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fentanyl citrate (oral transmucosal) (cont.)

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

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.

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 can occur if you use fentanyl before the MAO inhibitor has cleared from your body.

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

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

FDA pregnancy category C. It is not known whether fentanyl citrate is harmful to an unborn baby. It could 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.

How should I take fentanyl citrate (Actiq)?

Actiq (fentanyl citrate oral transmucosal) comes with a kit and instructions for storing and disposing of the Actiq units. 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.

You will also receive instructions for using the medicine. Follow these instructions carefully. Do not use the medication in larger amounts or for longer than prescribed by your doctor. Your doctor may occasionally change your dose to make sure you get the best results.

The Actiq transmucosal unit is a fentanyl citrate lozenge attached to a plastic handle. Each unit is wrapped in a child-proof blister pack. Cut the blister pack open with scissors when you are ready to use the unit.

Place the medicine in your mouth between your cheek and gum, and hold the handle with your fingers. Twirl the handle to move the medicine around in your mouth while sucking on it.

Allow the medicine to dissolve in your mouth for 15 minutes. Swallow when needed. Do not bite or chew the lozenge. Do not eat or drink anything while the unit is in your mouth. If you need to use a second unit, wait at least 15 minutes after you have finished the first unit.

If you feel dizzy or sick to your stomach before the medicine has completely dissolved, stop using the unit and call your doctor.

If you switch from using Actiq to using other forms of fentanyl, you will not use the same dose. Many forms of fentanyl are given at lower doses than Actiq. If you use the same dose of each medication, you may have life-threatening overdose symptoms.

Do not stop using any other pain medicines your doctor has prescribed for you. Call your doctor if fentanyl citrate does not relieve your pain.

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.

Keep track of how many Actiq units have been used from each new supply of this medicine. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not stop using fentanyl citrate suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using fentanyl citrate.

Store at room temperature away from moisture and heat. Leave each unit in its child-proof blister pack until you are ready to use it.

Pay special attention to your dental hygiene. Fentanyl citrate can cause dry mouth leading to tooth decay.

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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