AMINOCAPROIC ACID solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)

から入手可能:

Carnegie Pharmaceuticals, LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Aminocaproic acid 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, usually 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. ) Aminocaproic acid 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 aminocaproic acid. 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; a precipitate forms when protamine sulfate is dropped into citrated plasma. The test is negative in the presence of primary fibrinolysis. The euglobulin clot lysis test is abnormal in primary fibrinolysis but normal in DIC. Aminocaproic acid must not be used in the presence of DIC without concomitant heparin.

製品概要:

Aminocaproic acid Oral Solution USP, 0.25 g/mL Each mL of raspberry-flavored oral solution contains 0.25 g/mL of aminocaproic acid, USP. 8 Fl. Oz. (236.5 mL) Bottle – NDC 80005-130-22 Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature];Dispense in Tight Containers; Do Not Freeze.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

AMINOCAPROIC ACID- AMINOCAPROIC ACID SOLUTION
CARNEGIE PHARMACEUTICALS, LLC
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AMINOCAPROIC ACID ORAL SOLUTION, USP
RX ONLY
DESCRIPTION
Aminocaproic acid, USP is 6-aminohexanoic acid, which acts as an
inhibitor of
fibrinolysis.
Its chemical structure is:
Aminocaproic acid, USP is soluble in water, acid, and alkaline
solutions; it is sparingly
soluble in methanol and practically insoluble in chloroform.
Aminocaproic acid Oral Solution, USP for oral administration, contains
0.25 g/mL of
aminocaproic acid, USP 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.
CLINICAL PHARMACOLOGY
The fibrinolysis-inhibitory effects of aminocaproic acid appear to be
exerted principally
via inhibition of plasminogen activators and to a lesser degree
through antiplasmin
activity.
In adults, oral absorption appears to be a zero-order process with an
absorption rate of
5.2 g/hr. The mean lag time in absorption is 10 minutes. After a
single oral dose of 5 g,
absorption was complete (F=1). Mean ± SD peak plasma concentrations
(164 ± 28
mcg/mL) were reached within 1.2 ± 0.45 hours.
After oral administration, the apparent volume of distribution was
estimated to be 23.1
± 6.6 L (mean ± SD). Correspondingly, the volume of distribution
after intravenous
administration has been reported to be 30.0 ± 8.2 L. After prolonged
administration,
aminocaproic acid has been found to distribute throughout
extravascular and
intravascular compartments of the body, penetrating human red blood
cells as well as
other tissue cells.
Renal excretion is the primary route of elimination. Sixty-five
percent of the dose is
recovered in the urine as unchanged drug and 11% of the dose appears
as the
metabolite adipic acid. Renal clearance (116 mL/min) approximates
endogenous
creatinine clearance. The total body clearance is 169 mL/min. The
ter