Dicynon before surgery. Dicinon tablets: what they are for, method of use, what contraindications exist, instructions. Side effects Dicynon

A drug to prevent and stop bleeding. It affects the first stage of the hemostasis mechanism (interaction between the endothelium and platelets). Dicinone increases platelet adhesiveness, normalizes the strength of capillary walls (reducing their permeability), inhibits the biosynthesis of prostaglandins, which cause platelet disaggregation, vasodilation and increased capillary permeability.
When administered orally, the drug is almost completely absorbed from the gastrointestinal tract, reaching peak concentrations in the blood serum 4 hours after administration. About 72% of the dose taken is excreted unchanged in the urine within 24 hours.
After intravenous administration of the drug, the hemostatic effect is observed after 5-15 minutes, the maximum therapeutic effect is achieved within 1 hour. The effectiveness of the drug begins to decrease after 4-6 hours. After intravenous administration at a dose of 500 mg, the maximum level in blood plasma is achieved after 10 min and is 50 µg/ml. Approximately 72% of the administered dose is excreted unchanged in urine within 24 hours. Etamsylate crosses the placental barrier and passes into breast milk.

Indications for use of the drug Dicinon

Tablets, injection solution:

• prevention and treatment of bleeding during and after surgical operations in otolaryngology, gynecology, obstetrics, urology, dentistry, ophthalmology, plastic surgery;
• prevention and treatment of capillary bleeding of various etiologies and localization: hematuria, metrorrhagia, primary menorrhagia in women with intrauterine contraceptives, nosebleeds, bleeding due to gingivitis.

Solution for injections:

• in neonatology (the drug is prescribed as an angioprotector until microcirculation normalizes).

Use of the drug Dicinon

Pills
The daily dose is: 1-2 tablets 3-4 times a day. In severe cases, the dose is 3 tablets 3-4 times a day. For menorrhagia, 3-4 tablets per day are prescribed, starting 5 days before the expected start of menstruation and until the 5th day of the next menstrual cycle.
After surgery, take 1-2 tablets every 6 hours until the risk of bleeding disappears.
Solution for injections
Used intravenously (slowly) or intramuscularly. The optimal dose for adults is 10-20 mg/kg etamsylate and is administered in 3-4 doses. In most cases, the daily dose is 1-2 ampoules 3-4 times a day.
Before surgery, 1-2 ampoules are administered intravenously or intramuscularly. During the operation, 1-2 ampoules are administered intravenously; administration in the same dose can be repeated. After surgery, 1-2 ampoules are administered every 6 hours until the risk of bleeding disappears.
In neonatology, Dicinon is administered intramuscularly or intravenously in doses of 12.5 mg/kg (0.1 ml = 12.5 mg). Treatment should be started within the first 2 hours after birth and the drug should be used every 6 hours for 4 days up to a total dose of 200 mg/kg.
Dicynone can be applied topically (skin graft, tooth extraction) using a sterile gauze pad moistened with the drug.

Contraindications to the use of the drug Dicinon

Hypersensitivity to the components of the drug, acute porphyria, hemoblastosis in children. Increased blood clotting.

Side effects of the drug Dicinon

Pills: rarely - nausea, epigastric pain, dizziness, skin rash.
Solution for injections: headache, dizziness, facial flushing, transient skin reactions, nausea, epigastric pain, paresthesia of the lower extremities. Sometimes - a decrease in systolic pressure after intravenous administration of the drug. These side effects are mild and transient.

Special instructions for the use of the drug Dicinon

Before starting treatment, other causes of bleeding must be excluded.
The drug should be used with caution in patients with a history of thrombosis and thromboembolism. The drug is not effective in reducing platelet counts.
During pregnancy and breastfeeding. The safety of the drug has not been established. Dicynone should only be taken if the potential benefit to the mother outweighs the potential risk to the fetus. When using the drug, breastfeeding should be stopped.
Impact on the ability to drive vehicles and machinery. Does not affect.
The tablets should be taken with or after meals.
Do not use the drug if the color of the solution changes.

