Tranexamic Acid 650mg Tablets
It is used to treat heavy bleeding during monthly periods (menstruation).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antifibrinolytic
Pharmacologic Class
Lysine analogue; Plasminogen activator inhibitor
Pregnancy Category
B
FDA Approved
Nov 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tranexamic acid is a medication used to reduce heavy menstrual bleeding (menorrhagia). It works by helping your blood clot more effectively, which can lessen the amount and duration of your period.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it. Take the medication for the duration prescribed by your doctor. Do not take it for longer than recommended, and only take it when you are menstruating.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. Then, take your next dose at least 6 hours later. If it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it. Take the medication for the duration prescribed by your doctor. Do not take it for longer than recommended, and only take it when you are menstruating.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. Then, take your next dose at least 6 hours later. If it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed, usually for a few days during your period.
- Do not take more than the recommended dose or for longer than 5 days.
- Do not take this medication if you are also using hormonal birth control (pills, patch, ring, injection, or implant) due to an increased risk of blood clots, unless specifically advised by your doctor who has weighed the risks and benefits.
- Report any signs of blood clots immediately (e.g., leg pain/swelling, chest pain, shortness of breath, sudden severe headache, vision changes).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1300 mg (two 650 mg tablets) orally three times daily (TID) for a maximum of 5 days during menstruation.
Dose Range:
1300 - 1300 mg
Condition-Specific Dosing:
menorrhagia:
1300 mg orally TID for a maximum of 5 days during menstruation.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for menorrhagia in pre-menarcheal girls. For other indications, dosing is weight-based and typically IV.
Adolescent:
For post-menarcheal adolescents with menorrhagia, dosing is generally similar to adults, 1300 mg orally TID for a maximum of 5 days during menstruation.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 60-89 mL/min: 1300 mg orally twice daily (BID).
Moderate:
CrCl 30-59 mL/min: 1300 mg orally once daily (QD).
Severe:
CrCl 15-29 mL/min: 650 mg orally once daily (QD).
Dialysis:
Not recommended for patients with CrCl <15 mL/min. Tranexamic acid is dialyzable, but specific dosing for dialysis patients is not well-established for oral form; generally avoided or used with extreme caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Tranexamic acid is a synthetic derivative of the amino acid lysine. It exerts its antifibrinolytic effect by reversibly binding to plasminogen and plasmin, thereby preventing the binding of plasminogen to fibrin and the subsequent conversion of plasminogen to plasmin. This action inhibits the dissolution of fibrin clots, stabilizing the clot and reducing bleeding.
Pharmacokinetics
Absorption:
Bioavailability:
30-50% (oral)
Tmax:
Approximately 3 hours
FoodEffect:
Minimal effect on absorption.
Distribution:
Vd:
Approximately 9-12 L/1.73m²
ProteinBinding:
Approximately 3% (to plasminogen)
CnssPenetration:
Limited (CSF concentrations are approximately 1/10th of plasma concentrations)
Elimination:
HalfLife:
Approximately 2-11 hours (terminal elimination half-life)
Clearance:
Primarily renal clearance
ExcretionRoute:
Renal (glomerular filtration)
Unchanged:
>95%
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours (oral)
PeakEffect:
Approximately 3 hours
DurationOfAction:
Approximately 8-12 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Flushing
Weakness on one side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight
Changes in eyesight, eye pain, or severe eye irritation
Seizures
Twitching
Trouble controlling body movements
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Stomach pain
Back, muscle, or joint pain
Nose stuffiness
Muscle cramps
Feeling tired or weak
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Flushing
Weakness on one side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight
Changes in eyesight, eye pain, or severe eye irritation
Seizures
Twitching
Trouble controlling body movements
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Stomach pain
Back, muscle, or joint pain
Nose stuffiness
Muscle cramps
Feeling tired or weak
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache
- Weakness or numbness on one side of the body
- Slurred speech
- Sudden vision changes (blurred vision, loss of vision, changes in color perception)
- Pain, swelling, or warmth in your leg (especially in the calf or thigh)
- Chest pain, sudden cough, or shortness of breath
- Severe stomach pain
- Signs of an allergic reaction (hives, difficulty breathing, swelling of your face/lips/tongue/throat)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
A history of blood clots, current blood clots, or being at risk of developing blood clots.
Certain health conditions, including:
+ Bleeding in the brain
+ Difficulty perceiving certain colors
Concurrent use of medications that may increase the risk of blood clots, such as:
+ Factor IX complex
+ Anti-inhibitor coagulant complex
+ Hormone-based birth control methods
If you have acute promyelocytic leukemia (APL) and are receiving treatment with tretinoin.
To avoid potential interactions, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
Existing health problems
Verify with your doctor that it is safe to take this medication with your current medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
A history of blood clots, current blood clots, or being at risk of developing blood clots.
Certain health conditions, including:
+ Bleeding in the brain
+ Difficulty perceiving certain colors
Concurrent use of medications that may increase the risk of blood clots, such as:
+ Factor IX complex
+ Anti-inhibitor coagulant complex
+ Hormone-based birth control methods
If you have acute promyelocytic leukemia (APL) and are receiving treatment with tretinoin.
To avoid potential interactions, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
Existing health problems
Verify with your doctor that it is safe to take this medication with your current medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require your full attention.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, it is crucial to discuss this with your doctor.
As directed by your doctor, schedule an eye exam to monitor your eye health.
