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Pronunciation:

(a mee noe ka PROE ik AS id)

U.S. Brand Names:

Amicar®

Synonyms:

Epsilon Aminocaproic Acid

Generic Available:

Yes: Syrup, tablet

Canadian Brand Names:

Amicar®

Use:

Treatment of excessive bleeding from fibrinolysis

Use - Unlabeled/Investigational:

Treatment of traumatic hyphema; control bleeding in thrombocytopenia; control oral bleeding in congenital and acquired coagulation disorders

Pregnancy Risk Factor:

Pregnancy Implications:

Reproductive studies have not been conducted.

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to aminocaproic acid or any component of the formulation; disseminated intravascular coagulation (without heparin); evidence of an intravascular clotting process

Warnings/Precautions:

Avoid rapid I.V. administration; may induce hypotension, bradycardia, or arrhythmia. Aminocaproic acid may accumulate in patients with decreased renal function. Intrarenal obstruction may occur secondary to glomerular capillary thrombosis or clots in the renal pelvis and ureters. Do not use in hematuria of upper urinary tract origin unless possible benefits outweigh risks. Use with caution in patients with cardiac, renal, or hepatic disease. Do not administer without a definite diagnosis of laboratory findings indicative of hyperfibrinolysis. Inhibition of fibrinolysis may promote clotting or thrombosis; more likely due in the presence of DIC. Subsequently, use with great caution in patients with or at risk for veno-occlusive disease of the liver. Benzyl alcohol is used as a preservative in the injection, therefore, these products should not be used in the neonate. Do not administer with factor IX complex concentrates or anti-inhibitor coagulant complexes.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Arrhythmia, bradycardia, hypotension, peripheral ischemia, syncope, thrombosis

Central nervous system: Confusion, delirium, dizziness, fatigue, hallucinations, headache, intracranial hypertension, malaise, seizure, stroke

Dermatologic: Rash, pruritus

Gastrointestinal: Abdominal pain, anorexia, cramps, diarrhea, GI irritation, nausea

Genitourinary: Dry ejaculation

Hematologic: Agranulocytosis, bleeding time increased, leukopenia, thrombocytopenia

Neuromuscular & skeletal: CPK increased, myalgia, myositis, myopathy, rhabdomyolysis (rare), weakness

Ophthalmic: Watery eyes, vision decreased

Otic: Tinnitus

Renal: Failure (rare), myoglobinuria (rare)

Respiratory: Dyspnea, nasal congestion, pulmonary embolism

Overdosage/Toxicology:

Symptoms of overdose include acute renal failure, delirium, diarrhea, hepatic necrosis, nausea, seizures, transient hypotension, and thromboembolism. Aminocaproic acid may be removed by hemodialysis.

Drug Interactions:

Increased toxic effect with oral contraceptives, estrogens

Stability:

Store at 15°C to 30°C (59°F to 86°F). Dilute I.V. solution (1 g/50 mL of diluent) with D5W, 0.9% sodium chloride, or lactated Ringer's.

Compatibility:

Stable in D5W, NS

Compatibility when admixed: Compatible: Netilmicin

Mechanism of Action:

Competitively inhibits activation of plasminogen to plasmin, also, a lesser antiplasmin effect

Pharmacodynamics/Kinetics:

Onset of action: ~1-72 hours

Distribution: Widely through intravascular and extravascular compartments;

Vd: Oral: 23 L, I.V.: 30 L

Metabolism: Minimally hepatic

Half-life elimination: 2 hours

Time to peak: Oral: Within 2 hours

Excretion: Urine (65% as unchanged drug, 11% as metabolite)

Dosage:

Acute bleeding syndrome:

Children (unlabeled use): Oral, I.V.: 100-200 mg/kg during the first hour, followed by continuous infusion at 33.3 mg/kg/hour or 100 mg/kg every 6 hours

Adults: Oral, I.V.: 4-5 g during the first hour, followed by 1 g/hour for 8 hours or until bleeding controlled (maximum daily dose: 30 g)

Control bleeding in thrombocytopenia (unlabeled use): Adults:

Initial: I.V.: 0.1 g/kg over 30-60 minutes

Maintenance: Oral: 1-3 g every 6 hours

Control oral bleeding in congenital and acquired coagulation disorder (unlabeled use): Adults: Oral: 50-60 mg/kg every 4 hours

Traumatic hyphema (unlabeled use): Children and Adults: Oral: 100 mg/kg/dose every 4 hours (maximum daily dose: 30 g)

Dosing adjustment in renal impairment: May accumulate in patients with decreased renal function.