Drug interactions Dicynon

solution for injections not compatible with sodium bicarbonate solution and sodium lactate powder. The contents of the ampoule should not be mixed with other drugs in the same syringe. If Dicynon is mixed with physiological solution, it must be used immediately.
Pills: interactions with other drugs have not been established.

Overdose of the drug Dicinon, symptoms and treatment

No data.

Storage conditions for the drug Dicinon

In a dry place, protected from light, at temperatures up to 25 ° C.

List of pharmacies where you can buy Dicynone:

• Saint Petersburg

The action of the drug is based on the ability of ethamsylate to create thromboplastin. Dicinone in ampoules is used, according to the instructions for use, for bleeding and hemorrhage.

This is what genuine dicinone looks like in ampoules. Instructions for use must be included in the package

In addition to the main ingredient, the medication contains water, sodium disulfite and bicarbonate. The solution is colorless and transparent.

The drug promotes the formation of mucopolysaccharides, which protect protein fibers from damage and normalize capillary permeability. Dicynone removes excess fluid located in the bloodstream of the vessel, increases the strength of capillaries, provokes the creation of platelets in the hematopoietic bone marrow, prolongs their existence and enhances activity.

The advantage of Dicinon is that it does not constrict blood vessels, does not increase coagulation and does not provoke the formation of blood clots.

After 15 minutes after injection into the vein, the effect of the medicine appears. The peak effect is noticeable an hour after the injection. The total duration of action lasts no more than 6 hours.

In a situation where the medication is injected into the muscle, the effect becomes noticeable four hours after the injection.

Dicynone is perfectly absorbed in the body and is equally distributed throughout the organs and tissues. Practically does not react with proteins and enzymes contained in the blood. The medication is quickly eliminated from the body with urine and bile.

Indications for use of the drug Dicynon in ampoules

The medication is used for the prevention and treatment of cerebral hemorrhages during stroke, trauma, capillary bleeding, as well as in:

• gynecology;
• obstetrics;
• dentistry;
• urology;
• ophthalmology;
• otorhinolaryngology.

The medication is prescribed for damage to internal organs and hemorrhages in them: spleen, kidneys or liver; for bleeding caused by qualitative inferiority of platelets or a decrease in the number of formed elements in the blood; with slow blood clotting; with microangiopathy caused by diabetes; with hemorrhagic diathesis or vasculitis.

Dicinone in ampoules is used, according to the instructions and recommendations of doctors, in urology and gynecology for uterine dysfunction, menorrhagia, in women with intrauterine devices, metrorrhagia, endometriosis, hematuria, stopping bleeding after abortions and for hemorrhages inside the skull in newborns.

In dentistry, the medication is used for severe bleeding gums and during dental procedures and operations. In otorhinolaryngology - with epistaxis. In ophthalmology, the medicine is used to prevent hemophthalmos and secondary hemorrhages in the retina, as well as to reduce blood loss during ophthalmic surgical interventions.

Dicynone is also used for bleeding caused by Vergolf's disease.

Dicinone acts as an angioprotector for varicose syndromes, hepatitis, liver cirrhosis, radiation and chemotherapy, retinopathy, atherosclerosis, nephritis, angiopathy, toxic effects on blood vessels during viral and microbial infections.

Who should not use Dicinon: contraindications

Injections are effective if you use the drug Dicynon in ampoules. But the instructions for use prohibit the use of the medication if there is a history of:

• asthma;
• vascular thrombosis;
• thromboembolism;
• acute form of porphyria;
• intolerance or hypersensitivity to any components of the drug;
• tumors (both in children and adults).

Dicynone cannot be used for leukemia, osteogenic sarcoma and glucose-lactose deficiency.

