Instruction
by medical application drug
Description:
Colorless transparent solution.
Kodath: In02Vx01
Pharmacokinetics
Hemostatic effect intravenous application Etchase solution occurs in 5-15 minutes, the maximum effect - after 1-2 hours. The action continues for 4-6 hours, then within 24 hours gradually weakens. With intramuscular administration, the hemostatic effect occurs after 30-60 minutes.
After intravenous / intramuscular administration of 500 mg of etching, the maximum plasma concentration is achieved after 10 minutes and is 30-50 μg / ml.
Almost completely penetrates through the placental barrier. It is not known whether the ethalate penetrates the maternal milk.
About 90% of etching is associated with blood plasma proteins.
Ethallate is slightly exposed to metabolism.
About 80% of the administered dose is excreted through the kidneys unchanged. The half-life of blood plasma after intravenous administration is about 2 hours. About 85% of the administered dose of etching is excluded within 24 hours.
Clinical studies According to the use of ethimsisala in patients with impaired liver function and / or kidney has not been carried out.
Carefully
Thrombosis, thromboembolism in history; Bleeding against an overdose of anticoagulants.
Application during pregnancy and during lactation
There are no clinical data regarding the possibility of using the drug Ditinon in pregnant women. The use of ditinon during pregnancy is possible only if the estimated benefit for the mother exceeds the potential risk to the fetus.
When prescribing the drug during the lactation period, it should be resolved about the cessation of breastfeeding.
Interaction with other drugs
Pharmaceutically incompatible (in one syringe) with other drugs.
The solution for injections of dicinon is incompatible with a solution of sodium bicarbonate for injection and sodium solution of lactate. Introduction at a dose of 10 mg / kg 1 hour before dextrans (the average molecular weight of 30-40 thousand DA) prevents them from antiagregative.
Action: Introduction After not hemostatic action.
It is possible a combination with aminocaproic acid and Menadion sodium bisulfite.
Thiamine (vitamin B1) is inactivated by sodium sulfite, which is part of the drug dicinon.
Impact on the ability to concentrate attention
No special precautions are required.
Shelf life
5 years.
Do not apply after the expiration date.
Consumer claims to send
In Sandoz CJSC
123317, Moscow, Presnenskaya nab., D. 8, p. 1
Ditinon is a hemostatic preparation, a means to prevent and stop bleeding. The mechanism of action is due to the influence on the first stage of the hemostasis process (interaction between endothelium and platelets). Suppresses the splitting of the mucopolysaccharides of the vascular wall (antihialuronidase activity), and normalizes permeability in pathological processes. Ditinon acts hemostatically by increasing the rate of formation of primary thrombus.
The drug is prescribed for the prevention and control of hemorrhages in surface and internal capillaries of various etiologies, especially if the bleeding is due to the defeat of the endothelium.
After applying the standard dosage of ditinone tablets, the active substance is quickly absorbed from the tract and the maximum concentration is achieved by about 4 hours.
Important - ethalate penetrates breast milk and through a placental barrier.
Ditinon stimulates the formation of blood coagulation factor III, normalizes platelet adhesion. Does not affect the prothrombin time, does not have hypercoagulation properties and does not contribute to the formation of thrombov.
The angioprotective effect of ditinon is associated with the effect on the endothelium of capillaries and the basic substances of the inter-endothelial spaces. This angioprotective effect is manifested in the therapy of certain diseases associated with primary or secondary disorders of the microcirculation process.
In the early periods of pregnancy, the ditinon is prescribed in the absence of danger for the embryo, only in tablets and under the control of the doctor. In the second and third trimesters, it is used:
Indications for use in the general case
Features of use in gynecology:
Ditinon for stopping menstruation is a very strong and effective drug, but it should be used to stop abundant monthly, only as a last resort, and only after consulting with the doctor and the availability of direct testimony for reception.
In some situations, ditinon must be taken when bleeding caused by the use of intrauterine contraceptives - spirals. After removing the helix, bleeding stops using ditinon.
