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Tranexamic acid (Oral route)

Pronunciation:

tran-ex-AM-ik AS-id

Brand Names:

  • Lysteda

Dosage Forms:

  • Tablet
  • Syrup

Classifications:

Therapeutic—

Hemostatic

Uses of This Medicine:

Tranexamic acid is used to treat heavy menstrual bleeding in women. This medicine may be used by teenage females, but is not intended for use before the start of menstruation.

Tranexamic acid is an antifibrinolytic agent. It works by blocking the breakdown of blood clots, which prevents bleeding.

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

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 have not been performed on the relationship of age to the effects of tranexamic acid in children or teenage females younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of tranexamic acid have not been performed in the geriatric population. This medicine is not intended for use in women who are no longer having menstrual bleeding (postmenopausal).

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 taking 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 Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Levonorgestrel
  • Medroxyprogesterone Acetate
  • Mestranol
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel

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:

  • Acute promyelocytic leukemia—Use with caution. Using this medicine together with an oral tretinoin in patients with this condition may cause bleeding problems.
  • Blood clots, active or history of or
  • Deep vein thrombosis (blood clot in the leg) or
  • Pulmonary embolism (blood clot in the lung) or
  • Retinal artery or vein occlusion (blood clot in the eye), history of or
  • Stroke (blood clot in the brain)—Should not be used in patients with these conditions.
  • 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:

Take this medicine only as directed by your doctor. Do not take more 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 side effects.

Do not take this medicine when you do not have your period. You should wait until your monthly period has started before taking this medicine.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the tablet whole with liquids. Do not break, crush, or chew it.

Dosing—

The dose of this medicine 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 this medicine. 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.

  • For oral dosage form (tablets):
    • To treat heavy menstrual bleeding:
      • Adults—Two tablets (650 milligrams per tablet) three times a day in the morning, afternoon, and evening. The tablets should not be taken more than 5 days in a row for each monthly period.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you take a dose that is late, wait at least 6 hours before you take your next dose.

Storage—

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Tell your doctor if you are using birth control pills or other types of birth control (eg, patch, vaginal ring, or intrauterine device). You should not use this medication if you are also using combination hormonal contraception because it may increase your chance of having a blood clot, heart attack, or stroke. Your risk is even higher if you are overweight, if you smoke cigarettes, or if you are over 35 years of age.

This medicine may cause serious allergic reactions including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have shortness of breath, trouble breathing, chest tightness, flushing of the face, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Call your doctor right away if you have any eye problems, such as a change in your vision. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

If this medicine does not reduce your bleeding after two menstrual cycles or if it seems to stop working, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (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 immediately if any of the following side effects occur:

More common
Pale skin
trouble breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
Incidence not known
Anxiety
change in vision
chest pain or tightness
confusion
cough
difficulty with swallowing
dizziness or lightheadedness
fainting
fast heartbeat
numbness of the hands
pain, redness, or swelling in the arm or leg
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
skin rash, hives, or itching

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:

More common
Abdominal or stomach pain, discomfort, or tenderness
chills or fever
difficulty with moving
headache, severe and throbbing
joint or back pain
muscle aching or cramping
muscle pains or stiffness
stuffy or runny nose
Incidence not known
Diarrhea
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.


Last Updated: 11/4/2014

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