Dabigatran patient counseling information
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Instructions for Patients
- Tell patients to take PRADAXA exactly as prescribed.
- Remind patients not to discontinue PRADAXA without talking to the health care provider who prescribed it.
- Keep PRADAXA in the original bottle to protect from moisture. Do not put PRADAXA in pill boxes or pill organizers.
- When more than one bottle is dispensed to the patient, instruct them to open only one bottle at a time.
- Instruct patient to remove only one capsule from the opened bottle at the time of use. The bottle should be immediately and tightly closed.
- Advise patients not to chew or break the capsules before swallowing them and not to open the capsules and take the pellets alone.
- Advise patients that the capsule should be taken with a full glass of water.
Bleeding
Inform patients that they may bleed more easily, may bleed longer, and should call their health care provider for any signs or symptoms of bleeding.
Instruct patients to seek emergency care right away if they have any of the following, which may be a sign or symptom of serious bleeding:
- Unusual bruising (bruises that appear without known cause or that get bigger)
- Pink or brown urine
- Red or black, tarry stools
- Coughing up blood
- Vomiting blood, or vomit that looks like coffee grounds
Instruct patients to call their health care provider or to get prompt medical attention if they experience any signs or symptoms of bleeding:
- Pain, swelling or discomfort in a joint
- Headaches, dizziness, or weakness
- Reoccurring nose bleeds
- Unusual bleeding from gums
- Bleeding from a cut that takes a long time to stop
- Menstrual bleeding or vaginal bleeding that is heavier than normal
Gastrointestinal Adverse Reactions
Instruct patients to call their health care provider if they experience any signs or symptoms of dyspepsia or gastritis:
- Dyspepsia (upset stomach), burning, or nausea
- Abdominal pain or discomfort
- Epigastric discomfort, GERD (gastric indigestion)
Invasive or Surgical Procedures
Instruct patients to inform their health care provider that they are taking PRADAXA before any invasive procedure (including dental procedures) is scheduled.
Concomitant Medications
Ask patients to list all prescription medications, over-the-counter medications, or dietary supplements they are taking or plan to take so their health care provider knows about other treatments that may affect bleeding risk (e.g., aspirin or NSAIDs) or dabigatran exposure (e.g., dronedarone or systemic ketoconazole).
Prosthetic Heart Valves
Instruct patients to inform their health care provider if they will have or have had surgery to place a prosthetic heart valve.
Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
Copyright 2013 Boehringer Ingelheim Pharmaceuticals, Inc. ALL RIGHTS RESERVED
75461-11 IT5060XL112013
75457-11 IT5400T
301841-06 IT5624H[1]
References
- ↑ "ARGATROBAN INJECTION, SOLUTION [GLAXOSMITHKLINE LLC]". Retrieved 31 January 2014.