Brand Name

Pradaxa {Boehringer Ingelheim}

Generic Name

dabigatran, pronounced da BIG a tran

What is Pradaxa?

Pradaxa is a medication that helps to reduce your risk of stroke and blood clots. If you have a certain type of heart-rhythm disorder you may be prescribed Pradaxa. You may also be prescribed Pradaxa for purposes not listed in this medication guide

Key Facts About Pradaxa

Pradaxa helps to keep your blood from clotting, and it is known as a direct thrombin inhibitor.

Pradaxa is in in FDA pregnancy category C. Pradaxa is not known to affect an unborn baby. However, if you are pregnant you should tell your doctor before starting treatment with Pradaxa.
You should not breast-feed while taking Pradaxa, as we do not yet know if this medication can pass into breast milk.

You should not drink alcohol while taking Pradaxa. You increase your risk of stomach bleeding if you drink alcohol while taking Pradaxa.

If you are planning to have any kind of procedure or surgery (general or dental) let your practitioner know beforehand that you are taking Pradaxa. Your doctor may need you to stop taking your medication at least five days prior to your procedure to prevent excess bleeding. Your practitioner will advise you as to when you may start taking your usual Pradaxa dose again.

Pradaxa may cause you to bleed more easily. Take care when shaving or doing anything that may cause you to bleed. Tell your doctor right away if you have bleeding that will not stop.

Tell your doctor immediately if you have unusual bleeding, like from your nose, mouth, vagina, or rectum, purple or red pinpoint spots under your skin, pink or brown urine, bloody or tarry stools, heavy menstrual bleeding or if you are coughing up blood. Excessive bleeding may be accompanied by weakness, a faint feeling, and pain and swelling in your joints. Tell your doctor if you experience these symptoms right away.

Before You Take Pradaxa

If you are allergic to dabigatran, or if you have any active bleeding from a surgery, injury, or other cause you should not take Pradaxa.

If you are older than age 75 or take any type of blood thinners you should inform your doctor before taking Pradaxa.

Tell your doctor if you have kidney disease or a history of stomach ulcer or bleeding before starting treatment with Pradaxa.

You should tell your physician if you have recently used or received any other medications to treat or prevent blood clots.

Pradaxa Drug Interactions

You should inform your doctor if you are taking any of the following:

• Anticoagulants : including abciximab (ReoPro), alteplase (Activase), anagrelide (Agrylin), argatroban (Acova), bivalirudin (Angiomax), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat) and urokinase (Abbokinase)
• Antibiotics: like clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole) and rifampin (Rifater, Rifadin, Rifamate)
• Antifungal: medications like itraconazole (Sporanox) and ketoconazole (Nizoral) (Pradaxa is contraindicated with ketaconazole and should never be used in combination)
• Aspirin
• Diclofenac (Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze)
• Etodolac (Lodine)
• Heart or blood pressure medications: verapamil, guanidine, amiodarone
• HIV medications
• Ibuprofen (Motrin, Advil)
• Indomethacin (Indocin)
• Meloxicam (Mobic)
• Naproxen (Aleve, Naprosyn, Naprelan, Treximet)
• Organ transplant rejection medications like cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Prograf)
• St. John’s wort

Other drugs you take that are not listed may interact with Pradaxa. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Taking Pradaxa

Pradaxa may be taken with or without food. If you are concerned that Pradaxa may upset your stomach you may take it with food or milk to lessen any potential stomach upset.

You should take Pradaxa exactly as prescribed by your doctor. Do not take Pradaxa in larger or smaller amounts, or for shorter or longer than recommended. Follow the directions on your prescription label.

Swallow Pradaxa whole. Do not break, chew or crush this medication.

You should Pradaxa with a full (8 oz.) glass of water.

Pradaxa should be taken at least 2 hours before taking an antacid (if antacids are used).

Pradaxa needs to be stored at room temperature, and away from light, moisture and heat.

You must keep Pradaxa in its original container. Do not take this medication out of its bottle and put it in a pill box or daily organizer. If you receive more than a 30 day supply of Pradaxa at a time only open one bottle and finish it completely before opening the next bottle. Keep the bottle of Pradaxa tightly closed.

If four months or longer have passed and you have an opened bottle of Pradaxa you must throw this away and talk to your doctor about getting a new prescription.

If you miss a dose of Pradaxa, or are 6 hours late in taking your dose, you should attempt to take the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose do not take the missed dose in addition to your regular dose.

Pradaxa Side Effects

If you experience any of the following adverse effects you should stop taking Pradaxa and seek emergency medical help immediately:

• allergic reaction such as breathing difficulties, hives, swelling of your face., throat or tongue
• bloody, black or tarry stools or blood in your urine (may be pink or brown)
• bruising or bleeding easily
• coughing up blood, or vomit, that looks like coffee grounds
• menstrual bleeding that is excessively heavy
• swelling or pain in your joints
• weakness or fainting

Less serious side effects of Pradaxa may include:

• diarrhea
• heartburn
• indigestion
• nausea
• skin rash and itching (mild)
• upset stomach

It should be noted that this is not a complete list of possible side effects of Pradaxa. You should contact your physician for a complete list and medical advice regarding these effects.

Pradaxa Description and Dosing

Pradaxa capsules are available in 75 mg and 150 mg dosages. The 75 mg capsules have a cream-colored opaque cap imprinted in black with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted in black with “R75”. The 150 mg capsules have a light blue opaque cap imprinted in black with the Boehringer Ingelheim company symbol and a cream-colored opaque body imprinted in black with “R150”.

If you suspect that you have overdosed with Pradaxa you should seek emergency help immediately.

Ingredients in Pradaxa

The primary active ingredient in Pradaxa is dabigatran etexilate mesylate. Inactive ingredients include acacia, dimethicone, hypromellose, hydroxypropyl cellulose, talc, and tartaric acid. The capsule shell is composed of carrageenan, FD&C Blue No. 2 (150 mg only), FD&C Yellow No. 6, hypromellose, potassium chloride, titanium dioxide, and black edible ink.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

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