AMICAR is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other emergency measures may be required. 

Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as aplastic anemia; abruptio placentae; hepatic cirrhosis; neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. 

Urinary fibrinolysis, usually a normal physiological phenomenon, may frequently be associated with life-threatening complications following severe trauma, anoxia, and shock. Symptomatic of such complications is surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.) 

Intravenous 

AMICAR (aminocaproic acid) Injection is administered by infusion, utilizing the usual compatible intravenous vehicles (e.g., Sterile Water for Injection, Sodium Chloride for Injection, 5% Dextrose or Ringer's Injection). Although Sterile Water for Injection is compatible for intravenous injection the resultant solution is hypo-osmolar. RAPID INJECTION OF AMICAR INJECTION UNDILUTED INTO A VEIN IS NOT RECOMMENDED. 

For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 16 to 20 mL (4 to 5 g) of AMICAR Injection in 250 mL of diluent be administered by infusion during the first hour of treatment, followed by a continuing infusion at the rate of 4 mL (1 g) per hour in 50 mL of diluent. This method of treatment would ordinarily be continued for about 8 hours or until the bleeding situation has been controlled. 

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 

Oral Therapy 

If the patient is able to take medication by mouth, an identical dosage regimen may be followed by administering AMICAR Tablets or AMICAR Syrup, 25% as follows:

For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 10 tablets (5 g) or 4 teaspoonfuls of syrup (5 g) of AMICAR be administered during the first hour of treatment, followed by a continuing rate of 2 tablets (1 g) or 1 teaspoonful of syrup (1.25 g) per hour. This method of treatment would ordinarily be continued for about 8 hours or until the bleeding situation has been controlled. 

AMICAR®(aminocaproic acid)

AMICAR Injection

Each 20 mL vial contains 5 g of aminocaproic acid (250 mg/mL)as an aqueous solution with benzyl alcohol 0.9% as preservative. 

20 mL vial - NDC 66479-025-39

Store Between 15°- 30°C (59°- 86°F).  Do Not Freeze.

AMICAR® Syrup, 25%

Each mL of raspberry-flavored syrup contains 250 mg of aminocaproic acid.

16 Fl. Oz. (473 mL) Bottle - NDC 66479-023-56

Store Between 15°- 30°C (59°- 86°F). Dispense in tight containers . Do Not Freeze..

AMICAR 500 mg Tablets

Each 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, contains 500 mg of aminocaproic acid.

Bottle of 100— NDC 66479-021-82

Store Between 15°- 30 °C (59°- 86°F); Dispense in Tight Containers.

AMICAR 1000 mg Tablets

Each 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, contains 1000 mg of aminocaproic acid.

Bottle of 100 — NDC 66479-022-82

Store Between 15°- 30°C (59°- 86°F); Dispense in Tight Containers.

1.Stefanini M, Dameshek W: The Hemorrhagic Disorders, Ed. 2, New York, Grune and Stratton. 1962; pp. 510-514. 

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