AMINOCAPROIC ACID tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Novadoz Pharmaceuticals LLC

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Aminocaproic acid tablets, USP is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products 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 amegakaryocytic thrombocytopenia (accompanying 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 contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.) Aminocaproic acid should not be used when there is

Proizvod sažetak:

Aminocaproic acid Tablets USP, 500 mg Each white to off white colored, round shaped, uncoated tablets with break line debossed with “MA” and “17“ on one side and plain on other side, contains 500 mg of aminocaproic acid. Bottle of 30 – NDC 72205-049-30 Aminocaproic acid Tablets USP, 1,000 mg Each white to off white colored, capsule shaped, uncoated tablets with break line debossed with “MA” and “16“ on one side and plain on other side, contains 1,000 mg of aminocaproic acid. Bottle of 30 – NDC 72205-286-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in Tight Containers; Do Not Freeze.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

AMINOCAPROIC ACID - AMINOCAPROIC ACID TABLET
NOVADOZ PHARMACEUTICALS LLC
----------
AMINOCAPROIC ACID TABLETS USP, 500 MG AND 1,000 MG
RX ONLY
DESCRIPTION
Aminocaproic acid USP is 6-aminohexanoic acid, which acts as an
inhibitor of fibrinolysis.
Its chemical structure is:
Aminocaproic acid is freely soluble in water; it is slightly soluble
in methanol and
practically insoluble in chloroform and diethyl ether.
Each aminocaproic acid tablet, for oral administration contains 500 mg
or 1,000 mg of
aminocaproic acid, USP and the following inactive ingredients:
colloidal silicon dioxide,
crospovidone, magnesium stearate, microcrystalline cellulose, povidone
and stearic acid.
The FDA approved dissolution acceptance criterion differs from that in
the USP for
Aminocaproic Acid Tablets.
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. 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 clearance. The total body clearance is 169 mL/min. The
te