AMINOCAPROIC ACID tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Leading Pharma, LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Aminocaproic acid Tablets USP, 500 mg Each white, round, standard concave tablet debossed with "LP 231" on one side and scored on other side, contains 500 mg of aminocaproic acid. Bottle of 30 – NDC 69315-231-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in Tight Containers. Aminocaproic acid Tablets USP, 1000 mg Each white, caplet shaped tablet debossed with "LP 232" on one side and scored on other side, contains 1000 mg of aminocaproic acid. Bottle of 30 – NDC 69315-232-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in Tight Containers.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

AMINOCAPROIC ACID- AMINOCAPROIC ACID TABLET
LEADING PHARMA, LLC
----------
AMINOCAPROIC ACID TABLETS, 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 soluble in water, acid, and alkaline
solutions; it is sparingly
soluble in methanol and practically insoluble in chloroform.
Each Aminocaproic Acid Tablet, for oral administration contains 500 mg
or 1000 mg of
aminocaproic acid and the following inactive ingredients:
crospovidone, magnesium
stearate, 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 is useful in enhancing hemostasis when fibrinolysis
contributes to
bleed