Pradaxa (dabigatran etesilate)

Do’s

• Before starting Pradaxa and with each refill, read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist. If you have any questions, consult your healthcare provider
• Take Pradaxa by mouth with or without food as directed by your healthcare provider, usually twice a day.
• For children, the first dose should be taken in the morning and the second dose in the evening (about 12 hours apart).
• After a hip or knee replacement surgery, Praxada should be taken as directed by your healthcare provider, usually once a day.
• If stomach upset occurs while taking this medication, it can be taken with food.Swallow the capsules whole with a full glass of water (8 ounces/240 milliliters).
• For oral pellets, follow the specific instructions provided for administering to children.
• Keep Pradaxa tightly closed in the original bottle (or blister package) to protect it from moisture. 
• The dosage of this medication is based on your medical condition, kidney function, response to treatment, and other medications you may be taking. For children, the dosage is also based on age and weight.
• Use Pradaxa regularly at the same time(s) each day to get the most benefit from it. Take it exactly as directed.

Don’ts

• Avoid antacids within 24 hours after surgery, as they may affect the effectiveness of Pradaxa.
• Do not crush, chew, or break open the capsules.
• Do not put this medication in a pill box or medication reminder box
• Do not increase your dose or take this drug more often than directed.
• Do not stop taking this medication without consulting your healthcare provider.

Common Side Effects:

• Stomach pain or discomfort
• Upset stomach, burning
• Bleeding
• Heavy menstrual bleeding
• Nausea, vomiting, diarrhea

Serious Side Effects:

• Bruising or bleeding that will not stop (nosebleeds, bleeding gums, heavy menstrual or vaginal bleeding)
• Headache, weakness, dizziness, or feeling like you might pass out
• Bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds
• Urine that looks red, pink, or brown
• Unexpected pain, joint pain, or swelling

Other Potential Side Effects:

• Redness of the skin
• Skin rash, hives, welts, or itching skin
• Sweating
• Trouble breathing
• Unusual tiredness or weakness

This is not a complete list of side effects, and others may occur. If you experience any concerning symptoms, seek medical advice promptly.

Consult with a healthcare professional before taking Pradaxa if you are pregnant or planning to become pregnant. Additionally, if you are breastfeeding, discuss your treatment options and the best way to feed your child with your healthcare provider.

For pediatric patients, specific precautions and considerations are outlined, including recommendations for discontinuation before elective surgery and the avoidance of use in patients with certain levels of kidney function.

Pradaxa capsules should only be dispensed and stored in the original bottle or blister package to prevent breakdown and loss of potency.

Avoid the use of Pradaxa if a patient has a mechanical prosthetic heart valve, active pathological bleeding, or a history of hypersensitivity reaction to Pradaxa. It also emphasizes the risk of spinal and epidural hematomas in certain medical procedures.