Tablets for adults:
The standard daily dosage ditinon is 10-20 mg / kg body weight, divided by 3-4 reception. In most cases, one-time dose is 250-500 mg 3-4 times / day.
In exceptional cases, one-time dose can be increased to 750 mg 3-4 times / day.
Ditinon with abundant menstruation is prescribed 2 tablets 250 mg three times a day in a meal straggment. The studio lasts up to 10 days, starting five days before the start of bleeding.
In the postoperative period, the drug is prescribed in a single dose of 250-500 mg every 6 hours until the risk of bleeding is disappeared.
Hemorrhagic syndrome: three times a day, 6-8 mg / kg, the duration of reception to two weeks, according to the testimony it is possible to repeat the course in a week.
How much to drink ditinon? Duration and how much time to drink pills should be prescribed by the doctor, standard treatment up to 10 days.
Tablets for children (over 6 years old):
Standard daily dosage Ditinon for children is 10-15 mg / kg in 3-4 reception. The duration of use depends on the complexity of blood loss and ranges from 3 to 14 days from the moment of stopping bleeding. Tablets should be taken during or after meals.
There are no studies to apply patient dicinone tablets with impaired liver or kidney function. In these groups of patients, it is necessary to use the drug with caution.
The optimal daily dosage is 10-20 mg / kg, divided by 3-4 V / m or in / in (slow) injections.
Diabetic microangiopathy (hemorrhagia): an injection of intramuscularly 0.25 grams 3 times a day, injections for 3 months.
In operational interventions are prophylactically introduced in / in or per / m 250-500 mg per 1 hour before the operation. During operation, 250-500 mg is introduced. After the end of the operation, 250-500 mg of ditinon is introduced every 6 hours before the risk of bleeding.
Ditinon - injections for children
The daily dose is 10-15 mg / kg body weight, divided by 3-4 injections.
In neonatology: ditinon is introduced in / m or in / in (slowly) in a dose of 12.5 mg / kg (0.1 ml \u003d 12.5 mg). Treatment should be started during the first 2 hours after birth.
It is contraindicated to the use of both tablets and injections of dicinion at:
C care to prescribe during bleeding on the background of an overdose of anticoagulants.
Such reactions to ditinon are transient and not important.
There are information that in children with acute lymph and myelolomicosis, osteosarcoma ethalate, used to prevent bleeding, caused severe leukopenia.
After injection in the area of \u200b\u200bthe injection, it may appear red and itching, very rarely observed swelling of Quinka, bronchial asthma is sharpened. In some severe cases, a person may have anaphylactic shock.
Analogs of ditinon on the principle of action:
Please note - instructions for use dice, price and reviews for analogs are not suitable. In any case, they cannot be used as a guide for the use and dosage of analogs! When searching than replacing the digest, a qualified physician is needed.
Active substance: ethanzila.
Each tablet contains 250 mg of etchilage.
Excipients: anhydrous lemon acid (E 330), corn starch, monohydrate lactose, povidone, magnesium stearate.
White or almost white, round, biconavid pills.
Hemostatic means. Vitamin K and other hemostaticities.
ATX: B02BX01 code.
Pharmacological properties
Pharmacodynamics
Ethalizila is a synthetic hemostatic and an angioprotective agent acting at the initial hemostasis stage (at the stage of interaction between endothelium and platelets). Due to the improvement of platelet adhesion and the restoration of capillary resistance, it reduces the bleeding time and blood loss.
Ethallate does not have a vasoconstrictor effect, does not affect fibrinolysis and plasma coagulation factors.
Pharmacokinetics
Suction
When taking inside the ethalate is slowly and completely absorbed from the gastrointestinal tract. Absolute bioavailability is not installed. After receiving 500 mg inside the maximum concentration in the blood plasma, equal to 15 μg / ml, is achieved in approximately 4 hours.
Distribution
Ethallate is well distributed in the tissues. Binding with plasma proteins is about 95%. Penetrates through a placental barrier. In the blood of mother and cord blood, similar levels of the drug are observed. Does ethalate in breast milk penetrates, is unknown.
Metabolism
Ethalate is metabolized only to a limited degree.
