Tranexamic Acid Inj Sol, 100ml
It is used to treat or prevent bleeding in patients with hemophilia after having a tooth removed.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antifibrinolytic agent
Pharmacologic Class
Lysine analogue
Pregnancy Category
Category B
FDA Approved
Sep 1986
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tranexamic acid is a medicine given by injection that helps your blood clot. It is used to stop or reduce bleeding, for example, after an injury, surgery, or in certain bleeding disorders.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is administered intravenously over a specified period. It is essential to note that this drug should never be injected into the spinal column.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage procedures.
In the event that you miss a dose, contact your doctor immediately to determine the best course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage procedures.
In the event that you miss a dose, contact your doctor immediately to determine the best course of action.
Lifestyle & Tips
- Report any signs of blood clots immediately (e.g., pain, swelling, warmth in leg; chest pain, shortness of breath, sudden vision changes).
- Avoid activities that may increase bleeding risk if your underlying condition predisposes you to bleeding, unless advised by your doctor.
- Inform your healthcare provider about all medications you are taking, especially hormonal birth control or other blood thinners.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For general bleeding (e.g., trauma, surgery): 10 mg/kg IV (or 1 g IV) over 10 minutes, then 1 g IV over 8 hours. For dental extractions in hemophiliacs: 10 mg/kg IV immediately before surgery, then 10 mg/kg IV 3-4 times daily for 2-8 days.
Dose Range:
10 - 1000 mg
Condition-Specific Dosing:
Trauma-induced hemorrhage:
1 g IV over 10 minutes, then 1 g IV over 8 hours.
Dental extractions in hemophiliacs:
10 mg/kg IV immediately before surgery, then 10 mg/kg IV 3-4 times daily for 2-8 days.
Pediatric Dosing
Neonatal:
Not established for routine use, but used off-label in specific situations (e.g., cardiac surgery).
Infant:
Not established for routine use, but used off-label in specific situations (e.g., cardiac surgery).
Child:
Varies by indication. For trauma: 15 mg/kg IV over 10 minutes (max 1g). For cardiac surgery: 10 mg/kg IV loading dose, then 10 mg/kg/hr infusion.
Adolescent:
Generally adult dosing based on weight, or specific pediatric protocols for trauma/surgery.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: 10 mg/kg IV BID.
Moderate:
CrCl 10-50 mL/min: 10 mg/kg IV daily.
Severe:
CrCl <10 mL/min: 10 mg/kg IV every 24-48 hours.
Dialysis:
Administer after dialysis on dialysis days. Dose adjustment based on post-dialysis CrCl.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Tranexamic acid is a synthetic lysine analogue that competitively inhibits the activation of plasminogen to plasmin. At higher concentrations, it non-competitively inhibits plasmin. This action prevents the dissolution of fibrin clots by plasmin, thereby stabilizing the clot and reducing bleeding.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV)
Tmax:
Immediate (IV)
FoodEffect:
Not applicable (IV)
Distribution:
Vd:
9-12 L/1.73 m^2
ProteinBinding:
Approximately 3% (to plasminogen)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2 hours (terminal half-life)
Clearance:
Approximately 110 mL/min
ExcretionRoute:
Renal (glomerular filtration)
Unchanged:
>95%
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of IV administration)
PeakEffect:
Within minutes
DurationOfAction:
Antifibrinolytic effect persists for approximately 3 hours in plasma, but can last longer in tissues (e.g., 17 hours in urine).
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 immediate medical attention:
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 vision
Changes in vision, eye pain, or severe eye irritation
Seizures
Twitching
Trouble controlling body movements
Severe dizziness or fainting
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 experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Diarrhea
Upset stomach
Vomiting
* Dizziness
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. 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 immediate medical attention:
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 vision
Changes in vision, eye pain, or severe eye irritation
Seizures
Twitching
Trouble controlling body movements
Severe dizziness or fainting
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 experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Diarrhea
Upset stomach
Vomiting
* Dizziness
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. 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:
- Signs of a blood clot (e.g., severe pain or swelling in a leg, sudden chest pain, difficulty breathing, sudden severe headache, vision changes, weakness on one side of the body)
- Allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
- Any changes in vision or color perception
- Severe dizziness or fainting
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. Be sure to describe the allergic reaction and its symptoms.
A history of blood clots, current blood clots, or being at risk of developing blood clots.
Certain health conditions, such as:
+ Bleeding in the brain
+ Difficulty perceiving certain colors
Use of medications that may increase the risk of blood clots, including:
+ Factor IX complex
+ Anti-inhibitor coagulant complex
+ Hormone-based birth control
If you have acute promyelocytic leukemia (APL) and are receiving treatment with tretinoin.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Existing health problems
This information will help your doctor determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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. Be sure to describe the allergic reaction and its symptoms.
A history of blood clots, current blood clots, or being at risk of developing blood clots.
Certain health conditions, such as:
+ Bleeding in the brain
+ Difficulty perceiving certain colors
Use of medications that may increase the risk of blood clots, including:
+ Factor IX complex
+ Anti-inhibitor coagulant complex
+ Hormone-based birth control
If you have acute promyelocytic leukemia (APL) and are receiving treatment with tretinoin.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Existing health problems
This information will help your doctor determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.
Be aware that this medication has been associated with an increased risk of blood clots. If you have a history of blood clots, notify your doctor promptly and discuss this with them.
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, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Be aware that this medication has been associated with an increased risk of blood clots. If you have a history of blood clots, notify your doctor promptly and discuss this with them.