Administration:

I.V.: Rapid I.V. injection (IVP) should be avoided since hypotension, bradycardia, and arrhythmia may result.

Monitoring Parameters:

Fibrinogen, fibrin split products, creatine phosphokinase (with long-term therapy)

Reference Range:

Therapeutic concentration: >130 mcg/mL (concentration necessary for inhibition of fibrinolysis)

Test Interactions:

Increased potassium, creatine phosphokinase [CPK] (S)

Patient Education:

Take oral medication exactly as directed. This medication may cause dizziness and fatigue (use caution when driving or engaging in tasks that require alertness until response to drug is known); hypotension (use caution when rising from a lying or sitting position or climbing stairs); menstrual irregularities, increased body hair, or sexual dysfunction (should reverse when treatment is completed); or nausea or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help). Report immediately any chest pain; dyspnea; swelling; nosebleed; warmth, swelling, pain, or redness in calves; skin rash; muscle pain or weakness; ringing in ears; or acute abdominal cramping. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Dental Comment:

Antifibrinolytic drugs are useful to control bleeding after dental extractions in patients with hemophilia. A clinical trial reported that aminocaproic acid or tranexamic acid reduces both recurrent bleeding and the amount of clotting factor replacement therapy required. In adults, the oral dose was 50-60 mg aminocaproic acid per kg every 4 hours until dental sockets were completely healed.

Extemporaneous solutions incorporating 100 mg aminocaproic acid per 5 mL of oral solution have been used as an oral rinse with some success. Use, however, must be carefully considered since they may not show efficacy in all patients with either drug-induced or hereditary coagulation problems. Studies are ongoing and commercial products may be available in the future.

Mental Health: Effects on Mental Status:

May cause drowsiness

Mental Health: Effects on Psychiatric Treatment:

May cause hypotension which may be exacerbated by psychotropics; rarely may cause seizures; use caution with clozapine and bupropion

Oncology: Emetic Potential:

Very low (<10%)

Oncology: Vesicant:

Dosage Forms:

Injection, solution: 250 mg/mL (20 mL) [contains benzyl alcohol]

Syrup: 1.25 g/5 mL (240 mL, 480 mL)

Amicar®: 1.25 g/5 mL (480 mL) [raspberry flavor]

Tablet [scored]: 500 mg, 1000 mg

International Brand Names:

Acepramin® (HU); Acidum e-aminocapronicum® (PL); Amicar® (AU, CA, NZ, ZA); Caproamin Fides® (ES); Caprolisin® (BD, IT); Epsicaprom® (PT); Hemocaprol® (HK); Hemocid® (IN); Hemolysin® (BD); Ipsilon® (AR, BR); Sirupus Acidi-aminocapronici® (PL)

References

Bartholomew JR, Salgia R, and Bell WR, "Control of Bleeding in Patients With Immune and Nonimmune Thrombocytopenia With Aminocaproic Acid,"Arch Intern Med, 1989, 149(9):1959-61.

Crouch ER Jr, Williams PB, Gray MK, et al, "Topical Aminocaproic Acid in the Treatment of Traumatic Hyphema,"Arch Ophthalmol, 1997, 115(9):1106-12.

Gardner FH and Helmer RE 3rd, "Aminocaproic Acid. Use in Control of Hemorrhage in Patients With Amegakaryocytic Thrombocytopenia,"JAMA, 1980, 243(1):35-7.

Haut MT, Mauro VF, and Davis HH, "Effect of Renal Failure and Hemodialysis on Aminocaproic Acid Plasma Concentrations,"DICP, 1989, 23(11):922-3.

Mannucci P, "Hemostatic Drugs,"N Engl J Med, 1998, 339(4):245-53.

McGetrick JJ, Jampol LM, Goldberg MP, et al, "Aminocaproic Acid Decreases Secondary Hemorrhage After Traumatic Hyphema,"Arch Ophthalmol, 1983, 101(7):1031-3.

Pieramici DJ, Goldberg MF, Melia M, et al, "A Phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial of Topical Aminocaproic Acid (Caprogel) in the Management of Traumatic Hyphema,"Ophthalmology, 2003, 110(11):2106-12.

Teboul BK, Jacob JL, Barsoum-Homsy M, et al, "Clinical Evaluation of Aminocaproic Acid for Managing Traumatic Hyphema in Children,"Ophthalmology, 1995, 102(11):1646-53.

Walton W, Von Hagen S, Grigorian R, et al, "Management of Traumatic Hyphema,"Surv Ophthalmol, 2002, 47(4):297-334.

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