Detralex pills 500 mg 60 pcs
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Active ingredients
Hesperidin + Diosmin
Release form
Pills
Composition
1 tablet contains: Active ingredient: purified micronized flavonoid fraction 500 mg, including diosmin 450 mg (90%), flavonoids in terms of hesperidin 50 mg (10%). Excipients: gelatin - 31 mg, magnesium stearate - 4 mg, microcrystalline cellulose - 62 mg, sodium carboxymethyl starch - 27 mg, talc - 6 mg, purified water - 20 mg. The composition of the film shell: macrogol 6000 - 0.710 mg, sodium lauryl sulfate - 0.033 mg, premix for an orange-pink film shell (glycerol - 0.415 mg, magnesium stearate - 0.415 mg, hypromellose - 6.886 mg, iron dye ox id yellow - 0.161 mg, iron dye red oxide - 0.054 mg, titanium dioxide - 1.326 mg).
Pharmacological effect
Detralex has venotonic and angioprotective properties. The drug reduces the elasticity 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 indicators. A statistically reliable dose-dependent effect of the drug 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 2 pills. venous tone: using venous occlusive plethysmography has been shown to decrease menstruation of venous emptying. In patients with signs of pronounced microcirculation, after treatment with the drug Detralex, a statistically significant increase in capillary resistance was observed (statistically significant compared with placebo), as demonstrated by the method of angiostereometry.
Pharmacokinetics
Metabolism The drug is subjected to active metabolism, as evidenced by the presence of phenolic acids in the urine. Excretion is eliminated from the body mainly with faeces. With urine, on average, about 14% of the accepted amount of the drug. T1 / 2 is 11 hours.
Indications
Detralex is indicated for the treatment of symptoms of chronic venous diseases (elimination andsymptoms). Treatment of symptoms of venous lymphatic insufficiency: - Pain; - Spasms of the lower extremities; - Feeling of heaviness and distention in the legs; - Tired legs. Therapy of manifestations of venous lymphatic insufficiency: - Edema of the lower extremities; - Trophic changes of the skin and subcutaneous tissue; - Venous trophic ulcers. Symptomatic therapy of acute and chronic hemorrhoids.
Contraindications
- Hypersensitivity to the active ingredients or excipients that are part of the drug. It is not recommended to take the drug to nursing women.
Use during pregnancy and lactation
Pregnancy In experimental studies on animals, the teratogenic effects of the drug Detralex were not observed. So far, there have been no reports of adverse effects when using the drug in pregnant women. Breastfeeding Due to the lack of data on the release of the drug in breast milk, nursing women are not recommended. Effect on reproductive function Studies of reproductive toxicity showed no effect on reproductive function in rats of both sexes.
Dosage and administration
The drug is administered internally. The recommended dose for venous lymphatic insufficiency is 2 pills / day (for 1 or 2 doses): in the morning, in the afternoon and / or in the evening, during a meal. The duration of the course of treatment can be several months (up to 12 months ). In case of recurrence of symptoms, according to the recommendation of a doctor, the course of treatment can be repeated. The recommended dose for acute hemorrhoids is 6 pills / day: 3 pills each. in the morning and 3 tab. in the evening for 4 days, then - by 4 tab. / day: by 2 tab. in the morning and 2 tab. in the evening over the next 3 days. The recommended dose for chronic hemorrhoids is 2 pills / day with food intake.
Side effects
The side effects of the drug Detralex observed during clinical trials were mild. Disturbances of the gastrointestinal tract were mainly noted (diarrhea, dyspepsia, nausea, vomiting). While taking the drug Detralex, the following side effects were reported in the form of the following gradation: very often (more than 1/10), often (more than 1/100, less than 1 / 10), moderately (more than 1/1000, less than 1/100), rarely (more than 1/10 000, less than 1/1000), very rarely (less than 10 000),unspecified frequency (frequency cannot be calculated using available data). On the CNS side: rarely - dizziness, headache, general malaise. On the side of the gastrointestinal tract: often - diarrhea, dyspepsia, nausea, vomiting; infrequently - colitis; unspecified frequency - pain in the abdomen. On the skin side: rarely - rash, itching, hives; unspecified frequency - isolated swelling of the face, lips, eyelids; in exceptional cases, angioedema. The patient should be informed that if any, including during the therapy, appears during therapy. Not mentioned in the instructions, adverse reactions and sensations, as well as changes in laboratory parameters, should be reported to the doctor.
Overdose
Cases of overdose are not described. In case of overdose, the patient should immediately seek medical help.
Interaction with other drugs
Drug interaction of the drug Detralex was not noted. It is necessary to inform the attending physician about all medications taken by the patient.
special instructions
Before starting the use of the drug Detralex, the patient is advised to consult a doctor. In case of exacerbation of hemorrhoids, the prescription of the drug Detralex does not replace the specific treatment of other anal disorders. The duration of treatment should not exceed the recommended periods 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. If there are impaired venous circulation, the maximum effect of the treatment is provided by combining the therapy with a healthy (balanced) lifestyle: it is desirable to avoid long sun exposure, prolonged stay on the legs, and also recommended weight loss. Walking and, in some cases, wearing special stockings helps to improve blood circulation. The patient should immediately see a doctor if the condition worsens or there is no improvement in the treatment process. The effect on the ability to drive motor vehicles and control mechanisms The drug does not affect the ability to drive motor vehicles and doing work that requires a high rate of mental and physical reactions.