AMINOCAPROIC ACID injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Civica, Inc.

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Aminocaproic Acid Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, 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 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 frequently be associated with life-threatening complications following severe trauma, anoxia, and shock.  Symptomatic of such complications is surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system).  (See WARNINGS.) Aminocaproic acid should

Περίληψη προϊόντος:

Aminocaproic Acid Injection, USP, 250 mg/mL. For intravenous infusion after dilution. NDC 72572-015-25  20 mL multiple dose vial Boxes of 25 Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). Mfd for: Civica, Inc. Lehi, Utah 84043 Mfd by: American Regent, Inc. Shirley, New York 11967 IN015 Rev. 05/2020 MG #47339

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

AMINOCAPROIC ACID- AMINOCAPROIC ACID INJECTION, SOLUTION
CIVICA, INC.
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AMINOCAPROIC ACID INJECTION, USP
RX ONLY
DESCRIPTION
Aminocaproic Acid is 6-aminohexanoic acid, which acts as an inhibitor
of fibrinolysis. The structural
formula is:
NH CH (CH ) CH COOH
The molecular formula is: C H NO Molecular Weight: 131.17
Aminocaproic Acid is soluble in water, acid and alkaline solutions; it
is sparingly soluble in methanol
and practically insoluble in chloroform.
Aminocaproic Acid Injection, USP, for intravenous administration, is a
sterile pyrogen-free solution
containing 250 mg/mL of Aminocaproic Acid with Benzyl Alcohol 0.9%, as
a preservative, and Water
for Injection q.s. The pH is adjusted to approximately 6.8 with
Hydrochloric Acid and/or Sodium
Hydroxide.
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, whether
aminocaproic acid is administered orally or
intravenously. 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 cl