Dabigatran Etexilate

Name: Dabigatran Etexilate

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Very bad dizziness or passing out.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Feeling confused.
  • Feeling very tired or weak.
  • Very bad headache.
  • Very bad swelling.
  • Very bad belly pain.
  • Joint pain or swelling.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about dabigatran etexilate, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about dabigatran etexilate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using dabigatran etexilate.

Review Date: October 4, 2017

Pronunciation

(da BIG a tran ett EX ill ate)

Brand Names U.S.

  • Pradaxa

Off Label Uses

Postoperative thromboprophylaxis (knee replacement surgery)

Data from a randomized, double-blind, non-inferiority trial in patients undergoing total knee replacement surgery supports the use of dabigatran for postoperative thromboprophylaxis [Eriksson 2007]. Additional trials may be necessary to further define the role of dabigatran in this setting.

Based on the 2012 American College of Chest Physicians Evidence-Based Clinical Practice guidelines for antithrombotic therapy and prevention of thrombosis, dabigatran is effective and recommended for the prevention of DVT or PE in patients undergoing total knee arthroplasty.

Dosing Geriatric

DVT and pulmonary embolism/Nonvalvular atrial fibrillation (to prevent stroke and systemic embolism)/postoperative thromboprophylaxis: Oral: Numerous reports of excess anticoagulation, including fatalities, have been observed with use in older adults (ISMP [Smetzer 2012]; ISMP [Smetzer 2015]).

Patients >65 years: Refer to adult dosing. No dosage adjustment required unless renal impairment exists; however, risk of bleeding increases with age.

Patients ≥75 years: Use with extreme caution or consider other treatment options (see Warnings/Precautions) (ISMP [Smetzer 2012]; ISMP [Smetzer 2015]). No dosage adjustment provided in manufacturer’s labeling based on age alone (unless renal impairment coexists); however, risk of bleeding increases with age.

Dosing Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling; consistent changes in exposure or pharmacodynamics were not observed in a study of patients with moderate impairment.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience abdominal pain, nausea, or heartburn. Have patient report immediately to prescriber signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), severe dizziness, passing out, a fall hitting the head, signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), confusion, loss of strength and energy, severe headache, edema, or severe abdominal pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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