Description
Release form
The suspension for oral administration is uniform, light yellow in color, with a characteristic odor.
Pharmacological action
Detralex ® has venotonic and angioprotective properties. The drug reduces the extensibility of veins and venous congestion, reduces the permeability of capillaries and increases their resistance. The results of clinical studies confirm the pharmacological activity of the drug in relation to venous hemodynamics.
The statistically significant dose-dependent effect of Detralex ® was demonstrated for the following venous plethysmographic parameters: venous capacity, venous extensibility, time of venous emptying. The optimal dose-response ratio is observed when taking 1000 mg / day.
Detralex ® improves venous tone: using venous occlusal plethysmography, a decrease in venous emptying time was shown. In patients with signs of severe microcirculation disturbance after therapy with Detralex ®, there is a (statistically significant, compared with placebo) increase in capillary resistance, evaluated by angiostereometry.
The therapeutic efficacy of Detralex ® has been proven in the treatment of chronic lower extremity vein diseases, as well as in the treatment of hemorrhoids.
Detralex ® reduces unwanted side effects of invasive treatments for chronic venous diseases (reduces the frequency of unwanted side effects in the surgical and endovascular treatment of varicose veins: significantly reduces the intensity of postoperative pain, swelling and severity of hemorrhage 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 undergoes an active metabolism, which is confirmed 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).
Therapy for symptoms of venous-lymphatic insufficiency:
– pain
– cramps of the lower extremities
– feeling of heaviness and fullness in the legs
– tired legs.
Therapy for manifestations of venous-lymphatic insufficiency:
– edema of the lower extremities
– trophic changes in the skin and subcutaneous tissue
– venous trophic ulcers.
Symptomatic treatment of acute and chronic hemorrhoids.
Contraindications
– hypersensitivity to the active substance or excipients that make up the
preparation – fructose intolerance.
Not recommended for lactating women.
Use in pregnancy and lactation
Pregnancy
In experimental animal studies, no teratogenic effects were detected.
To date, there have been no reports of adverse effects when using the drug in pregnant women.
Breastfeeding period
Due to a lack of data regarding the excretion of the drug with breast milk, lactation is not recommended for women.
Impact on reproductive function
Reproductive toxicity studies have not shown an effect on reproductive function in rats of either sex.
Special instructions
Before using the Detralex ® preparation, the patient is advised to consult a doctor.
In case of exacerbation of hemorrhoids, the administration of Detralex ® does not replace the specific treatment of other anal disorders. The duration of treatment should not exceed the time specified in the dosage regimen. In the event that the symptoms do not disappear after the recommended course of therapy, an examination by a proctologist should be performed, who will select further therapy.
In the presence of impaired venous circulation, the maximum treatment effect is ensured by a combination of therapy with a healthy (balanced) lifestyle, it is advisable to avoid long exposure to the sun, prolonged stay on the legs, and it is recommended to reduce excess body weight. Hiking and, in some cases, wearing special stockings (compression hosiery) helps to improve blood circulation.
The patient should immediately consult a doctor if the condition worsens or no improvement occurs during treatment.
Effect on the ability to drive vehicles and control mechanisms
The drug does not affect the ability to drive a car and perform work that requires a high speed of mental and physical reactions.
Composition
1 sachet (10 ml)
purified micronized flavonoid fractions 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 qs – up to 10 ml.
Dosage and administration of
The drug is taken orally.
The recommended dose for venous-lymphatic insufficiency is 1000 mg (contents of 1 sachet) / day, preferably in the morning, during meals.
The duration of treatment can be several months (up to 12 months). In case of recurrence of symptoms, on the recommendation of a doctor, the course of 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 (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.
Side effects of
Side effects of Detralex ® seen in clinical trials were mild. Mostly, gastrointestinal disturbances (diarrhea, dyspepsia, nausea, vomiting) were noted.
While taking Detralex ®, the following side effects were reported in the form of the following gradation: very often (> 1/10), often (> 1 / 100.1 / 1000.1 / 10 000,
From the central nervous system: rarely – dizziness , headache, general malaise
From the gastrointestinal tract: often – diarrhea, dyspepsia, nausea, vomiting infrequently – pricks of unspecified frequency – pain in the abdomen
From the skin: rarely – skin rash, skin itching, urticaria of unspecified frequency – isolated swelling of the face lips, eyelids in exceptional cases – angioedema.
The patient should inform the doctor about the appearance of any, including not mentioned in the instructions, adverse reactions and sensations, as well as changes in laboratory parameters during therapy.
Drug Interactions
No drug interactions with Detralex ®.
The patient should inform the attending physician about all medications taken.
Overdose
Cases of overdose are not described.
In case of an overdose of the drug, the patient should immediately seek medical help.
Storage conditions
The product should be stored out of the reach of children at temperatures not exceeding 30 ° C.
Expiration
3 years.
Active ingredient
Hesperidin, Diosmin
Terms leave through pharmacies
without prescription
lekarstvennaja form
suspensions for ingestion
Indications
Indications
Angina pectoris, Prevention of acute myocardial infarction, Prevention of thrombosis, Prevention of thromboembolism, Hemorrhoids