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, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Hypotension (low blood pressure)
- Dizziness
- Headache
- Convulsions (seizures)
What to Do:
Seek immediate medical attention. Treatment is supportive. Hemodialysis may be considered to remove the drug from the body. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Contraindicated Interactions
- Factor IX complex concentrates
- Anti-inhibitor coagulant concentrates (e.g., FEIBA)
Major Interactions
- Hormonal contraceptives (e.g., oral contraceptives, patches, rings) - increased risk of thrombosis
- Tretinoin (all-trans retinoic acid) - increased risk of thrombotic complications, especially in acute promyelocytic leukemia (APL) patients
Moderate Interactions
- Chlorpromazine - theoretical risk of cerebral edema and visual disturbances
- Thrombolytic agents (e.g., alteplase, urokinase, streptokinase) - antagonism of therapeutic effect
- Anticoagulants (e.g., warfarin, heparin, DOACs) - theoretical antagonism of anticoagulant effect, though often used cautiously together in specific scenarios
Monitoring
Baseline Monitoring
Renal function (CrCl)
Rationale: Tranexamic acid is primarily renally excreted; dose adjustment is necessary in renal impairment.
Timing: Prior to initiation of therapy.
Coagulation parameters (PT, aPTT, fibrinogen, D-dimer)
Rationale: To assess baseline hemostatic status and monitor for procoagulant or antifibrinolytic effects.
Timing: Prior to initiation, especially in patients with underlying coagulopathies.
Routine Monitoring
Signs and symptoms of thromboembolic events
Frequency: Continuously during therapy and post-therapy.
Target: Absence of symptoms
Action Threshold: New onset of pain, swelling, redness in limb; chest pain, shortness of breath, sudden vision changes. Discontinue drug and investigate.
Visual acuity and color vision
Frequency: Periodically, especially with long-term use.
Target: Normal vision
Action Threshold: Any visual disturbances (e.g., blurred vision, impaired color vision). Discontinue drug and consult ophthalmologist.
Renal function
Frequency: As clinically indicated, especially in prolonged therapy or if renal function changes.
Target: Stable CrCl
Action Threshold: Significant decline in CrCl; adjust dose accordingly.
Symptom Monitoring
- Signs of thrombosis (e.g., leg pain/swelling, chest pain, shortness of breath, sudden severe headache, slurred speech, weakness/numbness on one side of body)
- Visual disturbances (e.g., blurred vision, impaired color vision)
- Allergic reactions (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
- Nausea, vomiting, diarrhea (common side effects)
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown fetal harm, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and potential benefits outweigh potential risks. Often used in life-threatening hemorrhage.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified, but generally avoided unless critical.
Second Trimester:
Considered relatively safe if indicated.
Third Trimester:
Considered relatively safe if indicated, especially for postpartum hemorrhage.
Lactation
L3 (Moderately safe). Tranexamic acid is excreted into breast milk in low concentrations. Infant exposure is minimal and adverse effects are unlikely. Monitor breastfed infant for diarrhea.
Infant Risk:
Low risk of adverse effects. Monitor for diarrhea or other gastrointestinal upset.
Pediatric Use
Dosing is established for various indications (e.g., trauma, cardiac surgery, dental procedures in hemophiliacs). Close monitoring of renal function and signs of thrombosis is important. Safety and efficacy in neonates and infants for all indications are not fully established.
Geriatric Use
No specific dose adjustment is required based on age alone, but dose should be adjusted based on renal function, which is often impaired in older adults. Increased risk of age-related renal impairment should be considered. Monitor for signs of thrombosis.
Clinical Information
Clinical Pearls
- Administer tranexamic acid injection slowly (over at least 10 minutes) to avoid hypotension.
- Do not mix tranexamic acid injection with blood, blood products, or solutions containing penicillin.
- Monitor patients for visual disturbances (e.g., impaired color vision) with long-term use, and discontinue if such changes occur.
- Exercise caution in patients with a history of thromboembolic disease or those receiving concomitant procoagulant factors or hormonal contraceptives due to increased risk of thrombosis.
- Tranexamic acid is not indicated for the treatment of disseminated intravascular coagulation (DIC) with predominant thrombotic activity.
Alternative Therapies
- Aminocaproic acid (another antifibrinolytic agent)
- Desmopressin (for certain bleeding disorders like hemophilia A or von Willebrand disease)
- Recombinant Factor VIIa (rFVIIa)
- Prothrombin complex concentrates (PCCs)
- Cryoprecipitate (source of fibrinogen, Factor VIII, vWF)
Cost & Coverage
Average Cost:
Variable per 100mg/mL vial
Generic Available:
Yes
Insurance Coverage:
Generally Tier 1 or 2 (preferred generic) for most insurance plans, depending on indication.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.
To ensure safe use, do not share your prescription medications with others, and never take medication that has been prescribed to someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not dispose of medications by flushing them down the toilet or pouring them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about drug take-back programs in your area, which can provide a safe and environmentally responsible way to dispose of unused medications.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist to see if this is the case. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider, who can provide you with accurate and personalized information.
In the event of a suspected overdose, it is critical to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. Be prepared to provide information about the medication, including the name, dosage, and time it was taken, as this will help healthcare professionals provide the most effective treatment.
To ensure safe use, do not share your prescription medications with others, and never take medication that has been prescribed to someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not dispose of medications by flushing them down the toilet or pouring them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about drug take-back programs in your area, which can provide a safe and environmentally responsible way to dispose of unused medications.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist to see if this is the case. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider, who can provide you with accurate and personalized information.
In the event of a suspected overdose, it is critical to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. Be prepared to provide information about the medication, including the name, dosage, and time it was taken, as this will help healthcare professionals provide the most effective treatment.