Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots.

Lysteda is used to treat heavy menstrual bleeding. This medication will not treat premenstrual syndrome (PMS).

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

You should not use this medication if you are allergic to tranexamic acid, if you have problems with the blood vessels in your eyes, or if you have ever had a stroke, blood clot, or bleeding in your brain.

Before using tranexamic acid, tell your doctor if you have kidney disease, leukemia, a history of endometriosis, or if your menstrual cycles are less than 21 days apart or longer than 35 days apart.

Do not start taking Lysteda until your period has started. Do not take it for longer than 5 days in a row. Talk with your doctor if your symptoms do not improve after 2 cycles of treatment.

Do not take more than 6 tablets in one 24-hour period.

Use a barrier form of birth control (such as a condom or diaphragm with spermicide). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may increase your risk of stroke, blood clot, or heart attack if they are used at the same time as Lysteda.

Do not share Lysteda with another person, even if they have the same symptoms you have.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not start taking Lysteda until your period has started. Do not take it for longer than 5 days in a row.

Lysteda is usually taken three times per day for up to 5 days during your menstrual period. Do not take more than 6 tablets in one 24-hour period.

Take tranexamic acid with a full glass of water.

You may take Lysteda with or without food.

Do not crush, chew, or break a Lysteda tablet. Swallow it whole.

Talk with your doctor if your symptoms do not improve after 2 cycles of treatment.

Store this medication at room temperature away from moisture and heat.

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 daily
Duration of therapy: 2 to 8 days

Comments: 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:

Dose: 1300 mg (two 650 mg tablets) orally three times a day (3900 mg/day) during monthly menstruation
Duration: Maximum of 5 days

Use: 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 daily
Duration of therapy: 2 to 8 days

Comments:
-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:

Post menarchal females:

Dose: 1300 mg (two 650 mg tablets) orally three times a day (3900 mg/day) during monthly menstruation

Duration: Maximum of 5 days

Use: For the treatment of cyclic heavy menstrual bleeding in post-menarchal females

You should not take Lysteda if you are allergic to tranexamic acid, or if you have:

• color blindness;

• problems with the blood vessels in your eyes;

• a history of stroke;

• if you have a history of bleeding in your brain; or

• if you have recently had a blood clot.

To make sure you can safely take Lysteda, tell your doctor if you have any of these other conditions:

• kidney disease;

• leukemia;

• a history of endometriosis; or

• if your menstrual cycles are less than 21 days apart or longer than 35 days apart.

It is not known whether tranexamic acid will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Tranexamic acid can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 years old without your doctor's advice.

Do not share Lysteda with another person, even if they have the same symptoms you have.

Take the missed dose as soon as you remember. Then take your next dose at least 6 hours later. Do not take 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 severe forms of some of the side effects listed in this medication guide.

Avoid using a hormonal form of birth control such as birth control pills, injections, implants, skin patches, and vaginal rings. Hormonal contraception may increase your risk of stroke, blood clot, or heart attack while you are taking Lysteda. If you need to use birth control during treatment with Lysteda, use a barrier form (such as a condom or diaphragm with spermicide).

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

Stop taking Lysteda and call your doctor at once if you have a serious side effect such as:

• problems with your vision (including color vision);

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• sudden chest pain or trouble breathing;

• pain or swelling in one or both legs;

• migraine headache;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• feeling like you might pass out.

Less serious side effects include:

• mild headache;

• runny or stuffy nose;

• stomach pain;

• tired feeling;

• eye redness; or

• back pain, joint or muscle pain.

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.

Tell your doctor about all other medicines you use, especially:

• hormonal birth control (such as birth control pills, injections, implants, skin patches, and vaginal rings);

• tretinoin (Vesanoid);

• chemotherapy medication to treat leukemia;

• any type of medication to treat a bleeding episode or a blood clot; or

• factor IX (Bebulin VH, Konyne 80, Profilnine SD, Proplex T, and others).

This list is not complete and other drugs may interact with Lysteda. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.