Tranexamic Acid Injection

Tranexamic Acid Injection is a prescription medication used to treat the symptoms of Dental Extraction in Patients with Hemophilia. 

• Tranexamic Acid Injection is available under the following different brand names: Cyklokapron

Adult and Pediatric dosage

Injectable solution

• 100mg/mL

Dental Extraction in Patients with Hemophilia

Adult and Pediatric dosage: 

• 10 mg/kg IV immediately before surgery or 10 mg/kg IV every 6-8 hours 1 day before surgery
• 25 mg/kg orally every 6-8 hours 1 day pre-surgery and 2-8 days post-surgery

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Tranexamic Acid Injection include:

• nausea, 
• vomiting, 
• diarrhea, 
• dizziness, 
• feeling light-headed, 
• mild itching or rash, and
• feeling unusually happy

Serious side effects of Tranexamic Acid Injection include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• problems with vision (including color vision), 
• lightheadedness, 
• seizure, 
• painful or difficult urination, 
• blood in the urine,
• sudden numbness or weakness (especially on one side of the body), 
• severe headache, 
• slurred speech, 
• balance problems, 
• chest pain, 
• sudden cough, 
• wheezing, 
• rapid breathing, 
• coughing up blood, and
• swelling, warmth, or redness in an arm or leg

Rare side effects of Tranexamic Acid Injection include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first

• Tranexamic Acid Injection has severe interactions with the following drugs:
  • prothrombin complex concentrate, human
• Tranexamic Acid Injection has serious interactions with the following drugs: 
  • anti-inhibitor coagulant complex
  • Factor IX
  • Factor IX, recombinant
• Tranexamic Acid Injection has moderate interactions with the following drugs.
  • defibrotide
  • mestranol
• Tranexamic Acid Injection has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Acquired defective color vision
• Subarachnoid hemorrhage
• Active intravascular clotting

Effects of drug abuse

• None

Short-Term Effects

• See “What are Side Effects Associated with Using Tranexamic Acid Injection?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tranexamic Acid Injection?”

Cautions

• Use caution in renal impairment, subarachnoid hemorrhage, vascular disease, thromboembolic history, and DIC
• Ureteral obstruction resulting from clot formation reported; use caution in patients with upper urinary tract bleeding
• Thromboembolism or venous and arterial thrombosis reported
• Ligneous conjunctivitis has been reported
• Concurrent use with anti-inhibitor coagulant complex/factor IX complex concentrates may further increase risk of thrombosis
• Concurrent use with tretinoin may exacerbate procoagulant effects
• Anaphylaxis reported with intravenous administration
• For intravenous use only; serious adverse reactions including seizures and cardiac arrythmias have occurred when drug inadvertently administered intrathecally instead of intravenously; confirm correct route of administration and avoid confusion with other injectable solutions that might be administered at same time as the drug; syringes containing drug should be clearly labeled with intravenous route of administration
• Visual disturbances
  • Visual defects (color vision change or visual loss) reported
  • In addition, although not seen in humans, focal areas of retinal degeneration have been observed in cats and dogs following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (1.6 to 22 times recommended usual human dose based on body surface area) from 6 days to 1 year
  • No retinal changes observed in eye examinations of patients treated with tranexamic acid for up to 8 years; patients expected to be treated for greater than 3 months may consider ophthalmic monitoring including visual acuity and optical coherence tomography at regular intervals; discontinue tranexamic acid in sodium chloride injection if changes in ophthalmological examination occur
• Seizures
  • May cause seizures, including focal and generalized seizures; the most common setting for tranexamic acid-induced seizures has been during cardiovascular surgery (a setting in which drug is not FDA approved and which uses doses of up to ten-fold higher than recommended human dose and in patients inadvertently given tranexamic acid into the neuraxial system)
  • Consider dose reduction during surgery and dose adjustments for patients with clinical conditions such as renal dysfunction; closely monitor patient during surgery
  • Consider electroencephalogram (EEG) monitoring for patients with history of seizures or who experience myoclonic movements, twitching, or show evidence of focal seizures; discontinue drug if seizures occur

Pregnancy and Lactation

• Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in second and third trimester and at time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes
• There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear
• Drug is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration
• Published literature reports presence of tranexamic acid in human milk; there are no data on effects of drug on breastfed child or effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition