DETRALEX SUSPENSION FOR ORAL ADMINISTRATION 1000 MG/10ML SACHET

Tradename

Detralex®

International non-proprietary or grouping name

Purified micronized flavonoid fraction (diosmin + flavonoids in terms of hesperidin)

Dosage Form

Suspension for oral administration.

Composition

One sachet (10 ml) contains:

Active substance:

Purified micronized flavonoid fraction of 1000 mg containing diosmin 900.0 mg (90%) and flavonoids, in terms of hesperidin 100.0 mg (10%).

Excipients:

Citric acid 12.5 mg, orange flavoring 15.0 mg, maltitol 1800.0 mg, sodium benzoate 15.0 mg, xanthan gum 50.0 mg, purified water q.s. up to 10 ml.

Description

Homogeneous suspension of light yellow color with a characteristic smell.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Detralex® has venotonic and angioprotective properties. The drug reduces vein distension and venous congestion, reduces capillary permeability and increases their resistance. The results of 1 clinical studies confirm the pharmacological activity of the drug in relation to venous hemodynamic parameters. The statistically significant dose-dependent effect of the drug Detralex® was demonstrated for the following venous plethysmographic parameters: venous capacity, venous distensibility, time of venous emptying. The optimal dose-effect ratio is observed when taking 1000 mg per day.Detralex® increases venous tone: using venous occlusive plethysmography, a decrease in venous emptying time has been shown. In patients with signs of pronounced microcirculation disorders, after drug therapy. Detralex® is marked (statistically significant compared with placebo) an increase in capillary resistance, as assessed by angiostereometry. The therapeutic efficacy of Detralex® has been proven in the treatment of chronic venous diseases of the lower limbs, as well as in the treatment of hemorrhoids. Detralex® reduces undesirable side effects of invasive treatment of chronic lung disease (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 release of the drug occurs with feces. With urine, on average, about 14% of the accepted amount of the drug is excreted. The half-life is 11 hours. The drug is subjected to active metabolism, as evidenced by the presence of phenolic acids in the urine.

Pharmacotherapeutic group

Venotonic and venoprotective agent.

INDICATIONS AND CONTRAINDICATIONS

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;
• cramps of the lower limbs;
• 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 ulcers.

Symptomatic therapy of acute and chronic hemorrhoids.

Contraindications

Hypersensitivity to the active substance or to excipients that make up the drug. Fructose intolerance. The use of the drug is not recommended for lactating women.

Pregnancy and lactation period

Pregnancy:

Animal experiments revealed no teratogenic effects. To date, there have been no reports of adverse effects in the use of the drug in pregnant women.

Lactation:

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.

Inside

The recommended dose for venous lymphatic insufficiency

1000 mg (contents of 1 sachet) per day, preferably in the morning, during the meal. The duration of the course of treatment can 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

3000 mg per day (1000 mg (contents of 1 sachet) in the morning, afternoon and evening) for 4 days, then 2000 mg per day (1000 mg (contents of 1 sachet) in the morning and evening) for the next 3 days.

The recommended dose for chronic hemorrhoids

1000 mg (contents of 1 sachet) per day at any convenient time of the day with meals.

SIDE EFFECT

Side effects of the drug

The side effects of Detralex®, observed during clinical trials, were mild. Disturbances in the gastrointestinal tract (diarrhea, dyspepsia, nausea, vomiting) were predominantly noted. While taking the drug Detralex®, the following side effects were reported, in the form of the following gradation: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1 000, <1/100); rarely (> 1/10 000, <1/1 000); extremely rarely (<1/10 000), unspecified frequency (frequency cannot be calculated from 5 available data).

From the side of the central nervous system:

Seldom: dizziness, headache, general malaise.

From the gastrointestinal tract: 

Often: diarrhea, dyspepsia, nausea, vomiting.

Infrequently: colitis.

Unspecified frequency: abdominal pain.

From the skin:

Rarely: rash, itching, urticaria.

Unspecified frequency: isolated swelling of the face, lips, eyelids.

In exceptional cases, angioedema.

INFORM THE DOCTOR ABOUT THE APPEARANCE OF ANYONE IN YOUR ANSWERE, NOT INCLUDED IN THIS INSTRUCTION, UNDESIRABLE REACTIONS AND SENSATIONS, AND ALSO, ABOUT CHANGES IN THE LABORATORY INDICATORS IN THE RESPONSE OF THE SYSTEM.

Overdose

Cases of overdose are not described.

In case of overdose, seek medical attention immediately.

Interaction with other drugs

Not noted.

IT IS NECESSARY TO INFORM THE MEDICAL DOCTOR ABOUT ALL YOU TAKE MEDICAL PREPARATIONS.

Special notes

• Before you start taking the drug Detralek®, it is recommended to consult with your 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 time specified in the section "Dosage and Administration". 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 blood circulation, the maximum effect of treatment is provided by a combination of therapy with a healthy (balanced) lifestyle: it is desirable to avoid long exposure to the sun, long stays on the legs, and it is recommended to reduce overweight. Walking and, in some cases, wearing special stockings help to improve blood circulation. Seek medical attention immediately if your condition worsens during the treatment process or if there is no improvement.
• Influence on the ability to drive and perform work requiring high speed mental and physical reactions: Does not affect.

Release form

Suspension for oral administration, 1000 mg / 10 ml. On 10 ml of suspension for intake in multilayered sachets (polyester, aluminum, polyethylene). On 15 or 30 sachets together with the instruction for medical use in a pack cardboard.

Storage

At a temperature not higher than 30 ° C. Keep out of reach of children.

Shelf life

3 years. Do not use after the expiration date printed on the package.

Vacation conditions

It is released without a prescription.