Gemtranix
Gemtranix: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Hemtranix
ATX code: B02AA02
Active ingredient: tranexamic acid (Tranexamic acid)
Producer: CJSC "PharmFirma" Sotex "(Russia)
Description and photo update: 2019-11-07
Prices in pharmacies: from 552 rubles.
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Gemtranix is a hemostatic agent.
Release form and composition
Dosage form - solution for intravenous administration: colorless, transparent (in a cardboard box 5 or 10 ampoules of 5 ml each and instructions for use of Gemtranix).
Composition of 5 ml (1 ampoule) solution:
- active substance: tranexamic acid (in terms of dry matter) - 250 or 500 mg;
- excipient: water for injection - up to 5 ml.
Pharmacological properties
Pharmacodynamics
The active component of Gemtranix, tranexamic acid, is an antifibrinolytic substance that specifically inhibits the activation of plasminogen (profibrinolysin) and its conversion to plasmin (fibrinolysin). When bleeding associated with an increase in fibrinolysis, it has both local and systemic hemostatic effects. Studies have shown that tranexamic acid in high concentrations reduces complement activity.
Pharmacokinetics
After intravenous administration of Gemtranix, the peak plasma concentration is reached immediately, after which the concentration gradually decreases.
The connection of tranexamic acid with plasma proteins (plasminogen) is approximately 3%. The initial V d (volume of distribution) is about 9–12 liters.
The substance crosses the placental barrier. In pregnant women, the concentration of tranexamic acid in serum after intravenous injection of 10 mg / kg is 10–53 μg / ml, in umbilical cord blood - in the range of 4–31 μg / ml. In breast milk, the concentration of tranexamic acid is 1/100 of that observed in the blood and 1/10 of that of intraocular and cerebrospinal fluid.
Tranexamic acid penetrates quickly into the synovial membranes and articular fluid, and with a delay into the cerebrospinal fluid. After administration of Gemtranix at a dose of 10 mg / kg to patients who underwent knee surgery, the concentration in synovial fluids corresponded to that in serum samples. Tranexamic acid is found in semen, where it inhibits fibrinolytic activity, but the drug has no effect on sperm migration.
The excretion of tranexamic acid occurs unchanged in the urine by glomerular filtration. The total renal clearance is equal to the total plasma clearance (110-116 ml / min). In the first 24 hours, approximately 90% of the dose is eliminated. T 1/2 (half-life) - approximately 3 hours.
In renal failure, the plasma concentration of tranexamic acid increases.
Indications for use
Gemtranix is prescribed for the treatment and prevention of bleeding caused by local or generalized fibrinolysis, including:
- gastrointestinal bleeding;
- metrorrhagia and menorrhagia;
- bleeding after surgical interventions on the urinary tract and prostate gland;
- bleeding during surgical interventions in the cavity of the pharynx, mouth and nose (tonsillectomy, adenoidectomy, tooth extraction);
- obstetric and gynecological bleeding (including those arising during gynecological surgical interventions);
- bleeding during abdominal, thoracic and other extensive surgical interventions (including cardiac surgery);
- bleeding, the development of which is associated with therapy with fibrinolytic drugs.
Contraindications
Absolute:
- subarachnoid hemorrhage (associated with the risk of ischemia and cerebral infarction, cerebral edema);
- fibrinolysis associated with consumption coagulopathy (hypocoagulation stage of DIC syndrome);
- renal failure in severe chronic course (in patients with a glomerular filtration rate up to 30 mg / ml / 1.73 m 2, which is associated with the risk of cumulation);
- arterial or venous thrombosis, including a burdened history (pulmonary embolism, deep vein thrombosis of the legs, intracranial vascular thrombosis, etc.), in case of impossibility of simultaneous use with anticoagulants;
- acquired disorders of color vision;
- a history of convulsions;
- menorrhagia in patients under the age of 16;
- age up to 1 year;
- hypersensitivity to the components of the drug.
Relative (the use of Gemtranix requires caution):
- hematuria, which is associated with diseases of the renal parenchyma, bleeding from the upper urinary tract (due to the high likelihood of secondary mechanical obstruction of the urinary tract by a blood clot with the occurrence of anuria);
- DIC syndrome;
- the presence of a high risk of thrombosis (aggravated history of thromboembolic events or family history of thromboembolic diseases, confirmed diagnosis of thrombophilia);
- blood in cavities, including the presence in the pleural and articular cavities, urinary tract;
- combined therapy with a prothrombin complex (drugs of coagulation factors II, VII, IX and X in combination) or an anti-inhibitory coagulant complex;
- simultaneous use with combined oral contraceptives (associated with an increased risk of arterial thrombosis and venous thromboembolic complications);
- combination therapy with anticoagulants;
- pregnancy and the period of breastfeeding.
