Aminocaproic Acid
General Injectables And Vaccines, Inc.
Human Prescription Drug
NDC 52584-346Aminocaproic Acid is a human prescription drug labeled by 'General Injectables And Vaccines, Inc.'. National Drug Code (NDC) number for Aminocaproic Acid is 52584-346. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Aminocaproic Acid drug includes Aminocaproic Acid - 250 mg/mL . The currest status of Aminocaproic Acid drug is Active.
Drug Information:
| Drug NDC: | 52584-346 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Aminocaproic Acid |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Aminocaproic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | General Injectables And Vaccines, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | AMINOCAPROIC ACID - 250 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 02 Jul, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 01 Apr, 2023 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA070010 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 17 Jan, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | General Injectables and Vaccines, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1718760
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| NUI: | N0000175634
N0000175632
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | U6F3787206
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Antifibrinolytic Agent [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Fibrinolysis [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Antifibrinolytic Agent [EPC]
Decreased Fibrinolysis [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 52584-346-16 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-346-16) / 20 mL in 1 VIAL, SINGLE-DOSE | 02 Jul, 2018 | 01 Apr, 2023 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Aminocaproic acid aminocaproic acid aminocaproic acid aminocaproic acid water hydrochloric acid
Indications and Usage:
Indications and usage 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. symptomatic of such complications is surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary syst
Read more...em). (see warnings .)
Warnings:
Warnings 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 injection, usp 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 admin
Read more...istration. 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 injection administration should be stopped if a rise in cpk is noted. resolution follows discontinuation of aminocaproic acid injection; however, the syndrome may recur if aminocaproic acid injection 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.
Dosage and Administration:
Dosage and administration intravenous aminocaproic acid injection, usp is administered by infusion, utilizing the usual compatible intravenous vehicles (e.g., sterile water for injection, sodium chloride for injection, 5% dextrose or ringerâs injection). although sterile water for injection is compatible for intravenous injection the resultant solution is hypo-osmolar. rapid injection of aminocaproic acid injection 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 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. 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 di
Read more...scoloration prior to administration, whenever solution and container permit. do not administer unless the solution is clear and seal is intact. discard unused portion.
Contraindications:
Contraindications 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 injection. 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 injection must not be used in the presence of dic without concomitant heparin.
Adverse Reactions:
Adverse reactions aminocaproic acid injection is generally well tolerated. the following adverse experiences have been reported: general: edema, headache, malaise. hypersensitivity reactions: allergic and anaphylactoid reactions, anaphylaxis. local reactions: injection site reactions, pain and necrosis. cardiovascular: bradycardia, hypotension, peripheral ischemia, thrombosis. gastrointestinal: abdominal pain, diarrhea, nausea, vomiting. hematologic: agranulocytosis, coagulation disorder, leukopenia, thrombocytopenia. musculoskeletal: cpk increased, muscle weakness, myalgia, myopathy (see warnings ), myositis, rhabdomyolysis. neurologic: confusion, convulsions, delirium, dizziness, hallucinations, intracranial hypertension, stroke, syncope. respiratory: dyspnea, nasal congestion, pulmonary embolism. skin: pruritus, rash. special senses: tinnitus, vision decreased, watery eyes. urogenital: bun increased, renal failure. there have been some reports of dry ejaculation during the period of
Read more... aminocaproic acid injection treatment. these have been reported to date only in hemophilia patients who received the drug after undergoing dental surgical procedures. however, this symptom resolved in all patients within 24 to 48 hours of completion of therapy.
Overdosage:
Overdosage a few cases of acute overdosage with aminocaproic acid injection 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 injection. the single dose of aminocaproic acid injection 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 50 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. 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.
Description:
Description aminocaproic acid injection, usp is a 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. 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 and water for injection. the solution contains no bacteriostat or antimicrobial agent and is intended for use only as a single-dose injection. when smaller doses are required the unused portion should be discarded. hydrochloric acid may be added to adjust ph to approximately 6.8 during manufacture. its chemical structure is: nh 2 - ch 2 - ch 2 - ch 2 - ch 2 - ch 2 - cooh molecular weight: 131.17 the semi-rigid vial is fabricated from a specifically formulated polyolefin. it is a copolymer of ethylene and propylene. the safety of the plastic has been confirmed by tests in animals according to usp biological standards for plastic containers. the container requires no vapor barrier to maintain the proper drug concentration.
Clinical Pharmacology:
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 ± 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
Read more... 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. 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.
How Supplied:
How supplied aminocaproic acid injection, usp is supplied in single-dose containers as follows: store at 20 to 25°c (68 to 77°f). [see usp controlled room temperature.] references image1.jpg image2.jpg
Package Label Principal Display Panel:
Sample package label label1.jpg