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:

Amneal Pharmaceuticals NY LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aminocaproic acid tablets are 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 evidenc

Product summary:

Aminocaproic Acid Tablets USP, 500 mg are supplied as round shape with notch, uncoated, biconvex, white to off-white tablets, debossed with identification marking “C” and “17” on either side of the score line on one side and plain on the other side. They are available as follows: Bottles of 30:                 NDC 60219-1637-3 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMINOCAPROIC ACID- AMINOCAPROIC ACID TABLET
AMNEAL PHARMACEUTICALS NY LLC
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AMINOCAPROIC ACID TABLETS, USP
(500 MG)
RX ONLY
DESCRIPTION
Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor
of fibrinolysis.
Its chemical structure is:
Aminocaproic acid, USP is a fine, white to almost white, crystalline
powder. It is freely soluble in
water, in acids, and in alkaline solutions; it is slightly soluble in
methanol and practically insoluble in
chloroform and in ether.
Each aminocaproic acid tablet, USP for oral administration contains
500 mg of aminocaproic acid, USP
and the following inactive ingredients: crospovidone type B, magnesium
stearate, povidone and stearic
acid.
Meets USP Dissolution Test 2.
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
app