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.

INN (International Name):

AMINOCAPROIC ACID

Composition:

AMINOCAPROIC ACID 250 mg in 1 mL

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 shoul

Product summary:

Aminocaproic Acid Injection, USP is supplied in single-dose containers as follows: NDC 0409-4346-73 Tray containing 25 Single-dose (20 mL in 30 mL) Fliptop Vials 5 g/20 mL (250 mg/mL) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

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
R 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
adminis