Drugplain

Aminocaproic acid .25 g/mL

Aminocaproic acid · SOLUTION · Novadoz Pharmaceuticals LLC

No Recall History
Plain English

Aminocaproic acid is a solution containing aminocaproic acid at .25 g/mL, taken oral. Manufactured by Novadoz Pharmaceuticals LLC.

Key Facts

Brand Name
Aminocaproic acid
Generic Name
Aminocaproic acid
NDC Code (Product)
72205-032
Manufacturer
Novadoz Pharmaceuticals LLC
Strength
.25 g/mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA215100
Drug Class
Antifibrinolytic Agent [EPC]
Marketing Start
09/26/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

haemorrhage108 reports
off label use62 reports
drug ineffective48 reports
death37 reports
epistaxis37 reports
fall31 reports
haemarthrosis29 reports
pain29 reports
hypotension27 reports
thrombocytopenia24 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 .)

Dosage & Administration

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 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 followe…

Warnings

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 f…

Contraindications

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

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 pat…

Frequently Asked Questions

What is Aminocaproic acid used for?

Aminocaproic acid contains Aminocaproic acid. It is a solution taken oral. Consult your doctor for specific uses.

Is Aminocaproic acid a controlled substance?

Aminocaproic acid is not classified as a controlled substance by the DEA.

What is the generic name for Aminocaproic acid?

The generic name for Aminocaproic acid is Aminocaproic acid. There are 11 other brand versions of Aminocaproic acid.

What is the NDC code for Aminocaproic acid .25 g/mL?

The NDC (National Drug Code) for Aminocaproic acid .25 g/mL is 72205-032, listed by Novadoz Pharmaceuticals LLC.

Product NDC

72205-032

Package NDC

72205-032-71

Other Aminocaproic acid Dosages

Other Aminocaproic Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)