Gemtranix, instructions for use: method and dosage
The Gemtranix solution is administered intravenously by drop or jet slowly at a rate of 50 mg / min. Rapid intravenous administration should be avoided.
The recommended dosage regimen for adults (the drug is used from the onset of bleeding until it stops):
- gastrointestinal bleeding, metrorrhagia and menorrhagia: 2-3 times a day, 500 mg;
- bleeding after surgical interventions on the urinary tract and prostate gland: 3 times a day, 1000 mg;
- bleeding during surgical interventions in the oral cavity, pharynx and nose: every 6-8 hours at 10-15 mg / kg;
- obstetric-gynecological bleeding, bleeding during thoracic, abdominal and other major surgical interventions: every 6-8 hours, 15 mg / kg;
- bleeding caused by the use of fibrinolytic drugs: every 6-8 hours, 10 mg / kg;
- bleeding during cardiac surgery: before the start of surgery, after induction of anesthesia, a loading dose of 15 mg / kg is administered, then intravenous infusion is performed at a rate of 4.5 mg / kg / hour throughout the operation; tranexamic acid at a dose of 0.6 mg / kg is injected into a heart-lung machine.
If long-term hemostatic therapy is required (longer than 48 hours), the use of tranexamic acid tablets is recommended.
The experience of using the drug in children is limited. In children from 1 year old, the recommended daily dose of Gemtranix for the treatment of bleeding associated with generalized and local fibrinolysis is 20 mg / kg.
With mild and moderate impairment of renal excretory function, the dose and frequency of administration of the drug should be adjusted.
At a serum creatinine concentration in the blood of 120–249 μmol / l (1.36–2.82 mg / dl) and a glomerular filtration rate of 60–89 ml / min / 1.73m 2, Gemtranix solution is administered at a dose of 15 mg / kg 2 times per day, with the value of these indicators, respectively, 250-500 μmol / l (2.83-5.66 mg / dl) and 30-59 ml / min / 1.73m 2, the indicated dose is administered once a day.
Side effects
Against the background of the use of Gemtranix, the following undesirable effects may develop (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rarely; with unknown frequency - the available data do not allow to accurately estimate the frequency of the development of a side effect):
- skin and subcutaneous tissues: rarely - allergic skin reactions, including allergic dermatitis;
- immune system: very rarely - hypersensitivity reactions, including anaphylactic shock;
- digestive system: often - vomiting, nausea, diarrhea (when the dose is reduced, these disorders disappear);
- nervous system: rarely - convulsions, dizziness;
- sense organs: rarely - visual impairment, including retinal vascular thrombosis, impaired color perception;
- cardiovascular system: rarely - a pronounced decrease in blood pressure (most often due to an excess of the rate of drug administration), thromboembolic complications; very rarely - arterial / venous thrombosis of different localization; with an unknown frequency - thrombosis of the central artery and retinal vein, acute myocardial infarction, thrombosis of the carotid or cerebral arteries, stroke, pulmonary embolism, deep vein thrombosis of the legs, occlusion of coronary artery bypass graft, renal artery thrombosis with the development of cortical necrosis and acute renal failure.
Overdose
Information about an overdose of Gemtranix is limited. There is information about one case of oral administration of tranexamic acid at a dose of 37,000 mg.
The main symptoms: orthostatic arterial hypotension, headache, dizziness, dyspepsia (in the form of vomiting, nausea, diarrhea), orthostatic symptoms (including dizziness that occurs when moving from a horizontal position to a vertical one). If there is a predisposition, the risk of thrombosis increases.
If an overdose is suspected, hospitalization is required. The antidote is unknown. It is necessary to induce vomiting, then gastric lavage is performed. During the first 1-2 hours, the intake of activated carbon is shown. If the patient is unconscious, or in cases of swallowing problems, activated charcoal can be administered through a nasogastric tube. Parenteral or oral administration of large amounts of fluid, forced diuresis is recommended. In some patients, the use of anticoagulants is justified.
special instructions
In hematuria associated with diseases of the renal parenchyma, Gemtranix should be used with caution, since intravascular deposition of fibrin is often noted, which can lead to aggravation of kidney damage. Also, the use of the drug in case of massive bleeding from the upper urinary tract of any etiology increases the likelihood of blood clots in the ureter and / or renal pelvis and, accordingly, the occurrence of secondary mechanical obstruction of the urinary tract and anuria.
Before using the drug and during treatment, it is required to consult an ophthalmologist (to determine visual acuity, color vision, fundus condition). In cases of visual impairment during the period of therapy, Gemtranix is canceled.
