Fibrostat500 mg

In medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.In surgery: Prophylaxis and antihemorrhagic ... Read moreIn medicine: Prophylaxis and therapy of hemophtoes, digestive hemorrhages, hemorrhagic syndromes in leukaemia, cirrhosis and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy and transfusion.In surgery: Prophylaxis and antihemorrhagic therapy during operations of any type and nature and particularly in pulmonary, cardiovascular and abdominal surgery and post-operative and traumatic shock.In urology: Prophylaxis and antihemorrhagic therapy of prostatic, vesical and renal surgery. Hematurias.In obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metrophathies, functional menometrorrhagias, idiopathic or IUD(lntra uterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment) and in cervical conization.In otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during a tonsillectomy, specialist surgery generally, epistaxis.In stomatology: Prophylaxis and antihemorrhagic therapy during maxillofacial operations, tooth extractions.In oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and thereby inhibit the growth of ovarian tumors. To cause regression of ascites secondary to carcinoma. To reduce bleeding during surgical interventions.

Anti-fibrinolytic drugs, Haemostatic drugs

Tranexamic acid competitively inhibits activation of plasminogen (via binding to the kringle domain), thereby reducing conversion of plasminogen to plasmin (fibrinolysin), an enzyme that degrades fibrin clots, fibrinogen, and other plasma proteins, including the procoagulant factors V and VIII. Tranexamic acid also directly inhibits plasmin activity, but higher doses are required than are needed to reduce plasmin formation. Tranexamic acid is rapidly absorbed from the gastrointestinal tract. Maximum serum levels are reached within 2-3 hours. After oral administration, about 40% of the dose is excreted in the urine during the first 24 hours. After intravenous administration 45% of the dose is excreted in the urine during the first day.

Intravenous administration is necessary only if it is difficult to give adequate doses by mouth. The recommended standard dose is 1 to 1.5 gm or 5-10 ml by slow intravenous injection at a rate of 1 ml/minute, two to three times daily. For the indications listed below the following doses are recommended. Prostatectomy: 5-10 ml by slow intravenous injection every eight hours (the first injection being given during the operation) for the first three days after surgery; thereafter 1-1.5 gm orally three to four times daily until macroscopic haematuria is no longer present. Menorrhagia: 1-1.5 gm orally three to four times daily for three to four days. Epistaxis: 1.5 gm orally three times daily for four to ten days. Fibrostat 500 mg injection may be applied topically to the nasal mucosa of patients suffering from epistaxis. This can be done by soaking a gauze strip in the solution, and then packing the nasal cavity. Haematuria: 1-1.5 gm orally 2-3 times daily until macroscopic haematuria is no longer present. Conisation of the cervix: 1.5 gm orally 3 times a day for 12 to 14 days post-operatively. Dental surgery in patients with coagulopathies: Immediately before surgery, 10 mg per kg body-weight should be given intravenously. After surgery, 25 mg per kg body-weight are given orally three to four times daily for six to eight days. Coagulation factor concentrate might be necessary to administrate. General fibrinolysis: 1 gm by slow intravenous injection three to four times daily. With fibrinolysis in conjunction with diagnosed, increased intravascular coagulation i.e. defibrillation syndrome, an anticoagulant such as heparin may be given with caution. Hereditary angioneurotic oedema: 1-1.5 gm orally two to three times daily as intermittent or continuous treatment depending on whether the patient has prodromal symptoms or not.

