AMINOCAPROIC ACID tablet

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:

MSN LABORATORIES PRIVATE LIMITED

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Aminocaproic acid tablets, USP 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

製品概要:

Aminocaproic acid Tablets, USP 500 mg Each white to off white colored, round shaped, uncoated tablets with break line debossed with "MA" and" 17 " on one side and plain on other side, contains 500 mg of aminocaproic acid. Bottle of 30 – NDC 69539-161-30 Store at 20° to 25°C (68° to 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 TABLET
MSN LABORATORIES PRIVATE LIMITED
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AMINOCAPROIC ACID TABLETS, USP 500 MG
RX ONLY
DESCRIPTION
Aminocaproic acid USP is 6-aminohexanoic acid, which acts as an
inhibitor of fibrinolysis.
Its chemical structure is:
Aminocaproic acid is freely soluble in water; it is slightly soluble
in methanol and practically insoluble
in chloroform and diethyl ether.
Each aminocaproic acid Tablet, for oral administration contains 500 mg
of aminocaproic acid USP and
the following inactive ingredients: colloidal silicon dioxide,
crospovidone, magnesium stearate,
microcrystalline cellulose, povidone and stearic acid.
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 AND USAGE
Aminocaproic acid tablets, USP is