Tranexamic Acid (Page 5 of 6)

14.4 Heavy Menstrual Bleeding Results over Time

The efficacy of tranexamic acid USP tablets 3900 mg/day over 3 menstrual cycles and over 6 menstrual cycles was demonstrated versus placebo in Studies 1 and 2 (see Figure 1). The change in menstrual bleeding loss from baseline was similar across all post-baseline treatment cycles.

Figure 1: Menstrual Bleeding Loss Levels over Duration of Therapy in Women with Heavy Menstrual Bleeding (Studies 1 and 2)

Figure 1
(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

Tranexamic acid USP tablets are provided as white oval-shaped 650 mg tablets. Each tablet is debossed with the marking “FP650”and are supplied as:

NDC 50268-772-13 (10 tablets per card, 3 cards per carton).

Dispensed in Unit Dose Package. For Institutional Use Only.

Storage

Store at room temperature 25° C (77° F); excursions permitted to 15-30° C (59-86° F). [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling ( Patient Information).

Thromboembolic Risk
Inform patients that tranexamic acid USP tablets may increase the risk of venous and arterial thrombosis or thromboembolism and to contact their healthcare provider for any signs or symptoms suggestive of thromboembolism [see Warnings and Precautions (5.1)].

Advise patients to discontinue use of tranexamic acid USP tablets and promptly report visual and ocular symptoms to their health care provider as retinal venous and arterial occlusion have been reported in patients using tranexamic acid USP tablets [see Warnings and Precautions (5.1)].

Severe Allergic Reactions
Inform patients that they should stop tranexamic acid USP tablets and seek immediate medical attention if they notice symptoms of a severe allergic reaction (e.g., shortness of breath or throat tightening) [see Warnings and Precautions (5.2)].

Administration Instructions
Instruct patients to take tranexamic acid USP tablets only during menstruation and for a maximum of 5 days each month [see Recommended Dosage (2.1)].

Manufactured for:
AvKARE
Pulaski, TN 38478

Mfg. Rev. 12/20
AV 09/22 (W)
AvPAK

PATIENT INFORMATION

TRANEXAMIC ACID (TRAN-ex-AM-ik AS-id), USP TABLETS, for oral use

Read the Patient Information that comes with tranexamic acid USP tablets before you start using the drug and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is tranexamic acid USP tablets?

Tranexamic acid USP tablets is a prescription medicine used to treat your heavy monthly period (menstruation) when your bleeding gets in the way of social, leisure and physical activities. Tranexamic acid USP tablets does not contain any hormones. On average, tranexamic acid USP tablets has been shown to lower the amount of blood lost during your monthly period by about one-third, but it is not meant to stop your period.

Tranexamic acid USP tablets is taken only during your period and is not meant to treat pre-menstrual symptoms (symptoms that occur before your bleeding starts). Tranexamic acid USP tablets does not affect your fertility and cannot be used as birth control. Tranexamic acid USP tablets does not protect you against diseases that you may get if you have unprotected sex.

Tranexamic acid USP tablets has not been studied in adolescents younger than 18 years of age.

Tranexamic acid is not for women who have already gone through menopause (post-menopausal).

Who should not take tranexamic acid USP tablets?

Do not take tranexamic acid USP tablets if you:

  • Are using a form of birth control that contains estrogen and a progestin (like a birth control pill, patch, or vaginal ring). Ask your healthcare provider before taking tranexamic acid USP tablets if you are not sure if your birth control method contains estrogen and a progestin.
  • Currently have a blood clot
  • Have ever had a blood clot
  • Have been told that you are at risk of having a blood clot
  • Are allergic to tranexamic acid

What should I tell my healthcare provider before taking tranexamic acid USP tablets?

