Dabigatran (Pradaxa): AFib Drug Side Effects & Dosage

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.

Pradaxa

Yes

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.

Common side effects of dabigatran include:

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.

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.

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.

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.

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.