Election
The half-life of plasma is an average of 8 hours. Approximately 70-80% oral dose is derived from the body unchanged with urine within 24 hours. Lee pharmacokinetics of etching in patients with impaired kidney function and (or) liver is unknown.
Age
Information about the pharmacokinetics of the drug in children and elderly patients is absent.
In surgery
Prevention and treatment of pre-and postoperative capillary bleeding with all complex operations or operations on well-vascularized tissues: in otorinolaryngology, gynecology, obstetrics, urology, dentistry, ophthalmology or plastic and rehabilitation surgery.
In therapy
Prevention and treatment of capillary bleeding of any origin and localization: hematuria, bloody vomiting, melan, nasal bleeding, bleeding from gums.
In gynecology
Metrragia, primary menorragia or menorragia caused by intrauterine contraceptive means in the absence of organic pathology.
Increased sensitivity to the active or any auxiliary substance of the drug;
acute porphyria;
children's age up to 6 years (for this form of release).
If the drug is prescribed to reduce abundant and (or) long-term menstrual bleeding and the desired effect cannot be achieved, it is necessary to eliminate the presence of another pathology capable of causing such a state.
Children
The drug is suitable for applications in children in recommended doses.
Patients with renal failure
The safety and effectiveness of treatment with ethanzilate in patients with renal failure has not been studied. Since the ethalate is completely excreted by the kidneys, with renal failure, a dose reduction may be required.
Results of laboratory tests
Ethalitis adopted in therapeutic doses may affect the results of an enzymatic analysis of creatinine definition in the direction of decline in indicators.
To exclude any possible effect of the drug on laboratory indicators, before the first use of ditinon, initial analyzes are performed (eg, blood), which will be required during treatment.
The drug contains lactose. Patients with such a rare hereditary pathology such as the intolerance to galactose, lactase deficiency or glucose-galactose absorption, should not be taken by this drug.
Pregnancy and breastfeeding
Clinical data on the use of the drug is not enough for pregnant women.
Animal experiments did not reveal any direct or indirect toxicity affecting the reproductive function. As a precautionary measure, it is preferable to avoid the use of the drug during pregnancy.
Due to the lack of data on the ability of the drug to penetrate into breast milk, breastfeeding is not recommended during treatment. If breastfeeding continues, the drug should be discontinued.
Influence does not.
For receiving inside.
Adults and teenagers (over 14 years old)
Before surgery: 1-2 Tablets Ditinon 250 mg(250-500 mg) an hour before surgery.
After operation: 1-2 Tablets Ditinon 250 mg(250-500 mg) every 4-6 hours for the entire time, while the risk of bleeding is preserved.
In therapy: usually 2 tablets Ditinon 250 mg(500 mg) 2-3 times a day (1000-1500 mg) while eating, drinking with a small amount of liquid.
In gynecology at menometrorrhrigia: 2 tablets Ditinon 250 mg(500 mg) 3 times a day (1500 mg) during meals, drinking a small amount of liquid. Treatment starts 5 days before the expected time of the beginning of monthly bleeding and continue within 10 days.
Children (6. – 14 years)
Half dose for adults.
Patients with hepatic or renal failure
In patients with hepatic or renal failure, clinical trials were not conducted. Therefore, it is necessary to be careful when appointing such patients with dicinone tablets 250 mg.
Elderly patients
Dose correction is not required.
Drug Pass
If you missed the drug, take the usual dose as soon as remember this. Do not take the missed dose if the next reception time is suitable. Never double the dose to compensate for missed.
Depending on the frequency of the appearance and system of organs, side effects are classified in accordance with the MedDRA Convention as follows: Very frequent (≥ 1/10), frequent (≥ 1/100,
Violations from the gastrointestinal tract
Frequent: nausea, diarrhea, discomfort in the abdomen.
Disturbing from the skin and subcutaneous fabrics
Frequent: rash.
General disorders and disorders at the injection site
Frequent: asthenia.
Very rare: fever.
Nervous System Violations
Frequent: Headache.
Vessel violations
Very rare: thromboembolia.
