Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)
airis PHARMA Private 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 should not be used when there is ev
Aminocaproic acid oral solution, USP is a clear, colorless to pale yellow-colored solution. Each mL of raspberry-flavored oral solution contains 0.25 g of aminocaproic acid, USP. 8 Fl. Oz. (236.5 mL) bottle with child-resistant closure NDC 71151-026-01 Store at 20° to 25°C (68° to 77°F); excursions permitted between 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 AIRIS PHARMA PRIVATE LIMITED ---------- AMINOCAPROIC ACID ORAL SOLUTION, USP RX ONLY DESCRIPTION Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is: Aminocaproic acid, USP is white or almost white crystalline powder or colorless crystals. It is freely soluble in water, slightly soluble in methanol, practically insoluble in acetone, hexane, methylene dichloride, and isopropyl alcohol. Aminocaproic acid oral solution, USP for oral administration, contains 0.25 g/mL of aminocaproic acid, USP with methylparaben 0.20%, propylparaben 0.02%, edetate disodium 0.30% as preservatives and the following inactive ingredients: bitter blocker, citric acid anhydrous, raspberry flavor, saccharin sodium dihydrate, sorbitol solution, and purified water. 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 cre Perskaitykite visą dokumentą