Drugplain

Pradaxa 20 mg/1

dabigatran etexilate · PELLET · Boehringer Ingelheim Pharmaceuticals, Inc.

1 Recall on Record
Plain English

Pradaxa is a pellet containing dabigatran etexilate at 20 mg/1, taken oral. Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..

Key Facts

Brand Name
Pradaxa
Generic Name
dabigatran etexilate
NDC Code (Product)
0597-0425
Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
Strength
20 mg/1
Dosage Form
PELLET
Route
ORAL
Marketing Status
Application #
NDA214358
Marketing Start
03/16/2022

Recall History

1 Recall on Record
Class II11/05/2012

Boehringer Ingelheim Roxane Inc

Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

gastrointestinal haemorrhage7,962 reports
cerebrovascular accident3,955 reports
fall3,064 reports
haemorrhage3,043 reports
anaemia2,650 reports
ischaemic stroke2,194 reports
death2,136 reports
dyspnoea2,074 reports
rectal haemorrhage2,004 reports
dizziness1,973 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days ( 1.1 ) To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated ( 1.2 ) 1.1 Treatment of Venous Thromboembolic Events in Pediatric Patients PRADAXA Oral Pellets are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days. 1.2 Reduction in the Risk of Recurrence of Venous Thromboembolic Events in Pediatric Patients PRADAXA Oral Pellets are indicated to reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Treatment of Pediatric Venous Thromboembolic Events (VTE): For pediatric patients aged 3 months to less than 2 years: age- and weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant ( 2.2 ) For pediatric patients 2 years to less than 12 years: weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant ( 2.2 ) Reduction in the Risk of Recurrence of Pediatric VTE: For pediatric patients aged 3 months to less than 2 years: age- and weight-based dosage, twice daily after previous treatment ( 2.2 ) For pediatric patients aged 2 years to less than 12 years: weight-based dosage, twice daily after previous treatment ( 2.2 ) Pradaxa Oral Pellets are NOT substitutable on a milligram-to-milligram basis with other dabigatran etexilate dosage forms ( 2.1 ) Review recommendations for converting to or from other oral or parenteral anticoagulants ( 2.5 , 2.6 ) Temporarily discontinue PRADAXA before invasive or surgical procedures when possible, then restart promptly ( 2.7 ) 2.1 Important Dosage Information Dabigatran etexilate is available in different dosage forms and not all dosage forms are approved for the same ind…

Contraindications

4 CONTRAINDICATIONS PRADAXA is contraindicated in patients with: Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see Adverse Reactions (6.1) ] Mechanical prosthetic heart valve [see Warnings and Precautions (5.4) ] Active pathological bleeding ( 4 ) History of serious hypersensitivity reaction to PRADAXA ( 4 ) Mechanical prosthetic heart valve ( 4 )

Drug Interactions

7 DRUG INTERACTIONS The concomitant use of PRADAXA with P-gp inhibitors has not been studied in pediatric patients but may increase exposure to dabigatran [see Warnings and Precautions (5.5) ] . P-gp inducers: Avoid coadministration with PRADAXA ( 5.5 ) The concomitant use of PRADAXA with P-gp inhibitors has not been studied in pediatric patients but may increase exposure to dabigatran ( 5.5 , 7 )

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Thrombotic Events after Premature Discontinuation [see Warnings and Precautions (5.1) ] Risk of Bleeding [see Warnings and Precautions (5.2) ] Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.3) ] Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves [see Warnings and Precautions (5.4) ] Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome [see Warnings and Precautions (5.6) ] The most serious adverse reactions reported with PRADAXA were related to bleeding [see Warnings and Precautions (5.2) ] . Most common adverse reactions (> 15%) are gastrointestinal adverse reactions and bleeding. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial…

Frequently Asked Questions

What is Pradaxa used for?

Pradaxa contains dabigatran etexilate. It is a pellet taken oral. Consult your doctor for specific uses.

Is Pradaxa a controlled substance?

Pradaxa is not classified as a controlled substance by the DEA.

What is the generic name for Pradaxa?

The generic name for Pradaxa is dabigatran etexilate. There are 10 other brand versions of dabigatran etexilate.

What is the NDC code for Pradaxa 20 mg/1?

The NDC (National Drug Code) for Pradaxa 20 mg/1 is 0597-0425, listed by Boehringer Ingelheim Pharmaceuticals, Inc..

Product NDC

0597-0425

Package NDC

0597-0425-78

Other Pradaxa Dosages

Other Dabigatran Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)