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  • Hexakapron Tablets
    / Teva


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    20 X 500 mg

    full basket chart 975 8038

    Dosage

    Doses should be reduced in renal impairment.
    Adults: The recommended standard dosage is 2-3 tablets, 2-3 times daily. For the indications listed below, specific recommendations are made as follows: (please refer also to the Physicians’ Prescribing Information for Hexakapron injection).
    Prostatectomy: Following I.V. administration (refer to the Physicians’ Prescribing Information for the injection), 2-3 Hexakapron tablets, 2-3 times daily, until macroscopic hematuria is no longer present.
    Dental Surgery: Factor VIII or IX concentrates and Hexakapron 10 mg/kg body weight should be administered intravenously immediately before surgery. Following surgery, 25 mg/kg body weight should be administered orally, 3-4 times daily, for 6-8 days. As a rule, it is not necessary to administer factor VIII or IX concentrates following surgery.
    Epistaxis: Hexakapron injection may be applied topically to the nasal mucosa, either using a spray or by soaking a gauze strip in the solution and then packing the nasal cavity.
    Hematuria: 2-3 tablets, 2-3 times daily, until macroscopic hematuria is no longer present.
    Menorrhagia: 2-3 tablets, 3-4 times daily, for 3-4 days. Hexakapron therapy should be initiated only after heavy bleeding has started. Use of the drug should be restricted to not more than 3 menstrual cycles.
    Hereditary Angioneurotic Edema: Some patients are aware of the onset of the illness. A suitable treatment for these patients is 2-3 tablets, intermittently, 2-3 times daily for several days. Other patients are treated continuously at this dosage.
    Children: Dosage should be calculated according to body weight, as 25 mg/kg orally.
    For full details see prescribing information.


    Indications

    General fibrin, prior to and following dental surgery in hemophiliacs, epistaxis, conization of cervix.


    Contra-Indications

    Known hypersensitivity to tranexamic acid or to any other ingredient of the preparation. Patients with active thromboembolic disease such as deep vein thrombosis, pulmonary embolism, and cerebral thrombosis. History of venous or arterial thrombosis.  Fibrinolytic conditions following consumption coagulopathy.  Patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients. Patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity,  History of convulsions. Severe renal impairment because of risk of accumulation.
    For full details see prescribing information.


    Special Precautions

    NOTE: The dose of tranexamic acid should be reduced in patients with renal impairment because of the risk of accumulation. Isolated cases of obstruction of the urinary tract due to blood clots have been observed when tranexamic acid has been used to treat severe bleeding from the upper urinary tract. Tranexamic acid therapy is not indicated in haematuria caused by diseases of the renal parenchyma. Intravascular precipitation of fibrin frequently occurs in these conditions and may aggravate the disease. In addition, in cases of massive renal haemorrhage of any cause, antifibrinolytic therapy carries the risk of clot retention in the renal pelvis. Although clinical evidence shows no significant increase in thrombosis, possible risk of thrombotic complications cannot be ruled out. Venous and arterial thrombosis or thromboembolism has been reported in patients treated with tranexamic acid. In addition, cases of central retinal artery and central retinal vein obstruction have been reported. A few patients have developed intracranial thrombosis with tranexamic acid but further observation is needed to assess the significance of this potential hazard. There are no data on the use of tranexamic acid in women taking oral contraceptive agents. Patients with a high risk for thrombosis (a previous thromboembolic event and a family history of thromboembolic disease) should use tranexamic acid only if there is a strong medical indication and under strict medical supervision. Tranexamic acid should not be administered concomitantly with Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased. Blood in body cavities such as pleural space, joint spaces and urinary tract (e.g. renal pelvis, bladder) may develop ‘indissoluble clots’ in these cavities due to extravascular blood clots which may be resistant to physiological fibrinolysis. Patients with irregular menstrual bleeding should not use tranexamic acid until the cause of the irregularity has been established. If menstrual bleeding is not adequately reduced by tranexamic acid an alternative treatment should be considered. Patients with disseminated intravascular coagulation (DIC) who require treatment with tranexamic acid must be under the strict supervision of a physician experienced in treating this disorder. Focal areas of retinal degeneration have developed in cats, dogs and rats following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (6 to 40 times the recommended usual human dose) from 6 days to 1 year. The incidence of such lesions has varied from 25% to 100% of animals treated and was dose related. At lower doses some lesions have appeared to be reversible. Limited data in cats and rabbits showed retinal changes in some animals with doses as low as 126 mg/kg/day (only about 3 times the recommended human dose) administered for several days to two weeks. No retinal changes have been reported or noted in eye examinations in patients treated with tranexamic acid for weeks to months in clinical trials. However, visual abnormalities, often poorly characterized, represent the most frequently reported postmarketing adverse reaction in Sweden. For patients who are to be treated continually for longer than several days, an ophthalmological examination, including visual acuity, color vision, eye-ground and visual fields is advised, before commencing and at regular intervals during the course of treatment. Tranexamic acid should be discontinued if changes in examination results are found. Patients who experience visual disturbance should be withdrawn from treatment.
    Use in Pregnancy: Safety of use of tranexamic acid in pregnancy has not been established. Drugs which have been taken by only a limited number or pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Reproduction studies performed in mice, rats and rabbits have not revealed any evidence of impaired fertility or adverse effects on the foetus due to tranexamic acid. The long-term clinical experience is limited to 21 pregnant women, treated for 1 to 18 weeks, in most cases to prevent further haemorrhage in connection with ablatio placentae. All women delivered alive and normal children except for prematurity. The short-term experience comprises 67 women with abruptio placentae treated with a single dose just before delivery by caesarean section. All deliveries went well and were not further complicated by haemorrhage. There are no adequate and well-controlled studies in pregnant women. However, tranexamic acid is known to cross the placenta and appears in cord blood at concentrations approximately equal to maternal concentration. Because animal reproduction studies are not always predictive of human response, tranexamic acid should be used during pregnancy only if clearly needed.
    Use in Breastfeeding: Tranexamic acid is secreted into the mother’s milk at a concentration of about one hundredth of the corresponding serum level. Therefore, caution should be exercised when administered to nursing mothers.
    Caution should be exercised in patients with hepatic, cardiac or renal insufficiency, and in massive hematuria from the upper urinary tract. Caution should also be exercised in patients exhibiting a thrombotic tendency, even if an anticoagulant is administered simultaneously. Treatment should be discontinued if disturbances in color vision arise. Tranexamic acid should be withdrawn if the patient develops muscle pain or weakness. Caution should be exercised in patients who have undergone transurethral prostatectomy since intravascular clotting may occur, following pre- and postoperative tranexamic acid therapy to reduce blood loss.
    For full details see prescribing information.


