AMINOCAPROIC ACID solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Aminocaproic Acid (UNII: U6F3787206) (Aminocaproic Acid - UNII:U6F3787206)

Tilgjengelig fra:

Taro Pharmaceuticals U.S.A., Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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, 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.) Aminocaproic acid should not be used when there is evidence of an a

Produkt oppsummering:

Aminocaproic acid oral solution, 0.25 g/mL Each mL of tutti frutti flavored oral solution contains 0.25 g/mL of aminocaproic acid. 8 Fl. Oz. (236.5 mL) Bottle with child-resistant closure – NDC 51672-4226-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in Tight Containers; Do Not Freeze.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMINOCAPROIC ACID- AMINOCAPROIC ACID SOLUTION
TARO PHARMACEUTICALS U.S.A., INC.
----------
AMINOCAPROIC ACID ORAL SOLUTION USP, 0.25 G/ML
RX ONLY
DESCRIPTION
Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor
of fibrinolysis.
Its chemical structure is:
C H
NO M.W. 131.17
Aminocaproic acid is soluble in water, acid, and alkaline solutions;
it is sparingly soluble in
methanol and practically insoluble in chloroform.
Aminocaproic acid oral solution for oral administration, contains 0.25
g/mL of
aminocaproic acid with methylparaben 0.22%, propylparaben 0.055%,
edetate disodium
0.30% as preservatives and the following inactive ingredients: citric
acid anhydrous,
noncrystalline sorbitol solution (70%), purified water, sucralose
powder, tutti frutti
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