国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)
Aurobindo Pharma Limited
ORAL
PRESCRIPTION DRUG
Aminocaproic acid oral solution 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 oral solution should not be used w
Aminocaproic Acid Oral Solution USP, 0.25 grams/mL Each mL of clear colorless to light yellow colored raspberry flavored oral solution contains 0.25 grams/mL of aminocaproic acid, USP available in: 8 Fl. Oz. (236.5 mL) Bottle NDC 59651-573-08 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in Tight Containers; Do Not Freeze.
Abbreviated New Drug Application
AMINOCAPROIC ACID - AMINOCAPROIC ACID SOLUTION AUROBINDO PHARMA LIMITED ---------- AMINOCAPROIC ACID ORAL SOLUTION RX ONLY DESCRIPTION Aminocaproic acid, USP is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is: Aminocaproic acid, USP is freely soluble in water, slightly soluble in methanol, practically insoluble in acetone, in hexane, in methylene dichloride and in isopropyl alcohol. Aminocaproic acid oral solution, USP for oral administration, contains 0.25 grams/mL of aminocaproic acid, USP with methylparaben 0.20%, propylparaben 0.05%, edetate disodium 0.30% as preservatives and the following inactive ingredients: art raspberry FL (contains propylene glycol), citric acid anhydrous, masking flavor (contains acesulfame, acetic acid, ammoniated glycyrrhizin, artificial flavors, aspartame, propylene glycol and water), purified water, sorbitol solution, and sucralose. 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 完全なドキュメントを読む