Doksi-Chem - instructions for use, dose, side effects, contraindications

Active substanceCalcium dobezilateCalcium dobezilate

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capsules inwards

Dosage form: & nbspcapsules

Composition:

1 capsule contains active substance: calcium dobezilate (in the form of calcium dobezilate monohydrate 521.51 mg) - 500.00 mg;

Excipients: corn starch - 25.164 mg, magnesium stearate - 8.326 mg;

Capsule №0:

body: titanium dioxide E171 - 0.8640 mg, iron oxide dye yellow E172-0.1440 mg;

lid: ferric oxide black E172 0.11920 mg, indigo carmine dye E132 0.1778 mg, titanium dioxide E171 0.40000 mg, iron oxide oxide yellow E172 0.5760 mg, gelatin up to 96 mg.

Description:

Hard gelatin capsule number 0, the capsule body is opaque light yellow, the lid is opaque dark green.

Contents of the capsule: powder from white to yellowish white. Conglomerates are allowed, which turn into free-flowing powder when the glass rod is lightly pressed.

Pharmacotherapeutic group:Angioprotective agent

ATX: & nbsp

C.05.B.X.01 Calcium dobezilate

Pharmacodynamics:Angioprotector, reduces the increased vascular permeability, increases the resistance of the 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 effect is related to a certain extent with an increase in the activity of plasma kinins.

Pharmacokinetics:

Quickly absorbed in the gastrointestinal tract. The maximum concentration in the blood plasma is reached 6 hours after ingestion. Binding to plasma proteins is 20-25%. Virtually does not penetrate the blood-brain barrier.

It is excreted by the kidneys (about 50%) and through the intestine (about 50%), basically unchanged for 24 hours, 10% - in the form of metabolites. The half-life is 5 hours.

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

Indications:

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

Venous insufficiency of varying severity and its consequences (pre-condition with tissue swelling, pain, paresthesia, congestive dermatitis, superficial phlebitis, varicose veins, trophic ulcers).

Contraindications:Hypersensitivity to calcium dobezilate 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 disease,hemorrhages caused by anticoagulants; pregnancy (I trimester), children's age (up to 13 years).

Pregnancy and lactation:

Adequate and strictly controlled studies of 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 vital indications if the expected effect of the application exceeds the possible risk to the fetus.

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

Dosing and Administration:

Inside, not liquid, with food.

Assign 500 mg 3 times a day for 2-3 weeks, then reduce the dose to 500 mg once a day. In the treatment of retinopathy and microangiopathy, 500 mg 3 times a day for 4-6 months are prescribed, then the daily dose is reduced to 500 mg once a day.

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

Side effects:Classification of adverse reactions by frequency of development: often - 1-10%, not often - 0.1-1%, rarely - 0.01-0.1%, very rarely, including individual cases - <0.01%.

Disorders from the gastrointestinal tract

Rarely: nausea, diarrhea, vomiting.

Disturbances from the skin and subcutaneous tissues

Rarely: allergic reactions (pruritus, rash).

General disorders

Rarely: fever, chills.

Disturbances from musculoskeletal and connective tissue

Rarely: arthralgia.

Violations of the blood and lymphatic system

In some cases: agranulocytosis. The reaction is reversible and disappears after discontinuation of therapy.

Overdose:There were no cases of overdose.

Interaction:The cases of drug interaction of calcium dobesilate have not been identified to date.

Special instructions:

The drug can be prescribed prophylactically.

When 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 dobezilate can affect the results of laboratory tests to determine the level of creatinine.

Effect on the ability to drive transp. cf. and fur:The drug does not adversely affect the ability to drive vehicles and work with mechanisms.

Form release / dosage:Capsules 500 mg.

Packaging:10 capsules per blister of polyvinylchloride film and aluminum foil printed lacquered. For 3 or 9 blisters together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C in a consumer package.

Keep out of the reach of children.

Shelf life:

5 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012627 / 01

Date of registration:28.03.2012 / 13.12.2016

Expiration Date:Unlimited

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp04.12.2017

Illustrated instructions

Instructions

Doxy-Hem® (Doxi-Hem®)