AMICAR 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:

Avera McKennan Hospital

INN (Διεθνής Όνομα):

AMINOCAPROIC ACID

Σύνθεση:

AMINOCAPROIC ACID 500 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

AMICAR- AMINOCAPROIC ACID TABLET
AVERA MCKENNAN HOSPITAL
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AMICAR (AMINOCAPROIC ACID)
ORAL SOLUTION AND TABLETS
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