Dabigatran (Pradaxa): AFib Drug Side Effects & Dosage

What is dabigatran? How does dabigatran work?

• Dabigatran is an oral drug used to treat and
  prevent blood clots (an anticoagulant or blood thinner) in the hearts of
  patients with atrial fibrillation. These clots are likely to break into pieces
  and travel to the brain to cause strokes.
• Similarly, it is used to treat and prevent blood clots in the deep veins of
  the legs (deep venous thrombosis or DVT) and blood clots in the lungs. Blood
  clots in the deep veins of the legs are likely to break into pieces and travel
  to the lungs to block arteries in the lungs (pulmonary embolus or PE).
  Dabigatran works by blocking the action of thrombin a protein that is necessary
  for the coagulation of blood that results in blood clots. Reducing the action of
  thrombin reduces the ability of blood to clot.
• Dabigatran was approved by the
  FDA on October 2010.

What brand names are available for dabigatran?

Pradaxa

Is dabigatran available as a generic drug?

Do I need a prescription for dabigatran?

Yes

What are the uses for dabigatran?

• Dabigatran is used for reducing the risk of blood clots in
  the heart, and resulting strokes in patients with atrial fibrillation who have
  no problems with their heart valves (nonvalvular atrial fibrillation). It also
  is used for treating and preventing deep venous thrombosis and pulmonary
  embolism.

What are the side effects of dabigatran?

Common side effects of dabigatran include:

• Bleeding
• Symptoms of gastritis

Other serious side effects include:

• The most serious side effect is major bleeding. Major bleeding includes
  hemorrhagic stroke, intracranial hemorrhage, fatal bleeding, and
  gastrointestinal bleeds.
• Dabigatran increases the risk of bleeding and can cause significant and,
  sometimes, fatal bleeding. All signs or symptoms of blood loss such as a drop in
  hemoglobin and/or hematocrit or low blood pressure should be evaluated and
  dabigatran should be discontinued in patients with active bleeding.

Atrial fibrillation is a(n) …
See Answer

What is the dosage for dabigatran?

• The recommended dose of dabigatran for non-valvular atrial fibrillation is 75 to 150 mg twice daily. The recommended dose for preventing or
  treating DVT or PE is 150 mg twice daily.

Which drugs or supplements interact with dabigatran?

• P glycoprotein (P-gp) inhibitors (for example, dronedarone
  or ketoconazole
  [Nizoral, Extina, Xolegel, Kuric]) increase blood levels of dabigatran.
• The dose of dabigatran should be reduced to 75 mg twice daily when
  administered with P-gp inhibitors in patients with moderate renal impairment (a
  creatinine clearance of 30-50 mL/min).
• Dabigatran should not be combined with P-gp inhibitors in patients with
  severe renal impairment (creatinine clearance of 15-30 mL/min).
• Combining dabigatran with P-gp inducers (for example, rifampin) reduces
  dabigatran blood levels and should generally be avoided.

Is dabigatran safe to take if I’m pregnant or breastfeeding?

• There are no adequate or well-controlled trials of dabigatran use in pregnant
  women.
• It is not known if dabigatran is excreted into human milk.

What else should I know about dabigatran?

What preparations of dabigatran are available?

• Capsules: 75 and 150 mg

How should I keep dabigatran stored?

• Dabigatran should be stored at 15 C to 30 C (59 F to 86 F).
• Once
  opened, it must be used within 4 months.
• The container should be kept tightly
  closed. Drug should be stored in the original package to protect it from
  moisture.