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 other emergency measures may be required.
Fibrinolytic bleeding may frequently be associated with surgical
complications following heart surgery (with or without cardiac bypass
procedures), and portacaval shunt; hematological disorders such as
aplastic anemia; acute and life-threatening abruptio placentae; hepatic
cirrhosis; and neoplastic disease such as carcinoma of the prostate,
lung, stomach, and cervix.
Urinary fibrinolysis,
usually a normal physiological phenomenon, may frequently be associated
with life-threatening complications following severe trauma, anoxia,
and shock. Symptomatic of such complications is surgical hematuria
(following prostatectomy and nephrectomy) or nonsurgical hematuria
(accompanying polycystic or neoplastic diseases of the genitourinary
system). (See
WARNINGS
.)
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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. Discard unused portion.
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HOW SUPPLIED
Aminocaproic Acid Injection, USP is supplied in single-dose
containers as follows:
5 g/20 mL (250 mg/mL)
aminocaproic acid, 20 mL in 30 mL Fliptop Vial (NDC 0409-4346-73,
List No. 4346).
Store at 20 to 25°C (68
to 77°F). [See USP Controlled Room Temperature.]
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