PRADAXA

PRADAXA

GENERIC NAME: BOEHRINGER INGELHEIM

DOSAGE               : 75 MG Capsule & 110 MG Capsule.

INDICATION       : 

Ø  Prevention of   VTE ( venous thromboembolism) – elective TKR  surgery.

Ø  To reduce the risk for Atrial Fibrillation and Stroke. 

Atrial fibrillation, characterized by an irregular heartbeat, can cause blood clots to form in the heart that can travel to the brain and cause a stroke. An estimated 2.3 million Americans are living with atrial fibrillation, and the prevalence is expected to increase to 5.6 million by 2050. Non-valvular atrial fibrillation, which accounts for up to 95 percent of diagnosed cases of atrial fibrillation, refers to cases of atrial fibrillation without rheumatic mitral valve disease, prosthetic heart valve or valve repair, according to the 2006 ACC/AHA/ESC guidelines.  Atrial fibrillation increases the risk of stroke nearly five times  and is associated with up to 15 percent of all strokes in the U.S. Atrial fibrillation imposes a substantial economic burden to the healthcare system, specifically the high costs associated with stroke.

CONTRAINDICATION      :

Ø   Serious Hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock)

Ø  Severe renal impairment

Ø  Active pathological bleeding

Ø  Hepatic impairment   or  liver disease

Ø  Organic lesion at risk of bleeding

Ø  Concomitant treatment with Quinidine

Ø  Concomitant treatment with  systemic ketoconazole

WARNINGS AND PRECAUTIONS:
Risk of Bleeding
PRADAXA increases the risk of bleeding and can cause significant and  sometimes fatal bleeding.

Risk factors for bleeding include:

• Medications that increase the risk of bleeding in general (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs).
• Labor and delivery

Promptly evaluate any signs or symptoms of blood loss, such as a drop in hemoglobin and/or hematocrit or hypotension. Discontinue PRADAXA in patients with active pathological bleeding.

Temporary Discontinuation of PRADAXA
Discontinuing PRADAXA for active bleeding, elective surgery, or invasive procedures places patients at an increased risk of stroke. Lapses in therapy should be avoided, and if PRADAXA must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.

Effect of P-gp Inducers and Inhibitors on PRADAXA Exposure
The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces dabigatran exposure and should generally be avoided.

 P-gp inhibitors ketoconazole, verapamil, amiodarone, quinidine, and clarithromycin, do not require dose adjustments. These results should not be extrapolated to other P-gp inhibitors.

ADVERSE REACTIONS :
In the pivotal trial comparing PRADAXA to warfarin, the most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal (GI) events.

PRADAXA 150 mg resulted in a higher rate of major GI bleeds and any GI bleeds compared to warfarin. I

 patients ≥75 years of age, the risk of major bleeding may be greater with PRADAXA than with warfarin.

 Patients on PRADAXA 150 mg had an increased incidence of GI adverse reactions.  These were commonly dyspepsia (including abdominal pain, upper abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and GI ulcer). 

Drug hypersensitivity reactions were reported in <0.1% of patients receiving PRADAXA.