If you are attempting to prevent pregnancy, use a non-hormonal form of birth control, such as condoms, while taking this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
If you experience heavy menstrual bleeding after two cycles or notice that the medication is no longer effective, consult your doctor to determine the best course of action.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, it is crucial to discuss this with your doctor.
As directed by your doctor, schedule an eye exam to monitor your eye health.
If you are attempting to prevent pregnancy, use a non-hormonal form of birth control, such as condoms, while taking this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
If you experience heavy menstrual bleeding after two cycles or notice that the medication is no longer effective, consult your doctor to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Hypotension (low blood pressure)
- Thromboembolic events (blood clots)
- Convulsions
What to Do:
Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and symptomatic. Gastric lavage may be considered if ingestion is recent. Maintain adequate hydration and monitor for signs of thrombosis.
Drug Interactions
Contraindicated Interactions
- Combined hormonal contraceptives (e.g., estrogen/progestin oral contraceptives, patches, rings) - increased risk of thrombosis.
- Factor IX complex concentrates (e.g., FEIBA) - increased risk of thrombosis.
Major Interactions
- Anti-inhibitor coagulant complex (e.g., FEIBA) - increased risk of thrombosis.
- Tretinoin (oral) - theoretical increased risk of thrombosis.
Moderate Interactions
- Anticoagulants (e.g., warfarin, direct oral anticoagulants) - theoretical antagonism of anticoagulant effect.
- Thrombolytics (e.g., alteplase, reteplase) - antagonism of thrombolytic effect.
- Other procoagulants (e.g., aprotinin) - additive procoagulant effects.
Minor Interactions
- Not many clinically significant minor interactions reported.
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Tranexamic acid is primarily renally eliminated; dose adjustment is required in renal impairment.
Timing: Prior to initiation of therapy.
Ophthalmic examination (visual acuity, color vision)
Rationale: Although rare, visual disturbances (e.g., color vision impairment) have been reported with long-term use. Not typically required for short-term menorrhagia treatment.
Timing: Consider for patients on prolonged therapy or with pre-existing visual impairment.
Routine Monitoring
Signs and symptoms of thromboembolic events (e.g., DVT, PE, stroke, MI)
Frequency: Daily during treatment and for a period after cessation.
Target: Absence of symptoms.
Action Threshold: Any new or worsening symptoms of thrombosis require immediate medical evaluation and discontinuation of tranexamic acid.
Visual disturbances (e.g., blurred vision, changes in color perception)
Frequency: Periodically, especially with prolonged use.
Target: Normal vision.
Action Threshold: Any new visual symptoms require discontinuation and ophthalmologic evaluation.
Renal function (CrCl)
Frequency: As clinically indicated, especially in patients with pre-existing renal impairment or risk factors for worsening renal function.
Target: Stable CrCl.
Action Threshold: Significant decline in CrCl may necessitate dose adjustment or discontinuation.
Symptom Monitoring
- Leg pain or swelling (especially unilateral)
- Chest pain or discomfort
- Shortness of breath or difficulty breathing
- Sudden severe headache
- Sudden weakness or numbness on one side of the body
- Slurred speech
- Sudden vision changes (e.g., blurred vision, loss of vision, changes in color perception)
- Abdominal pain (severe)
- Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified, but data are limited.
Second Trimester:
No specific increased risk identified, but data are limited.
Third Trimester:
No specific increased risk identified, but data are limited.
Lactation
Tranexamic acid is excreted into breast milk in small concentrations (approximately 1/100th of maternal plasma levels). The amount ingested by a breastfed infant is considered low. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor infant for any adverse effects.
Infant Risk:
L3 (Moderately safe - compatible with breastfeeding, but monitor infant for potential effects like diarrhea or rash, though unlikely at typical doses).
Pediatric Use
Safety and efficacy for menorrhagia have not been established in pre-menarcheal girls. For post-menarcheal adolescents, dosing is similar to adults. For other indications (e.g., bleeding disorders), IV tranexamic acid is used with weight-based dosing.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, dose selection for an elderly patient should be cautious, generally starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Renal function should be monitored.
Clinical Information
Clinical Pearls
- Tranexamic acid is specifically approved for heavy menstrual bleeding (menorrhagia) and should be taken only during the menstrual period, for a maximum of 5 days.
- It is contraindicated with combined hormonal contraceptives due to an increased risk of thrombosis. Patients must be carefully screened for concurrent use of these agents.
- Renal dose adjustment is crucial due to primary renal elimination. Failure to adjust can lead to accumulation and increased risk of adverse effects.
- Patients should be educated on the signs and symptoms of thromboembolic events and advised to seek immediate medical attention if they occur.
- While rare, visual disturbances (including color vision impairment) have been reported; patients should be advised to report any changes in vision.
Alternative Therapies
- Nonsteroidal anti-inflammatory drugs (NSAIDs) - e.g., ibuprofen, naproxen (reduce prostaglandin synthesis, which can reduce bleeding)
- Hormonal therapies - e.g., oral contraceptives, progestin-only therapies (oral, IUD, injection), GnRH agonists (suppress ovulation and endometrial growth)
- Desmopressin (DDAVP) - for menorrhagia associated with certain bleeding disorders (e.g., von Willebrand disease)
- Surgical options - e.g., endometrial ablation, hysterectomy (for severe, refractory cases)
Cost & Coverage
Average Cost:
Varies, typically $100-$300 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic), Tier 3 or Tier 4 (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.