AMINOCAPROIC ACID tablet AMINOCAPROIC ACID syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Versapharm Incorporated

INN (International Name):

AMINOCAPROIC ACID

Composition:

AMINOCAPROIC ACID 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, 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 evidence of an

Product summary:

Aminocaproic Acid Oral Solution USP, 0.25 g/mL Each mL of raspberry-flavored oral solution contains 0.25 g/ mL of aminocaproic acid and is supplied in bottles of 8 fl. oz. (237 mL), NDC 61748-044-08 and 16 fl. oz. (473 mL), NDC 61748-044-16. Aminocaproic Acid Tablets USP, 500 mg Each round, white tablet, debossed “VP” score “045”on one side contains 500 mg of aminocaproic acid and is supplied in bottles of 100 tablets, NDC 61748-045-01, and hospital unit-dose cartons of 100 tablets (10 blister cards of 10 tablets per blister card), NDC 61748-045-11. Aminocaproic Acid Tablets USP, 1000 mg Each oblong, white tablet, engraved with “XP” on one side and scored on the other with “A” to the left of the score and “20” on the right contains 1000 mg of aminocaproic acid in bottles of 100 tablets, NDC 61748-046-01.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMINOCAPROIC ACID- AMINOCAPROIC ACID TABLET
AMINOCAPROIC ACID- AMINOCAPROIC ACID SYRUP
VERSAPHARM INCORPORATED
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AMINOCAPROIC ACID TABLETS USP 500 MG, 1000 MG AND ORAL SOLUTION 0.25
G/ML
RX ONLY
DESCRIPTION
Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor
of fibrinolysis.
Its chemical structure is:
Aminocaproic acid is soluble in water, acid, and alkaline solutions;
it is sparingly soluble in methanol
and practically insoluble in chloroform.
Aminocaproic acid oral solution for oral administration contains 0.25
g/mL of aminocaproic acid and
the following inactive ingredients: citric acid (anhydrous),
methylparaben, propylene glycol,
propylparaben, purified water, saccharin sodium, sorbitol solution and
natural and artificial flavor.
Each aminocaproic acid tablet for oral administration contains either
500 mg or 1000 mg of
aminocaproic acid and the following inactive ingredients: magnesium
stearate, povidone and stearic
acid. The 1000 mg tablet also contains crospovidone.
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 do