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

Diabetic nephropathy, Diabetic retinopathy, Trophic ulcers

• 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 degrees of severity and its consequences (preeclampsia with signs of tissue edema, pain, paresthesias, congestive dermatosis; surface phlebitis, varicose veins, trophic ulcers).

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Active ingredient

Calcium dobesylate

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 No. 0:

Capsule:

Titanium dioxide E171 – 0.8640 mg,

Iron oxide yellow dye E172-0.1440 mg;

Cap:

Dye iron oxide black E 172 – 0.1920 mg, dye indigo carmine E132 – 0.1728 mg, titanium dioxide E171 – 0.4800 mg, dye iron oxide yellow E172 – 0.5760 mg, gelatin to 96 mg.

How to take, the dosage

It is taken orally with food without chewing.

Prescribed 500 mg 3 times a day for 2-3 weeks and then the dose is reduced to 500 mg once a day.

In treatment of retinopathy and microangiopathy 500 mg 3 times a day during 4-6 months and then the daily dose is reduced to 500 mg once a day.

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

Interaction

Cases of drug interaction of calcium dobesylate have not yet been identified.

Directions for use

Orally, without chewing, with meals.

Prescribed 500 mg 3 times a day for 2-3 weeks and then the dose is reduced to 500 mg once a day.

In treatment of retinopathy and microangiopathy 500 mg 3 times a day during 4-6 months and 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.

Special Instructions

In case of symptoms of agranulocytosis (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 may affect the results of laboratory tests to determine the level of creatinine.

Effect on the ability to drive vehicles and operate mechanisms

The drug has no adverse effects on the ability to drive vehicles and operate mechanisms.

Contraindications

Hypersensitivity to calcium dobesylate or any drug component, gastric and 12 duodenal ulcer (acute stage), gastrointestinal bleeding, kidney and liver diseases, hemorrhages caused by anticoagulants; pregnancy (I trimester), children (under 13 years).

Side effects

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

Gastrointestinal tract disorders. Rarely: nausea, diarrhea, vomiting.

Skin and subcutaneous tissue disorders. Rarely: allergic reactions (itching, rash).

General disorders. Rare: 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 discontinuation of therapy.

Overdose

No cases of overdose have been reported.

Pregnancy use

Adequate and strictly controlled safety studies of use in pregnant and lactating women have not been conducted.

The drug is contraindicated in the first trimester of pregnancy.

During the second and third trimesters of pregnancy the drug is administered only for vital indications in case the expected effect of administration exceeds the possible risk to the fetus.

When prescribing during lactation it is necessary to decide on stopping breast-feeding.