Aminocaproic Acid (Aminocaproic Acid)

Trade Name : Aminocaproic Acid

American Regent, Inc.

INJECTION, SOLUTION

Strength 250 mg/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 American Regent, Inc.. It is available in strength of 250 mg/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.u00a0 The structural formula is:
  • NHCH(CH)CHCOOH
  • The molecular formula is:u00a0 CHNOttttMolecular Weight: 131.17
  • Aminocaproic Acid is soluble in water, acid and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform.
  • Aminocaproic Acid Injection, USP, for intravenous administration, is a sterile pyrogen-free solution containing 250 mg/mL of Aminocaproic Acid with Benzyl Alcohol 0.9%, as a preservative, and Water for Injection q.s.u00a0 The pH is adjusted to approximately 6.8 with Hydrochloric Acid and/or Sodium Hydroxide.
  • 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).u00a0 Correspondingly, the volume of distribution after intravenous administration has been reported to be 30.0 u00b1 8.2 L.u00a0 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, whether aminocaproic acid is administered orally or intravenously. 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.u00a0 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 Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, 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 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 frequently be associated with life-threatening complications following severe trauma, anoxia, and shock.u00a0 Symptomatic of such complications is surgical hermaturia (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system).u00a0 (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:
  • Aminocaproic acid must not be used in the presence of DIC without concomitant heparin.
  • Aminocaproic Acid Injection, USP contains benzyl alcohol as a preservative. The administration of medications containing benzyl alcohol as a preservative to premature neonates has been associated with a fatal u201cGasping Syndromeu201d.u00a0 (See )
  • 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.u00a0 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.u00a0 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.u00a0 CPK levels should be monitored in patients on long-term therapy.u00a0 Aminocaproic acid administration should be stopped if a rise in CPK is noted.u00a0 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.u00a0 The patient received 2 g of aminocaproic acid every 6 hours for a total dose of 26 g.u00a0 Death was due to continued cerebrovascular hemorrhage.u00a0 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
  • Local Reactions
  • Cardiovascular
  • Gastrointestina
  • Hematologic
  • Musculoskeletal
  • Neurologic
  • Respiratory: Dyspnea, nasal congestion, pulmonary embolism.
  • 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 LD50 of aminocaproic acid were 3 and 12 g/kg, respectively, in the mouse and 3.2 and 16.4 g/kg, respectively, in the rat.u00a0 An intravenous infusion dose of 2.3 g/kg was lethal in the dog.u00a0 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.u00a0 Pharmacokinetic studies have shown that total body clearance of aminocaproic acid is markedly decreased in patients with severe renal failure.
  • Aminocaproic Acid Injection, USP is administered by infusion, utilizing the usual compatible intravenous vehicles (e.g., Sterile Water for Injection, Sodium Chloride Injection 0.9%, Dextrose Injection 5% or Ringeru2019s Injection).u00a0 Although Sterile Water for Injection is compatible for intravenous injection, the resultant solution is hypo-osmolar.u00a0 RAPID INJECTION OF AMINOCAPROIC ACID INJECTION, USP UNDILUTED INTO A VEIN IS NOT RECOMMENDED.
  • For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 16 to 20 mL (4 to 5 g) of Aminocaproic Acid Injection, USP in 250 mL of diluent be administered by infusion during the first hour of treatment, followed by a continuing infusion at the rate of 4 mL (1 g) per hour in 50 mL of diluent.u00a0 This method of treatment would ordinarily be continued for about 8 hours or until the bleeding situation has been controlled.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • If the patient is able to take medication by mouth, an identical dosage regimen may be followed by administering aminocaproic acid tablets or aminocaproic acid syrup, 25% as follows: For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 5 grams of aminocaproic acid tablets or syrup be administered during the first hour of treatment, followed by a continuing rate of 1 gram of aminocaproic acid tablets or 1.25 grams of aminocaproic acid syrup per hour. This method of treatment would ordinarily be continued for about 8 hours or until the bleeding situation has been controlled.
  • Aminocaproic Acid Injection, USP, 250 mg/mL.
  • For intravenous infusion after dilution.
  • NDC 0517-9120-25tt20 mL multiple dose vialttBoxes of 25
  • Store at 20u00b0-25u00b0C (68u00b0-77u00b0F); excursions permitted to 15u00b0-30u00b0C (59u00b0-86u00b0F) (See USP Controlled Room Temperature).
  • AMERICANn- Arrayn- REGENT, INC.n- Arrayn- SHIRLEY, NY 11967
  • *Stefanini M. Dameshek W: The Hemorrhagic Disorders, Ed.2, New York, Grune and Stratton.u00a0 1962; pp. 510-514.
  • IN9120
  • Rev. 6/07
  • PRINCIPAL DISPLAY PANEL - 20 mL Containern n n
  • AMINOCAPROIC ACIDINJECTION, USP
  • 250 mg/mL
  • 20 mL MULTIPLE DOSE VIAL
  • FOR IV INFUSION AFTER DILUTION
  • Rx Onlyn AMERICAN REGENT, INC.n
  • AMINOCAPROIC ACID
  • 250 mg/mL
  • NDC 0517-9120-25
  • 25 x 20 mL MULTIPLE DOSE VIALS
  • FOR INTRAVENOUS INFUSION AFTER DILUTION
  • Rx Only
  • Each mL contains: Aminocaproic Acid 250 mg, Benzyl Alcohol 0.9%, Water for Injection q.s.Sodium Hydroxide and/or Hydrochloric Acid to adjust pH. Sterile, nonpyrogenic.Initial Adult Dosage: 4 to 5 grams (16-20 mL) intravenously followed by 1 gram (4 mL) at hourly intervals thereafter. See enclosed insert.Store at 20u00b0-25u00b0C (68u00b0-77u00b0F); excursions permitted to 15u00b0-30u00b0C (59u00b0-86u00b0F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert.
  • AMERICAN n- Arrayn- REGENT, INC.
  • Rev. 11/05n n n
  • No data

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