Clinical Information
Gen. Code and Des.
6503 aminocaproic acid ORAL SOLUTION 250 MG/ML
Strength
250 mg/mL
Dose Form
SOLUTION, ORAL
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
20281600 HEMOSTATICS
Active Ingredients
2072 aminocaproic acid 60322
Inactive Ingredients
2468 propylene glycol 57556
2599 sorbitol 50704
2600 saccharin 81072
3203 paraben 99967
3785 edetic acid 60004
AMICAR- aminocaproic acid tablet
AMICAR- aminocaproic acid solution
Xanodyne Pharmaceuticals, Inc.
DESCRIPTION
AMICAR (aminocaproic acid) is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis.
AMICAR is soluble in water, acid, and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform.
AMICAR (aminocaproic acid) Oral Solution for oral administration, contains 0.25 g/mL of aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%, edetate disodium 0.30% as preservatives and the following inactive ingredients: sodium saccharin, sorbitol solution, citric acid anhydrous, natural and artificial raspberry flavor and an artificial bitterness modifier.
Each AMICAR (aminocaproic acid) Tablet, for oral administration contains 500 mg or 1000 mg of aminocaproic acid and the following inactive ingredients: povidone, crospovidone, stearic acid, and magnesium stearate.
CLINICAL PHARMACOLOGY
The fibrinolysis-inhibitory effects of AMICAR appear to be exerted principally via inhibition of plasminogen activators and to lesser degree through antiplasmin activity.
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 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
CONTRAINDICATIONS
AMICAR should not be used when there is evidence of an active intravascular clotting process.
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 AMICAR.
The following tests can be applied to differentiate the two conditions:
Platelet count is usually decreased in DIC but normal in primary fibrinolysis.
Protamine paracoagulation test is positive in DIC; precipitate forms when protamine sulfate is dropped into citrated plasma. The test is negative in the presence of primary fibrinolysis.
The euglobulin clot Iysis test is abnormal in primary fibrinolysis but normal in DIC.
AMICAR must not be used in the presence of DIC without concomitant heparin.
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 AMICAR 1000 mg Tablets or 10 AMICAR 500 mg Tablets ) or 20 milliliter of AMICAR Oral Solution ) be administered during the first hour of treatment, followed by continuing rate of AMICAR 1000 mg Tablet or AMICAR 500 mg Tablets ) or milliliter of AMICAR Oral Solution (1.25 g) per hour. This method of treatment would ordinarily be continued for about hours or until the bleeding situation has been controlled.
Pregnancy
Pregnancy Category C
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 AMICAR 1000 mg Tablets or 10 AMICAR 500 mg Tablets ) or 20 milliliter of AMICAR Oral Solution ) be administered during the first hour of treatment, followed by continuing rate of AMICAR 1000 mg Tablet or AMICAR 500 mg Tablets ) or milliliter of AMICAR Oral Solution (1.25 g) per hour. This method of treatment would ordinarily be continued for about 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 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 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.
