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

Active substance:
Etamsylate	- 125.0 mg
Excipients:
sodium disulfite (sodium metabisulphite)	- 2.5 mg
Sodium sulfite anhydrous	- 1.0 mg
disodium edetate dihydrate (disodium ethylenediaminetetraacetic acid)	- 0.5 mg
water for injections	- up to 1 ml

Description:

Transparent colorless or slightly colored liquid.

Pharmacotherapeutic group:hemostatic agent

ATX: & nbsp

B.02.B.X.01 Etamsylate

Pharmacodynamics:

Hemostatic agent. It also has angioprotective and proaggregant action. Stimulates the formation of platelets and their exit from the bone marrow. Hemostatic action due to activation of thromboplastin formation at the site of damage to small vessels and a decrease in the formation in the endothelium of prostacyclin vessels PgI2, promotes an increase in adhesion and aggregation of platelets, which ultimately leads to stopping or reducing bleeding. Increases the rate of formation of the primary thrombus and enhances its retraction, practically does not affect the concentration of fibrinogen and prothrombin time. Doses of more than 2-10 mg / kg do not lead to greater severity of the effect. With repeated injections, thrombus formation is intensified. Possessing anti-hyaluronidase activity and stabilizing ascorbic acid, it prevents destruction and promotes the formation in the capillary wall of mucopolysaccharides with a large molecular weight, increases the resistance of capillaries, reduces their fragility, normalizes permeability in pathological processes.Reduces the yield of fluid and diapedesis of blood elements from the vascular bed, improves microcirculation. Does not have vasoconstrictive action. Recovers pathologically altered bleeding time. The hemostasis does not influence the normal parameters of the system.

Hemostatic affect with intravenous administration of etamzilate occurs in 5-15 minutes, the maximum effect is manifested in 1-2 hours. The action lasts for 4-6 hours, then within 24 hours gradually weakens; when administered intramuscularly, the effect occurs 30-60 minutes later.

Pharmacokinetics:

The drug is well absorbed by intramuscular injection, weakly binds to plasma proteins and shaped elements of the blood. The therapeutic concentration in the blood is 0.05-0.02 mg / ml. Etamsylate evenly distributed in various organs and tissues (depends on the degree of their blood supply).

The drug is excreted from the body mainly by the kidneys (unchanged), in an insignificant quantity with bile. The half-life of the drug after intravenous administration is 1.9 hours, after intramuscular injection - 2.1 hours. After 5 minutes after intravenous injection of the kidneys, 20-30% of the injected drug is released, in full - after 4 hours.

Indications:

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

Contraindications:

Hypersensitivity to any ingredient in the drug, acute porphyria, hemoblastosis in children, thrombosis, thromboembolism.

Carefully:

When bleeding against the background of an overdose of anticoagulants, pregnancy.

Pregnancy and lactation:

The safety of etamzilate during 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.

During the treatment of the mother, breastfeeding should be discontinued.

Dosing and Administration:

Intravenous, intramuscular, in ophthalmology - subconjunctival and retrobulbar. Etamsylate can be administered intravenously drip in a 5% solution of glucose or in an isotonic solution of sodium chloride.

Adults: for prophylactic purposes for surgical interventions, the drug is administered intravenously or intramuscularly 1 hour prior to surgery at a dose of 0.25-0.5 g (2-4 ml of 125 mg / ml solution), if necessary during intravenous operation - at a dose of 0, 25-0.5 g (2-4 ml solution 125 mg / ml), with the danger of postoperative bleeding intravenously or intramuscularly - 0.5-0.75 g (4-6 ml solution 125 mg / ml) evenly throughout the day.

Children: if necessary during the operation is administered intravenously at the rate of 8-10 mg / kg body weight.

To stop bleeding injected intravenously or intramuscularly with 0.25-0.5 g (2-4 ml of a solution of 125 mg / ml), after which every 4-6 hours 0.25 g (2 ml of 125 mg / ml solution) for 5-10 days.

When treating metro- and menorrhagia the drug is prescribed in a single dose of 0.25 g (2 ml of a solution of 125 mg / ml) intravenously or intramuscularly every 6-8 hours for 5-10 days.

With diabetic microangiopathy the drug is administered intramuscularly in a single dose of 0.25-0.5 g three times a day for 10-14 days.

In ophthalmology the drug is administered subconjunctivalally or retrobulbarno - in a dose of 0.125 g (1 ml of a solution of 125 mg / ml).

The solution for injections can be applied topically (a sterile swab is impregnated and applied to the wound.

Side effects:

Headache, dizziness, redness of the face, an allergic rash, paresthesia of the lower extremities, lowering of blood pressure.

Interaction:

Do not mix Etamsylate with other medicines.

Administration of the drug at a dose of 10 mg / kg body weight 1 hour prior to administration of solutions of dextrans with an average molecular weight of 30,000-40000 prevents the antiaggregative effect of the latter; The introduction of etamzilate after solutions of dextrans does not exert a hemostatic effect.

It is possible to combine Etamsylate with aminocaproic acid and menadione sodium bisulfite.

Special instructions:

Care must be taken in patients who have ever had thrombosis or thromboembolism.

The drug is ineffective in patients with a reduced number of platelets.

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:

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:Solution for injection, 125 mg / ml.

Packaging:

2 ml in ampoules.

10 ampoules are placed in a box of cardboard with corrugated septa.

5 ampoules are placed in a contour mesh package made of a polyvinyl chloride film. 2 contour squares are placed in a pack of cardboard.

In each pack, a box put the instructions for use, knife or scarifier ampoule ampoule (ampoule when packing ring fracture point and the notch or ampoule opener scarifier not invest).

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LS-002265

Date of registration:28.09.2011

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia

Information update date: & nbsp05.10.2015

Illustrated instructions

Instructions

Etamsylate (Etamsylate)