Before taking tranexamic acid USP tablets, tell your healthcare provider about all of your medical conditions, including whether:

  • You have ever had a blood clot or been told that you are at risk of having a blood clot
  • You are using a form of birth control that contains estrogen and a progestin (like a birth control pill, patch, or vaginal ring). Using hormonal birth control along with tranexamic acid USP tablets may increase your chance of having a serious blood clot, stroke, or heart attack. For this reason, do not use tranexamic acid USP tablets if you use a form of birth control that contains estrogen and a progestin.
  • You are pregnant or think you may be pregnant
  • You are breastfeeding or plan to breast-feed. Tranexamic acid USP tablets can pass into your milk. Talk to your healthcare provider about the best way to feed your baby if you take tranexamic acid USP tablets.
  • The time between the start of your periods is less than 21 days or more than 35 days
  • You have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tranexamic acid USP tablets and other medicines can affect each other, causing side effects. Tranexamic acid USP tablets can affect the way other medicines work and other medicines can affect how tranexamic acid USP tablets works.

Especially tell your healthcare provider if you take:

  • Birth control pills or other hormonal birth control
  • Medicines used to help your blood form clots
  • Medicines used to break up blood clots
  • Any medicines to treat leukemia

Ask your healthcare provider if you are not sure if your medicine is one that is described above.

How should I take tranexamic acid USP tablets?

  • Take tranexamic acid USP tablets exactly as your healthcare provider tells you.
  • Do not take tranexamic acid USP tablets until your period has started.
  • Do not take tranexamic acid USP tablets for more than 5 days in a row.
  • Do not take tranexamic acid USP tablets when you do not have your period.
  • Once your period has started, take 2 tablets of tranexamic acid USP tablets three times per day (e.g., in the morning, afternoon, and evening).
  • Tranexamic acid USP tablets should be swallowed whole and not chewed or broken apart.
  • Tranexamic acid USP tablets may be taken with or without food.
  • Do not take more than 6 tablets of tranexamic acid USP tablets in a day. If you take more than 6 tablets, call your healthcare provider.
  • If you miss a dose, take it when you remember, and then take your next dose at least six hours later. Do not take more than two tablets at a time to make up for missed doses.
  • If tranexamic acid USP tablets does not help to lessen bleeding with your periods after 2 cycles or seems to stop working, talk to your healthcare provider.

What are the possible side effects of tranexamic acid USP tablets?

Tranexamic acid USP tablets can cause serious side effects, including:

  • Blood clots. You may have a higher risk of having serious blood clots if you take tranexamic acid USP tablets with:
    • medicines used to help your blood form clots
    • some medicines used to treat leukemia
  • Eye changes. Stop taking tranexamic acid USP tablets and promptly report any eye problems you have while taking tranexamic acid USP tablets. Your doctor will refer you to an eye doctor who will examine your eyes.
  • Allergic reaction. If you have severe shortness of breath and your throat feels tight, stop taking tranexamic acid USP tablets and get medical care right away.

The most common side effects of tranexamic acid USP tablets include:

  • Headaches
  • Sinus and nasal problems
  • Back pain
  • Pain in your abdomen
  • Pain in your muscles or joints
  • Anemia
  • Fatigue

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of tranexamic acid USP tablets. For more information, ask your healthcare provider or pharmacist.

If you notice a change in your usual bleeding pattern that worries you, or your heavy bleeding continues, contact your healthcare provider right away. This may be a sign of a more serious condition.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Amring Pharmaceuticals Inc. at 1-844-Amring1 (1-844-267-4641).

How should I store tranexamic acid USP tablets?

Store tranexamic acid USP tablets at room temperature between 59°F to 86°F (15°C to 30°C).

Keep tranexamic acid USP tablets and all medicines out of the reach of children.

General information about tranexamic acid USP tablets

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information Leaflets. Do not use tranexamic acid USP tablets for a condition for which it was not prescribed. Do not give tranexamic acid USP tablets to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about tranexamic acid USP tablets. If you would like more information about tranexamic acid USP tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about tranexamic acid USP tablets that is written for healthcare professionals. For more information, call AvKARE at 1-855-361-3993.

What are the ingredients of tranexamic acid USP tablets?

Active ingredient: tranexamic acid

Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, pregelatinized corn starch, povidone, hypromellose, stearic acid, and magnesium stearate.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:
AvKARE
Pulaski, TN 38478

Mfg. Rev. 12/20
AV 09/22 (W) AvPAK

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.