Blood violations and lymphatic system
Very rare: agranulocytosis, neutropenia, thrombocytopenia.
Violations by skeletal and muscular and connective tissue
Rare: arthralgia (joint pain), back pain / lower back.
Impaired immune system
Very rare: hypersensitivity, anaphylactic shock.
Disturbance of metabolism and nutrition
Very rare: acute porphyria.
These side effects are usually reversible after the cessation of treatment.
Instruction
for the use of medicinal drug for medical use
Carefully read this instruction before start using this medication. Keep instructions, it may be necessary again. If you have any questions, consult a doctor.
This medicine is assigned to you personally, and it should not be transmitted to other persons, since it can harm them even if you have the same symptoms as yours.
ethanzila.
pills.
1 tablet contains: Active substance: Ethallate - 250.0 mg.
Excipients: anhydrous lemon acid 12.5 mg; Starch corn 65.0 mg; Pisidone K25 10.0 mg; magnesium stearate 2.0 mg; Lactose 60.5 mg.
Description
Round bobble pills of white or almost white.
Hemostatic.
ATX code: In02Vx01
Pharmacodynamics
Ethalizila is a hemostatic, anti-emoragic and angioprotective agent, normalizes the permeability of the vascular wall, improves microcirculation. Stimulates the formation of platelets and their outlet of the bone marrow. Increases the adhesion of platelets, stabilizes the walls of the capillaries, thus reducing their permeability, inhibits the synthesis of prostaglandins, causing platelet disaggregation, vasodilation and increase the permeability of capillaries, which reduces the time of bleeding and reduces bloodstures. Increases the rate of formation of the primary thrombus and enhances its retraction, practically does not affect the fibrinogen concentration in blood plasma and prothrombin time. With repeated use, the thrombosis is enhanced.
Ethalate practically does not affect the composition of peripheral blood, its proteins and lipoproteins. The rate of sedimentation of erythrocytes can slightly decrease. Reduces fluid yield and diapelling of blood shaped blood elements from the vascular bed, improves microcirculation. Does not have a vasoconstrictor action.
Having antihilanonidase activity and stabilizing ascorbic acid, prevents destruction and contributes to the formation of mucopolysaccharides with a large molecular weight in the wall of capillaries, increases the resistance of capillaries, reduces their "fragility", normalizes permeability in pathological processes. This angioprotective effect is manifested in the treatment of various diseases associated with primary and secondary violations of the microcirculation process.
Pharmacokinetics
After taking inside the drug quickly and almost completely absorbed.
The maximum plasma concentration after applying 500 mg is reached after 4 hours and is 15 μg / ml.
Almost completely penetrates through the placental barrier. It is not known whether the ethalate penetrates the maternal milk. About 95% of etching is associated with blood plasma proteins.
Ethallate is slightly exposed to metabolism.
The half-life after applying is about 3.7 hours.
About 72% of the drug is excreted in kidneys within 24 hours unchanged.
Clinical studies on the use of etchilage in patients with impaired liver function and / or kidney has not been carried out.
Prevention and treatment of capillary bleeding of various etiology:
before and after operational interventions on all well-vascularized tissues in the dental, otorinolaryngological, gynecological, obstetric, urological, ophthalmological practice, plastic and reconstructive surgery;
Hematuria, metroragia, primary menorriage, menorrhagia in women with intrauterine contraceptives (in the absence of organic pathology), nasal bleeding, bleeding gum, vomiting with blood, melen.
Increased sensitivity to the components of the drug.
Acute porphyria.
Hemoblastosis in children (lymphoblastic and myeloblastic leukemia, osteosarcoma).
Thromboembolism, thrombosis.
Rare hereditary forms of lactose intolerance, lactase deficiency or glucose / galactose absorption (because it contains lactose).
Children's age up to 3 years (for this dosage form).
Carefully
Thrombosis, thromboembolism in history; Bleeding against the background of an overdose of anticoagulants, violation of the function of the liver and kidney (there is no clinical experience of application).
There are no clinical data regarding the possibility of using the drug Ditinon in pregnant women. The use of ditinon during pregnancy is possible only if the estimated benefit for the mother exceeds the potential risk to the fetus.
