Product Overview
Composition
1 capsule contains the active ingredient:
Calcium dobesylate (in the form of calcium dobesylate monohydrate 521.51 mg) - 500.00 mg
Excipients:
Corn starch - 25.164 mg
Magnesium stearate - 8.326 mg;
Capsule number 0:
Body:
Titanium dioxide E171 - 0.8640 mg,
Iron dye yellow oxide E172 - 0.1440 mg;
Cap:
Iron dye black oxide E 172 - 0.1920 mg, indigo carmine dye E132 - 0.1728 mg, titanium dioxide E171 - 0.4800 mg, iron dye yellow oxide E172 - 0.5760 mg, gelatin up to 96 mg.
pharmachologic effect
Pharmacodynamics
Angioprotector, reduces increased vascular permeability, increases the resistance of capillary walls, improves microcirculation and drainage function of lymphatic vessels, moderately reduces platelet aggregation and blood viscosity, increases the elasticity of the erythrocyte membrane.
The action is associated to a certain extent with an increase in the activity of plasma kinins.
Pharmacokinetics
Rapidly absorbed in the gastrointestinal tract.
The maximum concentration in blood plasma is reached 6 hours after ingestion.
Plasma protein binding is 20-25%. Practically does not penetrate the blood-brain barrier.
It is excreted by the kidneys (about 50%) and through the intestines (about 50%), mainly unchanged within 24 hours, 10% - in the form of metabolites. The half-life is 5 hours.
In very small quantities (0.4 μg / ml after taking 1.5 g of the drug) is excreted in breast milk.
Indications
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Vascular lesions with increased fragility and capillary permeability (diabetic retinopathy and nephropathy) and other microangiopathies associated with various cardiovascular and metabolic diseases.
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Venous insufficiency of varying severity and its consequences (pre-varicose state with symptoms of tissue edema, pain, paresthesia, congestive dermatosis; superficial phlebitis, varicose veins, trophic ulcers).
Application during pregnancy and lactation
Adequate and strictly controlled studies of the safety of use in pregnant and lactating women have not been conducted.
The use of the drug is contraindicated in the first trimester of pregnancy.
In the second and third trimesters of pregnancy, the drug is prescribed only for health reasons, if the expected effect of use exceeds the possible risk to the fetus.
When prescribing during lactation, it is necessary to resolve the issue of stopping breastfeeding.
Recommendations for use
Inside, without chewing, during meals.
Prescribe 500 mg 3 times a day for 2-3 weeks, then the dose is reduced to 500 mg once a day.
In the treatment of retinopathy and microangiopathy, 500 mg is prescribed 3 times a day for 4-6 months, then the daily dose is reduced to 500 mg once a day.
The course of treatment is from 3-4 weeks to several months, depending on the therapeutic effect.
Contraindications
Hypersensitivity to calcium dobesilate or any component of the drug, gastric ulcer and duodenal ulcer (in the acute stage), bleeding from the gastrointestinal tract, kidney and liver diseases, hemorrhages caused by anticoagulants; pregnancy (I trimester), children's age (up to 13 years).
Side effects
Classification of adverse reactions according to the frequency of development: often - 1-10%, infrequently - 0.1-1%, rarely - 0.01-0.1%, very rarely, including individual cases - <0.01%.
Disorders from the gastrointestinal tract. Rarely: nausea, diarrhea, vomiting.
Skin and subcutaneous tissue disorders. Rarely: allergic reactions (itching, rash).
General disorders. Rarely: fever, chills.
Musculoskeletal and connective tissue disorders. Rarely: arthralgia.
Disorders of the blood and lymphatic system. In some cases: agranulocytosis. The reaction is reversible and disappears after stopping therapy.
Interaction
Cases of drug interactions with calcium dobesylate have not yet been identified.
How to take, course of administration and dosage
Inside, without chewing, during meals.
Prescribe 500 mg 3 times a day for 2-3 weeks, then the dose is reduced to 500 mg once a day.
In the treatment of retinopathy and microangiopathy, 500 mg is prescribed three times a day for 4-6 months, then the daily dose is reduced to 500 mg once a day.
The course of treatment is from 3-4 weeks to several months, depending on the therapeutic effect.
Overdose
Overdose cases were not observed.
Special instructions
The drug can be administered prophylactically.
If symptoms of agranulocytosis appear (fever, headache, chills, weakness, pain when swallowing, inflammation of the oral mucosa), you should immediately consult a doctor and conduct a clinical blood test.
Calcium dobesylate can interfere with laboratory tests to determine creatinine levels.
Influence on the ability to drive vehicles and work with mechanisms
The drug does not adversely affect the ability to drive vehicles and work with mechanisms.
Release form
Capsules 500 mg.
10 capsules in a PVC / AL blister.
3 blisters with instructions for use in a cardboard box.
Storage conditions
At a temperature not exceeding 25 ° С in consumer packaging.
Keep out of the reach of children.
Shelf life
5 years
