Aminocaproic Acid (Aminocaproic Acid)

Trade Name : Aminocaproic Acid

Akorn Inc.

SYRUP

Strength 0.25 g/mL

AMINOCAPROIC ACID Antifibrinolytic Agent [EPC],Decreased Fibrinolysis [PE]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Aminocaproic Acid (Aminocaproic Acid) which is also known as Aminocaproic Acid and Manufactured by Akorn Inc.. It is available in strength of 0.25 g/mL per ml. Read more

Aminocaproic Acid (Aminocaproic Acid) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx only
  • 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.
  • Aminocaproic acid oral solution for oral administration, contains 0.25 g/mL of aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%, edetate disodium 0.30% as preservatives and the following inactive ingredients: sodium saccharin, sorbitol solution, citric acid anhydrous, natural and artificial raspberry flavor and an artificial bitterness modifier.
  • Each aminocaproic acid tablet for oral administration contains either 500 mg or 1000 mg of aminocaproic acid and the following inactive ingredients: povidone, crospovidone, stearic acid, and magnesium stearate.
  • 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 u00b1 SD peak plasma concentrations (164 u00b1 28 mcg/mL) were reached within 1.2 u00b1 0.45 hours.
  • After oral administration, the apparent volume of distribution was estimated to be 23.1 u00b1 6.6 L (mean u00b1 SD). Correspondingly, the volume of distribution after intravenous administration has been reported to be 30.0 u00b1 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 terminal elimination half-life for aminocaproic acid is approximately 2 hours.
  • Aminocaproic acid 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 ).
  • Aminocaproic acid should not be used when there is evidence of an active intravascular clotting process.
  • When there is uncertainty as to whether the cause of bleeding is primary fibrinolysis or disseminated intravascular coagulation (DIC), this distinction must be made before administering aminocaproic acid.
  • The following tests can be applied to differentiate the two conditions:
  • Platelet count is usually decreased in DIC but normal in primary fibrinolysis.
  • Protamine paracoagulation test is positive in DIC; a precipitate forms when protamine sulfate is dropped into citrated plasma. The test is negative in the presence of primary fibrinolysis.
  • The euglobulin clot lysis test is abnormal in primary fibrinolysis but normal in DIC.
  • Aminocaproic acid must not be used in the presence of DIC without concomitant heparin.
  • In patients with upper urinary tract bleeding, aminocaproic acid administration has been known to cause intrarenal obstruction in the form of glomerular capillary thrombosis or clots in the renal pelvis and ureters. For this reason, aminocaproic acid should not be used in hematuria of upper urinary tract origin, unless the possible benefits outweigh the risk.
  • Subendocardial hemorrhages have been observed in dogs given intravenous infusions of 0.2 times the maximum human therapeutic dose of aminocaproic acid and in monkeys given 8 times the maximum human therapeutic dose of aminocaproic acid.
  • Fatty degeneration of the myocardium has been reported in dogs given intravenous doses of aminocaproic acid at 0.8 to 3.3 times the maximum human therapeutic dose and in monkeys given intravenous doses of aminocaproic acid at 6 times the maximum human therapeutic dose.
  • Rarely, skeletal muscle weakness with necrosis of muscle fibers has been reported following prolonged administration. Clinical presentation may range from mild myalgias with weakness and fatigue to a severe proximal myopathy with rhabdomyolysis, myoglobinuria, and acute renal failure. Muscle enzymes, especially creatine phosphokinase (CPK) are elevated. CPK levels should be monitored in patients on long-term therapy. Aminocaproic acid administration should be stopped if a rise in CPK is noted. Resolution follows discontinuation of aminocaproic acid; however, the syndrome may recur if aminocaproic acid is restarted.
