AMINOCAPROIC ACID injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Aminocaproic Acid Injection, USP is supplied in single-dose containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] References * Stefanini, M. and Dameshek, W.: The Hemorrhagic Disorder, Ed. 2, New York. Grune and Stratton, pp. 510-514, 1962. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. LAB-0947-3.0 Revised: 6/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMINOCAPROIC ACID- AMINOCAPROIC ACID INJECTION, SOLUTION
HOSPIRA, INC.
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AMINOCAPROIC ACID
INJECTION, USP
5 G/20 ML (250 MG/ML)
PLASTIC FLIPTOP VIAL Rx only
_DESCRIPTION_
Aminocaproic Acid Injection, USP is a 6-aminohexanoic acid, which acts
as an inhibitor of fibrinolysis.
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 and Water for Injection. The
solution contains no
bacteriostat or antimicrobial agent and is intended for use only as a
single-dose injection. When smaller
doses are required the unused portion should be discarded.
Hydrochloric acid may be added to adjust
pH to approximately 6.8 during manufacture.
Its chemical structure is:
NH - CH - CH - CH - CH - CH - COOH
Molecular Weight: 131.17
The semi-rigid vial is fabricated from a specifically formulated
polyolefin. It is a copolymer of
ethylene and propylene. The safety of the plastic has been confirmed
by tests in animals according to
USP biological standards for plastic containers. The container
requires no vapor barrier to maintain the
proper drug concentration.
_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 ± 8.2 L. After
prolonged adm