Dabigatran etexilate mesylate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Black Box Warning
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DISCONTINUING PRADAXA IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE
See full prescribing information for complete Boxed Warning.
Condition Name: (iscontinuing PRADAXA places patients at an increased risk of thrombotic events. If anticoagulation with PRADAXA must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.)
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Overview
Dabigatran etexilate mesylate is an Anti-coagulant that is FDA approved for the {{{indicationType}}} of reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Esophagitis, Gastritis, Gastroesophageal reflux disease, Gastrointestinal hemorrhage Gastrointestinal ulcer, Indigestion, Bleeding.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
<h4>Condition 1</h5>
- Dosing Information
- (Dosage)
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Dabigatran etexilate mesylate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Dabigatran etexilate mesylate Contraindications in the drug label.
Warnings
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DISCONTINUING PRADAXA IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE
See full prescribing information for complete Boxed Warning.
Condition Name: (iscontinuing PRADAXA places patients at an increased risk of thrombotic events. If anticoagulation with PRADAXA must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant.)
|
There is limited information regarding Dabigatran etexilate mesylate Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Dabigatran etexilate mesylate Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Dabigatran etexilate mesylate Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Dabigatran etexilate mesylate Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Dabigatran etexilate mesylate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dabigatran etexilate mesylate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Dabigatran etexilate mesylate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Dabigatran etexilate mesylate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Dabigatran etexilate mesylate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Dabigatran etexilate mesylate in geriatric settings.
Gender
There is no FDA guidance on the use of Dabigatran etexilate mesylate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Dabigatran etexilate mesylate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Dabigatran etexilate mesylate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Dabigatran etexilate mesylate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dabigatran etexilate mesylate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Dabigatran etexilate mesylate in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Dabigatran etexilate mesylate Administration in the drug label.
Monitoring
There is limited information regarding Dabigatran etexilate mesylate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Dabigatran etexilate mesylate and IV administrations.
Overdosage
There is limited information regarding Dabigatran etexilate mesylate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Dabigatran etexilate mesylate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Dabigatran etexilate mesylate Mechanism of Action in the drug label.
Structure
There is limited information regarding Dabigatran etexilate mesylate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Dabigatran etexilate mesylate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Dabigatran etexilate mesylate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Dabigatran etexilate mesylate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Dabigatran etexilate mesylate Clinical Studies in the drug label.
How Supplied
There is limited information regarding Dabigatran etexilate mesylate How Supplied in the drug label.
Storage
There is limited information regarding Dabigatran etexilate mesylate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Dabigatran etexilate mesylate Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Dabigatran etexilate mesylate interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Dabigatran etexilate mesylate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Dabigatran etexilate mesylate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.