Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)
Seton Pharmaceuticals, LLC
ORAL
PRESCRIPTION DRUG
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 should not be used when
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 13925-530-30 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 13925-531-30 Store at 20°C - 25 °C (68°F - 77°F) [See USP controlled room temperature] Dispense in Tight Containers.
Abbreviated New Drug Application
AMINOCAPROIC ACID- AMINOCAPROIC ACID TABLET SETON PHARMACEUTICALS, LLC ---------- 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 Aminocaproi Կարդացեք ամբողջական փաստաթուղթը