Adults- The usual dose: 500-1000 mg 3 times daily. For prophylaxis: The mean recommended daily doses are 0.5-1 gm orally, 500 mg by the parenteral (intravenous or intramuscular) route. For therapy of hemorrhagic manifestations: the oral dose increases to 1-3 gm given in divided doses: in cases of particular seriousness and urgency, begin by injecting an ampoule (500 mg) slowly by intravenous route and administer the necessary subsequent oral doses. Children- For prophylaxis: For every kg of body weight from 5-10 mg are orally administered daily in divided doses. For therapeutic purposes: The oral doses are doubled (from 10 to 20 mg/kg), while the intravenous and intramuscular treatment is begun with 10 mg/kg (=0.5 ml every 5 kg) by the slow intravenous route, continuing the oral administration up to the required dose. Where it is more convenient (e.g. in small babies) the ampoules, diluted in a little sweetened water, maybe orally administered instead of the Capsules. Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Fibrostat 500 mg is a synthetic Amino Acid that is incompatible with solutions containing penicillins (eg: Benzyl penicillin). Thrombolytic drugs like Streptokinase & Urokinase antagonise the antifibrinolytic action of Fibrostat 500 mg. The potential for thrombus formation may be increased by concomitant administration of estrogen containing drugs, like oral contraceptives. Direct admixture of Fibrostat 500 mg with whole blood should be avoided during Transfusion.

Known individual hypersensitivity to the product. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, serious kidney failure.

Fibrostat 500 mg is generally well tolerated; there may be infrequent cases of sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems. After oral administration there may be sign of nausea, diarrhea, gastric pyrosis. There are rare cases of postural hypotension. In the case of hypersensitivity to Fibrostat 500 mg, avoid or suspend treatment and start a suitable therapy.

Tranexamic acid crosses the placenta. Clinical experience of use in pregnant women is limited. Animal studies have not supplied any evidence of an increased incidence of fetal damage. Tranexamic acid is excreted into breast milk, but it is not likely to influence the child at therapeutic doses.

Fibrostat 500 mg should be used in cases where there is hyperfibrinolysis. The prophylactic treatment must begin 24 hours before the operation and continue until 3-4 days after it. The therapy of hemorrhages must be prolonged for at least 24 hours after manifestations have disappeared. In hematuria, especially when this is not accompanied by any other hemorrhagic manifestations, reduce the doses to prevent formation of clots in the urinary tract. Fibrostat 500 mg must not be used in serious renal insufficiency or anuric syndromes and must only be used with caution in less serious renal dysfunctions. The administration of product requires particular care in cardiopathic and hepatopathic subjects.

Store in a dry place at 15-30°C, away from light and keep out of children's reach.

Children: Oral dose: 25 mg/kg 2 to 3 times daily for 7 to 10 days. Injection: 10 mg/kg 6 to 8 hours for 7 to 10 days.Pediatric Use: The drug has had limited use in pediatric patients, principally in connection with tooth extraction. The limited data suggest that dosing instructions for adults can be used for pediatric patients needing Tranexamic acid therapy.

Anti-fibrinolytic drugs, Haemostatic drugs

This is a preparation of Fibrostat 500 mg (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a substance endowed with a strong antifibrinolytic action and both in vivo and in vitro it has proved to be 10 times more active than conventional hemostatics, depending on the test. The antihemorrhagic action of Fibrostat 500 mg is essentially due to an inhibition of the plasminogen activation of both exogenous activators like streptokinase and endogenous ones like urokinase and the plasminogen tissue activator. This fact is particularly important for the clinical use of Fibrostat 500 mg, because it ensures an antihemorrhagic activity with an antifibrinolytic mechanism under a variety of conditions.The acute toxicity of Fibrostat 500 mg is extremely low and chronic toxicity almost non-existent. Fibrostat 500 mg is well absorbed by oral route and the effect is already seen 15-30 minutes after administration. It is excreted mainly by renal route but more slowly than conventional hemostatics. These features make the Fibrostat 500 mg effect more lasting than those conventional hemostatics. Considerably lower single doses of Fibrostat 500 mg can thus be administered at greater intervals without the drug plasma levels dropping to inefficient levels of antifibrinolytic activity between one dose and the other.Fibrostat 500 mg at therapeutic doses does not interfere with clotting processes and even a prolonged administration has not been seen to be accompanied by any tendency to thrombophilia.

Since the transplacental passage of the drug and its possible effects on the fetus are unknown, Fibrostat 500 mg should not be administered during known and presumed pregnancy. Fibrostat 500 mg passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.