AMINOCAPROIC ACID injection, solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Henry Schein, Inc.

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

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

製品概要:

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.]  NDC 0409-4346-73  Tray containing 25 Single-dose  (20 mL in 30 mL Fliptop Vials  NDC 0404-9812-20  1 20 mL in 30 mL Single-dose  Fliptop Vial in a bag  (Vial bears NDC 0409-4346-16)  5 g/20 mL  (250 mg/mL)

認証ステータス:

Abbreviated New Drug Application

製品の特徴

AMINOCAPROIC ACID- AMINOCAPROIC ACID INJECTION, SOLUTION
HENRY SCHEIN, INC.
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AMINOCAPROIC ACID INJECTION, USP
5 G/20 ML (250 MG/ML)
PLASTIC FLIPTOP VIAL
RX ONLY
DESCRIPTION
5 g/20 mL (250 mg/mL)
Plastic Fliptop Vial
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 re