Dicinone - instructions for use, dose, side effects, contraindications

Etamsylate is a hemostatic, antihemorrhagic and angioprotective agent, normalizes permeability of the vascular wall, improves microcirculation. Stimulates the formation of platelets and their exit from the bone marrow. 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 enhances its retraction, practically does not affect the concentration of fibrinogen in the blood plasma and prothrombin time. With repeated use, thrombus formation is intensified.

Etamsylate practically does not affect the composition of peripheral blood, its proteins and lipoproteins. The rate of erythrocyte sedimentation may decrease slightly. Reduces the yield of fluid and diapedesis of blood elements from the vascular bed, improves microcirculation. Does not have vasoconstrictive action.

Possessing anti-hyaluronidase activity and stabilizing ascorbic acid, it prevents destruction and promotes the formation of mucopolysaccharides with a large molecular mass in the capillary wall, increases the resistance of capillaries, reduces their "brittleness", normalizes permeability in pathological processes. This angioprotective action is manifested in the treatment of various diseases associated with primary and secondary disturbances of the microcirculation process.

Pharmacokinetics:

Hemostatic effect with intravenous application of etamzilate solution comes in 5-15 minutes, maximum effect after 1-2 hours. The action lasts for 4-6 hours, then within 24 hours gradually weakens. With intramuscular injection, the haemostatic effect occurs in 30-60 minutes.

After intravenous / intramuscular injection of 500 mg etamzilate, the maximum plasma concentration is reached after 10 minutes and is 30-50 μg / ml.

Virtually completely penetrates the placental barrier. It is not known whether the ethamylate in mother's milk. About 90% of etamzilate binds to plasma proteins.

Etamsylate is slightly metabolized.

About 80% of the administered dose is excreted through the kidneys unchanged. The half-life from blood plasma after intravenous administration is about 2 hours. About 85% of the administered dose of etamzilate is excreted within 24 hours.

Clinical studies on the use of etamzilate in patients with impaired liver and / or kidney function were not performed.

Indications:

Prevention and treatment of capillary bleeding of various etiologies:

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

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

- diabetic microangiopathy (hemorrhagic diabetic retinopathy, repeated bleeding in the retina, hemophthalmus);

- intracranial hemorrhage in newborns and premature infants.

Contraindications:

- Hypersensitivity to the components of the drug;

- bronchial asthma, confirmed hypersensitivity to sodium sulfite;

- acute porphyria;

- hemoblastosis in children (lymphoblastic and myeloblastic leukemia, osteosarcoma);

- thromboembolism, thrombosis.

Carefully:

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

Pregnancy and lactation:

There are no clinical data on the possible use of Dicycin in pregnant women. Dicycin during pregnancy is only possible if the intended benefit to the mother exceeds the potential risk to the fetus.

When prescribing the drug during lactation, the question of stopping breastfeeding should be resolved.

Dosing and Administration:

Intramuscularly, intravenously. 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.

Adults

During surgical interventions prophylactically administered intravenously or intramuscularly 250-500 mg (1-2 ampoules) intravenously or 1 hour before the operation intramuscularly.

During the operation intravenously inject 250-500 mg (1-2 ampoules) etamzilate, if necessary, the administration of this dose can be repeated again.

After operation injected every 4-6 hours 250-500 mg (1-2 ampoules) until the risk of bleeding disappears.

To stop bleeding injected intravenously or intramuscularly 250-500 mg (1-2 ampoules), then every 4-6 hours for 250 mg for 5-10 days.

When treating metro- and menorrhagia the drug is used in a single dose of 250 mg intravenously or intramuscularly every 6-8 hours for 5-10 days.

With diabetic microangiopathy the drug is administered subconjunctivalally or retrobulbarno in a dose of 125 mg (1/2 ampoule).

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

Children: the dose for adults should be reduced by 50%.

In neonatology Dicinone is used intramuscularly at a dose of 10 mg per kg of body weight (0.1 ml = 12.5 mg). Treatment should begin within the first 2 hours after birth, then every 6 hours for 4 days.

If Dicinone is mixed with 0.9% sodium chloride solution, it should be applied immediately.

Side effects:

According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1 / 10000,<1/1000) and very rarely (<1/10000), including individual messages.

From the digestive system

often: nausea, heaviness in the epigastric region.

From the skin and subcutaneous tissues

often: skin rash;

frequency is unknown: hyperemia of the facial skin.

From the nervous system

often: headache;

frequency is unknown: dizziness, paresthesia of the lower extremities.

From the side of the cardiovascular system

rarely: thromboembolism, marked decrease in blood pressure.

On the part of the blood and lymphatic system

rarely: agranulocytosis, neutropenia, thrombocytopenia.

From the side of the musculoskeletal system

rarely: arthralgia.

From the immune system

rarely: allergic reactions.

Other

often: asthenia;

rarely: fever.

Overdose:

To date, no cases of overdose have been described.

If an overdose has occurred, you need to start symptomatic therapy.

Interaction:

Pharmaceutically incompatible (in one syringe) with other medications.

Solution for injection Dicycin is incompatible with sodium bicarbonate solution for injection and sodium lactate solution.

Introduction in a dose of 10 mg / kg for 1 hour before dextran (the average molecular weight of 30-40 thousand. Da) prevents their antiaggregant effect; the administration after does not have hemostatic effect.

Possible combination with aminocaproic acid and menadione sodium bisulfite.

Thiamine (vitamin B₁) is inactivated by sodium sulfite, which is part of the Dicycin preparation.

Special instructions:

For use only in hospitals and clinics.

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 is not effective in patients with thrombocytopenia. When hemorrhagic complications associated with an overdose of anticoagulants, it is recommended to use specific antidotes. The use of Dicycin in patients with impaired blood coagulation is possible, but it should be supplemented by the introduction of drugs that eliminate the revealed deficiency or defect factors of the coagulation system.

Because of the increased risk of hypotension (a pronounced reduction in blood pressure) with parenteral administration of Dicinone, caution should be exercised in patients with unstable blood pressure or a tendency to hypotension.

Solution for injection Dicycin in its composition contains sodium sulfite as an antioxidant, which can cause allergic reactions, nausea, diarrhea in patients with increased sensitivity to it. Allergic reactions can be expressed and manifested anaphylactic shock and / or life-threatening attacks of suffocation. Frequency of occurrence is unknown, however such pathological the reaction is more common in patients with bronchial asthma. If such an allergic reaction occurs, Dicycin should be discontinued immediately.

Clinical studies on the use of Dicycin in patients with impaired liver and kidney function were not performed, so caution should be exercised when using etamzilate in this category of patients. Special precautions for the destruction of unused medicinal product is not required.

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

No special precautions are required.

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

Packaging:

2 ml of the drug in an ampoule of colorless neutral glass with a point of breaking red.On the top of the ampoule is a blue ring.

5 or 10 ampoules per blister, 2 or 5 blisters per cardboard pack, along with instructions for use.

Storage conditions:

Store at a temperature of no higher than 25 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013946 / 02

Date of registration:12.12.2007

The owner of the registration certificate: Lek dd Lek dd Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp05.10.2015

Illustrated instructions

Instructions

Dicycin (Dicynone)