Amicar Oral Solution Generic Name & Formulations
Tabs—30; Oral soln—236.5mL
- Bottle containing 236.5mL Each mL of raspberry-flavored oral solution contains 250 mg of aminocaproic acid.
Oral solution: Store between 15°-30°C (59°-86°F); dispense in tight containers; do not freeze.
Amicar Oral Solution Indications
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.
Amicar Oral Solution Contraindications
Amicar Oral Solution Boxed Warnings
Amicar Oral Solution 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.
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.
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.
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
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 Oral Solution Interactions
Amicar Oral Solution Adverse Reactions
Bradycardia, hypotension, GI upset, edema, headache, malaise, CNS effects, thrombosis, others; rare: myopathy.
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
Amicar Oral Solution Note
Amicar Oral Solution Patient Counseling