Pronunciation:

tran-ex-AM-ik AS-id

Brand Names:

• Cyklokapron

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Hemostatic

Uses of This Medicine:

Tranexamic acid injection is used to control or prevent excessive or heavy bleeding during dental procedures in patients with hemophilia.

Tranexamic acid injection is an antifibrinolytic agent. It works by blocking the breakdown of blood clots. It may also be used for other conditions as determined by your doctor.

This medicine is to be given only by or under the direct supervision of your doctor.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tranexamic acid injection in the pediatric population.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tranexamic acid injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution for patients receiving this medicine.

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 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desogestrel
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Gestodene
• Levonorgestrel
• Medroxyprogesterone
• Mestranol
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Segesterone
• Ulipristal

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
• 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots, active or
• Subarachnoid hemorrhage (bleeding in the brain)—Should not be used in patients with these conditions.

• Eye or vision problems or
• Seizures, history of—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. This medicine is for short-term use only, usually 2 to 8 days.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine to make sure this medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase your or your child's risk of developing blood clots. Check with your doctor right away if you or your child have swelling and pain in your arms, legs, or stomach, chest pain, trouble breathing, loss of sensation, confusion, or problems with muscle control or speech.

Receiving this medicine together with birth control pills may also increase your risk of developing blood clots. Use another form of birth control (including condoms, spermicide) to keep from getting pregnant.

This medicine may increase your risk for seizures. This risk may more likely to occur if you are having a surgery for a heart or blood vessel problem. Talk to your doctor if you have any concerns.

This medicine may cause a serious allergic reaction, called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

If you or your child will be receiving tranexamic acid injection for longer than several days, your doctor may want you to have your eyes checked regularly by an ophthalmologist (eye doctor). Blurred vision, difficulty with reading, or any other change in vision may occur during or after treatment this medicine.

This medicine may make you dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 or nurse immediately if any of the following side effects occur:

Incidence not known

Anxiety

bloody or cloudy urine

blurred or loss of vision

changes in vision

chest pain or tightness

confusion

cough

difficult or painful urination

difficulty swallowing

disturbed color perception

dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position

double vision

fast heartbeat

halos around lights

hives, itching, skin rash

migraine headache

night blindness

numbness of the hands

overbright appearance of lights

pain, redness, or swelling in the arm or leg

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

seizures

sudden decrease in the amount of urine

sweating

trouble breathing

tunnel vision

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:

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site

diarrhea

giddiness

nausea

vomiting

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.