Use of Dicinon during pregnancy and lactation

You should avoid injections during pregnancy. Use may only be prescribed if the intended benefit to the mother outweighs the risks to the embryo.

During pregnancy, the medication is used to combat brown and spotting discharge, detachment of the placenta and the outer membrane of the embryo.

In a situation where the use of the medication is prescribed during breastfeeding, the administration of Dicynon is possible, but subject to cessation of lactation. This is due to the fact that the drug substance, passing through all barriers, enters breast milk, and with it into the baby’s body.

How to use Dicinon

Injections of the drug are made into a muscle or vein (only in medical institutions), also into the space surrounding the eyeball and behind the eyeball.

The solution is also applied locally - a sterile cotton swab or napkin soaked in Dicynone is applied to the wound or into the oral cavity (for dental procedures).

Instructions for use for adults

Adults are administered no more than 20 mg of the drug per 1 kg of body weight. This dose is divided into 4 times, injections are carried out intravenously or intramuscularly. On the recommendation of a specialist, the dosage can be increased to 750 mg of medication per day.

Instructions for use for children

Children are prescribed Dicynon in ampoules with caution. Instructions for use for children suggest administration of no more than 10 mg (total) per unit of mass. There should be 4 injections in one day.

But usually the dosage for a child is calculated individually by the doctor.

For intracranial bleeding in newborn infants, drug therapy should begin no later than 2 hours after birth. Injections are given every 6 hours for four days.

Instructions for use for uterine bleeding

To prevent bleeding from the uterus, 250 mg of medication is injected into the body every 7 hours. The entire therapy lasts no more than ten days.

Dicinone helps fight abnormal bleeding, irregular menstruation, very heavy discharge and metrorrhagia.

Exceeding the dosage for gynecological diseases provokes a cessation of menstruation and disruption of the entire menstrual cycle. The question of prescribing the drug for strong or prolonged discharge is decided exclusively by the doctor. Using the drug, you can delay the onset of menstrual flow for no more than 2 weeks.

But in this case, it is necessary to be careful when prescribing the drug, because after drug therapy, the entire cycle may shift or there is a risk of hormonal disorders.

When using a medication to stop uterine bleeding, it is more than possible that some side effects may occur. For example, heartburn, dizziness, numbness of the limbs and others.

To consolidate the achieved effect, you need to take a second course of Dicinon before the start of the next menstruation.

Instructions for use in surgery

In surgery, the drug is used to prevent bleeding in the intestines, lungs and other internal organs; when removing tumor tumors.

To reduce blood loss during surgical interventions, Dicynon is administered in ampoules. Instructions for use in surgery suggest administration of the drug 60 minutes before surgery in the amount of two ampoules (500 mg). Then repeated injections can be carried out during the operation and after its completion every 5 hours to stop bleeding and to prevent postoperative bleeding.

It is necessary to pay attention to the fact that Dicinone, mixed with a solution of sodium chloride, must be introduced into the body immediately.

Dicinone in ampoules: side effects and complications

Before starting therapy with Dicynon, you should pay attention to the fact that the medication can cause side effects. Often, rashes and hyperemia may appear on the skin, and headaches and dizziness may appear on the nervous system. Problems with the digestive system may occur:

• heartburn;
• nausea;
• vomit;
• heaviness;
• pain syndromes.

In addition, Dicynon has a serious effect on the cardiovascular, lymphatic and circulatory systems. The effect is manifested in a decrease in blood pressure, the occurrence of thromboembolism, thrombocytopenia, neutropenia, and agranulocytosis.

Effects on the immune system are very rare. But it can manifest itself in the form of allergic reactions, itching, swelling and redness.

Side effects may include fever and asthenia. Also, sometimes redness and itching appear at the injection site.

Special instructions for the use of the drug Dicinon

Dicynon solution in ampoules is intended for use only in clinics and other medical institutions.

The use of the drug is possible in individual doses, calculated for the patient personally by the doctor.

Caution should be exercised when prescribing the drug to patients who have suffered thrombosis and bleeding caused by taking anticoagulants. You should stop using the medication if you are intolerant or excessively sensitive to etamsylate.

If hemorrhagic complications are observed due to anticoagulant therapy, then antidotes must be used.

The drug can be taken prophylactically. For these purposes, it is either injected into a vein or taken orally.

Dicinone is not compatible with other medications in the same container, but it can be prescribed together with other medications of different action groups.

The drug must be stored in a dark, cool place with an air temperature of no more than 25°C.

The instructions for use state that the total period of use of Dicinone in ampoules should not be more than ten days. For diseases of the circulatory system and lesions of the blood vessels, the course of use of the drug should be no more than 2 weeks.

If there is a need to carry out Dicinon therapy for longer than the recommended period, then the total dosage should be gradually reduced.

Currently, medicine has made great strides forward. Medicines have been created that stop even severe bleeding, for example, Dicinone in ampoules. By using the drug according to the instructions, you can only bring benefits to the body.

Videos: Dicyonon what it is and how to use it

Dicynon in ampoules. Instructions for use, reviews, indications:

What is dicynon:

Hemostatic drug.
Drug: DICYNON
Active substance of the drug: etamsylate
ATX coding: B02BX01
KFG: Hemostatic drug. Thromboplastin formation activator
Registration number: P No. 013946/02
Registration date: 12/12/07
Owner reg. cert.: LEK d.d. (Slovenia)

Release form of Dicynon, drug packaging and composition.

Tablets are white or almost white, round, biconvex.

1 tab.
ethamsylate
250 mg

Excipients: anhydrous citric acid, corn starch, povidone K25, magnesium stearate, lactose.

10 pieces. - blisters (10) - cardboard packs.

The solution for intravenous and intramuscular administration is colorless, transparent.

1 ml
1 amp.
ethamsylate
125 mg
250 mg

Excipients: sodium disulfite, water for injection, sodium bicarbonate (used in some cases to correct pH).

2 ml - ampoules (5) - blisters (2) - cardboard packs.
2 ml - ampoules (5) - blisters (5) - cardboard packs.
2 ml - ampoules (10) - blisters (2) - cardboard packs.
2 ml - ampoules (10) - blisters (5) - cardboard packs.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action Dicynon

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

After intravenous administration, the drug begins to act within 5-15 minutes; the maximum effect is observed after 1 hour, the duration of action is 4-6 hours.

Pharmacokinetics of the drug.

Suction and distribution

After intravenous administration of the drug at a dose of 500 mg, Cmax is reached after 10 minutes and is 50 mcg/ml.

After oral administration, the drug is quickly and almost completely absorbed. After taking the drug at a dose of 50 mg, Cmax is reached after 4 hours and is 15 mcg/ml.

Etamzilate crosses the placental barrier and is excreted in breast milk.

Removal

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

After intravenous administration, T1/2 is about 2 hours; after oral administration, T1/2 is about 8 hours.

Indications for use:

Prevention and treatment of capillary bleeding of various etiologies:

During and after surgical operations on all well-vascularized tissues in otorhinolaryngology, gynecology, obstetrics, urology, dentistry, ophthalmology and plastic surgery;

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

Diabetic microangiopathy (hemorrhagic diabetic retinopathy, repeated retinal hemorrhages, hemophthalmos);

Intracranial hemorrhages in newborns and premature infants.

Dosage and method of administration of the drug.

Pills

The optimal daily dose for adults is 10-20 mg/kg body weight, divided into 3-4 doses. In most cases, a single dose is 250-500 mg 3-4 times a day. In exceptional cases, the single dose can be increased to 750 mg 3-4 times a day.

For menorrhagia, 750-1000 mg/day is prescribed, starting from the 5th day of the expected menstruation until the 5th day of the next menstrual cycle.

