Tranexam, 50 mg/ml 5 ml 10 pcs

Name: Tranexam, 50 mg/ml 5 ml 10 pcs
SKU: 234902
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EAN: 4601026307461 SKU: 234902 Categories: Blood Diseases, Hemostatic, Medicine

Description

Tranexamic has a hemostatic, anti-inflammatory, anti-allergic effect.

Tranexamic acid is an antifibrinolytic agent specifically inhibiting the activation of profibrinolysin (plasminogen) and its conversion into fibrinolysin (plasmin).

It has local and systemic hemostatic action in bleeding associated with increased fibrinolysis as well as anti-inflammatory, anti-allergic, anti-infective and

anti-tumor action due to suppression of formation of kinins and other active peptides involved in allergic and inflammatory reactions.

The intrinsic analgesic activity of tranexamic acid was confirmed in the experiment, as well as the supersumptive andotensive effect with respect to the analgesic activity of opiates.

Pharmacokinetics

The distribution in tissues is relatively uniform (exception is cerebrospinal fluid, where the concentration is 1/10 of the plasma concentration); penetrates through the placental and blood-brain barrier, into breast milk (about 1% of the concentration in maternal plasma).

Detected in seminal fluid, where it reduces fibrinolytic activity, but does not affect sperm migration. The initial volume of distribution is 9-12 liters.

The binding to plasma proteins (profibrinolysin) is less than 3%. In the blood about 3% is bound to protein (plasminogen).

The concentration in cerebrospinal fluid is 1/10 of plasma. Total renal clearance is equal to plasma clearance. Antifibrinolytic concentration in various tissues persists for 17 hours, in plasma – up to 7-8 hours.

A small part is metabolized. The concentration-time curve has a three-phase shape with a half-life of -2 hours in the terminal phase. Total renal clearance is equal to plasma clearance (7 l/h).

Extracted by the kidneys (main route – glomerular filtration) – more than 95% unchanged in the first 12 hours.

Two metabolites of tranexamic acid have been identified: N-acetylated and deaminated derivatives. There is a risk of cumulation of tranexamic acid in impaired renal function.

Indications

Nasal bleeding, BleedingProphylaxis and treatment of bleeding due to generalized or localized fibrinolysis in adults and children 1 year and older, including: Menorrhagia and metrorrhagia; gastrointestinal bleeding; bleeding after prostate and urinary tract surgery; bleeding during surgical interventions in the nose, mouth and pharynx (adenoidectomy, tonsillectomy, tooth extraction); bleeding during thoracic, abdominal and other extensive surgical interventions (including. bleeding (including during cardiac surgery); obstetric and gynecological bleeding (including bleeding during gynecological surgical interventions); bleeding caused by the use of fibrinolytic drugs.

Active ingredient

Tranexamic acid

Composition

1 liter of solution for intravenous administration contains

Active substance:

Tranexamic acid 50 g;

Auxiliary substances:

