Brand Names:

• Advate
• Alphanine SD
• Amicar
• Benefix
• Crosseal Fibrin Sealant (Human)
• Cyklokapron
• DDAVP
• Evithrom
• Helixate FS
• Hemofil-M
• Hyate:C
• Kogenate FS
• Novoseven
• NovoSeven RT
• Recothrom
• Thrombin-JMI
• Trasylol

Dosage Forms:

• Tablet
• Syrup
• Solution

Uses of This Medicine:

Antifibrinolytic agents are used to treat serious bleeding, especially when the bleeding occurs after dental surgery (particularly in patients with hemophilia) or certain other kinds of surgery. These medicines are also sometimes given before an operation to prevent serious bleeding in patients with medical problems that increase the chance of serious bleeding.

Antifibrinolytic agents may also be used for other conditions as determined by your doctor.

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

Before Using This Medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Although there is no specific information comparing use of aminocaproic acid or tranexamic acid in children with use in other age groups, these medicines are not expected to cause different side effects or problems in children than they do in adults.

Aminocaproic acid injection should not be given to newborns. It contains a preservative called benzyl alcohol that can cause a condition called “gasping syndrome” with very serious unwanted effects.

Older adults

• For aminocaproic acid: Although there is no specific information comparing use of aminocaproic acid in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.
• For tranexamic acid: Tranexamic acid has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Studies on birth defects have not been done in humans. However, these medicines have been given to pregnant women without causing birth defects or other problems.

Studies on effects of aminocaproic acid in pregnancy have not been done in animals. Tranexamic acid has not been shown to cause birth defects or other problems in animal studies.

Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding

These medicines have not been reported to cause problems in nursing babies. However, small amounts of tranexamic acid pass into the breast milk. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Other medicines

Using medicines in this class 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
• Chlorpromazine
• 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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood in the urine or
• Color vision problems or
• Heart disease or
• Kidney disease or
• Liver disease The chance of side effects may be increased.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more or less 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 unwanted effects.

Dosing

The dose medicines in this class 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 these medicines. 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 prevent or treat serious bleeding:
  • For oral dosage forms (syrup or tablets):
    • Adults For the first hour, the dose is 5 grams. Then the dose is 1 or 1.25 grams per hour for eight hours.
    • Children Dose is based on body weight or size and must be determined by your doctor. For the first hour, the dose is usually 100 milligrams (mg) per kilogram (kg) (45.4 mg per pound) of body weight. Then the dose is 33.3 mg per kg (15.1 mg per pound) of body weight per hour.
  • For injection dosage form:
    • Adults At first, the dose is 4 to 5 grams injected into a vein, over a period of one hour. Then the dose is 1 gram per hour, injected into a vein over a period of eight hours.
    • Children Dose is based on body weight or size and must be determined by your doctor. At first, the dose is usually 100 mg per kg (45.4 mg per pound) of body weight, injected into a vein over a period of one hour. Then the dose is 33.3 mg per kg (15.1 mg per pound) of body weight per hour, injected into a vein.

• To prevent or treat serious bleeding after dental surgery:
  • For oral dosage form (tablets):
    • Adults and children Dose is based on body weight and must be determined by your doctor. The dose is usually 25 milligrams (mg) per kilogram (kg) (11.4 mg per pound) of body weight every six to eight hours, beginning one day before surgery. After surgery, the dose is usually 25 mg per kg (11.4 mg per pound) of body weight every six to eight hours for two to eight days.
  • For injection dosage form:
    • Adults and children Dose is based on body weight and must be determined by your doctor. The dose is usually 10 mg per kg (4.5 mg per pound) of body weight, injected into a vein just before surgery. After surgery, the dose is usually 10 mg per kg (4.5 mg per pound) of body weight, injected into a vein every six to eight hours for seven to ten days.

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.

For aminocaproic acid (e.g., Amicar): If you miss a dose, take it as soon as possible. However, if you do not remember until it is almost time for your next dose, double the next dose. Then go back to your regular dosing schedule.

For tranexamic acid (e.g., Cyklokapron): If you miss a dose, take it as soon as possible. Then take any remaining doses for the day at regularly spaced times. Do not double doses. If you have any questions about this, check with your doctor.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

If you will be taking tranexamic acid for longer than several days, your doctor may want you to have your eyes checked regularly by an ophthalmologist (eye doctor). This will allow your doctor to check for unwanted effects that may be caused by this medicine.

If you are using aminocaproic acid syrup as a mouth rinse to control oral bleeding, and you are in the first or second trimester of pregnancy, you should spit out the syrup after rinsing without swallowing it.

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.

The same effect that makes aminocaproic acid or tranexamic acid help prevent or stop bleeding also may cause blood clots that could be dangerous. Check with your doctor immediately if any of the following possible signs and symptoms of blood clots occur:

Less common or rare

Headache (severe and sudden)

loss of coordination (sudden)

pains in chest, groin, or legs, especially the calves

shortness of breath (sudden)

slurred speech (sudden)

vision changes (sudden)

weakness or numbness in arm or leg

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

For aminocaproic acid

Dizziness

headache

muscle pain or weakness (severe and continuing)

ringing or buzzing in ears

skin rash

slow or irregular heartbeat with the injection only

stomach cramps or pain

stuffy nose

sudden decrease in amount of urine

swelling of face, feet, or lower legs

unusual tiredness or weakness

weight gain (rapid)

For tranexamic acid

Blurred vision or other changes in vision

dizziness or lightheadedness

unusual tiredness or weakness

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:

Diarrhea

dry ejaculation

nausea or vomiting

unusual menstrual discomfort

watery eyes

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