Amicar

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using aminocaproic acid and call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• sudden cough, rapid breathing, fast heart rate;
• pain or swelling in one or both legs;
• muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
• urinating less than usual or not at all;
• drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
• swelling, weight gain, feeling short of breath;
• slow heart rate, trouble breathing, feeling like you might pass out;
• numbness or tingling in your arms or legs;
• easy bruising or bleeding, purple or red pinpoint spots under your skin; or
• confusion, hallucinations;

Less serious side effects may include:

• mild muscle pain or weakness;
• headache, tired feeling;
• nausea, vomiting, stomach pain, diarrhea;
• (in men) decreased amount of semen when having an orgasm;
• stuffy nose, watery eyes
• vision problems, ringing in your ears; or
• mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

AMICAR (aminocaproic acid) is generally well tolerated. The following adverse experiences have been reported:

Edema, headache, malaise.

Allergic and anaphylactoid reactions, anaphylaxis.

Bradycardia, hypotension, peripheral ischemia, thrombosis.

Abdominal pain, diarrhea, nausea, vomiting.

Agranulocytosis, coagulation disorder, leukopenia, thrombocytopenia.

CPK increased, muscle weakness, myalgia, myopathy (see WARNINGS), myositis, rhabdomyolysis.

Confusion, convulsions, delirium, dizziness, hallucinations, intracranial hypertension, stroke, syncope.

Dyspnea, nasal congestion, pulmonary embolism.

Pruritis, rash.

Tinnitus, vision decreased, watery eyes.

BUN increased, renal failure. There have been some reports of dry ejaculation during the period of AMICAR (aminocaproic acid) 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.

A few cases of acute overdosage with AMICAR (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 AMICAR (aminocaproic acid) . The single dose of AMICAR (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 AMICAR (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 AMICAR (aminocaproic acid) is removed by hemodialysis and may be removed by peritoneal dialysis. Pharmacokinetic studies have shown that total body clearance of AMICAR (aminocaproic acid) is markedly decreased in patients with severe renal failure.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

A synthetic monoamino carboxylic acid that is an inhibitor of fibrinolysis.b

In the U.S.

• Amicar

Available Dosage Forms:

• Solution
• Syrup
• Tablet

Therapeutic Class: Hemostatic

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.

Pediatric

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.

Geriatric

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

Pregnancy

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.

Interactions with 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

Interactions with Food/Tobacco/Alcohol

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.

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.

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 receiving 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

Pregnancy Category: C

Lactation: Not known whether excreted in breast milk, use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.