Aminocaproic acid intravenous

FDA label, Hospira, Inc., intravenous, effective 2026-04-30. Full label on DailyMed

Other products: Aminocaproic acid

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Antifibrinolytic Agent

Dosing in kidney impairment

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. WARNINGS In patients with upper urinary tract bleeding, aminocaproic acid administration has been known to cause intrarenal obstruction in the form of glomerular capillary thrombosis or clots in the renal pelvis and ureters.

Clinical presentation may range from mild myalgias with weakness and fatigue to a severe proximal myopathy with rhabdomyolysis, myoglobinuria, and acute renal failure. Muscle enzymes, especially creatine phosphokinase (CPK) are elevated. CPK levels should be monitored in patients on long-term therapy. Aminocaproic Acid Injection administration should be stopped if a rise in CPK is noted.

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Preparation and administration

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DOSAGE AND ADMINISTRATION Intravenous Aminocaproic Acid Injection, USP is administered by infusion, utilizing the usual compatible intravenous vehicles (e.g., Sterile Water for Injection, Sodium Chloride for Injection, 5% Dextrose or Ringer’s Injection). Although Sterile Water for Injection is compatible for intravenous injection the resultant solution is hypo-osmolar.

RAPID INJECTION OF AMINOCAPROIC ACID INJECTION UNDILUTED INTO A VEIN IS NOT RECOMMENDED. For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 16 to 20 mL (4 to 5 g) of aminocaproic acid in 250 mL of diluent be administered by infusion during the first hour of treatment, followed by a continuing infusion at the rate of 4 mL (1 g) per hour in 50 mL of diluent.

This method of treatment would ordinarily be continued for about 8 hours or until the bleeding situation has been controlled. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer unless the solution is clear and seal is intact.

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  • Aminocaproic acid intravenous

Contraindications

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.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for aminocaproic acid intravenous. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy 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.

Lactation

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when aminocaproic acid is administered to a nursing woman.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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