Tracid 500

Generic

Tranexamic Acid

 

Indications

In medicine, hemophilia prophylaxis and treatment, digestive hemorrhages, hemorrhagic syndromes in leukemia, cirrhosis, and hemophilia, thrombocytopenic purpura, and transfusion-related accidents.

Prophylaxis and antihemorrhagic therapy following prostatic, vesical, and renal surgery in urology. Hematurias.

Prophylaxis and treatment of postpartum and puerperium hemorrhages, hemorrhagic neuropathies, functional menometrorrhagia, idiopathic or IUD (intrauterine Device) induced menorrhagias, primitive hyperfibrinolysis (abruptio placentae, premature placenta detachment), and cervical conization in obstetrics.

Prophylaxis and antihemorrhagic therapy after a tonsillectomy, specialty surgery in general, and epistaxis in otorhinolaryngology.

Prophylaxis and antihemorrhagic therapy after maxillofacial procedures and tooth extractions in stomatology.

To encourage the creation of a fibrin capsule to wall off and thereby prevent the growth of ovarian tumors in oncology (as supportive therapy). To cause ascites to disappear as a result of cancer. To lessen bleeding during surgical procedures.

 

Pharmacology

This is a tranexamic acid preparation (trans-4 aminomethyl-cyclohexane carboxylic acid). Tranexamic acid is a potent antifibrinolytic agent that has been shown to be 10 times more active than standard hemostatics in vivo and in vitro, depending on the assay. Tranexamic acid's antihemorrhagic effect is primarily due to an inhibition of plasminogen activation by both exogenous activators such as streptokinase and endogenous activators such as urokinase and the plasminogen tissue activator. This is very significant for Tranexamic Acid's therapeutic application since it ensures antihemorrhagic activity with an antifibrinolytic mechanism in a range of situations.

Tranexamic Acid's acute toxicity is exceedingly low, and its chronic toxicity is nearly non-existent. Tranexamic Acid is well absorbed when taken orally, and the effects can be visible 15-30 minutes after taking it. It is primarily eliminated by the kidneys, but at a slower rate than traditional hemostatics. Because of these characteristics, Tranexamic Acid has a longer-lasting effect than traditional hemostatics. Thus, significantly smaller single doses of Tranexamic Acid can be given at longer intervals without the drug's plasma levels decreasing below ineffective antifibrinolytic activity between doses.

Tranexamic Acid does not interfere with clotting processes at therapeutic levels, and even long-term use has not been linked to an increased risk of thrombophilia.

 

Dosage & Administration

Adults should take 500-1000 mg three times a day.

For prophylaxis, oral dosages of 0.5-1 gm and parenteral (intravenous or intramuscular) doses of 500 mg are advised.

For hemorrhagic signs, raise the oral dose to 1-3 gm given in divided doses: in cases of extreme seriousness and urgency, start by slowly injecting an ampoule (500 mg) intravenously and then administering the appropriate oral doses.

Children: For prophylaxis, 5-10 mg are orally supplied daily in split dosages for every kilogram of body weight.

For therapeutic reasons, oral doses are doubled (from 10 to 20 mg/kg), and intravenous and intramuscular treatment is started with 10 mg/kg (=0.5 ml every 5 kg) using the slow intravenous route, with oral administration continuing until the needed dose is reached. The ampoules, diluted in a little sweetened water, could be given orally instead of the capsules where it is more convenient (e.g. in little newborns).

There is no need to reduce the dosage in elderly people unless there is evidence of renal failure.

 

Interaction

Tranexamic Acid is a synthetic amino acid that reacts badly with penicillin-containing solutions (eg: Benzylpenicillin). Thrombolytic medicines like Streptokinase and Urokinase work against Tranexamic Acid's antifibrinolytic effect. Concurrent administration of estrogen-containing medicines, such as oral contraceptives, may increase the risk of thrombus development. During the transfusion, a direct combination of Tranexamic Acid with whole blood should be avoided.

 

Contraindications

Individual hypersensitivity to the product has been identified. Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, and severe renal failure are all examples of thromboembolic disease.

 

Side Effects

Tranexamic Acid is generally well accepted; nevertheless, weariness, conjunctival irritation, nasal obstruction, itching, skin reddening, and exanthems may occur in rare cases.

Nausea, diarrhea, and gastric pyrosis may occur after oral dosing.

Postural hypotension is a rare occurrence.

If you have a hypersensitivity to tranexamic acid, stop taking it or stop taking it until you find a medication that works for you.

 

Pregnancy & Lactation

Tranexamic Acid should not be used during known or suspected pregnancy because the drug's transplacental passage and potential effects on the fetus are unclear. Tranexamic Acid is excreted in breast milk at a concentration of about one-twentieth of that seen in maternal blood. In the infant, an antifibrinolytic effect is improbable.

 

Precautions & Warnings

When there is hyperfibrinolysis, Tranexamic Acid should be taken. The preventative treatment must begin 24 hours prior to the procedure and last for 3-4 days afterward.

Hemorrhage treatment must be continued for at least 24 hours after the symptoms have subsided.

Reduce the doses if you have hematuria, especially if it isn't accompanied by any other hemorrhagic symptoms. This will help prevent clots in the urinary tract.

Tranexamic Acid should be avoided in cases of severe renal insufficiency or anuric syndromes, and should only be administered with caution in cases of less severe renal impairment.

 

Therapeutic Class

Hemostatic medications, anti-fibrinolytic drugs.

 

Storage Conditions

Store at 15-30°C in a dry place away from light and out of reach of youngsters.

 

Pharmaceutical Name

ACME Laboratories Ltd.