  • The possibility of cardiac muscle damage should also be considered when skeletal myopathy occurs. One case of cardiac and hepatic lesions observed in man has been reported. The patient received 2 g of aminocaproic acid every 6 hours for a total dose of 26 g. Death was due to continued cerebrovascular hemorrhage. Necrotic changes in the heart and liver were noted at autopsy.
  • No data
  • Aminocaproic acid is generally well tolerated. The following adverse experiences have been reported:
  • General:
  • Hypersensitivity Reactions:
  • Cardiovascular:
  • Gastrointestinal:
  • Hematologic:
  • Musculoskeletal:n- Array
  • Neurologic:
  • Respiratory:
  • Skin:
  • Special Senses:
  • Urogenital:
  • A few cases of acute overdosage with aminocaproic acid administered intravenously have been reported. The effects have ranged from no reaction to transient hypotension to severe acute renal failure leading to death. One patient with a history of brain tumor and seizures experienced seizures after receiving an 8 gram bolus injection of aminocaproic acid. The single dose of aminocaproic acid causing symptoms of overdosage or considered to be life-threatening is unknown. Patients have tolerated doses as high as 100 grams while acute renal failure has been reported following a dose of 12 grams.
  • The intravenous and oral LD of aminocaproic acid were 3.0 and 12.0 g/kg respectively in the mouse and 3.2 and 16.4 g/kg respectively in the rat. An intravenous infusion dose of 2.3 g/kg was lethal in the dog. On intravenous administration, tonic-clonic convulsions were observed in dogs and mice.
  • No treatment for overdosage is known, although evidence exists that aminocaproic acid is removed by hemodialysis and may be removed by peritoneal dialysis. Pharmacokinetic studies have shown that total body clearance of aminocaproic acid is markedly decreased in patients with severe renal failure.
  • An identical dosage regimen may be followed by administering aminocaproic acid tablets or aminocaproic acid oral solution as follows:
  • For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 5 aminocaproic acid 1000 mg tablets or 10 aminocaproic acid 500 mg tablets (5 g) or 20 milliliters of aminocaproic acid oral solution (5 g) be administered during the first hour of treatment, followed by a continuing rate of 1 aminocaproic acid 1000 mg tablet or 2 aminocaproic acid 500 mg tablets (1 g) or 5 milliliters of aminocaproic acid oral solution (1.25 g) per hour. This method of treatment would ordinarily be continued for about 8 hours or until the bleeding has been controlled.
  • Aminocaproic Acid Oral Solution USP, 0.25 g/mL
  • Each mL of raspberry-flavored oral solution contains 0.25 g/ mL of aminocaproic acid.
  • 8 Fl. Oz. (237 mL) Bottle - NDC 17478-447-08
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]; Dispense in a tight container with a child-resistant closure. Do not Freeze.
  • Aminocaproic Acid Tablets USP, 500 mg
  • Each round, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 10 on the right, contains 500 mg of aminocaproic acid.
  • Bottle of 30 u2013 NDC 17478-768-30
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]; Dispense in a tight container with a child-resistant closure. Do not Freeze.
  • Aminocaproic Acid Tablets USP, 1000 mg
  • Each oblong, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 20 on the right, contains 1000 mg of aminocaproic acid.
  • Bottle of 30 u2013 NDC 17478-769-30
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]; Dispense in a tight container with a child-resistant closure. Do not Freeze.
  • u00b9Stefanini M, Dameshek W: The Hemorrhagic Disorders, Ed. 2, New York, Grune and Stratton, 1962; pp. 510-514.
  • Manufactured for: n n Lake Forest, IL 60045
  • Code 909C00
  • Rev. 12/18u00a0u00a0u00a0u00a0
  • Bottle Label u2013 8 Fl. Oz. (236.5 mL)
  • NDC 17478-447-08 u00a0
  • Aminocaproic Acid u00a0
  • Oral Solution, USP
  • 0.25 grams/mL
  • Rx Only
  • 8 Fl. Oz. (236.5 mL)u00a0
  • Akorn
  • u00a0u00a0u00a0 u00a0n
  • Bottle Label u2013 500 mg Tablet
  • NDC 17478-768-30
  • Aminocaproic Acid
  • Tablets, USP
  • 500 mg
  • Rx Only 30 Tablets
  • Akorn
  • Bottle Label u2013 1000 mg Tablet
  • NDC 17478-769-30
  • Aminocaproic Acid
  • Tablets, USP
  • 1000 mg
  • Rx Only 30 Tablets
  • Akorn

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