Tranexam tab n / 250mg film about 30 pc

Description

Composition
Active substance:
Tranexamic acid 250 mg.
Excipients:
Microcrystalline cellulose, giproloza, sodium carboxymethyl starch, talc, colloidal silicon dioxide, calcium stearate. sheath: hypromellose, titanium dioxide, talc, macrogol.
Description:
Biconvex tablets coated membrane sheath white, oblong shape. The cross section – white or white with Valium or grayish color.
Product form:
Tablets, film-coated 250 mg. 10 tablets in blisters of PVC film and aluminum foil printed patent. 3, the contour of cellular packaging together with instructions for use placed in a pile of cardboard.
Contraindications
Hypersensitivity to the drug, subarachnoid hemorrhage.
Dosage
250 mg
Indications
Bleeding or risk of bleeding in the background:
strengthen local fibrinolysis (uterine, including the background of von Willebrand disease and other bleeding disorders, nasal, gastrointestinal bleeding, hematuria, bleeding after prostatectomy, conization for cancer, tooth extraction in patients with hemorrhagic diathesis); amplification generalized fibrinolysis (malignant neoplasm of pancreas and prostate gland, surgery on thoracic organs, postpartum bleeding, manual removal of placenta, leukemia, liver disease).
Bleeding during pregnancy.
Hereditary angioneurotic edema, allergic diseases (eczema, allergic dermatitis, urticaria, toxic and drug eruption).
Inflammatory diseases (tonsillitis, pharyngitis, laryngitis, stomatitis, aphthae oral mucosa).
Interaction with other drugs
In combination with the use of hemostatic agents and gemokoagulazoy possible activation of thrombogenesis.
Overdose
There are limited data on cases of overdosing. One case of an overdose (ingestion of 37 g of tranexamic acid).
Symptoms: dizziness, headache, nausea, vomiting, orthostatic symptoms (including, dizziness during the transition from a horizontal to a vertical position..), Orthostatic hypotension. In predisposed patients increases the risk of thrombosis.
Treatment: Antidote is unknown. In case of suspected overdose tranexamic acid required hospitalization. In assisting, induce vomiting, then to gastric lavage. Activated charcoal reduces the absorption of tranexamic acid when administered during the first 1-2 hours after the overdose. If the patient is unconscious, or in violation of swallowing activated charcoal can be administered through a nasogastric tube. Recommended ingestion or parenteral administration of large amounts of fluid to enhance renal excretion, diuresis, control of the amount of urine. In some cases it may be appropriate use of anticoagulants.
pharmachologic effect
Pharmacological group:
Hemostat.
Pharmacological properties:
Antifibrinolytic agent. Tranexamic acid specifically inhibits activation of plasminogen (plasminogen) and its transformation into a fibrinolysin (plasmin). Has local and systemic hemostatic effect when bleedings associated with increased fibrinolysis (pathology platelets, menorrhagia). Also tranexamic acid by suppressing the formation of kinins and other active peptides involved in allergic and inflammatory reactions, have anti-allergic and anti-inflammatory action.
Pharmacodynamics:
Antifibrinolytic agent. Tranexamic acid specifically inhibits activation of plasminogen (plasminogen) and its transformation into a fibrinolysin (plasmin). Has local and systemic hemostatic effect when bleedings associated with increased fibrinolysis (pathology platelets, menorrhagia). Also tranexamic acid by suppressing the formation of kinins and other active peptides involved in allergic and inflammatory reactions, have anti-allergic and anti-inflammatory action.
Pharmacokinetics:
Absorption after oral administration of doses in the range 0.5-2 g – 30-50%. Time of onset of the maximum concentration when administered 0.5, 1 and 2 g – 3h, the maximum concentration – 5, 8, and 15 micrograms / ml, respectively. Communication with plasma proteins (plasminogen) – less than 3%.
Distributed in tissues relatively uniformly (with an exception – the cerebrospinal fluid, where the concentration is 1/10 of the plasma); It crosses the placental barrier, the breast milk (about 1% of the concentration in maternal plasma). It is found in the seminal fluid, which reduces the fibrinolytic activity, but has no effect on sperm migration. The initial volume of distribution – 9-12 liters. Antifibrinolytic concentration in various tissues preserved 17 hours in plasma – up to 7-8 hours.
A small portion is metabolized. area under the curve is a curve shape with a three-phase half-life in the terminal phase – 3 h total renal clearance is the plasma (7 l / h).. Excreted by the kidneys (core path – glomerular filtration) – greater than 95% unchanged during the first 12 hours.
Identification tranexamic acid metabolite 2: N-acetylated and deaminated derivative. When impaired renal function there is a risk of cumulation tranexamic acid.
Pregnancy and breast-feeding
In preclinical studies, tranexamic acid has no teratogenic effects. Adequate and strictly controlled study efficacy and safety of drugs tranexamic acid in pregnant women were not conducted. Tranexamic acid crosses the placenta and umbilical may be present in blood in a concentration close to that of the parent.
Since the reproductive function studies in animals are not always predictive of responses in human, tranexamic acid should be used during pregnancy only if absolutely necessary.
Tranexamic acid penetrates into breast milk (concentration of the drug in human milk is about 1% of the concentration in the mother’s plasma). The development of anti-fibrinolytic effect of the infant is unlikely. Nevertheless, caution should be exercised in the application of tranexamic acid in nursing mothers.
Conditions of supply of pharmacies
On prescription.
side effects
Before the drug could experience nausea, vomiting, heartburn, diarrhea, rash, itching, loss of appetite, drowsiness, dizziness. There may be a violation of color; rarely – thrombosis, thromboembolism.
special instructions
Before and during treatment is necessary to conduct the inspection ophthalmologist for visual acuity, color vision, the state of the fundus.
Animal studies revealed no teratogenic and embryotoxic action.
The ability of tranexamic acid influence the speed and psychomotor reactions on the ability to transport or other mechanical means not investigated. Tranexamic acid can cause dizziness and blurred vision, and, accordingly, may affect the ability to engage in potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
At a temperature of not higher than 30 ° C. Keep out of the reach of children.
Dosing and Administration
Inside.
When administered by local fibrinolysis 1000 – 1500 mg 2-3 times a day.
When profuse uterine bleeding appoint 1000 – 1500 mg 3-4 times a day for 3-4 days.
When bleeding occurs in the background of von Willebrand disease and other bleeding disorders 1000-1500 mg 3-4 times a day. Duration of treatment – 3-10 days.
After surgery, conization of 1500 mg administered three times a day for 12-14 days.
When administered by nasal bleedings 1000 mg 3 times daily for 7 days. Patients with coagulopathy after tooth extraction appoint 1000-1500 mg 3-4 times a day for 6-8 days.
If bleeding during pregnancy is 250-500 mg 3-4 times a day until it stops bleeding. The average duration of treatment – 7 days. In hereditary angioedema appoint 1000-1500 mg 2-3 times a day, continuously or intermittently, depending on the presence of prodromal symptoms. When symptoms of allergy and inflammation of 1000-1500 mg 2-3 times a day for 3-9 days, depending on the severity of the condition.
When generalized fibrinolysis therapy begins to parenteral (intravenous) administration Traneksama followed by oral intake of 1000 – 1500 mg 2-3 times a day.
In case of violation of renal excretory function requires correction dosing regime: the creatinine concentration in blood 120-250 pmol / l, 1000 mg administered two times a day; creatinine at a concentration of 250 – 500 pmol / l, 1000 mg administered one time a day; when creatinine concentration of greater than 500 pmol / l administered at 500 mg 1 time per day.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist