Amicar Tablets

  • Bleeding disorders

Amicar Tablets Generic Name & Formulations

General Description

Aminocaproic acid 500mg, 1000mg; scored tabs.

Pharmacological Class


How Supplied

Tabs—30; Oral soln—236.5mL

How Supplied


  • Amicar 500mg (round, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 10 on the right)—Bottles of 30
  • Amicar 1000mg (oblong, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 20 on the right)—Bottles of 30


Tablets: Store between 15°-30°C (59°-86°F); dispense in tight containers.



Generic Availability


Amicar Tablets Indications


Bleeding associated with fibrinolysis.

Amicar Tablets Dosage and Administration

Prior to Treatment Evaluations

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.

  • Platelet count usually decreased in DIC but normal in primary fibrinolysis.
  • Protamine paracoagulation test positive in DIC but negative in the presence of primary fibrinolysis.
  • The euglobulin clot lysis test is abnormal in primary fibrinolysis but normal in DIC.

Do not administer without a definite diagnosis and/or lab finding indicative of hyperfibrinolysis. The use of aminocaproic acid should be accompanied by tests designed to determine the amount of fibrinolysis present.


Initially 5g during 1st hour, then 1g/hour for 8 hours or until bleeding is controlled.


Not recommended.

Renal Impairment

Higher plasma concentrations of aminocaproic acid may occur in patients with severe renal failure.

Amicar Tablets Contraindications


Active intravascular clotting process. Disseminated intravascular coagulation without concomitant heparin.

Amicar Tablets Boxed Warnings

Not Applicable

Amicar Tablets Warnings/Precautions


Upper urinary tract bleeding: not recommended. Cardiac, hepatic or renal disease. Risk of myopathy with long-term use; monitor creatine phosphokinase (CPK); discontinue if CPK rises. Avoid rapid IV administration. Neonates. Pregnancy (Cat.C). Nursing mothers.


Upper Urinary Tract Bleeding

Amicar has been known to cause intrarenal obstruction (eg, glomerfuler capillary thrombosis, clots in the renal pelvis and ureters). Do not use in hematuria of upper urinary tract origin, unless the benefits outweigh the risks.

Prolonged Administration

Skeletal muscle weakness with necrosis of muscle fibers has been reported. Monitor creatine phosphokinase (CPK) levels in patients on long-term therapy. Discontinue treatment if a rise in CPK is observed. CPK elevation resolves following discontinuation; however, it may recur if Amicar is restarted. Cardiac muscle damage should also be considered when skeletal myopathy occurs.

Pregnancy Considerations

It is not known whether aminocaproic acid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Administer only if clearly needed.

Nursing Mother Considerations

Use caution in nursing women as it is unknown whether aminocaproic acid is excreted in human milk.

Pediatric Considerations

Safety and effectiveness in pediatric patients have not been established. 

Renal Impairment Considerations

Higher plasma concentrations of aminocaproic acid may occur in patients with severe renal failure.

Amicar Tablets Pharmacokinetics


After a single oral dose of 5g, mean ± SD peak plasma concentrations (164 ± 28mcg/mL) were reached within 1.2 ± 0.45 hours.


After oral administration, volume of distribution was estimated to be 23.1 ± 6.6 L (mean±SD).


Renal excretion is the primary route of elimination. Terminal elimination half-life is approximately 2 hours.

Amicar Tablets Interactions


Avoid concomitant Factor IX complex or Anti-inhibitor Coagulant concentrates; may increase thrombosis risk.

Amicar Tablets Adverse Reactions

Adverse Reactions

Bradycardia, hypotension, GI upset, edema, headache, malaise, CNS effects, thrombosis, others; rare: myopathy.

Adverse Reactions

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: Increased CPK, muscle weakness, myalgia, myopathy, 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: Increased BUN, renal failure, dry ejaculation (in hemophilia patients who received the drug after undergoing dental surgical procedures). 

Amicar Tablets Clinical Trials

See Literature

Amicar Tablets Note

Not Applicable

Amicar Tablets Patient Counseling

See Literature