AMINOCAPROIC ACID tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Edenbridge Pharmaceuticals LLC.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 abruption 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 

Resumo do produto:

Aminocaproic Acid Tablets USP, 500 mg    Each round, convex, white to off-white tablet scored on one side and imprinted with  on the other side, contains 500 mg of Aminocaproic acid, USP. Bottle of 30 – NDC 42799 054 02   Store   at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature];Dispense in Tight Containers.         

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AMINOCAPROIC ACID - AMINOCAPROIC ACID TABLET
EDENBRIDGE PHARMACEUTICALS LLC.
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DESCRIPTION
Aminocaproic acid, USP is 6-
aminohexanoic acid, which acts as an inhibitor of fibrinolysis.
Its chemical structure is:
Aminocaproic acid is soluble in water, acid, and alkaline solutions;
it
is sparingly soluble in methanol and practically insoluble in
chloroform.
Each Aminocaproic Acid Tablet USP, for oral administration contains
500 mg of
aminocaproic acid and the following inactive ingredients: povidone,
crospovidone, stearic acid, and magnesium stearate.
FDA approved dissolution specification differs from the USP
dissolution specification.
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 terminal elimination half-life for aminocaproic acid is
approximately 2 hours.
INDICATIONS & USAGE
Aminocaproic acid
is useful in enhanci