In the postoperative period, the drug is prescribed in a single dose of 250-500 mg every 6 hours until the risk of bleeding disappears.

Children are prescribed a daily dose of 10-15 mg/kg in 3-4 doses.

Solution for IM and IV injections

The optimal daily dose for adults is 10-20 mg/kg, divided into 3-4 IM or IV (slow) injections.

For adults undergoing surgical interventions, a prophylactic dose of 250-500 mg is administered intravenously or intramuscularly 1 hour before surgery. During surgery, 250-500 mg is administered intravenously; this dose can be repeated again. After surgery, 250-500 mg is administered every 6 hours until the risk of bleeding disappears.

For children, the daily dose is 10-15 mg/kg body weight, divided into 3-4 administrations.

In neonatology: Dicinone is administered intramuscularly or intravenously (slowly) at a dose of 12.5 mg/kg (0.1 ml = 12.5 mg). Treatment should begin within the first 2 hours after birth.

The solution for IM and IV injections can be used topically: a sterile swab or gauze pad is soaked in the solution and applied to the wound (skin graft, tooth extraction).

If Dicynone is mixed with saline, it should be administered immediately.

Side effects of Dicynon:

From the central nervous system and peripheral nervous system: headache, dizziness, paresthesia of the lower extremities.

Dermatological reactions: facial skin hyperemia.

From the digestive system: nausea, heartburn, heaviness in the epigastric region.

From the cardiovascular system: decrease in systolic blood pressure.

Contraindications to the drug:

Acute porphyria;

Hemoblastosis in children (lymphoblastic and myeloblastic leukemia, osteosarcoma);

Thrombosis;

Thromboembolism;

Hypersensitivity to the components of the drug and sodium sulfite.

The drug should be prescribed with caution in case of thrombosis, a history of thromboembolism, bleeding due to an overdose of anticoagulants.

Use during pregnancy and lactation.

Use during pregnancy is possible only in cases where the potential benefit of therapy for the mother outweighs the possible risk to the fetus.

If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Special instructions for the use of Dicynon.

Before starting treatment, other causes of bleeding should be excluded.

1 tablet of Dicynone contains 60.5 mg of lactose (the maximum daily dose of lactose should not exceed 5 g). The drug should not be prescribed to patients with congenital glucose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption syndrome.

The solution for intramuscular and intravenous administration is intended only for use in hospitals and clinics.

Impact on the ability to drive vehicles and operate machinery

No special precautions required.

Drug overdose:

Data on overdose of the drug Dicinon are not provided.

Interaction of Dicinon with other drugs.

Administration of a dose of 10 mg/kg body weight 1 hour before the administration of dextrans prevents their antiplatelet effect. Administration of Dicynone after administration of dextrans does not have a hemostatic effect.

A combination with aminocaproic acid and menadione sodium bisulfite is possible.

Pharmaceutical interactions

Pharmaceutically incompatible (in the same syringe) with other drugs.

Incompatible with sodium bicarbonate injection and sodium lactate solution.

Terms of sale in pharmacies.

The drug is available with a prescription.

Terms of storage conditions for the drug Dicinon.

The drug in the form of a solution for intramuscular and intravenous administration should be stored in a place protected from light, out of reach of children, at a temperature not exceeding 25°C. Shelf life – 5 years.

The drug in tablet form should be stored in a place protected from light and moisture, out of reach of children, at a temperature not exceeding 25°C. Shelf life – 5 years.

If staining appears, the injection solution should not be used.

Dicynone is a hemostatic drug intended to prevent, reduce and completely stop bleeding. Available in the form of injection solution and tablets.

Pharmacological action of Dicinone

In accordance with the instructions for Dicynon, the active component of the drug is etamsylate. Excipients in the tablets include corn starch, citric acid, povidone K25, magnesium stearate, lactose. Auxiliary components of the solution for injection are sodium bicarbonate, sodium disulfide, water for injection.