    Side Effects

    Nausea, vomiting, diarrhea, giddiness, hypotension when intravenous injection is too rapid.
    For full details see prescribing information.


    Drug interactions

    Clinically important interactions have not been observed with tranexamic acid tablets. Because of the absence of interaction studies, simultaneous treatment with anticoagulants must take place under the strict supervision of a physician experienced in this field.


    Pregnancy and Lactation

    Pregnancy: Safety of use of tranexamic acid in pregnancy has not been established. Drugs which have been taken by only a limited number or pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed.
    Reproduction studies performed in mice, rats and rabbits have not revealed any evidence of impaired fertility or adverse effects on the foetus due to tranexamic acid. The long-term clinical experience is limited to 21 pregnant women, treated for 1 to 18 weeks, in most cases to prevent further haemorrhage in connection with ablatio placentae. All women delivered alive and normal children except for prematurity. The short-term experience comprises 67 women with abruptio placentae treated with a single dose just before delivery by caesarean section. All deliveries went well and were not further complicated by haemorrhage. There are no adequate and well-controlled studies in pregnant women. However, tranexamic acid is known to cross the placenta and appears in cord blood at concentrations approximately equal to maternal concentration. Because animal reproduction studies are not always predictive of human response, tranexamic acid should be used during pregnancy only if clearly needed.
    Lactation: Tranexamic acid is secreted into the mother’s milk at a concentration of about one hundredth of the corresponding serum level. Therefore, caution should be exercised when administered to nursing mothers.


    Overdose

    Overdose data are limited. There is one report of overdose in which a seventeenyear-old ingested 37 g of tranexamic acid and after receiving treatment with gastric lavage, mild intoxication was reported. Symptoms of overdose may include dizziness, headache, nausea, vomiting, diarrhoea, orthostatic symptoms and hypotension. There is no known antidote for tranexamic acid overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures should be instituted as required.Activated charcoal may reduce absorption of tranexamic acid if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube once the airway is protected. In addition to this, monitor vital signs to detect a possible hypotensive episode. Monitor fluid and electrolyte status in patients with severe vomiting or diarrhoea and administer IV fluids and replace electrolytes as necessary. Monitor urine output and maintain adequate diuresis. Monitor for clinical evidence of thromboembolic complications (e.g. chest pain, shortness of breath, flank pain, extremity pain). Because there is a risk of thrombosis in predisposed individuals; anticoagulant therapy should be considered in these patients. In symptomatic patients, support respiratory and cardiac function. Monitor blood count, renal function, pulse oximetry and/or blood gases and obtain a chest x-ray. Obtain an ECG and institute continuous cardiac monitoring.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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