Adult Dosing

Acute bleeding syndromes due to elevated fibrinolytic activity

• 5000 mg PO in the first hour; then 1000 mg PO q1 hr x 8 hrs or until the bleeding is controlled

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• For enhancement of hemostasis in acute, life-threatening hemorrhage due to systemic hyperfibrinolysis or urinary fibrinolysis

• Hypersensitivity to any of the ingredients of the product
• Evidence of an active intravascular clotting process
• Disseminated intravascular coagulation (DIC) without concomitant heparin

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Aminocaproic acid may cause intrarenal obstruction in the form of glomerular capillary thrombosis or clots in the renal pelvis and ureters when used in patients with upper urinary tract bleeding. Hence, should be used in hematuria of upper urinary tract origin, only if the possible benefits outweigh the risk
• Prolonged administration of aminocaproic acid can cause skeletal muscle weakness with necrosis of muscle fibers. Clinical presentation may range from mild myalgias with weakness and fatigue to a severe proximal myopathy with rhabdomyolysis, myoglobinuria, and acute renal failure. Monitor creatine phosphokinase (CPK) levels periodically during long-term use and discontinue the therapy if a rise in CPK is noted
• Consider the possibility of cardiac muscle damage when skeletal myopathy occurs due to aminocaproic acid use
• Do not use without a definite diagnosis and/or laboratory finding indicative of hyperfibrinolysis because aminocaproic acid inhibits both the action of plasminogen activators and to a lesser degree, plasmin activity
• There have been reports indicating increased incidence of certain neurological deficits such as hydrocephalus, cerebral ischemia, or cerebral vasospasm associated with the use of antifibrinolytic agents in the treatment of subarachnoid hemorrhage (SAH). However, these events have also been described as part of the natural course of SAH; hence, the drug relatedness is unclear
• Do not administer with Factor IX complex concentrates or anti-inhibitor coagulant concentrates as it may increase the risk of thrombosis
• Before administering aminocaproic acid, the amount of fibrinolysis present should be determined by using both semiquantitative and quantitative techniques for the determination of profibrinolysin, fibrinolysin, and antifibrinolysin

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Cardiovascular diseases

Pregnancy Category:C

Breastfeeding: As per manufacturer's data, it is not known whether the drug is excreted in human milk; caution should be exercised when administered to a nursing woman.

• NEURO: Confusion, convulsions, delirium, dizziness, hallucinations, intracranial hypertension, stroke
• CNS: Headache, seizures
• CV: Bradycardia, hypotension, peripheral ischemia, thrombosis, syncope
• RESP: Dyspnea, nasal congestion, pulmonary embolism, neonatal gasping syndrome
• HYPERSENSITIVITY: Allergic and anaphylactoid reactions, anaphylaxis
• GI: Abdominal pain/cramps, diarrhea, nausea, vomiting
• HEMA: Agranulocytosis, coagulation disorders, leukopenia, thrombocytopenia
• MUSC: CPK increased, muscle weakness, myalgia, myopathy, myositis, rhabdomyolysis
• DERM: Pruritus, rash
• EENT: Tinnitus, decreased vision, watery eyes
• GU: Renal failure, increased BUN
• MISC: Edema, malaise

• Antifibrinolytic agent; binds reversibly to plasminogen and blocks the binding of plasminogen to fibrin and its subsequent conversion to plasmin there by inhibiting fibrinolysis, which reduces the amount of bleeding
• Metabolism: Liver; CYP450: Unknown
• Excretion: Urine primarily (65% unchanged)
• Half-life: 2 hrs

US Trade Name(s)

• Amicar

US Availability

aminocaproic acid (generic)

• TABS: 500 mg
• SOLN: 250 mg/mL

Amicar

• TABS: 500, 1000 mg
• SOLN: 250 mg/mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Hemostatic Agent

Antifibrinolytic Agents

Pricing data from www.DrugStore.com in U.S.A.

• Amicar 500 MG TABS [Bottle] (XANODYNE PHARMACEUTICALS)
  INC mg = $30
  mg = $90
• Aminocaproic Acid 500 MG TABS [Bottle] (VERSAPHARM)
  100 mg = $195.79
  300 mg = $566.19

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Amicar 1000 MG Oral Tablet

Ingredient(s): 6-Aminocaproic Acid

Imprint: XP;A;20

Color(s): White

Shape: Oval

Size (mm): 22.00

Score: 2

Inactive Ingredient(s): povidone / crospovidone / stearic acid / magnesium stearate

Drug Label Author:
XANODYNE PHARMACEUTICALS, INC.

DEA Schedule:
Non-Scheduled

Drug Name: Amicar 500 MG Oral Tablet

Pill Image:

[
See full size image]

Ingredient(s): 6-Aminocaproic Acid

Imprint: XP;A;10

Color(s): White

Shape: Round

Size (mm): 13.00

Score: 2

Inactive Ingredient(s): povidone / crospovidone / stearic acid / magnesium stearate

Drug Label Author:
XANODYNE PHARMACEUTICALS, INC.

DEA Schedule:
Non-Scheduled