Water for injection – up to 1 liter

How to take, the dosage
How to take, the dosage
“
Intravenously by drip or stream slowly; infusion rate 1 ml/min (50 mg/min). Rapid intravenous administration should be avoided!
Adult patients:
Menorrhagia and metrorrhagia, gastrointestinal bleeding: 500 mg (2 ampoules of 5 ml) 2-3 times a day from the time the bleeding develops until it stops.
Treatment of bleeding after prostate and urinary tract surgery: 1000 mg (4 ampoules of 5 ml) 3 times daily from development of bleeding until it stops.
Prevent and treat bleeding during surgical interventions in the nose, mouth and pharynx: 10-15 mg/kg body weight every 6-8 hours until bleeding stops.
Prevention and treatment of bleeding during thoracic, abdominal and other major surgical interventions: 15 mg/kg body weight every 6-8 hours until bleeding stops.
Prevention and treatment of bleeding during cardiac surgery: Load dose of 15 mg/kg after induction of anesthesia before the start of surgery, followed by intravenous infusion at 4.5 mg/kg/hr throughout surgery; tranexamic acid at a dose of 0.6 mg/kg in the ventilator is recommended.
Treatment of obstetrical and gynecological bleeding (including bleeding during gynecological surgical procedures): 15 mg/kg body weight every 6-8 hours from the onset of bleeding until it stops.
Treatment of bleeding caused by the use of fibrinolytic drugs: 10 mg/kg body weight every 6-8 hours from the onset of bleeding until it stops.
If prolonged (more than 48 hours) hemostatic therapy is necessary, the use of tranexamic acid preparations in tablet form is recommended.
Children over 1 year
The experience with tranexamic acid preparations in children is limited. The recommended dose of the drug in the treatment of bleeding due to local and generalized fibrinolysis is 20 mg/kg/day.
The use of the drug in special patient groups
Kidney function impairment
In patients with mild to moderate impaired renal excretory function, adjustment of the dose and frequency of tranexamic acid is necessary:
Serum creatinine concentration
Globular Filtration Rate (GFR)
Dose of tranexamic acid
Rate of administration
120-249 μmol/L
(1.36-2.82 mg/dL)
60-89 ml/min/1.73m2
15 mg/kg body weight
2 times a day
250-500 μmol/L
(2.83-5.66 mg/dL)
30-59 ml/min/1.73m2
15 mg/kg body weight
1 time per day
Interaction
Interaction
Pharmaceutically incompatible with blood products, solutions containing penicillin, urokinase, hypertensive agents (norepinephrine deoxyepinephrine hydrochloride, metarmine bitartrate), tetracyclines dipyridamole, diazepam.
Hemostatic drugs, hemocoagulase potentiate the activation of thrombosis.
Special Instructions
Special Instructions
Before and during treatment with tranexamic acid it is necessary to consult an ophthalmologist (determination of visual acuity, color vision, fundus condition). If there are visual disturbances during treatment with tranexamic acid, the drug should be discontinued. Tranexamic acid preparations should be used with caution in hematuria caused by kidney parenchyma diseases, because in these conditions there is often intravascular deposition of fibrin, which may aggravate kidney damage. In addition, in cases of massive bleeding of any etiology from the upper urinary tract, antifibrinolytic therapy increases the risk of blood clot formation in the renal pelvis and/or ureter and, accordingly, secondary mechanical obstruction of the urinary tract and development of anuria. Although the clinical studies have not revealed a significant increase in the incidence of thrombosis, but the risk of thrombotic complications can not be completely excluded. Cases of venous and arterial thrombosis and thromboembolism have been described in patients receiving tranexamic acid. In addition, cases of central retinal artery occlusion and central retinal vein occlusion have been reported. Several patients developed intracranial thrombosis during treatment with tranexamic acid. Accordingly, in patients with a high risk of thrombosis (history of thromboembolic complications, cases of thromboembolism in relatives, verified diagnosis of thrombophilia) tranexamic acid should be used only if absolutely necessary and under strict medical supervision. Before the use of tranexamic acid, an examination aimed at identifying risk factors of thromboembolic complications should be performed. The presence of blood in cavities such as the pleural cavity, joint cavities and urinary tract (including the renal pelvis and bladder) may lead to the formation of an “insoluble clot” due to extravascular clotting, which may be resistant to physiological fibrinolysis. Patients with irregular menstrual bleeding should not be prescribed tranexamic acid until the cause of dysmenorrhea is established. If menstrual bleeding volume is inadequately reduced during tranexamic acid treatment, alternative treatment should be considered. The efficacy and safety of tranexamic acid in the treatment of menorrhagia in patients under 16 years of age have not been established. Caution should be exercised when using tranexamic acid in women simultaneously taking combined oral contraceptives due to an increased risk of thrombosis (See section “Interaction with other medicinal products”). In patients with DICH who require treatment with tranexamic acid, therapy should be carried out under the close supervision of a physician experienced in the treatment of this disease. Due to the lack of adequate clinical studies, concomitant use of tranexamic acid with anticoagulants should be carried out under the close supervision of a specialist experienced in the treatment of blood clotting disorders. If during the use of tranexamic acid visual impairment is observed, it is necessary to stop taking the drug and consult a physician.
Contraindications
Contraindications
Hypersensitivity to tranexamic acid or other drug components; Severe chronic renal failure (glomerular filtration rate [GFR] less than 30 mg/mL/1.73m2) due to the risk of cumulation; Venous or arterial thrombosis at present or in the history (deep leg thrombosis, pulmonary thromboembolism, intracranial thrombosis, etc.).Fibrinolysis due to consumption coagulopathy (hypocoagulable stage of disseminated intravascular coagulation syndrome [DIC]); Convulsions in the history; Acquired color vision disorder; Subarachnoid hemorrhage (due to the risk of cerebral edema, ischemia and cerebral infarction); Treatment of menorrhagia in patients under the age of 16 years (no experience of use); Childhood under 1 year (no experience of use).
Side effects
Side effects
The incidence of adverse drug reactions is determined according to the WHO classification: very common (≥1/10), common (≥1/100, 1/10), infrequent (≥1/1000, 1/100), rare (≥1/10000, 1/1000), very rare (1/10000), incidence unknown (cannot be determined from available data). Gastrointestinal disorders: common – nausea, vomiting, diarrhea (symptoms disappear with dose reduction). Skin and subcutaneous tissue disorders: rare – skin allergic reactions, including allergic dermatitis. Visual disorders: rare – visual disturbances, including color perception disorders, retinal vascular thrombosis. Vascular disorders: rare – thromboembolic complications, marked BP reduction (usually due to excessively rapid intravenous administration); very rare – arterial and venous thrombosis of various localizations; frequency unknown – acute myocardial infarction, cerebral artery thrombosis, carotid artery thrombosis, stroke, deep vein thrombosis in legs, pulmonary embolism, renal artery thrombosis with development of cortical necrosis and acute renal failure, aortocoronary shunt occlusion, central artery and retinal vein thrombosis. Immune system disorders: very rare – hypersensitivity reactions, including anaphylactic shock. Nervous system disorders: rarely – dizziness, seizures.
Pregnancy use
Pregnancy use
In preclinical studies tranexamic acid had no teratogenic effects. Adequate and strictly controlled studies of efficacy and safety of tranexamic acid in pregnant women have not been conducted. Tranexamic acid penetrates the placenta and may be present in umbilical cord blood at concentrations close to maternal concentration. Because reproductive studies in animals do not always predict reactions in humans, tranexamic acid should only be used during pregnancy if absolutely necessary. Tranexamic acid penetrates into breast milk (concentration of the drug in milk is about 1% of the concentration in maternal plasma). Development of antifibrinolytic effect in the infant is unlikely. Nevertheless, caution should be exercised when using tranexamic acid in nursing mothers.
Similarities
Similarities
Cyclogemal
Additional information
Weight 0.110 kg
Shelf life
5 years. Do not use after the expiration date printed on the package.
Conditions of storage
At a temperature not exceeding 25 ° C. Keep out of reach of children.
Manufacturer
Moscow Endocrine Plant, Russia
Medication form
solution
Brand
Moscow Endocrine Plant