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Precautions and Warnings With Fentanyl Lozenge

Specific Fentanyl Lozenge Precautions and Warnings

Some warnings and precautions to be aware of with this drug include the following:
 
  • This medication should only be used in people who are already taking scheduled, around-the-clock opioids and are tolerant to their effects, which means the body has become accustomed to the opioid. People who are not opioid tolerant may experience life-threatening breathing problems, or death, from even small fentanyl lozenge doses.
 
  • Do not substitute a fentanyl lozenge for other medications that contain fentanyl. Substituting a fentanyl lozenge for another fentanyl product could result in an overdose, as the doses used in these medications are not the same. Other products that contain fentanyl include but are not limited to:
 

 

  • Because it has a high risk for abuse and overdose, this medication is only available through a special program called the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) program. You, your healthcare provider, and your pharmacy must be enrolled in the program before you can receive this medication. Your healthcare provider and pharmacy will help you enroll in the program. For inpatient use (such as within a hospital), only the pharmacy (not the prescriber or the patient) needs to be enrolled. 
 
  • There have been reports of death in children who have accidentally used a fentanyl lozenge. It is very important to store this medication in a safe place, away from children who may mistake the lozenges for a lollipop. Also, make sure to safely dispose of used lozenges, especially if they are not completely consumed (see Actiq Storage and Disposal for more information).
 
  • Fentanyl lozenges contain sugar, which could be important for people with diabetes. In addition, the sugar in these lozenges could cause tooth decay or cavities. Talk with your dentist about proper tooth care while you are using this medication.
 
  • Do not use more than two fentanyl lozenges for any breakthrough pain episode. Using more than two lozenges could lead to an overdose. Talk to your healthcare provider if your pain is not alleviated after one or two lozenges.
 
  • Fentanyl lozenges may cause serious problems, including death, if used in people for whom the medication was not prescribed. Do not share this medication with someone else, even if they seem to have the same symptoms as you.
 
  • The fentanyl lozenge is a narcotic medication with a significant potential for abuse (see Actiq Abuse). Do not use the drug more frequently, or at a higher dose, than prescribed. Store it in a safe place to prevent theft. If you, or someone you know, may be developing a problem with fentanyl lozenge abuse, please seek help from a healthcare provider.
 
  • Fentanyl lozenges can cause life-threatening slow and irregular breathing (called "respiratory depression"). Certain people have an increased risk for respiratory depression, including:
 
    • Older adults
    • People who already have breathing problems
    • People who are taking other medications that affect breathing.
 
  • This medication may be particularly dangerous for people with head injuries or high intracranial pressure. It should only be used with extreme caution in such circumstances.
 
  • Fentanyl lozenges can cause a slow heart rate (bradycardia) and should be used with caution in people who already have a very slow heart rate.
 
  • Do not drive or operate heavy machinery until you know how fentanyl lozenges affect you. These lozenges can make you drowsy, and your reflexes and reaction times may be significantly altered, even if you feel fine.
 
  • The fentanyl lozenge comes with a medication guide that describes the correct way to use it. Make sure to read this medication guide each time you get your prescription filled.
 
 
  • The active ingredient in this medication passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Actiq and Breastfeeding).
 
  • The fentanyl lozenge is a pregnancy Category C medication, which means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Actiq and Pregnancy).
 
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Fentanyl Lozenge Drug Information

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