AMICAR- 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:

Carilion Materials Management

INN (International Name):

LISINOPRIL

Composition:

LISINOPRIL 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AMICAR 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 .) AMICAR should not be used when there is evidence of an active intravascular c

Product summary:

Product: 68151-3023 NDC: 68151-3023-1 1 TABLET in a BLISTER PACK

Authorization status:

New Drug Application

Summary of Product characteristics

AMICAR - AMINOCAPROIC ACID TABLET
CARILION MATERIALS MANAGEMENT
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AMICAR
R ONLY
DESCRIPTION
AMICAR (aminocaproic acid) is 6-aminohexanoic acid, which acts as an
inhibitor of fibrinolysis.
Its chemical structure is:
AMICAR is soluble in water, acid, and alkaline solutions; it is
sparingly soluble in methanol and
practically insoluble in chloroform.
AMICAR (aminocaproic acid) Oral Solution for oral administration,
contains 0.25 g/mL of
aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%,
edetate disodium 0.30% as
preservatives and the following inactive ingredients: sodium
saccharin, sorbitol solution, citric acid
anhydrous, natural and artificial raspberry flavor and an artificial
bitterness modifier.
Each AMICAR (aminocaproic acid) Tablet, 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 AMICAR 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, AMICAR 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