70/100Limited · 1 source
Based on 1 source · Manufacturer recall-safety score (FDA recall history) — not an efficacy or quality rating. methodology →
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~$27.66 /30
Overview
The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C 34 H 41 N 7 O 5 ⋅ CH 4 O 3 S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is off-white to yellowish powder. It is freely soluble in methanol and ethanol, practically insoluble in acetone, ethyl acetate and water. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose phthalate, pelletized tartaric acid, talc. The capsule shell is composed of carrageenan, hypromellose, potassium chloride and titanium dioxide. Additionally, 110 mg and 150 mg capsule shell also contains FD&C Blue No. 2. The empty hard hypromellose capsule shells are printed with edible black ink…
How to use
2 DOSAGE AND ADMINISTRATION • Non-valvular Atrial Fibrillation in Adult Patients: o For patients with CrCl >30 mL/min: 150 mg orally, twice daily ( 2.2 ) o For patients with CrCl 15 to 30 mL/min: 75 mg orally, twice daily ( 2.2 ) • Treatment of DVT and PE in Adult Patients : o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after 5 to 10 days of parenteral anticoagulation ( 2.2 ) • Reduction in the Risk of Recurrence of DVT and PE in Adult Patients : o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after previous treatment ( 2.2 ) • Prophylaxis of DVT and PE Following Hip Replacement Surgery in Adult Patients : o For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once daily ( 2.2 ) • Treatment of Pediatric VTE: o For pediatric patients: weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant ( 2.3 ) • Reduction in the Risk of Recurrence of Pediatric VTE: o For pediatric patients: weight-based dosage, twice daily after previous treatment ( 2.3 ) • Dabigatran etexilate capsules are NOT substitutable on a milligram-to-milligram basis with other dabigatran etexilate dosage forms • Review recommendations for converting to or from other oral or parenteral anticoagulants ( 2.6 , 2.7 ) • Temporarily discontinue dabigatran etexilate capsules before invasive or surgical procedures when possible, then restart…
Side effects
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 dabigatran etexilate 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 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 trials of another drug and may not reflect the rates observed in practice. Adult Trials Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation The RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) study provided safety information on the…
Warnings
Important safety information
WARNING: (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including dabigatran etexilate capsules , increases the risk of thrombotic events. If anticoagulation with dabigatran etexilate capsules a re discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.6, 2.7, 2.8) and Warnings and Precautions (5.1)]. (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with dabigatran etexilate capsules who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • use of indwelling epidural catheters • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • a history of traumatic or repeated epidural or spinal punctures • a history of spinal deformity or…
Interactions
7 DRUG INTERACTIONS • P-gp inducers: Avoid coadministration with dabigatran etexilate capsules ( 5.5 ) • P-gp inhibitors in adult patients with CrCl 30 to 50 mL/min: Reduce dosage or avoid ( 7 ) • P-gp inhibitors in adult patients with CrCl <30 mL/min: Not recommended ( 7 ) 7.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients The concomitant use of dabigatran etexilate with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided [see Clinical Pharmacology (12.3)] . P-gp inhibition and impaired renal function are the major independent factors that result in increased exposure to dabigatran [see Clinical Pharmacology (12.3)] . Concomitant use of P-gp inhibitors in patients with renal impairment is expected to produce increased exposure of dabigatran compared to that seen with either factor alone. In patients with moderate renal impairment (CrCl 30 to 50 mL/min), reduce the dosage of dabigatran etexilate to 75 mg twice daily when administered concomitantly with the P-gp inhibitors dronedarone or systemic ketoconazole. The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dosage adjustment of dabigatran etexilate. These results should not be extrapolated to other P-gp inhibitors [see Warnings and Precautions (5.5), Use in…
Drug class
May treat
Dosage forms
CAPSULE
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Frequently asked questions
- What is Pradaxa?
- The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C 34 H 41 N 7 O 5 ⋅ CH 4 O 3 S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is: Dabigatran etexilate mesylate is off-white to yellowish powder. It is freely soluble in methanol and ethanol, practically insoluble in acetone, ethyl acetate and water. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate) or 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose phthalate, pelletized tartaric acid, talc. The capsule shell is composed of carrageenan, hypromellose, potassium chloride and titanium dioxide. Additionally, 110 mg and 150 mg capsule shell also contains FD&C Blue No. 2. The empty hard hypromellose capsule shells are printed with edible black ink…
- What does Pradaxa treat?
- Pradaxa (Dabigatran Etexilate Mesylate) is indicated for pulmonary embolism, venous thrombosis, per its drug-label indications. This is general reference, not medical advice.
- How is Pradaxa rated?
- pharmaranks gives Pradaxa a composite score of 3.5 out of 5, combining 1 weighted source (regulatory data weighted highest) and 12 user reviews. See our methodology at /how-we-rate.
- How much does Pradaxa cost?
- Pradaxa has a typical acquisition cost of about $27.66 per unit, based on CMS NADAC data.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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pradaxa
70/100