"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.
Additional Prialt Information
Prialt - User Reviews
Prialt User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Chronic Pain/Back Pain
Find tips and advances in treatment.