There are no data regarding the allocation of ethimsisilacy with breast milk.
Therefore, when applying the drug during lactation, it should be resolved about the cessation of breastfeeding.
Inside.
The optimal daily dose of adults for adults is 10-20 mg / kg body weight per day, divided by 3-4 receptions. In most cases, one-time dose is 250-500 mg (1-2 tablets), if necessary, one-time dose can be increased to 750 mg (3 tablets).
Adults and teenagers (over 12 years old, weighing more than 40 kg)
In the preoperative period 250-500 mg (1-2 tablets) 1 hour before the operation.
In the postoperative period 250-500 mg (1-2 tablets) every 4-6 hours until the risk of bleeding is disappeared.
To stop bleeding 500 mg (2 tablets) every 8-12 hours (1000-1500 mg per day) with a meal or small amount of water.
In the treatment of metro- and menorgia 500 mg (2 tablets) 3 times a day (1500 mg per day) for 5-10 days.
Children from 3 to 12 years
Half dose for adults.
According to the World Health Organization (WHO), undesirable effects are classified in accordance with their development frequency as follows: often (\u003e 1/100,<1/10), нечасто (>1/1000, <1/100), редко (>1/10000, <1/1000) и очень редко (<1/10000), включая отдельные сообщения.
From the digestive system
often: Nausea, diarrhea, discomfort in the epigastric area.
From the side of the skin and subcutaneous fabrics
often: skin rash;
frequency unknown: Skin hyperemia.
From the nervous system
often: headache;
frequency unknown: Dizziness, paresthesia lower extremities.
From the cardiovascular system
rarely: thromboembolia;
frequency is not known: A pronounced decrease in blood pressure.
From the blood system and lymphatic system
rarely: Agranulocytosis, neutropenia, thrombocytopenia.
From the musculoskeletal system
seldom: arthralgia.
From the immune system
rarely: Allergic reactions.
Others
often: asthenia;
rarely: fever.
Available in the treatment of side effects are usually reversible when canceling the drug.
In the event of the development of skin reactions or fever, it is necessary to stop therapy and inform about this doctor, since this may be a manifestation of the reaction of hypersensitivity.
So far, no overdose cases are not described.
If an overdose occurred, it is necessary to start symptomatic therapy.
Interaction with other drugs
There is still no data on the interaction of etchilage with other drugs.
It is possible a combination with aminocaproic acid and Menadion sodium bisulfite.
Before starting treatment, other reasons for bleeding should be excluded.
The drug is not effective in patients with thrombocytopenia.
With hemorrhagic complications associated with the overdose of anticoagulants, it is recommended to use specific antidots.
The use of the drug ditinon in patients with disturbed indicators of the coagulation system of blood is possible, but it must be supplemented with the introduction of drugs that eliminate the identified deficit or defect of the coagulation system of blood.
Clinical studies on the use of the drug dicinon in patients with impaired liver and kidney function was not carried out, so caution should be taken when applying ethimizila in the category of patients.
Special precautions during the destruction of an unused drug is not required.
Impact on the ability to concentrate attention
No special precautions are required.
Tablets 250 mg, 10 tablets in a blister from aluminum / PVC / PVDX.
1, 2, 3, 5 or 10 blisters in a cardboard pack together with instructions for use.
Store at a temperature not higher than 25 ° C, in a dry place protected from light.
Keep out of the reach of children.
5 years.
Do not apply after the expiration date.
On prescription.
Lek dd,
Verovshkova 57, 1526 Ljubljana, Slovenia.
Consumer claims to send
CJSC Sandoz
123317, Moscow, Presnenskaya nab., D. 8, p. 1
Ditinon belongs to hemostatic drugs. The drug activates the formation of thromboplastin. I will consider the instructions for the use of this medication.
What is the ditinon composition and form of release?
The medicine is produced in round white color tablets, they are double-screwed, where the active substance is the ethalate in the amount of 250 mg. Auxiliary components: anhydrous citric acid, starch corn, added povidone K25, in addition, magnesium stearate, as well as lactose.
