Amicar (Aminocaproic Acid) - Indications and Dosage

INDICATIONS AND USAGE

AMICAR is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products 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 amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.

Urinary fibrinolysis, usualIy a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.)

DOSAGE AND ADMINISTRATION

An identical dosage regimen may be followed by administering AMICAR Tablets or AMICAR Oral Solution as follows:

For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 5 AMICAR 1000 mg Tablets or 10 AMICAR 500 mg Tablets (5 g) or 20 milliliter of AMICAR Oral Solution (5 g) be administered during the first hour of treatment, followed by a continuing rate of 1 AMICAR 1000 mg Tablet or 2 AMICAR 500 mg Tablets (1 g) or 5 milliliter of AMICAR Oral Solution (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.

HOW SUPPLIED:

AMICAR^®

(aminocaproic acid)

AMICAR Oral Solution, 0.25 g/mL

Each mL of raspberry-flavored oral solution contains 0.25 g/mL 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.