The drug has angioprotective and proaggregate properties. During the use of Dicinon, the formation of platelets and their release from the bone marrow are stimulated. The hemostatic effect of the drug is due to the fact that Dicinon promotes the activation of thromboplastin formation at sites of damage to small vessels and reduces the formation of prostacyclin in the vascular endothelium. The drug increases platelet adhesion and aggregation, which stops or reduces bleeding.

Thanks to the components of the drug, the rate of formation of the primary thrombus increases and its retraction increases without affecting the prothrombin period and fibrinogen concentration. When using Dicynone in a dosage of more than 2-20 mg/kg, the effect does not increase. With repeated administrations, the process of thrombus formation intensifies.

Since the drug has antihyaluronidase activity, when injecting a solution or taking Dicynon tablets, ascorbic acid is stabilized, which prevents destruction and promotes the formation of mucopolysaccharides with a significant molar mass in the walls of capillaries. The drug helps to increase the resistance of capillaries by reducing their fragility and normalizing permeability during pathological processes.

Dicinone reduces the diapedesis of blood plasma formed elements and the release of excess fluid from the vascular bed, and also normalizes the microcirculation process.

According to the instructions, Dicinon does not have a hypercoagulable or vasoconstrictive effect and does not contribute to the process of thrombus formation.

When using Dicynone, bleeding that is pathologically altered by time is restored without changing the parameters of the hemostatic system.

Dicinon is used effectively during menstruation, as it helps reduce blood loss during menorrhagia.

The therapeutic effect with intravenous administration of the drug occurs within 10-15 minutes, the maximum effect appears after 1.5 - 2 hours. The duration of action of Dicinon is 4-6 hours. When administered intramuscularly, the effect occurs within 3-4 hours. When taking Dicinon tablets orally, the maximum effect occurs after 2-3 hours. After a course of therapy, the therapeutic effect lasts for 5-8 days.

Indications for use of Dicinone

The instructions for Dicinon indicate that the drug is prescribed for the prevention and treatment of capillary bleeding of various origins:

• Hematuria, primary menorrhagia, metrorrhagia, menorrhagia when using intrauterine contraceptives, bleeding gums, nosebleeds;
• Hemorrhagic diabetic retinopathy, hemophthalmos, retinal hemorrhages;
• Intracranial hemorrhages in premature and newborn infants.

After and during surgical operations, Dicinon is used to stop bleeding in well-vascularized tissues in gynecology, otorhinolaryngology, urology, obstetrics, dentistry, plastic surgery and ophthalmology.

Dicinon is also prescribed for menstruation.

Directions for use and dosage

Dicynon injection solution is intended for intravenous and intramuscular administration. For the treatment of ophthalmological diseases - retrobulbar (behind the eyeball) and in the form of eye drops.

The optimal daily dosage for adults is 10-20 mg/kg (it should be divided into 3-4 injections).

For adults undergoing surgical interventions, 250-500 mg of solution is administered intramuscularly or intravenously 1 hour before the start of the operation. During and after surgery, Dicinon is administered only intravenously, several times if necessary. After surgery, it is recommended to administer the drug every 6 hours until the risk of bleeding completely disappears.

For children, the daily dosage is 10-15 mg per 1 kg of child weight and is divided into 3-4 injections.

For newborns, Dicinone at a dose of 12 mg/kg should be administered slowly intramuscularly or intravenously during the first two hours after birth.

When mixing a drug with a saline solution, the substance must be administered immediately.

Dicynon tablets are intended for oral administration. The daily dose for adults is 10-20 mg per 1 kg of weight and is divided into 3-4 doses. As a rule, a single dose is 200-500 mg, and in individual cases it can reach 750 mg.

Dicynone for menstruation is prescribed from the 5th day of menstruation until the 5th day of the next menstruation at a dose of 750-1000 mg per day.

