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

The drug increases the formation of capillaries in the walls of mucopolysaccharides of large molecular weight and increases the stability of capillaries, normalizes their permeability in pathological processes, improves microcirculation; has a hemostatic effect. Hemostatic effect is due to the activation of thromboplastin formation at the site of damage to small vessels. The drug stimulates the formation of III factor of blood coagulation, normalizes the adhesion of platelets. The drug does not affect the level of fibrinogen and prothrombin time, does not have hypercoagulable properties and does not contribute to the formation of clots (blood clots).

Pharmacokinetics:

After intravenous administration ethamylate starts to operate within 5-15 minutes. The maximum effect is 1 hour after the dose. The drug lasts for 4-6 hours. After the administration of 500 mg, the maximum plasma concentration is reached after 10 minutes (50 μg / ml).

The half-life from blood plasma after intravenous administration is about 2 hours. Etamsylate evenly distributed in various organs and tissues (depends on the degree of their blood supply).

The drug is well absorbed by intramuscular injection, weakly binds to plasma proteins and shaped elements of the blood. With intramuscular injection, the haemostatic effect occurs in 30-60 minutes. The half-life of plasma after intramuscular injection is 2.1 hours.

It penetrates the placental barrier and into the mother's milk.

About 72% of the administered dose is excreted through the kidneys during the first 24 hours in unchanged form.

Indications:

Prevention and treatment of capillary bleeding of various etiologies:

- during and after surgery on all well-vascularized tissues in dental, otorhinolaryngological, gynecological, urological, ophthalmic practice, obstetrics and plastic surgery;

- Hematuria, metrorrhagia, primary menorrhagia, menorrhagia in women with intrauterine contraceptives, nosebleeds, bleeding gums;

- diabetic microangiopathy (hemorrhagic diabetic retinopathy, repeated haemorrhage into the retina, hemophthalmus);

- intracranial hemorrhage in newborns and premature infants.

Contraindications:

- Hypersensitivity to the components of the drug;

- hypersensitivity to sodium bisulfite;

- acute porphyria;

- hemoblastosis in children (lymphoblastic and myeloblastic leukemia);

- thromboembolism, thrombosis;

- the period of breastfeeding.

Carefully:

A thrombosis, a thromboembolism in the anamnesis; bleeding against an overdose of anticoagulants, pregnancy.

Pregnancy and lactation:

In studies on animals teratogenic effects of etamzilate have not been identified. In clinical studies, the fetotoxic effect of etamzilate was not observed. However, given the lack of clinical experience, the use of etamzilate during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

Data on the penetration of etamzilate into breast milk are absent. When prescribing the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Intravenous, intramuscular.

Etamsylate can be administered intravenously drip in a 5% solution of glucose or in an isotonic solution of sodium chloride.

The optimal daily dose of etamzilate for adults is 10-20 mg / kg body weight per day, divided into 3-4 doses, in the form of intramuscular or slow intravenous injection.

If ethamylate mixed with saline, it should be used immediately.

Adults: at operative interventions prophylactically enter intravenously or intramuscularly 250-500 mg for 1 hour before the operation, 250-500 mg is intravenously administered during the operation, if necessary, the administration of this dose can be repeated again. After the operation, inject every 6 hours 250-500 mg until the risk of bleeding disappears.

For children: daily dose is 10-15 mg / kg body weight divided into 3-4 doses.

In neonatology: ethamylate is administered intramuscularly or intravenously at a dosage of 12.5 mg per kg of body weight (0.1 ml = 12.5 mg). Treatment should begin within the first 2 hours after birth.

In the treatment of metromenorrhagia, the drug is prescribed in a single dose of 250 mg (2 ml of 12.5% solution) intravenously or intramuscularly every 6-8 hours for 5-10 days.

In diabetic microangiopathy, the drug is administered intramuscularly during 10-14 days in a single dose of 250-500 mg three times a day.

Side effects:

Allergic reactions, headache, dizziness, paresthesia of the lower extremities, decreased systolic blood pressure, facial skin hyperemia, nausea, heartburn, epigastric gravity, hyperthermia, skin rashes.

Overdose:

No cases of an overdose of ethamylate have been reported to date.

Interaction:

Etamsylate is pharmaceutically incompatible (in one syringe) with other medicines.

The solution of etamzilate is incompatible with sodium bicarbonate solution for injection and sodium lactate solution.

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 antiplatelet effect of the latter; the administration of etamzilate after solutions of dextrans does not exert a haemostatic effect. It is possible to combine etamzilate with aminocaproic acid and menadione sodium bisulfite.

Special instructions:

For use only in medical institutions.

Before starting treatment, other causes of bleeding should be ruled out.

When the color of the solution appears, it can not be used.

The drug can be used topically (for example, in the case of a skin graft, after tooth extraction, etc.): a sterile swab or napkin is impregnated with a solution and applied to the wound.

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.

The drug contains sodium bisulfite, which in rare cases can cause severe hypersensitivity reactions (including anaphylactic shock) and bronchospasm.

In the case of hyperthermia, treatment should be discontinued.

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

Etamsylate does not affect the ability to drive a car and other working mechanisms.

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

Packaging:

2 ml in ampoules of colorless transparent glass (type I), colored or white dot on the ampoule marked the place of breakdown; For each ampoule, stick a label or mark with a fast-fitting paint.

10 ampoules per blister of PVC, 1 or 5 blisters together with instructions for use in a pack of cardboard.

Storage conditions:

Store in a 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 expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002436

Date of registration:21.04.2014

Date of cancellation:2019-04-21

The owner of the registration certificate:ALVILS, LTD. ALVILS, LTD. Russia

Manufacturer: & nbsp

NORTH CHINA PHARMACEUTICAL CORPORATION China

Representation: & nbspAlvils, OOOAlvils, OOO

Information update date: & nbsp05.10.2015

Illustrated instructions

Instructions

Etamsylate (Etamsylate)