AMINOCAPROIC ACID tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

American Health Packaging

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Aminocaproic Acid Tablets USP 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, 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

Περίληψη προϊόντος:

Aminocaproic Acid Tablets USP, 500 mg Each oval, white to off-white tablet, engraved with AMG on one side and scored on the other with 3 to the left of the score and 19 on the right, contains 500 mg of aminocaproic acid. Unit dose packages of 30 (3 x 10) NDC 60687-724-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

AMINOCAPROIC ACID- AMINOCAPROIC ACID TABLET
AMERICAN HEALTH PACKAGING
----------
AMINOCAPROIC ACID TABLETS USP
8472421/0123F
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.
Each Aminocaproic Acid Tablet USP for oral administration contains 500
mg of
aminocaproic acid USP and the following inactive ingredients:
povidone, crospovidone,
stearic acid, and magnesium stearate.
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 are useful in enhancing hemostasis when
fibrinolysis