Doxi-Hem, 500 mg capsules 90 pcs

Pharmacodynamics

Angioprotector, reduces increased vascular permeability, increases the resistance of capillary walls, improves microcirculation and drainage function of lymph vessels, moderately reduces platelet aggregation and blood viscosity, increases the elasticity of red blood cell membrane.

Action is associated, to some extent, with an increase in plasma kininin activity.

Pharmacokinetics

Rapidly absorbed in the gastrointestinal tract.

Maximal concentration in plasma is reached 6 hours after oral administration.

Binding to plasma proteins is 20-25 %. It practically does not pass through the blood-brain barrier.

It is excreted by the kidneys (about 50%) and through the intestines (about 50%), mainly unchanged within 24 hours, 10% – as metabolites. Half-life period is 5 hours.

Very small amounts (0.4 mcg/ml after taking 1.5 g of the drug) are excreted with breast milk.

Indications

Vascular lesions with increased capillary fragility and permeability (diabetic retinopathy and nephropathy) and other microangiopathies associated with various cardiovascular and metabolic diseases.

Venous insufficiency of varying severity and its consequences (prevaricose condition with symptoms of tissue swelling, pain, paresthesia, congestive dermatosis; superficial phlebitis, varicose veins, trophic ulcers).

Pharmacological 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 from the gastrointestinal tract.

The maximum concentration in blood plasma is achieved 6 hours after oral administration.

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. Half-life: 5 hours

In very small quantities (0.4 mcg/ml after taking 1.5 g of the drug) it is excreted in breast milk.

Special instructions

The drug can be prescribed 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 dobesilate may interfere with laboratory test results for creatinine levels.

Impact on the ability to drive vehicles and operate machinery

The drug does not adversely affect the ability to drive vehicles and operate machinery.

Active ingredient

Calcium dobesilate

Composition

1 capsule contains the active ingredient:

Calcium dobesylate (in the form of calcium dobesilate monohydrate 521.51 mg) – 500.00 mg

Excipients:

Corn starch – 25.164 mg

Magnesium stearate – 8.326 mg;

Capsule No. 0:

Housing:

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 oxide yellow dye E172 – 0.5760 mg, gelatin up to 96 mg.

Pregnancy

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 outweighs the possible risk to the fetus.

When prescribed during lactation, it is necessary to resolve the issue of stopping breastfeeding.

Contraindications

Hypersensitivity to calcium dobesilate or any component of the drug, peptic ulcer of the stomach and duodenum (in the acute stage), bleeding from the gastrointestinal tract, kidney and liver diseases, hemorrhages caused by anticoagulants; pregnancy (first trimester), childhood (up to 13 years).

Side Effects

Classification of adverse reactions by frequency of development: often – 1-10%, infrequently – 0.1-1%, rarely – 0.01-0.1%, very rarely, including isolated cases – <0.01%.

Gastrointestinal disorders. Rarely: nausea, diarrhea, vomiting.

Disorders of the skin and subcutaneous tissues. 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 cessation of therapy.

Interaction

Cases of drug interactions with calcium dobesilate have not been identified to date.

Overdose

There were no cases of overdose.

Recommendations for use

Orally, without chewing, during meals.

Prescribe 500 mg 3 times a day for 2-3 weeks, then reduce the dose to 500 mg 1 time a day.

When treating retinopathy and microangiopathy, 500 mg is prescribed 3 times a day for 4-6 months, then the daily dose is reduced to 500 mg 1 time a day.

The course of treatment is from 3-4 weeks to several months, depending on the therapeutic effect.

Storage conditions

At a temperature not exceeding 25°C in consumer packaging.

Keep out of the reach of children.

Shelf life

5 years

Manufacturer

Hemofarm A.D., Serbia