AMINOCAPROIC ACID tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Optimus Pharma Private Limited

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Aminocaproic acid tablets are 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 tablets shou

ملخص المنتج:

Aminocaproic acid tablets USP, 500 mg Each round, white to off white tablet, engraved with ‘SET’ on one side and scored on the other with ‘A’ to the left of the score and ‘50’ on the right, contains 500 mg of aminocaproic acid. Bottle of 30 with child-resistant closure, NDC 73216-110-01 Store at 20°C - 25 °C (68°F - 77°F) [See USP controlled room temperature] Dispense in Tight Containers. Aminocaproic acid tablets USP, 1000 mg Each oblong, white to off white tablet, engraved with ‘SET’ on one side and scored on the other with ‘A’ to the left of the score and ‘10’ on the right, contains 1000 mg of aminocaproic acid. Bottle of 30 with child-resistant closure, NDC 73216-111-01 Store at 20°C - 25 °C (68°F - 77°F) [See USP controlled room temperature] Dispense in Tight Containers.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

AMINOCAPROIC ACID- AMINOCAPROIC ACID TABLET
OPTIMUS PHARMA PRIVATE LIMITED
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AMINOCAPROIC ACID TABLETS, USP
RX ONLY
DESCRIPTION
Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor
of fibrinolysis.
Its chemical structure is:
Aminocaproic acid is soluble in water, acid, and alkaline solutions;
it is sparingly soluble in
methanol and practically insoluble in chloroform.
Each aminocaproic acid tablet, for oral administration contains 500 mg
or 1000 mg of
aminocaproic acid and the following inactive ingredients:
crospovidone, magnesium
stearate, microcrystalline cellulose, povidone and stearic acid.
USP dissolution test 2 used
CLINICAL PHARMACOLOGY
The fibrinolysis-inhibitory effects of aminocaproic acid tablets
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 tablets have 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
terminal elimination
half-life for aminocaproic acid tablets is approximately 2 hours.
INDICATIONS AND USAGE
Aminoca