"July 10, 2015 -- Popular painkillers like ibuprofen and naproxen have carried warnings for years about potential risks of heart attacks and strokes. This week, the FDA decided to strengthen those warnings on the medications, known as nonsteroidal"...
- 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: 4/5/2016
This monograph has been modified to include the generic and brand name in many instances.
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