Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Aminocaproic Acid Injection, USP, 250 mg/mL. For intravenous infusion after dilution. NDC 72572-015-25 20 mL multiple dose vial Boxes of 25 Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). Mfd for: Civica, Inc. Lehi, Utah 84043 Mfd by: American Regent, Inc. Shirley, New York 11967 IN015 Rev. 05/2020 MG #47339; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- Container Label NDC 72572-015-01 Rx Only Aminocaproic Acid Injection, USP 5 g/20 mL (250 mg/mL) 20 mL Multiple Dose Vial For intravenous use after dilution. Mfd for: Civica, Inc. Lehi, UT 84043 Mfd by: American Regent, Inc. Shirley, New York 11967 Container Label - Civica; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton Labeling NDC 72572-015-25 Rx Only Aminocaproic Acid Injection, USP 5 g/20 mL (250 mg/mL) 25 x 20 mL Multiple Dose Vials For intravenous infusion after dilution. Each mL contains: Aminocaproic Acid 250 mg, Benzyl Alcohol 0.9%, Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid to adjust pH. Sterile, nonpyrogenic. Initial Adult Dosage: 4 to 5 grams (16-20 mL) intravenously followed by 1 gram (4 mL) at hourly intervals thereafter. See enclosed insert. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. Mfd by: Civica, Inc. Lehi, UT 84043 Mfd by: American Regent, Inc. Shirley, New York 11967 Rev. 04/2020 Carton Labeling; Serialization Label Serialization Label - Civica
- HOW SUPPLIED Aminocaproic Acid Injection, USP, 250 mg/mL. For intravenous infusion after dilution. NDC 72572-015-25 20 mL multiple dose vial Boxes of 25 Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). Mfd for: Civica, Inc. Lehi, Utah 84043 Mfd by: American Regent, Inc. Shirley, New York 11967 IN015 Rev. 05/2020 MG #47339
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- Container Label NDC 72572-015-01 Rx Only Aminocaproic Acid Injection, USP 5 g/20 mL (250 mg/mL) 20 mL Multiple Dose Vial For intravenous use after dilution. Mfd for: Civica, Inc. Lehi, UT 84043 Mfd by: American Regent, Inc. Shirley, New York 11967 Container Label - Civica
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton Labeling NDC 72572-015-25 Rx Only Aminocaproic Acid Injection, USP 5 g/20 mL (250 mg/mL) 25 x 20 mL Multiple Dose Vials For intravenous infusion after dilution. Each mL contains: Aminocaproic Acid 250 mg, Benzyl Alcohol 0.9%, Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid to adjust pH. Sterile, nonpyrogenic. Initial Adult Dosage: 4 to 5 grams (16-20 mL) intravenously followed by 1 gram (4 mL) at hourly intervals thereafter. See enclosed insert. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert. Mfd by: Civica, Inc. Lehi, UT 84043 Mfd by: American Regent, Inc. Shirley, New York 11967 Rev. 04/2020 Carton Labeling
- Serialization Label Serialization Label - Civica
Overview
Aminocaproic Acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. The structural formula is: NH 2 CH 2 (CH 2 ) 3 CH 2 COOH The molecular formula is: C 6 H 13 NO 2 Molecular Weight: 131.17 Aminocaproic Acid is soluble in water, acid and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform. Aminocaproic Acid Injection, USP, for intravenous administration, is a sterile pyrogen-free solution containing 250 mg/mL of Aminocaproic Acid with Benzyl Alcohol 0.9%, as a preservative, and Water for Injection q.s. The pH is adjusted to approximately 6.8 with Hydrochloric Acid and/or Sodium Hydroxide.
Indications & 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 .)
Dosage & 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 Injection 5% 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, USP 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 Injection, USP 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. Oral Therapy: If the patient is able to take medication by mouth, an identical dosage regimen may be followed by administering aminocaproic acid tablets or aminocaproic acid syrup, 25% as follows: For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 5 grams of aminocaproic acid tablets or syrup be administered during the first hour of treatment, followed by a continuing rate of 1 gram of aminocaproic acid tablets or 1.25 grams of aminocaproic acid syrup per hour. This method of treatment would ordinarily be continued for about 8 hours or until the bleeding situation has been controlled.
Warnings & Precautions
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 with a fatal “Gasping Syndrome”. (See PRECAUTIONS, Pediatric Use. ) 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. For this reason, aminocaproic acid should not be used in hematuria of upper urinary tract origin, unless the possible benefits outweigh the risk. Subendocardial hemorrhages have been observed in dogs given intravenous infusions of 0.2 times the maximum human therapeutic dose of aminocaproic acid and in monkeys given 8 times the maximum human therapeutic dose of aminocaproic acid. Fatty degeneration of the myocardium has been reported in dogs given intravenous doses of aminocaproic acid at 0.8 to 3.3 times the maximum human therapeutic dose and in monkeys given intravenous doses of aminocaproic acid at 6 times the maximum human therapeutic dose. Rarely, skeletal muscle weakness with necrosis of muscle fibers has been reported following prolonged administration. 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 administration should be stopped if a rise in CPK is noted. Resolution follows discontinuation of aminocaproic acid; however, the syndrome may recur if aminocaproic acid is restarted. The possibility of cardiac muscle damage should also be considered when skeletal myopathy occurs. One case of cardiac and hepatic lesions observed in man has been reported. The patient received 2 g of aminocaproic acid every 6 hours for a total dose of 26 g. Death was due to continued cerebrovascular hemorrhage. Necrotic changes in the heart and liver were noted at autopsy.
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. 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 must not be used in the presence of DIC without concomitant heparin.
Adverse Reactions
Aminocaproic acid is generally well tolerated. The following adverse experiences have been reported: General : Edema, headache, malaise. Hypersensitivity Reactions : Allergic and anaphylactoid reactions, anaphylaxis. Local Reactions : Injection site reactions, pain and necrosis. Cardiovascular : Bradycardia, hypotension, peripheral ischemia, thrombosis. Gastrointestina l: Abdominal pain, diarrhea, nausea, vomiting. Hematologic : Agranulocytosis, coagulation disorder, leukopenia, thrombocytopenia. Musculoskeletal : CPK increased, muscle weakness, myalgia, myopathy (see WARNINGS ), myositis, rhabdomyolysis. Neurologic : Confusion, convulsions, delirium, dizziness, hallucinations, intracranial hypertension, stroke, syncope. Respiratory: Dyspnea, nasal congestion, pulmonary embolism. Skin : Pruritus, rash. Special Senses : Tinnitus, vision decreased, watery eyes. Urogenital : BUN increased, renal failure. There have been some reports of dry ejaculation during the period of aminocaproic acid treatment. These have been reported to date only in hemophilia patients who received the drug after undergoing dental surgical procedures. However, this symptom resolved in all patients within 24 to 48 hours of completion of therapy.
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