AMINOCAPROIC ACID solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Aurobindo Pharma Limited

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Aminocaproic acid oral solution 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 oral solution should not be used w

Dettagli prodotto:

Aminocaproic Acid  Oral Solution USP, 0.25 grams/mL                                                      Each mL of clear colorless to light yellow colored raspberry flavored oral solution contains 0.25 grams/mL of aminocaproic acid, USP available in: 8 Fl. Oz. (236.5 mL) Bottle                  NDC 59651-573-08 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in Tight Containers; Do Not Freeze.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

AMINOCAPROIC ACID - AMINOCAPROIC ACID SOLUTION
AUROBINDO PHARMA LIMITED
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AMINOCAPROIC ACID ORAL SOLUTION
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 freely soluble in water, slightly soluble in
methanol, practically
insoluble in acetone, in hexane, in methylene dichloride and in
isopropyl alcohol.
Aminocaproic acid oral solution, USP for oral administration, contains
0.25 grams/mL of
aminocaproic acid, USP with methylparaben 0.20%, propylparaben 0.05%,
edetate
disodium 0.30% as preservatives and the following inactive
ingredients: art raspberry FL
(contains propylene glycol), citric acid anhydrous, masking flavor
(contains acesulfame,
acetic acid, ammoniated glycyrrhizin, artificial flavors, aspartame,
propylene glycol and
water), purified water, sorbitol solution, and sucralose.
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