Fondaparinux patient counseling information: Difference between revisions
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== Patient Counseling Information== | |||
See FDA-Approved Patient Labeling | |||
===Patient Advice=== | |||
If the patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDS, platelet inhibitors, or other anticoagulants, they should be informed to watch for signs and symptoms of spinal or epidural hematomas, such as tingling, numbness (especially in the lower limbs) and muscular weakness. If any of these symptoms occur, the patients should contact his or her physician immediately. | |||
The use of aspirin and other NSAIDS may enhance the risk of hemorrhage. Their use should be discontinued prior to ARIXTRA therapy whenever possible; if co-administration is essential, the patient’s clinical and laboratory status should be closely monitored. [See Drug Interactions (7).] | |||
If patients must self-administer ARIXTRA (e.g., if ARIXTRA is used at home), they should be advised of the following: | |||
:*ARIXTRA should be given by subcutaneous injection. Patients must be instructed in the proper technique for administration.:*As with all anticoagulants, the most important risk with ARIXTRA administration is bleeding. Patients should be counseled on signs and symptoms of possible bleeding.:*It may take them longer than usual to stop bleeding. | |||
:*They may bruise and/or bleed more easily when they are treated with ARIXTRA. | |||
:*They should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician [see Warnings and Precautions (5.1, 5.4)]. | |||
:*To tell their physicians and dentists they are taking ARIXTRA and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken [see Warnings and Precautions (5.1)]. | |||
:*To tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs. [See Drug Interactions (7).] | |||
:*Keep out of the reach of children. | |||
===FDA-Approved Patient Labeling=== | |||
Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information. | |||
ARIXTRA is a registered trademark of the GlaxoSmithKline group of companies. | |||
GlaxoSmithKline | |||
Research Triangle Park, NC 27709 | |||
©2013, GlaxoSmithKline group of companies. All rights reserved. | |||
ARX:10PI | |||
PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=05bb2dd4-5fb5-4ec9-29a8-d200e62d1a8f | publisher = | date = | accessdate = }}</ref> | <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARIXTRA (FONDAPARINUX SODIUM) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=05bb2dd4-5fb5-4ec9-29a8-d200e62d1a8f | publisher = | date = | accessdate = }}</ref> | ||
Revision as of 00:08, 6 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Patient Counseling Information
See FDA-Approved Patient Labeling
Patient Advice
If the patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDS, platelet inhibitors, or other anticoagulants, they should be informed to watch for signs and symptoms of spinal or epidural hematomas, such as tingling, numbness (especially in the lower limbs) and muscular weakness. If any of these symptoms occur, the patients should contact his or her physician immediately.
The use of aspirin and other NSAIDS may enhance the risk of hemorrhage. Their use should be discontinued prior to ARIXTRA therapy whenever possible; if co-administration is essential, the patient’s clinical and laboratory status should be closely monitored. [See Drug Interactions (7).]
If patients must self-administer ARIXTRA (e.g., if ARIXTRA is used at home), they should be advised of the following:
- ARIXTRA should be given by subcutaneous injection. Patients must be instructed in the proper technique for administration.:*As with all anticoagulants, the most important risk with ARIXTRA administration is bleeding. Patients should be counseled on signs and symptoms of possible bleeding.:*It may take them longer than usual to stop bleeding.
- They may bruise and/or bleed more easily when they are treated with ARIXTRA.
- They should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician [see Warnings and Precautions (5.1, 5.4)].
- To tell their physicians and dentists they are taking ARIXTRA and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken [see Warnings and Precautions (5.1)].
- To tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs. [See Drug Interactions (7).]
- Keep out of the reach of children.
FDA-Approved Patient Labeling
Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information.
ARIXTRA is a registered trademark of the GlaxoSmithKline group of companies.
GlaxoSmithKline
Research Triangle Park, NC 27709
©2013, GlaxoSmithKline group of companies. All rights reserved.
ARX:10PI
PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
References
Adapted from the FDA Package Insert.