AMINOCAPROIC ACID solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Amneal Pharmaceuticals NY LLC

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 should not be used when there is evi

Ürün özeti:

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 with child-resistant closure –     NDC 69238-1596-8 5 mL unit dose cup                                                                 NDC 69238-1596-3 10 unit dose cups in a tray                                                      NDC 69238-1596-4 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in Tight Containers; Do Not Freeze.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

AMINOCAPROIC ACID- AMINOCAPROIC ACID SOLUTION
AMNEAL PHARMACEUTICALS NY LLC
----------
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 freely soluble in water, in acid, and in
alkaline solutions, slightly
soluble in methanol and in alcohol, practically insoluble in
chloroform and in ether.
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, citric acid anhydrous, glycerin, propylene
glycol, purified water,
natural and artificial raspberry flavor.
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 clea