Label: AMINOCAPROIC ACID injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 12, 2024

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  • SPL UNCLASSIFIED SECTION
    Rx Only
  • DESCRIPTION
    Aminocaproic Acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis.  The structural formula is: NH - 2CH - 2(CH - 2) 3CH - 2COOH - The molecular formula is:  C ...
  • CLINICAL PHARMACOLOGY
    The fibrinolysis-inhibitory effects of aminocaproic acid appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity. In adults ...
  • INDICATIONS AND USAGE
    Aminocaproic Acid Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and ...
  • 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 ...
  • WARNINGS
    Aminocaproic Acid Injection, USP contains benzyl alcohol as a preservative. The administration of medications containing benzyl alcohol as a preservative to premature neonates has been associated ...
  • PRECAUTIONS
    General - Aminocaproic acid inhibits both the action of plasminogen activators and to a lesser degree, plasmin activity.  The drug should NOT be administered without a definite diagnosis and/or ...
  • ADVERSE REACTIONS
    Aminocaproic acid is generally well tolerated. The following adverse experiences have been reported: General: Edema, headache, malaise. Hypersensitivity Reactions: Allergic and anaphylactoid ...
  • OVERDOSAGE
    A few cases of acute overdosage with aminocaproic acid administered intravenously have been reported. The effects have ranged from no reaction to transient hypotension to severe acute renal ...
  • DOSAGE AND ADMINISTRATION
    Aminocaproic Acid Injection, USP is administered by infusion, utilizing the usual compatible intravenous vehicles (e.g., Sterile Water for Injection, Sodium Chloride Injection 0.9%, Dextrose ...
  • HOW SUPPLIED
    Aminocaproic Acid Injection, USP, 250 mg/mL. For intravenous infusion after dilution. NDC 0517-9120-25 20 mL multiple dose vial Boxes of 25 - Store at 20°-25°C (68°-77°F); excursions permitted to ...
  • REFERENCES
    *Stefanini M. Dameshek W: The Hemorrhagic Disorders, Ed.2, New York, Grune and Stratton.  1962; pp. 510-514.
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - VIAL LABEL - AMINOCAPROIC ACID - INJECTION, USP - 250 mg/mL(5 g/20 mL) 20 mL MULTIPLE DOSE VIAL - FOR IV INFUSION AFTER DILUTION - Rx Only - PRINCIPAL ...
  • Serialization Label
    Serialization Label
  • INGREDIENTS AND APPEARANCE
    Product Information