Lysteda

DRUG DESCRIPTION

LYSTEDA (tranexamic acid tablets) is an antifibrinolytic drug. The chemical name is trans-4-aminomethylcyclohexanecarboxylic acid. The structural formula is:

LYSTEDA™ (tranexamic acid)  Structural Formula Illustration

Tranexamic acid is a white crystalline powder. It is freely soluble in water and in glacial acetic acid and is very slightly soluble in ethanol and practically insoluble in ether. The molecular formula is C8H15N02 and the molecular weight is 157.2.

Tranexamic acid tablets are provided as white oval-shaped tablets and are not scored. Each tablet is debossed with the marking “XP650.” The active ingredient in each tablet is 650 mg tranexamic acid. The inactive ingredients contained in each tablet are: microcrystalline cellulose, colloidal silicon dioxide, pregelatinized corn starch, povidone, hypromellose, stearic acid, and magnesium stearate.

What are the precautions when taking tranexamic acid tablets (Lysteda)?

Before taking tranexamic 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, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding in the brain (subarachnoid hemorrhage), history of blood clots (such as in the legs, lung, brain, eye), certain heart diseases (irregular heartbeat, heart valve problems), a certain serious blood clotting problem (disseminated intravascular coagulation-DIC), kidney problems (including blood in the urine), irregular menstrual bleeding of unknown cause.

Before having surgery, tell your doctor or dentist...

Read All Potential Precautions of Lysteda »


Lysteda Consumer (continued)

SIDE EFFECTS: See also How to use section.

Nausea, vomiting, diarrhea, and muscle pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Although unlikely, this medication may cause serious blood clot problems. Stop taking tranexamic acid and get medical help right away if any of these unlikely but serious side effects occur: coughing up blood, fainting, pain/swelling/warmth in the groin/calf, swelling/weakness/redness/pain in the arms/legs, signs of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion), change in the amount of urine, vision changes (such as color vision changes, decreased vision/blindness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking tranexamic 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, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding in the brain (subarachnoid hemorrhage), history of blood clots (such as in the legs, lung, brain, eye), certain heart diseases (irregular heartbeat, heart valve problems), a certain serious blood clotting problem (disseminated intravascular coagulation-DIC), kidney problems (including blood in the urine), irregular menstrual bleeding of unknown cause.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is usually used during your menstrual period. Therefore, it is unlikely to be used during pregnancy. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.



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