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fentanyl (sublingual) (cont.)

What should I discuss with my healthcare provider before taking fentanyl (Abstral, Subsys)?

Do not take fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Do not take fentanyl if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days.

Tell your doctor if there are children living in the home where you will store this medicine. Keep fentanyl out of the reach of children. The amount of fentanyl in each Abstral tablet or Subsys spray unit can be fatal to a child.

To make sure you can safely take fentanyl sublingual, tell your doctor if you have any of these other conditions:

  • a breathing disorder such as wheezing, asthma, or chronic obstructive pulmonary disease (COPD);
  • seizures, epilepsy, or a history of head injury or brain tumor;
  • low blood pressure, slow heartbeats or other heart rhythm disorder;
  • mental illness such as depression, schizophrenia, or hallucinations;
  • liver or kidney disease; or
  • a personal or family history of drug or alcohol addiction.

Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share fentanyl with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether fentanyl will harm an unborn baby. Fentanyl may cause breathing problems, seizure, or addiction and withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using fentanyl sublingual.

Fentanyl may also cause drowsiness, breathing problems, or addiction and withdrawal symptoms in a nursing infant. Do not breast-feed while you are taking fentanyl sublingual.

How should I take fentanyl sublingual (Abstral, Subsys)?

Use exactly as prescribed. Never use fentanyl in larger amounts, or for longer than recommended by your doctor. Keep using your around-the-clock narcotic pain medicine but never take Abstral or Subsys together with a second form of fentanyl.

Do not use Abstral or Subsys to replace any other form of fentanyl, such as Actiq, Fentora, Onsolis, Duragesic, Lazanda, or generic brands of fentanyl (injection, skin patch, dissolving film, or "lollipop" device).

If you switch to Abstral or Subsys from another form of fentanyl, you will not use the same dose. You must start with the lowest dose (100 micrograms). Your doctor may change your dose to make sure you get the best results.

Place the Abstral tablet under your tongue, as far back as you can. Do not break, chew, suck, or swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Do not drink or eat anything during this time.

You may use a second Abstral tablet 30 minutes after the first. Use only the same strength and amount you used for the first dose. Call your doctor if you still have pain after taking the second tablet. Do not take more than 2 tablets for each episode of breakthrough cancer pain. You must wait at least 2 hours after your last dose of Abstral before you can treat a new pain episode.

Point the Subsys spray nozzle into your mouth, lift your tongue, and spray the medicine under your tongue. Hold the liquid under the tongue for 30 to 60 seconds. Do not spit, swallow, or rinse your mouth during this time.

You may use a second Subsys spray unit 30 minutes after the first. Use only the same strength and amount you used for the first dose. Call your doctor if you still have pain after using the second spray. Do not use more than 2 sprays for each episode of breakthrough cancer pain.You must wait at least 4 hours after your last dose of Subsys before you can treat a new pain episode.

Do not treat more than 4 pain episodes per day with fentanyl sublingual. Call your doctor if you have breakthrough pain more than 4 times in one day.

Do not stop taking fentanyl or your other narcotic pain medicine without your doctor's advice. Ask your doctor how to avoid withdrawal symptoms when you stop using pain medication.

Store in the original carton at room temperature, away from heat and moisture. Keep track of the amount of medicine used from each carton. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Keep out of the reach of children. The amount of fentanyl in each Abstral tablet or Subsys spray unit can be fatal to a child.

Carefully follow the instructions for disposing of this medicine when it is no longer needed. Throw away any unused Abstral tablets by removing them from the blister pack and flushing them down a toilet. Dispose of used Subsys spray units in the disposal bags provided with this medication. Empty any unused spray units into the disposal bottle provided.

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.

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