Tranexamic acid

Tranexamic acid stops enzymes in the body from breaking down blood clots.

Cyklokapron is used to prevent bleeding in people with hemophilia who need to have a tooth removed. This medication is typically given right before the dental procedure, and daily for up to 8 days afterward.

Tranexamic acid may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Cyklokapron is given as an infusion into a vein just before your tooth is pulled. You may need to keep using this medicine for up to 8 days afterward.

A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Your vision may need to be tested while you are using tranexamic acid.

Store this medicine at room temperature. Prepare an injection only when you are ready to give it.

Each vial or ampule is for one use only. Throw it away after one use, even if there is still medicine left inside.

You should not use Cyklokapron if you are color blind, if you have issues with the blood vessels in your eyes, or if you have ever had a stroke, blood clot, or bleeding in your brain.

You should not use Cyklokapron if you are allergic to tranexamic acid, or if you have:

• problems with the blood vessels in your eyes;
• color blindness (only if you are receiving the injectable form of tranexamic acid); or
• a history of stroke, blood clot, or bleeding in your brain.

Tell your doctor if you have ever had:

• kidney disease;
• a bladder or kidney infection; or
• leukemia.

Tell your doctor if you are pregnant or breastfeeding.

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

Cyklokapron may cause serious side effects. Stop using Cyklokapron and call your doctor right away if you have:

• problems with your vision (including color vision);
• a light-headed feeling, like you might faint;
• a seizure;
• painful or difficult urination, blood in your urine;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg--swelling, warmth, or redness in an arm or leg.

Common side effects include:

• nausea, vomiting, diarrhea;
• dizziness, feeling light-headed;
• mild itching or rash; or
• feeling unusually happy.

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

Usual Adult Dose for Bleeding:

Initial dose: 10 mg/kg intravenously, immediately before dental extraction Maintenance dose: 10 mg/kg intravenously three to four times dailyDuration of therapy: 2 to 8 daysComment: Infuse no more than 1 mL/minute to avoid hypotension.Use: Short-term use in patients with hemophilia to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following a tooth extraction.

Usual Adult Dose for Menstrual Disorders:

Tablets:Dose: 1300 mg (two 650 mg tablets) orally three times a day (3900 mg/day) during monthly menstruationDuration: Maximum of 5 daysUse: For the treatment of cyclic heavy menstrual bleeding

Usual Pediatric Dose for Bleeding:

Initial dose: 10 mg/kg intravenously, immediately before dental extraction Maintenance dose: 10 mg/kg intravenously three to four times dailyDuration of therapy: 2 to 8 daysComments: -The limited data suggest that dosing instructions for adults can be used for pediatric patients needing therapy for tooth extractions. -Infuse no more than 1 mL/minute to avoid hypotension.Use: Short-term use in patients with hemophilia to reduce or prevent hemorrhage and reduce the need for replacement therapy during tooth extractions.

Usual Pediatric Dose for Menstrual Disorders:

Tablets: Dose: 1300 mg orally three times a day (3900 mg/day) during monthly menstruationDuration: Maximum of 5 days Use: For the treatment of cyclic heavy menstrual bleeding in post-menarchal females

Call your doctor for instructions if you miss a dose.

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

Overdose symptoms may include headache, confusion, vision problems, vomiting, diarrhea, numbness or weakness, problems with speech or balance, feeling light-headed, or fainting.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Tell your doctor about all your other medicines, especially:

• any type of medication to treat a bleeding episode or a blood clot; or
• factor IX complex (Bebulin, Bebulin VH, Profilnine, and others).

This list is not complete. Other drugs may affect tranexamic acid (Cyklokapron), including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.