjected to active metabolism, as evidenced by the presence of phenolic acids in the urine.
Indications
Detralex® is indicated for the treatment of symptoms of chronic venous disease (elimination and relief of symptoms).
Treatment of symptoms of venous lymphatic insufficiency:
- pain;
- convulsions of the lower extremities;
- feeling of heaviness and fullness in the legs;
- "tired" legs.
Therapy of manifestations of venous lymphatic insufficiency:
- swelling of the lower extremities;
- trophic changes in the skin and subcutaneous tissue;
- venous trophic ulcers.
Symptomatic therapy of acute and chronic hemorrhoids.
Composition
1 sachet (10 ml)
purified micronized flavonoid fraction 1000 mg, incl. Diosmin 900 mg (90%), flavonoids in terms of hesperidin 100 mg (10%)
Excipients: citric acid - 12.5 mg, orange flavoring - 15 mg, maltitol - 1800 mg, sodium benzoate - 15 mg, xanthan gum - 50 mg, purified water q.s. - up to 10 ml.
Detralex® is marketed under different brands and generic names, and comes in different dosage forms:
| Brand name | Manufacturer | Country | Dosage form |
|---|---|---|---|
| Detralex | suspension | ||
| Detralex | Servier/Serdyx | Russia | pills |
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Dosage and Administration
The drug is taken orally.
The recommended dose for venous lymphatic insufficiency is 1000 mg (content of 1 sachet) per day, preferably in the morning, during the meal.
The duration of treatment may be several months (up to 12 months). In the case of recurrence of symptoms, according to the recommendation of the doctor, the treatment can be repeated.
The recommended dose for acute hemorrhoids is 3000 mg / day (1000 mg each (contents of 1 sachet) in the morning, afternoon and evening) for 4 days, then 2000 mg / day (1000 mg each (contents of 1 sachet) in the morning and evening) over the next 3 days.
The recommended dose for chronic hemorrhoids is 1000 mg (contents of 1 sachet) / day at any convenient time of the day with meals.
Adverse reactions
The side effects of Detralex®, observed during clinical trials, were mild. Disturbances from a gastrointestinal tract (diarrhea, dyspepsia, nausea, vomiting) were mainly noted.
While taking the drug Detralex®, the following side effects were reported in the form of the following grades: very often (> 1/10), often (> 1 / 100,1 / 1000,1 / 10 000,
From the side of the central nervous system: rarely - dizziness, headache, general malaise.
On the part of the digestive tract: often - diarrhea, dyspepsia, nausea, vomiting; infrequently - colitis; unspecified frequency - abdominal pain.
For the skin: rarely - skin rash, pruritus, urticaria; unspecified frequency - isolated swelling of the face, lips, eyelids; in exceptional cases, angioedema.
The patient should inform the doctor about the appearance of any, incl. undesirable reactions and sensations not mentioned in the instructions, as well as changes in laboratory parameters during therapy.
Contraindications
- hypersensitivity to the active substance or excipients that make up the drug;
- fructose intolerance.
The use of the drug is not recommended for lactating women.
Drug interactions
Drug interaction of the drug Detralex® was not observed.
The patient should inform the attending physician about all medications taken.
Pregnancy and Lactation
Pregnancy
In experimental animal studies, no teratogenic effects were identified.
To date, there have been no reports of adverse effects in the use of the drug in pregnant women.
Breastfeeding period
Due to the lack of data on the elimination of the drug in breast milk, breastfeeding women are not recommended to take the drug.
Reproductive Impact
Reproductive toxicity studies showed no effect on reproductive function in rats of both sexes.
Special instructions
Before starting the use of Detralex®, the patient is advised to consult a doctor.
In case of exacerbation of hemorrhoids, the administration of the drug Detralex® does not replace the specific treatment of other anal disorders. The duration of treatment should not exceed the time specified in the section "Dosage regimen". In the event that the symptoms do not disappear after the recommended course of therapy, a proctologist should be examined, who will select further therapy.
In the presence of disorders of the venous circulation, the maximum effect of treatment is provided by a combination of therapy with a healthy (balanced) lifestyle; It is advisable to avoid long stay in the sun, long stays on the legs, and it is also recommended to reduce overweight. Hiking and, in some cases, wearing special stockings (compression knitwear) helps to improve blood circulation.
The patient should immediately consult a doctor if the condition worsened or there was no improvement in the treatment process.
Influence on ability to drive motor transport and control mechanisms
The drug does not affect the ability to drive and perform work requiring high speed mental and physical reactions.
Overdosage
Cases of overdose are not described.
In case of overdose, the patient should immediately seek medical attention.
- Brand name: Detralex
- Active ingredient: Hesperidin, Diosmin
- Dosage form: Suspension for oral administration homogeneous, light yellow color, with a characteristic odor.
- Manufacturer: Salut-M
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