During clinical trials, a significant increase in the incidence of thrombosis was not revealed, however, the likelihood of thrombotic complications is not completely excluded. In patients treated with tranexamic acid, cases of venous and arterial thrombosis and thromboembolism have been described. There have also been reports of cases of central retinal vein / artery occlusion. Several patients developed intracranial thrombosis. Accordingly, if there is a high risk of thrombosis, Gemtranix should be used only when absolutely necessary and under the strict supervision of a physician. Before using the drug, an examination should be carried out in order to identify risk factors for thromboembolic complications.
In the presence of blood cavities in them, an insoluble clot may form in them (associated with extravascular blood coagulation), which can be resistant to physiological fibrinolysis.
Women with dysmenorrhea should not be prescribed the drug until the cause is established. If, against the background of the use of Gemtranix, the volume of menstrual bleeding is inadequately reduced, alternative therapy should be considered.
In patients with disseminated intravascular coagulation, tranexamic acid should be used under the close supervision of a physician experienced in the treatment of this disease. For such patients, Gemtranix is prescribed only if there are symptoms of a predominance of activation of the fibrinolytic system in combination with acute severe bleeding. In general, this group of patients is characterized by the following hematological data:
- prolongation of prothrombin time;
- shortening of the lysis period of the euglobulin clot;
- a decrease in the plasma concentration of fibrinogen, plasminogen and its activators, factors V and VIII, α-2 macroglobulin;
- normal plasma concentrations of factors II, VIII and X;
- normal platelet count;
- an increase in the plasma concentration of fibrin degradation products.
It is assumed that the underlying disease does not modify individual indicators of the hematological profile. To stop bleeding in such acute cases, a single injection of 1000 mg of Gemtranix is sufficient. The use of the drug is possible only after obtaining the relevant data of laboratory examination and expert examination of this information.
Influence on the ability to drive vehicles and complex mechanisms
During the period of Gemtranix's use, dizziness and visual impairment may develop, therefore, care must be taken when driving vehicles.
Application during pregnancy and lactation
Gemtranix during pregnancy can be used only in cases of extreme necessity. When conducting preclinical studies, it was found that tranexamic acid has no teratogenic effect. There have been no strictly controlled and adequate studies of the safety profile of tranexamic acid preparations in pregnant women. The substance crosses the placenta and may be contained in the umbilical cord blood in concentrations close to maternal.
The drug passes into breast milk. It is assumed that the occurrence of an antifibrinolytic effect in infants is unlikely. However, when using Gemtranix during lactation, care must be taken.
Pediatric use
Due to the lack of experience of use, Gemtranix is not prescribed for patients under 1 year old.
The safety and efficacy of Gemtranix in the treatment of menorrhagia in patients under the age of 16 has not been established.
With impaired renal function
Application Gemtraniksa in severe chronic renal failure (in patients with glomerular filtration rate of less than 30 mg / ml / 1,73m 2) is contraindicated.
Drug interactions
Special clinical studies aimed at studying the interaction of tranexamic acid and other drugs have not been conducted. It was found that tranexamic acid interferes with the pharmacological action of thrombolytic (fibrinolytic) drugs.
Other possible interactions:
- combined oral contraceptives: against the background of combined use, the likelihood of arterial thrombosis and venous thromboembolic complications (including ischemic stroke and myocardial infarction) increases. There is no experience with Gemtranix and combined oral contraceptives;
- hydrochlorothiazide, desmopressin, ranitidine, ampicillin-sulbactam, nitroglycerin: the risk of thrombotic complications may increase (including the development of myocardial infarction);
- preparations of blood coagulation factors II, VII, IX and X in combination (prothrombin complex) or anti-inhibitory coagulant complex: against the background of combined use, the risk of thrombosis increases;
- anticoagulants: combined use should be carried out under strict medical supervision;
- hemostatic agents: activation of thrombus formation may be noted.
Gemtranix is pharmaceutically compatible with unfractionated heparin and most infusion solutions (Ringer's solution, 0.9% sodium chloride solution, 5% dextrose solution, dextrans), incompatible with norepinephrine, urokinase, dipyridamole and diazepam.
Gemtranix should not be mixed with blood products and antibiotics (penicillins, tetracyclines).
Analogs
Analogs of Gemtranix are: Stagemin, Trameston, Tranexamic acid, Traxara, Tranexam, Troxaminat, Tranexolon, Transamcha, Exacil, Cyclohemal, etc.
Terms and conditions of storage
Store at temperatures up to 25 ° C, do not freeze. Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Gemranix
Reviews of Gemtranix are few, since the drug is usually used in a hospital setting and is rarely found in pharmacies.
Price for Gemtranix in pharmacies
The approximate price for Gemtranix (50 mg / ml, 10 ampoules of 5 ml each) is 1,060 rubles.
Gemtranix: prices in online pharmacies
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Drug name Price Pharmacy |
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Gemtranix 50 mg / ml solution for intravenous administration 5 ml 10 pcs. 552 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
