Etamsylate - instructions for use, doses, side effects, contraindications

Excipients: sodium pyrosulfite (sodium pyrosulfite technical) 2.5 mg, sodium sulfite (sodium sulfonate) 1 mg, disodium edetate (disodium ethylenediaminetetraacetic acid salt) [Trilon B]) 0.5 mg, water for injection up to 1 ml.

Description:Transparent colorless or slightly colored liquid.

Pharmacotherapeutic group:hemostatic agent

ATX: & nbsp

B.02.B.X.01 Etamsylate

Pharmacodynamics:

Etamsylate is a hemostatic drug. Hemostatic effect is based on increased interaction between the endothelium and platelets. Increases the adhesion of platelets, stabilizes the walls of capillaries, thus reducing their permeability, inhibits the synthesis of prostaglandins, which cause platelet disaggregation, vasodilation and increased capillary permeability, which reduces bleeding time and reduces blood loss. Increases the rate of formation of the primary thrombus and strengthens its retraction, practically does not affect the level of fibrinogen and prothrombin time.

Recovers pathologically altered bleeding time. The hemostasis does not influence the normal parameters of the system.

Hemostatic effect with intravenous Etamzilate solution comes in 5-15 minutes, the maximum effect - after 1-2 hours. The action lasts for 4-6 hours, then within 24 hours gradually weakens; with the / m introduction the effect is somewhat slower.

Pharmacokinetics:

The drug is well absorbed. Therapeutic concentration in the blood - 0.05-0.02 mg / ml.Evenly distributed in various organs and tissues (depends on the degree of their blood supply). It weakly binds to plasma proteins and formed elements of blood.

Quickly excreted from the body, mainly by the kidneys (unchanged), and also with bile. The half-life after intramuscular injection is 2.1 hours, after intravenous administration -1.9 hours.

After 5 minutes after intravenous injection of kidneys, 20-30% injected drug, completely withdrawn after 4 hours.

Indications:

Prophylaxis and stopping of bleeding: parenchymal and capillary bleeding (including traumatic, surgery in operations, heavily vascularized organs and tissues, surgical interventions in dental, urological, ophthalmic, otolaryngological practice, intestinal, renal, pulmonary hemorrhage, metro - and menorrhagia in fibromyoma, etc.), secondary bleeding against thrombocytopenia and thrombocytopathy, hypocoagulation, hematuria; intracranial hemorrhage (including in newborns and premature infants); nosebleeds on the background of arterial hypertension, bleeding due to medication, hemorrhagic diathesis (incl.Verlhof, Willebrand-Jurgens disease, thrombocytopathy), diabetic microangiopathy (hemorrhagic diabetic retinopathy, retinal hemorrhage, haemophthalmia).

Contraindications:

Acute, porphyria, hemoblastosis in children, hypersensitivity to the components of the drug; thrombosis; thromboembolism.

Carefully:

When bleeding against the background of an overdose of anticoagulants.

Pregnancy and lactation:

Safety of the use of Etamsylate in pregnancy is not established. Etamsylate should be used during pregnancy only if the potential benefit to the mother exceeds the possible risk to the fetus.

Breastfeeding should be stopped during treatment with a drug by the mother Etamsylate.

Dosing and Administration:

Etamsylate is administered intravenously, intramuscularly. In ophthalmic practice - subconjunctival and retrobulbar.

Adults: for prophylactic purposes for surgical interventions, the drug is administered intravenously or intramuscularly 1 hour before the operation at a dose of 250-500 mg (2-4 ml), if necessary during operations - in a dose of 250-500 mg (2-4 ml) and prophylactically - 500-750 mg (4-6 ml) intravenously or intramuscularly,evenly during the day after the operation.

Children: if necessary during the operation Etamsylate administered intravenously at the rate of 8-10 mg / kg body weight. Treatment can begin from the first days of life.

To stop bleeding Etamsylate injected intravenously or intramuscularly 250-500 mg (2-4 ml), then every 4-6 hours for 250 mg (2 ml) for 5-10 days.

When treating metro-menorrhagia Etamsylate is prescribed in a single dose of 250 mg (2 ml) intravenously or intramuscularly every 6-8 hours for 5-10 days.

Hemorrhages in diabetic microangiopathy - intramuscularly 250-500 mg (2-4 ml) 3 times a day or 125 mg (1 ml) 2 times a day for 2-3 months.

In ophthalmology Etysylate is administered subconjunctivalally or retrobulbarno - in a dose of 125 mg (1 ml).

Side effects:

Heartburn, heaviness in the epigastric region, headache, dizziness, hyperemia of the facial skin, reduction of systolic blood pressure, paresthesia of the lower extremities, allergic reactions.

Interaction:

Pharmaceutically incompatible (in one syringe) with other medicinal drugs.

Introduction at a dose of 10 mg / kg for 1 hour before dextrans (mean Mol. weight 30-40 thousand Yes) prevents their antiaggregant effect; the administration after does not have hemostatic effect.

It is possible to combine with aminocaproic acid and menadione sodium, bisulphite.

Special instructions:

Care must be taken (despite the absence of induction of thrombosis) in the administration of etamzilate to patients with thrombosis or thromboembolism in the anamnesis.

When hemorrhagic complications associated with an overdose of anticoagulants, it is recommended to use specific antidotes.

The use of etamzilate in patients with impaired blood coagulation indexes is possible, but it should be supplemented by the introduction of drugs that eliminate the revealed deficiency or defect factors of the coagulation system.

Effect on the ability to drive transp. cf. and fur:

The adverse effect of the drug on the ability to drive a car and other activities that require concentration of attention and speed of psychomotor reactions have not been reported.

Form release / dosage:

Solution for injection, 125 mg / ml.

Packaging:

2 ml per ampoule of neutral glass. For 10 ampoules with instruction for use and a knife for opening ampoules or a scarifier ampullum is placed in a box of cardboard.

5 or 10 ampoules are placed in a contoured cell pack of a polyvinylchloride film or polyethylene terephthalate tape and aluminum foil or paper with a polyethylene coating or without a foil, or without paper.

According to 1, 2 or 10 contour cells (5 ampoules each) or 1, 2 or 5 contour cell packs (10 ampoules each) with instructions for use and a vial for opening ampoules or a scarifier ampoule put in a pack of cardboard.

When you pack the ampoules with a break ring or break point, the ampoule opener or ampoule scapper is not put in.

Storage conditions:

In the dark place at a temperature of 2 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Terms of leave from pharmacies:On prescription

Registration number:LS-000035

Date of registration:15.06.2011

The owner of the registration certificate:NOVOSIBHIMFARM, OJSC NOVOSIBHIMFARM, OJSC Russia

Manufacturer: & nbsp

NOVOSIBHIMFARM, OJSC Russia

Representation: & nbspNOVOSIBHIMFARM, OJSCNOVOSIBHIMFARM, OJSC

Information update date: & nbsp05.10.2015

Illustrated instructions

Instructions

Etamsylate (Etamsylate)