"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"...
- Advise patients that psychiatric symptoms (paranoia, hostility, mania, depressive, suicidal) and cognitive symptoms (confusion, memory problems, speech disorder) may occur during treatment with PRIALT.
- Caution patients against engaging in hazardous activity requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle during treatment with PRIALT.
- Caution patients about possible combined effects with other CNS-depressant drugs. Dosage adjustments may be necessary when PRIALT is administered with such agents because of the potentially additive effects.
- Advise patients to contact a physician if the patient experiences new or worsening muscle pain, soreness, weakness with or without darkened urine.
- Instruct patients and their caregivers to contact a physician immediately
if the patient has any of the following
- A change in mental status (e.g., lethargy, confusion, disorientation, decreased alertness)
- A change in mood, perception (hallucinations, including unusual tactile sensations in the oral cavity)
- Symptoms of depression or suicidal ideation
- Nausea, vomiting, seizures, fever, headache, and/or stiff neck, as these may be symptoms of developing meningitis
- Decreased level of consciousness, unresponsiveness or stupor
- New muscular symptoms (e.g., muscle cramps, myalgias)
- Withdrawal symptoms (e.g., nausea, insomnia, flu-like symptoms) as a result of abruptly discontinuing opioid therapy
- Development of serious skin reaction (e.g., bullous dermatitis, skin ulcers, skin exfoliation)
For use only in the Medtronic SynchroMed® II Infusion System and CADD-Micro Ambulatory Infusion Pump.
Last reviewed on RxList: 9/12/2011
This monograph has been modified to include the generic and brand name in many instances.
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