Description
Pharmacological action
DetralexВ® 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 trials confirm the pharmacological activity of the drug with respect to venous hemodynamics. The statistically significant dose-dependent effect of DetralexВ® was demonstrated for the following venous plethysmographic parameters:
venous capacity,
venous extensibility,
venous emptying time.
Optimal ratio dose-response observed when taking 1000 mg per day. DetralexВ® increases venous tone: venous occlusion plethysmography has been shown to decrease venous emptying time.
In patients with signs of severe microcirculatory dysfunction, after treatment with DetralexВ®, there is a (statistically significant compared with placebo) increase in capillary resistance, evaluated by angiostereometry.
The therapeutic efficacy of DetralexВ® has been proven in the treatment of chronic lower extremity vein diseases, as well as in the treatment of hemorrhoids.
Indications
Detralex® is indicated for the treatment of symptoms of chronic venous diseases (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 therapy of acute and chronic hemorrhoids.
Contraindications
hypersensitivity to the active components or excipients that make up the drug.
due to lack of data on the allocation of the drug with breast milk, lactation is not recommended for women taking the drug.
Pregnancy and lactation
Pregnancy
Animal experiments have not revealed teratogenic effects.
To date, there have been no reports of any side effects when using the drug in pregnant women.
Breastfeeding
Due to a lack of data regarding the excretion of the drug in breast milk, lactating women are not recommended to take the drug.
Special instructions
Before starting to use DetralexВ®, the patient is advised to consult a doctor.
In case of exacerbation of hemorrhoids, the administration of DetralexВ® 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 that case, if 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 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 helps to improve blood circulation.
The patient should consult a doctor immediately if the condition worsens or no improvement occurs during treatment.
The drug does not affect the ability to drive vehicles and perform work that requires a high speed of mental and physical reactions.
Composition
One film-coated tablet contains:
Active ingredient:
Purified, micronized flavonoid fraction, calculated on the dry matter, 1000.00 mg, consisting of: diosmin 900 mg (90%), flavonoids in terms of hesperidin 100 mg (10%).
Excipients:
Purified water 40.00 mg,
gelatin 62.00 mg,
magnesium stearate 8.00 mg,
microcrystalline cellulose 124.00 mg,
sodium carboxymethyl starch type A 54.00 mg,
talc 12 mg
tablet core mass: 1340 mg1).
Film sheath:
Sodium lauryl sulfate 0.130 mg,
premix for the orange-pink film sheath OY-S-8761, consisting of:
glycerol 1.628 mg,
hypromellose 27.039 mg,
macrogol 6000 0.651 mg magnesium,
macrogol 6000 mg ,
dye iron oxide red 0.211 mg,
titanium dioxide 5.205 mg,
dye iron oxide yellow 0.633 mg.
Excipient for polishing tablets:
macrogol 6000 1, 300 mg
Weight of film-coated tablets 1378.425 mg.
1) Given the average humidity of the purified, micronized flavonoid fraction – 4%, (or 40 mg per tablet), the amount of substance per tablet is 1040.00 mg.
Dosage and administration
The drug is prescribed orally.
The recommended dose for venous-lymphatic insufficiency is 1 tablet / day, preferably in the morning, during meals.
Risk on tablet is intended solely for division to facilitate swallowing.
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 3 tablets / day (1 tablet in the morning, afternoon and evening) for 4 days, then 2 tablets / day (1 tablet. morning and evening) for the next 3 days.
The recommended dose for chronic hemorrhoids is 1 tablet / day.
Side effects of
Gastrointestinal tract symptoms include nausea and stomach discomfort, vomiting, and diarrhea.
From the central nervous system, headache and dizziness may occur.
Very rarely, allergic manifestations such as rash, itching, and urticaria can occur on the skin. Urticaria is an acute allergic reaction characterized by rapid onset of blisters. Accompanied by itching.
If you experience any side effects, you should consult your doctor about the need for treatment adjustment.
Overdose
Overdose cases not described.
If you overdose, seek medical attention immediately.
Storage conditions
No special storage conditions are required.
Keep out of the reach of children.
Expiration
4 years.
Do not use after the expiration date printed on the package.
Deystvuyuschee substances
hesperidin, diosmin
dosage form
tablets
Appointment of
Children by doctor’s appointment, Adult doctor’s appointment
Indications
Hemorrhoids, Varicoses, Trophic yazv
Servye / Serdiks, Russia
