Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Aminocaproic Acid Tablets USP, 500 mg are supplied as round shape with notch, uncoated, biconvex, white to off-white tablets, debossed with identification marking “C” and “17” on either side of the score line on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 69238-1637-3 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP.; PRINCIPAL DISPLAY PANEL NDC 69238-1637-3 Aminocaproic Acid Tablets USP, 500 mg Rx only 30 Tablets Amneal Pharmaceuticals LLC dsdf
- HOW SUPPLIED Aminocaproic Acid Tablets USP, 500 mg are supplied as round shape with notch, uncoated, biconvex, white to off-white tablets, debossed with identification marking “C” and “17” on either side of the score line on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 69238-1637-3 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP.
- PRINCIPAL DISPLAY PANEL NDC 69238-1637-3 Aminocaproic Acid Tablets USP, 500 mg Rx only 30 Tablets Amneal Pharmaceuticals LLC dsdf
Overview
Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is: Aminocaproic acid, USP is a fine, white to almost white, crystalline powder. It is freely soluble in water, in acids, and in alkaline solutions; it is slightly soluble in methanol and practically insoluble in chloroform and in ether. Each aminocaproic acid tablet, USP for oral administration contains 500 mg of aminocaproic acid, USP and the following inactive ingredients: crospovidone type B, magnesium stearate, povidone and stearic acid. Meets USP Dissolution Test 2. 10
Indications & Usage
Aminocaproic acid tablets are useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products 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 amegakaryocytic thrombocytopenia (accompanying 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, usualIy a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system) (see WARNINGS ).
Dosage & Administration
The dosage regimen for administering aminocaproic acid tablets is as follows: For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 10 aminocaproic acid 500 mg tablets (5 g) be administered during the first hour of treatment, followed by a continuing rate of 2 aminocaproic acid 500 mg tablets (1 g) 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 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. Cardiovascular: Bradycardia, hypotension, peripheral ischemia, thrombosis. Gastrointestinal: 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: Pruritis, 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. T o report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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