Aminocaproic acid

Name: Aminocaproic acid

Aminocaproic Acid Brand Names

Aminocaproic Acid may be found in some form under the following brand names:

  • Amicar

Forms of Medication

Aminocaproic Acid is available in the following forms:

  • Injectable Solution
  • Oral Solution
  • Oral Tablet

Aminocaproic Acid Dosage and Administration

Administration

Administer orally or by IV infusion.b

Oral Administration

Administer orally if the patient is able to take oral medication.b

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.b

Avoid rapid IV administration; hypotension, bradycardia, and/or arrhythmia may result.b

Dilution

For the initial infusion (loading dose), add 4–5 g of aminocaproic acid (16–20 mL of the injection) to 250 mL of diluent.b

For maintenance infusions, add 1 g of aminocaproic acid (4 mL of the injection) to 50 mL of diluent to provide a final concentration of approximately 20 mg/mL.b

Rate of Administration

Initial infusion (loading dose): Infuse 4–5 g over 1 hour in adults.b

Maintenance infusion: Infuse 1 g per hour in adults.b

Dosage

Pediatric Patients

Bleeding Due to Elevated Fibrinolytic Activity† Oral

100 mg/kg or 3 g/m2 during the first hour, then 33.3 mg/kg per hour or 1 g/m2 per hour (maximum 18 g/m2 in 24 hours) has been used.a Manufacturer states that safety and efficacy not established in pediatric patients.b

IV

Initial infusion (loading dose): 100 mg/kg or 3 g/m2 over 1 hour has been used.a Manufacturer states that safety and efficacy not established in pediatric patients.b

Maintenance infusion

Maintenance infusion: 33.3 mg/kg per hour or 1 g/m2 per hour (maximum 18 g/m2 in 24 hours) has been used.a Manufacturer states that safety and efficacy not established in pediatric patients.b

Adults

Bleeding Due to Elevated Fibrinolytic Activity Oral

5 g during the first hour, then 1–1.25 g per hour for about 8 hours or until bleeding has been controlled.a b

IV

Initial infusion (loading dose): 4–5 g over 1 hour.b

Maintenance infusion: 1 g per hour for about 8 hours or until bleeding has been controlled.b

Ocular Hemorrhage† Oral

100 mg/kg (up to 5 g) every 4 hours, up to a maximum daily dosage of 30 g, for 5 days has been used;100 101 102 103 lower daily dosages also may be effective.102

Hereditary Hemorrhagic Telangiectasia† Oral

1 or 1.5 g twice daily for 1–2 months, followed by 1–2 g daily.112

Prescribing Limits

Pediatric Patients

Bleeding Due to Elevated Fibrinolytic Activity† Oral or IV

Maximum 18 g/m2 in 24 hours.a

Adults

Ocular Hemorrhage Oral

Maximum 30 g daily.100 101 102 103

Advice to Patients

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products.b

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b

  • Importance of advising patients of other important precautionary information.b (See Cautions.)

Precautions While Using aminocaproic acid

It is very important that your doctor check your progress while you are using aminocaproic acid. Blood tests may be needed to see if the medicine is working properly and to check for unwanted effects.

Using aminocaproic acid for a long time may cause muscle problems and serious kidney disease. Check with your doctor right away if you have a dark-colored urine; fever; joint pain; muscle cramps or spasms; or unusual tiredness or weakness.

Make sure any doctor or dentist who treats you knows that you are using aminocaproic acid. aminocaproic acid may affect the results of certain medical tests.

aminocaproic acid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
  • Anxiety
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • change in the ability to see colors, especially blue or yellow
  • chest pain or discomfort
  • chills
  • confusion
  • cough or hoarseness
  • dark-colored urine
  • decreased frequency or amount of urine
  • difficult or labored breathing
  • difficulty with moving
  • difficulty with speaking
  • difficulty with swallowing
  • dizziness or lightheadedness
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • double vision
  • fainting
  • fast heartbeat
  • fever with or without chills
  • general feeling of discomfort or illness
  • general feeling of tiredness or weakness
  • headache
  • hives
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • increased thirst
  • itching of the skin
  • joint pain
  • loss of appetite
  • lower back or side pain
  • muscle aching or cramping
  • muscle cramps or spasms
  • muscle pain or stiffness
  • muscular pain, tenderness, wasting, or weakness
  • nausea and vomiting
  • numbness and tingling of the face, fingers, or toes
  • pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
  • painful or difficult urination
  • pale, bluish-colored, or cold hands or feet
  • pinpoint red spots on the skin
  • problems with bleeding or clotting
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash
  • slow or irregular heartbeat
  • slow speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden shortness of breath or troubled breathing sweating
  • swelling
  • swelling of the face, fingers, or lower legs
  • swollen glands
  • swollen joints
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • tightness in the chest
  • troubled breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weak or absent pulses in the legs
  • weight gain
  • wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Abdominal or stomach pain
  • confusion as to time, place, or person
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decreased vision
  • diarrhea
  • ejaculation without semen
  • hearing loss
  • holding false beliefs that cannot be changed by fact
  • mood or mental changes
  • seeing, hearing, or feeling things that are not there
  • stuffy nose
  • unusual excitement, nervousness, or restlessness
  • watery eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Onset of Action

~1 to 72 hours

Time to Peak

Oral: 1.2 ± 0.45 hours

Half-Life Elimination

1 to 2 hours

Storage

Store intact vials, tablets, and syrup at 15°C to 30°C (59°F to 86°F). Do not freeze injection or syrup. Solutions diluted for IV use in D5W or NS to concentrations of 10-100 mg/mL are stable at 4°C (39°F) and 23°C (73°F) for 7 days (Zhang, 1997).

Adverse Reactions

Frequency not defined.

Cardiovascular: Arrhythmia, bradycardia, edema, hypotension, intracranial hypertension, peripheral ischemia, syncope, thrombosis

Central nervous system: Confusion, delirium, dizziness, fatigue, hallucinations, headache, malaise, seizure, stroke

Dermatologic: Rash, pruritus

Gastrointestinal: Abdominal pain, anorexia, cramps, diarrhea, GI irritation, nausea, vomiting

Genitourinary: Dry ejaculation

Hematologic: Agranulocytosis, bleeding time increased, leukopenia, thrombocytopenia

Local: Injection site necrosis, injection site pain, injection site reactions

Neuromuscular & skeletal: CPK increased, myalgia, myositis, myopathy, rhabdomyolysis (rare), weakness

Ophthalmic: Vision decreased, watery eyes

Otic: Tinnitus

Renal: BUN increased, intrarenal obstruction (glomerular capillary thrombosis), myoglobinuria (rare), renal failure (rare)

Respiratory: Dyspnea, nasal congestion, pulmonary embolism

Miscellaneous: Allergic reaction, anaphylactoid reaction, anaphylaxis

Postmarketing and/or case reports: Hepatic lesion, hyperkalemia, myocardial lesion

(web3)