Amicar Oral Solution

— THERAPEUTIC DISORDERS TREATED —
  • Bleeding disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Amicar Oral Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Aminocaproic acid 250mg/mL; raspberry-flavor.

    Pharmacological Class

    Hemostatic.

    See Also

    How Supplied

    Tabs—30; Oral soln—236.5mL

    How Supplied

    Oral Solution

    • Bottle containing 236.5mL Each mL of raspberry-flavored oral solution contains 250 mg of aminocaproic acid.

    Storage

    Oral solution: Store between 15°-30°C (59°-86°F); dispense in tight containers; do not freeze.

    Manufacturer

    Akorn, Inc.

    Generic Availability

    YES

    Amicar Oral Solution Indications

    Indications

    Bleeding associated with fibrinolysis.

    Amicar Oral Solution 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.

    Adult

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

    Children

    Not recommended.

    Renal Impairment

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

    Amicar Oral Solution Contraindications

    Contraindications

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

    Amicar Oral Solution Boxed Warnings

    Not Applicable

    Amicar Oral Solution Warnings/Precautions

    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.

    Warnings/Precautions

    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 Oral Solution Pharmacokinetics

    Absorption

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

    Distribution

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

    Elimination

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

    Amicar Oral Solution Interactions

    Interactions

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

    Amicar Oral Solution 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 Oral Solution Clinical Trials

    See Literature

    Amicar Oral Solution Note

    Not Applicable

    Amicar Oral Solution Patient Counseling

    See Literature

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