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Tranexamic acid

Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce th.

Prescription medicine Intravenous Safety alerts on record

How to use Tranexamic acid

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. ( 1 )

How to take it and how often
  • Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy
  • After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days
  • Infuse no more than 1 mL/minute to avoid hypotension
  • Reduce the dosage for patients with renal impairment
  • Recommended Dosage The recommended dose of tranexamic acid injection is 10 mg/kg actual body weight intravenously administered as a single-dose, immediately before tooth extractions
  • Infuse no more than 1 mL/minute to avoid hypotension [see Warnings and Precautions ]
  • Following tooth extraction, tranexamic acid injection may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight 3 to 4 times daily, intravenously
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
  • For intravenous infusion, tranexamic acid injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions
  • Heparin may be added to tranexamic acid injection
  • Tranexamic acid injection should NOT be mixed with blood
  • The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin
  • Discard any unused portion
  • The diluted mixture may be stored for up to 4 hours at room temperature prior to patient administration. …
Strengths it comes in

Injection: 1,000 mg tranexamic acid (100 mg per mL) clear and colorless solution in 10 mL single-dose vials. Injection: 1,000 mg tranexamic acid (100 mg per mL) in 10 mL single-dose vials. ( 3 )

Children
  • There are limited data concerning the use of tranexamic acid injection
  • In pediatric patients with hemophilia who are undergoing tooth extraction
  • The limited data suggest that there are no significant pharmacokinetic differences between
  • Adults and pediatric patients
Older adults

Clinical studies of tranexamic acid injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

While you are taking it
  • Thromboembolic Risk Inform patients that tranexamic acid injection 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
  • Advise patients using hormonal contraception that combined use with tranexamic acid injection may increase the risk for thromboembolic adverse reactions and to use effective alternative (nonhormonal) contraception during therapy with tranexamic acid injection [see Warnings and Precautions , Drug Interactions , Use in Specific Populations ] . …
Talk to a doctor first if
  • Tranexamic acid injection, USP is contraindicated: In patients with subarachnoid hemorrhage
  • Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients
  • In patients with active intravascular clotting [see Warnings and Precautions ]
  • In patients with hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions ] . …
Medicines it may not mix with

Prothrombotic Medical Products: Avoid concomitant use, can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid. ( 5.1 , 7.1 , 8.3 ) 7.1 Prothrombotic Medical Products Avoid concomitant use of tranexamic acid injection with medical products that are prothrombotic because concomitant use can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.3 )] .

Warnings

Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use. ( 5.1 ) Risk of Medication Errors Due to Incorrect Route of Administration: FOR INTRAVENOUS USE ONLY. ( 5.2 ) Seizures: Inadvertent injection into neuraxial system may result in seizures. ( 5.3 ) Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention. ( 5.4 ) Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur. ( 5.5 ) Dizziness: Advise patients not to drive if dizziness occurs. …

Possible side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Thromboembolic Risk [see Warnings and Precautions ( 5.1 )] Seizures [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Visual Disturbances [see Warnings and Precautions ( 5.5 )] Dizziness [see Warnings and Precautions ( 5.6 )] Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avenacy Inc. at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

Pregnancy and breastfeeding

8.1 Pregnancy Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. …

If you take too much

Cases of overdosage of tranexamic acid injection have been reported. Based on these reports, symptoms of overdosage may be gastrointestinal, e.g., nausea, vomiting, diarrhea; hypotensive, e.g., orthostatic symptoms; thromboembolic, e.g., arterial, venous, embolic; neurologic, e.g., visual impairment, convulsions, headache, mental status changes; myoclonus; and rash.

How to store it

Storage Conditions Store at 20º to 25°C (68º to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. …

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2024-03-15.

Brands around the world

Products with Tranexamic acid as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Tranexamic AcidTRANEXAMIC ACID 10 mg/mL · Injection, Solution · Nexus Pharmaceuticals LLC
NDC 14789-115Label
Tranexamic AcidTRANEXAMIC ACID 100 mg/mL · Injection, Solution · Gland Pharma Limited
NDC 68083-160Label
Tranexamic Acid In Sodium ChlorideTRANEXAMIC ACID 10 mg/mL · Injection, Solution · Gland Pharma Limited
NDC 68083-613Label
Tranexamic AcidTRANEXAMIC ACID 1 g/g · Powder · Medisca Inc.
NDC 38779-3211Label
Tranexamic AcidTRANEXAMIC ACID 650 mg/1 · Tablet · Dr. Reddy's Laboratories Inc.
NDC 75907-309Label

Nigeria (NAFDAC)

NAFDACTranexamic Acid Injection C4-1808NAFDACPrexam Capsules B4-5899NAFDACHemsamic Tablets B4-6753NAFDACPrexam Injection B4-5037NAFDACUnotation Injection B4-8451NAFDACTranalion 500 Tablet C4-1854NAFDACImpexxia Tranexamic Acids Tablets 500 mg_ C4-0771NAFDACTrenaxa 500 Tablet (Tranexamic Acid BP 500 mg) B4-8340

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30U.S. FDA Class III
12 Jun 2023 · Amring Pharmaceuticals Inc · TerminatedFailed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13U.S. FDA Class III
13 Jun 2023 · AVKARE LLC · OngoingFailed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-1U.S. FDA Class III
26 Sep 2022 · AuroMedics Pharma LLC · OngoingPresence of Particulate Matter: Piece of metal found in a vial
Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, ManufactuU.S. FDA Class I
17 Aug 2020 · Mylan Institutional LLC · TerminatedLabeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Tranexamic acid

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3 free checks left today Official sources: U.S. FDA · EMA (EU) · NAFDAC · WHO alerts

Questions about Tranexamic acid

What is Tranexamic acid used for?

Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy duri (From the official U.S. FDA label.)

How do I take Tranexamic acid?

Follow your prescription or the leaflet in your pack. The official label says: Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy. ( 2.1 ) After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days. Infuse no more than 1 mL/minute to avoid hypotension. ( 2.1 ) Reduce the dosage for patients with renal impairment. ( 2.2 , 8.6 ) 2.1 Recommended Dosage…

Do I need a prescription for Tranexamic acid?

Usually yes. Tranexamic acid is a prescription medicine in most countries. Rules differ by country.

What brands contain Tranexamic acid?

Tranexamic acid is sold under names such as Cyklokapron, Lysteda, Tranexamic Acid. Brand names differ between countries.

How can I check that my Tranexamic acid is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.