Amicar

Before taking aminocaproic acid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as paraben preservatives in the liquid product), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: bleeding of unknown cause, a certain bleeding condition (disseminated intravascular coagulation-DIC), a certain clotting problem (active intravascular clotting), a certain cause of blood in the urine (upper urinary tract bleeding).Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, liver disease, kidney disease, other blood/bleeding disorders (e.g., hemophilia, uremia).This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

AMICAR®
(aminocaproic acid)

AMICAR (aminocaproic acid) Oral Solution, 0.25 g/mL

Each mL of raspberry-flavored oral solution contains 0.25 g/mL of aminocaproic acid.

16 Fl. Oz. (473 mL) Bottle – NDC 66479-023-56

Store Between 15°-30°C (59°-86°F); Dispense in Tight Containers; Do Not Freeze.

AMICAR (aminocaproic acid) 500 mg Tablets

Each round, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 10 on the right, contains 500 mg of aminocaproic acid.

Bottle of 100 – NDC 66479-021-82

Store Between 15°-30°C (59°-86°F); Dispense in Tight Containers.

AMICAR (aminocaproic acid) 1000 mg Tablets

Each oblong, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 20 on the right, contains 1000 mg of aminocaproic acid.

Bottle of 100 – NDC 66479-022-82

Store Between 15°-30°C (59°-86°F); Dispense in Tight Containers.

Marketed by : Xanodyne Pharmaceuticals, Newport, KY 41071, Rev. 09/08.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Since aminocaproic acid is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include urinating less than usual, feeling light-headed, or fainting.

• 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.)

Amicar 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 Amicar 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.

Amicar®
(aminocaproic acid)

Amicar Oral Solution, 0.25 g/mL

Each mL of raspberry-flavored oral solution contains 0.25 g/mL of aminocaproic acid.

8 Fl. Oz. (236.5 mL) Bottle – NDC 49411-052-08

Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature];Dispense in Tight Containers; Do Not Freeze.

Amicar 500 mg Tablets

Each round, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 10 on the right, contains 500 mg of aminocaproic acid.

Bottle of 30 – NDC 49411-050-30

Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature];Dispense in Tight Containers; Do Not Freeze.

Amicar 1000 mg Tablets

Each oblong, white tablet, engraved with XP on one side and scored on the other with A to the left of the score and 20 on the right, contains 1000 mg of aminocaproic acid.

Bottle of 30 – NDC 49411-051-30

Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature];Dispense in Tight Containers; Do Not Freeze.

Bottle Label – 8 Fl. Oz. (236.5 mL)
NDC 49411-052-08
Amicar®
Aminocaproic Acid
Oral Solution
0.25 grams/mL
Rx only
8 Fl. Oz. (236.5 mL)

Aminocaproic acid is a man-made form of a protein that occurs naturally in the body and helps the blood clot.

Aminocaproic acid is used to treat bleeding episodes in people with certain medical conditions such as aplastic anemia (lack of blood cells and platelets), cirrhosis of the liver, placenta abruptio (early separation of the placenta in pregnancy), urinary bleeding, and certain types of cancer. Aminocaproic acid is also used to prevent bleeding after heart surgery or placement of a shunt near the liver to control high blood pressure

Aminocaproic acid may also be used for purposes not listed in this medication guide.

You should not use this medication if you are allergic to it. Your doctor will perform blood tests to make sure you do not have other conditions that would prevent you from safely using aminocaproic acid.

Before you use aminocaproic acid, tell your doctor if you have kidney disease, or a history of stroke or blood clot.

To be sure this medication is not causing harmful effects, your blood cells and kidney function may need to be tested often. Do not miss any follow-up visits to your doctor for blood or urine tests.

Tell your doctor if you also use any clotting medications such as factor IX complex or anti-inhibitor coagulant complex (Autoplex, Feiba VH).

Stop taking aminocaproic acid and call your doctor if you have a serious side effect such as sudden numbness or weakness, pain or swelling in your legs, sudden cough, feeling short of breath, muscle tenderness or weakness with flu symptoms and dark colored urine, swelling, weight gain, urinating less than usual or not at all, sudden headache or confusion, or problems with vision, speech, or balance.

Do not give this medication to a child.

Since aminocaproic acid is used as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Your pharmacist can provide more information about aminocaproic acid.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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