"The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product appr"...
(dabigatran etexilate mesylate) Capsules
(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS,
(B) SPINAL/EPIDURAL HEMATOMA
(A) Premature Discontinuation Of Pradaxa Increases The Risk Of Thrombotic Events
Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA isdiscontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].
(B) Spinal/Epidural Hematoma
Epidural or spinal hematomas may occur in patients treated with PRADAXA 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 spinal surgery
- optimal timing between the administration of PRADAXA and neuraxial procedures is not known [see WARNINGS AND PRECAUTIONS].
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see WARNINGS AND PRECAUTIONS].
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see WARNINGS AND PRECAUTIONS].
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 C34H41N7O5 • CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:
Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol.
PRADAXA capsules are supplied in 75, 110, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 172.95 mg dabigatran etexilate mesylate (equivalent to 150 mg dabigatran etexilate), 126.83 mg dabigatran etexilate mesylate (equivalent to 110 mg dabigatran etexilate), or 86.48 mg dabigatran etexilate mesylate (equivalent to 75 mg dabigatran etexilate) along with the following inactive ingredients: acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, hypromellose, potassium chloride, titanium dioxide, black edible ink, and FD&C Blue No. 2 (150 mg and 110 mg capsules only), or FD&C Yellow No. 6 (150 mg and 75 mg capsules only).
What are the possible side effects of dabigatran (Pradaxa)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using dabigatran and call your doctor at once if you have a serious side effect such as:
- any bleeding that will not stop;
- weakness, feeling like you might pass out;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
- blood in your urine or stools, black or tarry stools;
- coughing up blood or vomit that looks like...
What are the precautions when taking dabigatran etexilate mesylate (Pradaxa)?
Before taking dabigatran, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: mechanical heart valve, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood disorders (such as anemia, hemophilia, thrombocytopenia), liver disease, recent major injury/surgery, stroke, frequent falls/injuries.
It is important that all your doctors and dentists know that you take dabigatran. Before having surgery or any medical/dental procedures, tell your doctor...
Last reviewed on RxList: 12/7/2015
This monograph has been modified to include the generic and brand name in many instances.
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