HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PRADAXA safely and effectively. See full prescribing information for PRADAXA.
PRADAXA® (dabigatran etexilate mesylate) capsules for oral use
Initial U.S. Approval: 2010
INDICATIONS AND USAGE
PRADAXA is a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (1)
DOSAGE AND ADMINISTRATION
For patients with CrCl >30 mL/min: 150 mg orally, twice daily (2.1)
For patients with CrCl 15-30 mL/min: 75 mg orally, twice daily (2.1)
Instruct patients not to chew, break, or open capsules (2.1)
Review recommendations for converting to or from other oral or parenteral anticoagulants (2.2, 2.3)
Temporarily discontinue PRADAXA before invasive or surgical procedures when possible, then restart promptly (2.4)
DOSAGE FORMS AND STRENGTHS
Capsules:75 mg and 150 mg (3)
CONTRAINDICATIONS
Active pathological bleeding (4)
History of serious hypersensitivity reaction to PRADAXA (4)
WARNINGS AND PRECAUTIONS
Risk of bleeding: PRADAXA can cause serious and, sometimes, fatal bleeding. Promptly eva luate signs and symptoms of blood loss. (5.1)
Temporary discontinuation: Avoid lapses in therapy to minimize risk of stroke (5.2)
P-gp inducers and inhibitors: Avoid coadministration of rifampin with PRADAXA because of effects on dabigatran exposure (5.3)
ADVERSE REACTIONS
Most common adverse reactions (>15%) are gastritis-like symptoms and bleeding (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Geriatric use: Risk of bleeding increases with age (8.5)
See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide 
Revised: 11/2010
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1  Recommended Dose
2.2  Converting from or to Warfarin
2.3  Converting from or to Parenteral Anticoagulants
2.4  Surgery and Interventions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1  Risk of Bleeding
5.2  Temporary Discontinuation of PRADAXA
5.3  Effect of P-gp Inducers and Inhibitors on Dabigatran Exposure
6 ADVERSE REACTIONS
6.1  Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6  Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1  Instructions for Patients
17.2  Bleedin