Side effects of Dicynon

During the use of Dicinon, the following side effects may occur from the body systems:

• Central and peripheral nervous system: dizziness, headaches, paresthesia of the lower extremities;
• Digestive system and gastrointestinal tract: heartburn, nausea, feeling of heaviness in the epigastric area;
• Other: facial skin flushing, allergic reactions (skin rash, itching, redness, swelling, urticaria), decreased blood pressure.

Contraindications to the use of Dicinone

Dicinon solution and tablets are not prescribed in the presence of acute porphyria, lymphoblastic and myeloblastic leukemia in children, osteosarcoma, thrombosis, thromboembolism, or hypersensitivity to the components of the drug.

Dicinone is prescribed with caution in case of a history of thromboembolism and bleeding that occurs due to an overdose of anticoagulants.

During pregnancy, taking the drug is permitted only in cases where the benefits of therapy for the mother significantly outweigh the possible risks for the child.

When prescribing Dicinon during lactation, it is necessary to temporarily stop breastfeeding during treatment.

Overdose

Taking Dicynone during menstruation in quantities exceeding those prescribed can lead to a stop of menstruation and a delay in the start of the next cycle.

Additional Information

Dicinon injection solution is intended for use only in clinics and hospitals.

The instructions for Dicinon indicate that the drug must be stored in a dark, cool, dry place out of reach of children. Shelf life – 5 years.

Dispensed from pharmacies with a doctor's prescription.

Compound

Active substance: etamsylate.

2 ml of solution (one ampoule) contains 250 mg of ethamsylate.

1 ml of solution contains 125 mg of ethamsylate.

Excipients: sodium metabisulfite (E223), sodium bicarbonate, water for injection.

Description

Colorless, transparent solution.

Pharmacotherapeutic group

Hemostatic agents. Vitamin K and other hemostatic agents.

ATX code: B02BX01.

Pharmacological properties

Pharmacodynamics

Etamsylate is a synthetic hemostatic and angioprotective agent that acts at the initial stage of hemostasis (at the stage of interaction between the endothelium and platelets). By improving platelet adhesion and restoring capillary resistance, it reduces bleeding time and blood loss.

Etamsylate does not have a vasoconstrictor effect and does not affect fibrinolysis and plasma coagulation factors.

Pharmacokinetics

A peak plasma level of 50 mcg/ml is observed 10 minutes after intravenous administration of ethamsylate at a dose of 500 mg. With intramuscular administration of the same dose of etamsylate, a peak plasma level of 30 mcg/ml is observed after 1 hour. Plasma protein binding is about 95%. Etamzilate penetrates the placental barrier. Similar levels of the drug are observed in maternal and cord blood. It is unknown whether ethamsylate passes into breast milk. Etamsylate is poorly metabolized. Etamsylate is excreted mainly by the kidneys, with 85% unchanged. The half-life from plasma is 2.1 hours (i.m.) and 1.9 hours (i.v.). About 70–80% of the dose is excreted in the urine during the first 24 hours.

Whether the pharmacokinetics of etamsylate changes in patients with renal and/or hepatic impairment is unknown.

Indications for use

Prevention of pre-, intra- or postoperative capillary bleeding during all complex operations or operations on well-vascularized tissues: in otorhinolaryngology, gynecology, obstetrics, urology, dentistry, ophthalmology or plastic and reconstructive surgery.

Treatment of capillary bleeding of any origin and location.

Prevention of periventricular hemorrhages in premature infants.

Contraindications

Acute porphyria.

Bronchial asthma, hypersensitivity to sulfites.

Hypersensitivity to any of the components of the drug.

Precautionary measures

Due to the risk of a drop in blood pressure during parenteral administration, caution should be exercised in patients with unstable blood pressure or hypotension (see section "Side Effects").

The drug contains sodium metabisulfite, which may cause allergic reactions, nausea and diarrhea in susceptible patients.

