CAPROLEX 1 GM

Caprolex inj

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Product Description

Caprolex®

aminocaproic acid

 Description

Caprolex®  (aminocaproic acid) is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis.

 

Caprolex® (aminocaproic acid) is soluble in water, acid, and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform.

Caprolex®(aminocaproic acid) Oral Solution for oral administration, contains 0.25 g/mL of aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%, edetate disodium 0.30% as preservatives and the following inactive ingredients: sodium saccharin, sorbitol solution, citric acid anhydrous, natural and artificial raspberry flavor and an artificial bitterness modifier.

Composition: Each 5 ml ampule cointains 1 gm aminocaproic acid. Each 10 ml ampule cointains 2 gm aminocaproic acid.

Mechanism of action

Aminocaproic acid binds reversibly to the kringle domain of plasminogen and blocks the binding of plasminogen to fibrin and its activation to plasmin. With NO activation of plasmin, there is a reduction in fibrinolysis. This consequently will reduce the amount of bleeding post surgery. Elevated plasma levels of lipoprotein have been shown to increase the risk of vascular disease. Lipoprotein 9a)a has two components, apolipoprotein B-100, linked to apolipoprotein . Aminocaproic acid may change the conformation of apoliprotein , changing its binding properties and potentially preventing the formation of lipoprotein.

Pharmacokinetics

Half life: The terminal elimination half-life is approximately 2 hours.

Excretion: Renal excretion is the primary route of elimination.

Indications:

to treat excessive postoperative bleeding, especially after procedures in which a great amount of bleeding is expected, such as cardiac surgery. It can be given orally or intravenously. A meta-analysis found that lysine analogs like aminocaproic acid significantly reduced blood loss in patients undergoing coronary artery bypass grafting.

Aminocaproic acid can also be used to treat the overdose and/or toxic effects of the thrombolytic pharmacologic agents tissue plasminogen activator(commonly known as tPA) and streptokinase.

Dosages and administration:

Dosage of   Caprolex® (aminocaproic acid) must be adjusted to individual cases according to the severity of the hemmohagic event. it must however born in mind that Caprolex® (aminocaproic acid) cleared rapidely by renal rought, so that administration must be repeted every 4-6 houes. The average dose is 8-16 g a day.i.e. 1 ampule of Caprolex® according to the case, every 6 hours. Caprolex® is equally effective by mouth and intarvenous injection. In cases of particular severaty , or when it is sought to obtain a high blood concentartion quickly it is advisable to start treatment by intravenous rought, with slow injection of two Caprolex® ampules with an interval of 30-60 minutes between them, continuing with divided doses until a dosage of 20-25 grams in the 24 hour is reached.

In any case , administration of the drug must be continued until complete cessation of all symptoms

Caprolex® could be intarveniusly administered , following suitable dilution in Physiological solution.

Side effects

  • mild muscle pain or weakness;
  • headache, tired feeling;
  • nausea, vomiting, stomach pain, diarrhea;
  • (in men) decreased amount of semen when having an orgasm;
  • stuffy nose, watery eyes
  • vision problems, ringing in your ears; or
  • Mild skin rash.

Contraindication

  • Aminocaproic acid should not be used when there is evidence of an active intravascular clotting process.
  • When there is uncertainty as to whether the cause of bleeding is primary fibrinolysis or disseminated intravascular coagulation (DIC), this distinction must be made before administering Aminocaproic Acid Injection.
  • The following tests can be applied to differentiate the two conditions:
  • Platelet count is usually decreased in DIC but normal in primary fibrinolysis.
  • Protamine paracoagulation test is positive in DIC; a precipitate forms when protamine sulfate is dropped into citrated plasma. The test is negative in the presence of primary fibrinolysis.
  • The euglobulin clot lysis test is abnormal in primary fibrinolysis but normal in DIC.
  • Aminocaproic Acid Injection must not be used in the presence of DIC without concomitant heparin.

Pregnancy and lactation

Pregnancy Category C. Animal reproduction studies have not been conducted with aminocaproic acid. It is also not known whether aminocaproic acid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminocaproic Acid Injection should be given to a pregnant woman only if clearly needed.

Storage

Store in a cool, dry place, protected from light. Store the suspension below 30°C. Keep out of reach of children.

Presentation

Box of 5 ampoules 1g/5ml & box of 5 ampoules 2g/10ml.

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