"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...
Information for Patients/Caregivers
If clinically advisable, patients (or their caregivers) receiving ROXICODONE® (oxycodone hydrochloride) tablets should be given the following information by the physician, nurse, pharmacist or caregiver:
- Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.
- Patients should be advised not to adjust the dose of ROXICODONE (oxycodone hydrochloride) ® without consulting the prescribing professional.
- Patients should be advised that ROXICODONE (oxycodone hydrochloride) ® may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g. driving, operating heavy machinery).
- Patients should not combine ROXICODONE (oxycodone hydrochloride) ® with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because additive effects may occur.
- Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.
- Patients should be advised that ROXICODONE (oxycodone hydrochloride) ® is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
- Patients should be advised that if they have been receiving treatment with ROXICODONE (oxycodone hydrochloride) ® for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the ROXICODONE (oxycodone hydrochloride) ® dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.
Last reviewed on RxList: 12/3/2010
This monograph has been modified to include the generic and brand name in many instances.
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