Aminocaproic acid (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [2]
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Overview
Aminocaproic acid (injection) is a hemostatic that is FDA approved for the treatment of acute bleeding syndromes due to elevated fibrinolytic activity. Common adverse reactions include abdominal pain, nausea, vomiting, diarrhea, headache dizziness, confusion, hallucinations, blurred vision, tinnitus.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Acute Bleeding Syndromes due to Elevated Fibrinolytic Activity
Dosing Information
Oral administration
- An identical dosage regimen may be followed by administering aminocaproic acid tablets or aminocaproic acid oral solution as follows:
- For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 5 aminocaproic acid 1000 mg tablets or 10 aminocaproic acid 500 mg tablets (5 g) or 20 milliliter of aminocaproic acid oral Solution (5 g) be administered during the first hour of treatment, followed by a continuing rate of 1 aminocaproic acid 1000 mg tablet or 2 aminocaproic acid 500 mg tablets (1 g) or 5 milliliter of aminocaproic acid oral solution (1.25 g) per hour. This method of treatment would ordinarily be continued for about 8 hours or until the bleeding situation has been controlled.
IV administration
- Aminocaproic acid injection 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 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 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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition 1
- Developed by: (Organisation)
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Condition 2
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Non–Guideline-Supported Use
Intraocular Hemorrhage
- Dosing Information
- 100 mg/kg PO q4h.[1]
Postoperative Hemorrhage Prophylaxis
- Dosing Information
- Administer 3 boluses (10 gram each) of epsilon-aminocaproic acid (EACA) diluted in saline solution 0.9% (total volume 40mL) after anesthesia induction, administration of protamine and administration of heparin in the pump.[2]
Dental Procedure Hemorrhage Prophylaxis and Treatment in Hemophilic Patients
- Dosing information
- 100 mg/kg 4 to 6 hours after surgery PO to a maximum dose of 6 g q6h.[3]
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Aminocaproic acid (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Non–Guideline-Supported Use
Post-Surgery Intraocular Hemorrhage
- Dosing Information
- 5 g 60 minutes before surgery, then 5 g q6h.[4]
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 Iysis test is abnormal in primary fibrinolysis but normal in DIC.
AMICAR must not be used in the presence of DIC without concomitant heparin.
Warnings
Conidition 1
(Description)
Adverse Reactions
Clinical Trials Experience
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Cardiovascular
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Miscellaneous
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Condition 2
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Postmarketing Experience
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Drug Interactions
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Drug 5
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Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
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Labor and Delivery
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Nursing Mothers
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Pediatric Use
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Geriatic Use
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Race
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Renal Impairment
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Hepatic Impairment
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Females of Reproductive Potential and Males
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Immunocompromised Patients
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Others
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Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
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Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
Solution
Compatible
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Not Tested
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Variable
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Incompatible
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Y-Site
Compatible
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Not Tested
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Variable
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Incompatible
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Admixture
Compatible
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Not Tested
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Variable
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Incompatible
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Syringe
Compatible
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Not Tested
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Variable
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Incompatible
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TPN/TNA
Compatible
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Not Tested
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Variable
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Incompatible
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Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
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Chronic Overdose
Signs and Symptoms
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Management
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Pharmacology
Aminocaproic acid (injection)
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Nonclinical Toxicology
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Clinical Studies
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How Supplied
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Storage
There is limited information regarding Aminocaproic acid (injection) Storage in the drug label.
Images
Drug Images
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Patient Counseling Information
(Patient Counseling Information)
Precautions with Alcohol
Alcohol-Aminocaproic acid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Aminocaproic acid (injection) Brand Names in the drug label.
Look-Alike Drug Names
- (Paired Confused Name 1a) — (Paired Confused Name 1b)
- (Paired Confused Name 2a) — (Paired Confused Name 2b)
- (Paired Confused Name 3a) — (Paired Confused Name 3b)
Drug Shortage Status
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Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ McGetrick JJ, Jampol LM, Goldberg MF, Frenkel M, Fiscella RG (1983). "Aminocaproic acid decreases secondary hemorrhage after traumatic hyphema". Arch Ophthalmol. 101 (7): 1031–3. PMID 6870623.
- ↑ Daily PO, Lamphere JA, Dembitsky WP, Adamson RM, Dans NF (1994). "Effect of prophylactic epsilon-aminocaproic acid on blood loss and transfusion requirements in patients undergoing first-time coronary artery bypass grafting. A randomized, prospective, double-blind study". J Thorac Cardiovasc Surg. 108 (1): 99–106, discussion 106-8. PMID 8028387.
- ↑ Djulbegovic B, Marasa M, Pesto A, Kushner GM, Hadley T, Joseph G; et al. (1996). "Safety and efficacy of purified factor IX concentrate and antifibrinolytic agents for dental extractions in hemophilia B." Am J Hematol. 51 (2): 168–70. doi:10.1002/(SICI)1096-8652(199602)51:2<168::AID-AJH14>3.0.CO;2-E. PMID 8579061.
- ↑ de Bustros S, Glaser BM, Michels RG, Auer C (1985). "Effect of epsilon-aminocaproic acid on postvitrectomy hemorrhage". Arch Ophthalmol. 103 (2): 219–21. PMID 3883968.