Pronunciation:

a-mee-noe-ka-PROE-ik AS-id

Brand Names:

• Amicar

Dosage Forms:

• Solution
• Tablet

Classifications:

Therapeutic—

Hemostatic

Uses of This Medicine:

Aminocaproic acid is an antifibrinolytic agent. It is used to treat serious bleeding conditions, especially when the bleeding occurs after dental surgery or other kinds of surgery. This medicine is also sometimes given before an operation to prevent serious bleeding for patients with medical problems that increase the chance of bleeding.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of aminocaproic acid in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of aminocaproic acid in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anti-Inhibitor Coagulant Complex
• Tretinoin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots, active or
• Disseminated intravascular coagulation or DIC (blood clotting problem)—Should not be used in patients with these conditions.

• Blood clots, history of or
• Hematuria (blood in the urine)—Use with caution. May make these conditions worse.

• Kidney disease—The effects of this medicine may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Measure the oral solution with a marked measuring spoon, oral syringe, or medicine cup.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• To treat bleeding problems:
  • For oral dosage form (solution or tablets):
    • Adults—5 grams (g) or 4 teaspoonfuls as a single dose for the first hour, followed by 1 g or 1 teaspoonful every hour for 8 hours or until bleeding has been controlled.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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

Using this medicine 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 this medicine. This medicine may affect the results of certain medical tests.

Side Effects of This Medicine:

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.