AMINOCAPROIC ACID tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Aminocaproic Acid (UNII: U6F3787206) (Aminocaproic Acid - UNII:U6F3787206)

Available from:

Vitruvias Therapeutics

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aminocaproic Acid Tablets 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 Tablets should not be used when there is

Product summary:

Aminocaproic Acid Tablets, USP 500 mg Each round, white to off-white tablet, bisect debossed with logo "010" on top and bottom of the scored line on one side and the other side is blank, contains 500 mg of aminocaproic acid. Bottle of 30 – NDC 69680-115-30 Bottle of 100 – NDC 69680-115-00 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 oblong, white to off-white tablet, bisect debossed with logo "009" on left and right of the scored line on one side and the other side is blank, contains 1000 mg of aminocaproic acid. Bottle of 30 – NDC 69680-116-30 Bottle of 100 – NDC 69680-116-00 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in Tight Containers.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMINOCAPROIC ACID- AMINOCAPROIC ACID TABLET
VITRUVIAS THERAPEUTICS
----------
AMINOCAPROIC ACID TABLETS, USP
RX ONLY
DESCRIPTION
Aminocaproic Acid Tablets (aminocaproic acid) is 6-aminohexanoic acid,
which acts as
an inhibitor of fibrinolysis. Its chemical structure is:
C H
NO M.W. 131.17
Aminocaproic acid is soluble in water, acid, and alkaline solutions;
it is sparingly soluble in
methanol and practically insoluble in chloroform.
Each Aminocaproic Acid Tablets, for oral administration contains 500
mg or 1000 mg of
aminocaproic acid and the following inactive ingredients: povidone,
crospovidone, stearic
acid, and magnesium stearate.
CLINICAL PHARMACOLOGY
The fibrinolysis-inhibitory effects of Aminocaproic Acid Tablets
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 Tablets 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 Tablets is approximately 2 hours.
6 13
2
INDICATIONS AND USAGE
Aminocaproic A