Abstral Warnings and Precautions
Specific Precautions and Warnings With AbstralSome warnings and precautions to be aware of prior to taking this pain medicine 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 gotten used to the opioid). People who are not opioid tolerant may experience life-threatening breathing problems, or even death, from taking this medication.
- Because it has a high risk for abuse and overdose, Abstral 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 Abstral. 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.
- Doses of Abstral are not equivalent to doses of other fentanyl-containing medications. The initial Abstral dosage should be 100 mcg, even in people who are already taking another fentanyl medication. Starting Abstral at a higher amount could cause an overdose.
- Abstral should not be substituted for any other medication that contains fentanyl. Doing this could result in an overdose.
- Abstral could cause serious problems, including death, if taken by a child or someone for whom the medication was not prescribed. Do not share this medication with anyone. Store it in a safe place to help prevent theft or accidental ingestion by someone else (see Abstral Storage and Disposal for more information).
- Do not drink alcohol while using this medication. Consuming alcohol with Abstral could be dangerous, potentially causing extreme drowsiness, confusion, memory loss, or difficulty breathing.
- Abstral is a narcotic opioid medication with a significant potential for abuse (see Abstral Abuse). Do not take the drug more frequently or at a higher dose than prescribed. If you think you may be developing a problem with addiction or abuse, please seek help from a healthcare provider.
- Like all narcotics, Abstral can cause physical dependence, which means you may experience uncomfortable withdrawal symptoms if you suddenly stop taking it. If you no longer need this medication, talk to your healthcare provider about the best way to stop using it (see Abstral Withdrawal for more information).
- Like all opioids, Abstral can cause life-threatening breathing problems (called "respiratory depression"). People who have respiratory depression may take slow and shallow breaths or deep breaths separated by long pauses. Certain people may have an increased risk for respiratory depression with Abstral, including:
- Older adults
- People who already have breathing difficulties
- People who are not tolerant to opioids
- People who are taking certain other medications.
- This medicine may be particularly dangerous for people with head injuries or high intracranial pressure. It should only be used with extreme caution in such people.
- Abstral 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 this medicine affects you. It might make you extremely drowsy. Your reflexes and reaction times may be significantly altered, even if you feel fine.
- Abstral comes with a medication guide that describes the correct way to use it. Make sure to read this guide each time you get your prescription filled, as new information may be available.
- Abstral may react with a number of other medications (see Abstral Drug Interactions for more information).
- This medicine passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Abstral and Breastfeeding).
- Abstral is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Abstral and Pregnancy).