The pills are placed in blisters, they are cleaned into a countearting place from children, in light protected, as well as from moisture, where the temperature does not increase more than 25 degrees. The term of their shelf is equal to five years.
The next dosage form is a colorless solution, it is used by a parenteral method, in particular intravenously and intramuscularly. A active component is present with a medicine with a medicine with a medicine, its dosage can be 125 or 250 milligrams.
The auxiliary substances of the solution Ditinon: sodium disulfite, sodium hydrocarbonate, in addition, added water for injection. The tool is produced in ampoules two milliliters, a container of colorless glass, placed in blisters of ten pieces. You can buy medicine by recipe.
What does ditinon have an action?
The hemostatic drug dicinon increases the formation of mucopolysaccharides in capillaries and increases the stability of the walls of the vessels, normalizes their permeability, in addition, improves microcirculation. The medicine activates the formation of thromboplastin in the immediate place of damage.
The drug stimulates the formation of the desired blood coagulation factor III, in addition, normalizes platelet adhesion. It does not affect the so-called prothrombin time, does not contribute to the formation of thrombus.
After intravenous administration, the ditinon begins to act in five or fifteen minutes, while the maximum effect of the drug exposure is observed by about one hour, the duration of the medication reaches six hours.
After applying the tablet form, the dicinon drug is quite quickly absorbed from the digestive tract. The maximum concentration occurs four hours later. Active compound - ethalate penetrates breast milk and through a placental barrier.
What do ditinon testimony for use?
The drug is prescribed for the prevention and treatment of so-called capillary bleeding arising from the following reasons:
During operational intervention on the tissues and organs in otorinolaryngological practice, in dentistry, in addition, in gynecology, urology, ophthalmology, as well as in plastic surgery;
Under hematuria, metrragia (bleeding from the uterus), in the presence of nasal bleeding, in addition, when bleeding the gums;
The drug is effective in diabetic microangiopathy.
Ditinon is effective in intracranial hemorrhages diagnosed in newborns, as well as premature babies.
What is the contraindication ditinon to use?
Among the contraindications to the use of the drug, the following states can be noted:
The presence of thrombosis;
Hemoblastosis in children (osteosarcoma, leukemia);
Do not use drug during thromboembolism;
With increased sensitivity to some components of the medicine.
With caution, the hemostatic preparation is prescribed during bleeding developed against the background of an overdose of drugs from the anticoagulant group.
What are the ditinon use and dosage?
Tablets are usually prescribed at a dose of 10-20 mg / kg, while the dosage is divided into three, four receptions. In exceptional cases, one permanent dose can be 750 milligrams.
The solution is used intravenously or intramuscularly, it is prescribed in an amount of from 250 to 500 mg directly per hour before surgery. During, as well as after surgery, the introduction of the medication is repeated.
After mixing the ditinon with saline, it is recommended to be administered immediately, since during storage such a mixture quickly loses its medicinal qualities.
Overdose ditinone
Overdose data is not provided. If the pills are used in large numbers simultaneously, it is necessary to equip the stomach to be equipped and cause a doctor to render appropriate treatment.
What is the side effects at ditinon?
Ditinon's drug instructions using the drug reminds that it can cause the following side effects: paresthesia mainly in the lower limbs, the headache is joined, allergic reactions, heartburn, dizziness, decrease in blood pressure, nausea, occurs in the abdomen, especially it is felt in the epigastric area .
special instructions
Before starting therapy with a hemostatic drug, it is necessary to eliminate other causes of bleeding. It is worth noting that the tableted form of this medication includes lactose, therefore, the medication should not be used to patients with lactase deficiency or malabsorption syndrome.
With the appearance of dyeing of the drug solution and if there is a sediment in it, it should be discarded from its introduction. Parenteral forms of the drug are intended for use only in medical facilities.
What are the ditinon analogs?
Ethailate-Fereyn, ethalate, as well as a ethalate-agency belong to the analogues.
Conclusion
We have considered a means of dicinon (tablets, solution), instructions for the use of the drug. Use ditinon only after the recommendation of the attending physician.