Allergic reactions can be severe, including anaphylactic shock, and can cause life-threatening asthma attacks. The prevalence of such allergic reactions is unknown but is likely to be low. Increased sensitivity to sulfites in patients with bronchial asthma is observed more often than in persons who do not suffer from this disease (see section “Contraindications”). If a hypersensitivity reaction develops, administration of the drug must be stopped immediately. In case of skin reactions or fever, stop treatment and inform your doctor, as such symptoms may be signs of a hypersensitivity reaction.

If the drug is prescribed to reduce heavy and (or) prolonged menstrual bleeding, and the desired effect cannot be achieved, it is necessary to exclude the presence of another pathology that can cause this condition.

Children

The drug is suitable for use in children in recommended doses.

The drug can be prescribed for the prevention of periventricular hemorrhages in premature infants. For dosage recommendations, see the section “Dosage and Administration.”

Patients with kidney failure

The safety and effectiveness of etamsylate treatment in patients with renal failure have not been studied. Since ethamsylate is completely excreted by the kidneys, dose reduction may be necessary in cases of renal failure.

Laboratory test results

Etamsylate used in therapeutic doses can affect the results of enzymatic analysis for determining creatinine in the direction of reducing the indicators.

To exclude any possible effect of the drug on laboratory parameters, before the first use of Dicynon, initial tests (eg, blood) that will be required during treatment are performed.

Pregnancy and breastfeeding

Clinical data on the use of the drug in pregnant women is limited.

Experiments on animals did not reveal any direct or indirect toxicity affecting reproduction. As a precaution, it is preferable to avoid use of the drug during pregnancy.

Due to the lack of data on the ability of the drug to pass into breast milk, breastfeeding during treatment is not recommended. If breastfeeding continues, the use of the drug should be discontinued.

Influenceonabilitymanagevehicles and work with machinery

Has no effect.

Directions for use and doses

Adults and teenagers

Before surgery: 1-2 ampoules IV or IM an hour before surgery.

During the operation: 1-2 ampoules IV, repeat as needed.

After operation: 1-2 ampoules, repeat every 4-6 hours as long as the risk of bleeding remains.

In emergency situations and depending on the severity of the case: 1-2 ampoules IV or IM, repeat every 4-6 hours until the risk of bleeding disappears.

Local application: wet a napkin with the contents of one ampoule and apply it to the bleeding area or place it in the cavity formed after tooth extraction.

If necessary, repeat the application. A combination with oral or parenteral administration is possible.

Children

Half dose for adults.

Newborns

10 mg per kg body weight (0.1 ml = 12.5 mg) by intramuscular injection in the first 2 hours after birth, then every 6 hours for 4 days.

Patients with liver or kidney failure

No clinical trials have been conducted in patients with hepatic or renal impairment. Therefore, caution must be exercised when prescribing Dicynon injection solution to such patients.

The injection solution is incompatible with solutions containing sodium bicarbonate or lactate.

Dicynone solution should not be mixed with other medications in the same syringe.

If the drug is mixed with saline, it should be used immediately.

Side effect

Side effects observed with etamsylate are listed below. Very common (≥ 1/10), frequent (≥ 1/100,

Gastrointestinal disorders

Frequent: nausea, diarrhea, discomfort in the abdominal area.

Rare: bitter taste.

Skin and subcutaneous tissue disorders

Common: rash.

General and administration site disorders

Frequent: asthenia.

Very rare: fever.

Nervous system disorders

Frequent: headache.

Vascular disorders

Very rare: thromboembolism, arterial hypotension.

Blood and lymphatic system disorders

Very rare: agranulocytosis, neutropenia, thrombocytopenia.

Musculoskeletal and connective tissue disorders

Rare: joint pain, back/lower back pain.

Immune system disorders

Very rare: hypersensitivity, anaphylactic shock.

Metabolic and nutritional disorders

Very rare: acute porphyria.

These reactions are usually reversible after stopping treatment.