Aminocaproic Acid .25 g/mL Solution, 236.5 mL
Other active recalls for Aminocaproic Acid (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Antifibrinolytic Agent class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- Aminocaproic acid is used to help stop bleeding that happens when your body's own clot-dissolving system goes into overdrive. Normally that system is a good thing — it prevents clo...
- What exactly is aminocaproic acid being used for in my case?
- It depends on your situation. If you're in a hospital setting or it's an emergency, you'll likely receive it through an IV drip — slowly, over time. If you're able to take medicine...
- How will I be given this medication — will I get a pill or an IV?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.579 | $136.89 / 236.5 ml |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Aminocaproic Acid .25 g/mL 00054-1100-58 | Hikma | 236.5 ml | $0.579 | AA | Availability likely | — |
| Aminocaproic Acid .25 g/mL 31722-0035-23 | Camber | 236.5 ml | $0.579 | AA | Availability likely | — |
| Aminocaproic acid .25 g/mL 52817-0815-08 | TruPharma | 236.5 ml | $0.579 | AA | Availability likely | — |
| Aminocaproic Acid .25 g/mL 59651-0573-08 | Aurobindo | 236.5 ml | $0.579 | AA | Availability likely | — |
| Aminocaproic Acid .25 g/mLthis 69680-0114-08 | Vitruvias | 236.5 ml | $0.579 | AA | Availability likely | — |
| Aminocaproic Acid .25 g/mL 70377-0104-11 | Biocon | 236.5 ml | $0.579 | AA | Availability likely | — |
| Aminocaproic Acid .25 g/mL 71921-0175-08 | Florida | 236.5 ml | $0.579 | AA | Availability likely | — |
| Aminocaproic Acid .25 g/mL 80005-0130-22 | Carnegie | 236.5 ml | $0.579 | AA | Availability likely | — |
| Aminocaproic acid .25 g/mL 54288-0151-01 | BPI | 236.5 ml | — | AA | FDA listed | — |
| Aminocaproic acid .25 g/mL 69238-1596-04 | Amneal | 10 cups | — | AA | FDA listed | — |
| Aminocaproic Acid .25 g/mL 72162-2646-02 | Bryant | 236.5 ml | — | AA | FDA listed | — |
| Aminocaproic acid .25 g/mL 72205-0032-71 | Novadoz | 236.5 ml | — | AA | FDA listed | — |
| Aminocaproic Acid .25 g/mL 83745-0294-08 | Apozeal | 236.5 ml | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69680-0114-08 You're viewing this | 236.5 mL in 1 BOTTLE (69680-114-08) | 2024-07-19 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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 .)
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION An identical dosage regimen may be followed by administering Aminocaproic Acid Oral Solution as follows: For the treatment of acute bleeding syndromes due to elevated fibrinolytic activity, it is suggested that 20 milliliter of Aminocaproic Acid Oral Solution (5 g) be administered during the first hour of treatment, followed by a continuing rate of 5 milliliter 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 situation has been controlled.
⛔ Contraindications ▾
CONTRAINDICATIONS Aminocaproic Acid Oral Solution 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 Oral Solution. 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 Oral Solution must not be used in the presence of DIC without concomitant heparin.
⚠️ Warnings ▾
WARNINGS In patients with upper urinary tract bleeding, Aminocaproic Acid Oral Solution 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 Oral Solution 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 Oral Solution administration should be stopped if a rise in CPK is noted.
Resolution follows discontinuation of Aminocaproic Acid Oral Solution; however, the syndrome may recur if Aminocaproic Acid Oral Solution 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Aminocaproic Acid Oral Solution is generally well tolerated. The following adverse experiences have been reported: General: Edema, headache, malaise. Hypersensitivity Reactions: Allergic and anaphylactoid reactions, anaphylaxis.
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: Pruritis, 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 Aminocaproic Acid Oral Solution 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.
🔄 Drug / Laboratory Test Interactions ▾
Drug Laboratory Test Interactions Prolongation of the template bleeding time has been reported during continuous intravenous infusion of aminocaproic acid at dosages exceeding 24 g/day. Platelet function studies in these patients have not demonstrated any significant platelet dysfunction. However, in vitro studies have shown that at high concentrations (7.4 mMol/L or 0.97 mg/mL and greater) aminocaproic acid inhibits ADP and collagen-induced platelet aggregation, the release of ATP and serotonin, and the binding of fibrinogen to the platelets in a concentration-response manner.
Following a 10 g bolus of Aminocaproic Acid Oral Solution, transient peak plasma concentrations of 4.6 mMol/L or 0.60 mg/mL have been obtained. The concentration of Aminocaproic Acid Oral Solution necessary to maintain inhibition of fibrinolysis is 0.99 mMol/L or 0.13 mg/mL. Administration of a 5 g bolus followed by 1 to 1.25 g/hr should achieve and sustain plasma levels of 0.13 mg/mL.
Thus, concentrations which have been obtained in vivo clinically in patients with normal renal function are considerably lower than the in vitro concentrations found to induce abnormalities in platelet function tests. However, higher plasma concentrations of aminocaproic acid may occur in patients with severe renal failure.
🤰 Pregnancy ▾
Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Aminocaproic Acid Oral Solution. It is also not known whether Aminocaproic Acid Oral Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminocaproic Acid Oral Solution should be given to a pregnant woman only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🆘 Overdosage ▾
OVERDOSAGE 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 Oral Solution 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 3.0 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 Oral Solution is removed by hemodialysis and may be removed by peritoneal dialysis.
Pharmacokinetic studies have shown that total body clearance of Aminocaproic Acid Oral Solution is markedly decreased in patients with severe renal failure.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The fibrinolysis-inhibitory effects of Aminocaproic Acid Oral Solution 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 ±
6.6L (mean ± SD). Correspondingly, the volume of distribution after intravenous administration has been reported to be 30.0 ±
8.2L. After prolonged administration, Aminocaproic Acid Oral Solution 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 Oral Solution is approximately 2 hours.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Aminocaproic Acid Oral Solution, 0.25 g/mL Each mL of blueberry-flavored oral solution contains 0.25 g/mL of aminocaproic acid. 8 Fl. Oz. (236.5 mL) Bottle – NDC 69680-114-08 Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature];Dispense in Tight Containers; Do Not Freeze.
📋 Description ▾
DESCRIPTION Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is: chemical-structure 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, USP for oral administration, contains 0.25 g/mL of aminocaproic acid with methylparaben 0.20%, propylparaben 0.05% and edetate disodium dihydrate 0.332% as preservatives and the following inactive ingredients: saccharin sodium, sorbitol, purified water, citric acid monohydrate, propylene glycol and artificial blueberry flavoring.
Chemical Structure