fentanyl citrate (oral transmucosal)

Brand name(s):

fentanyl, Actiq

What is the most important information I should know about fentanyl citrate?

Do not use fentanyl citrate if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects could occur.

You should not use this medication 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.

Keep both the used and the unused Actiq units out of the reach of children. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit.

Seek emergency medical attention if you think you have used too much of this medicine or if anyone else has accidentally swallowed it. An overdose of this medicine can be fatal. Overdose symptoms may include weak pulse, fainting, shallow breathing, or breathing that stops. Fentanyl citrate may be habit-forming and should be used only by the person it was prescribed for. Fentanyl citrate should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Keep track of how many Actiq units have been used from each new supply of this medicine. Fentanyl citrate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Do not use more than four Actiq units per day.

What is fentanyl citrate?

Fentanyl citrate is a narcotic pain medicine.

Fentanyl citrate treats "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for short-term pain relief.

Fentanyl citrate may also be used for other purposes not listed in this medication guide.

What should I discuss with my health care provider before taking fentanyl citrate?

You should not use this medication unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid, Palladone), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), oxymorphone (Numorphan, Opana), and others. Talk with your doctor if you are not sure you are opioid-tolerant.

You should not use fentanyl citrate if you have had an allergic reaction or severe side effects when using any narcotic pain medicine.

Before using fentanyl citrate, tell your doctor if you are allergic to any drugs, or if you have:

a breathing disorder such as asthma or chronic obstructive pulmonary disease (COPD);
a seizure disorder;
a history of head injury or brain tumor;
liver or kidney disease;
low blood pressure, heart disease;
a history of depression or other mental illness; or
a history of drug or alcohol addiction.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. It could also cause addiction or withdrawal symptoms in a newborn if the mother uses fentanyl citrate during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Fentanyl citrate can pass into breast milk and may cause sleepiness or breathing problems in a nursing baby. Fentanyl citrate may also cause addiction and withdrawal symptoms in a nursing infant. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more sensitive to the effects of this medicine.

If you are diabetic, you should know that each fentanyl citrate lozenge contains 2 grams (one-half teaspoon) of sugar.

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