Fentanyl citrate (oral transmucosal)

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.

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.

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.

How should I take fentanyl citrate?

Actiq (fentanyl citrate oral transmucosal) comes with a kit and instructions for storing and disposing of the Actiq units. It is very important to 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 from this medication.

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.

Do not use more than four Actiq units per day.

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

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 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 stop using fentanyl citrate suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using this medication.

Store this medicine 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 while you are using this medication. Fentanyl citrate can cause dry mouth leading to tooth decay.

What happens if I miss a dose?

Since fentanyl citrate is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use more than four Actiq units per day.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine or if anyone else has accidentally swallowed it. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit.

Overdose symptoms may include weak pulse, fainting, shallow breathing, or breathing that stops.

What should I avoid while taking fentanyl citrate?

Cold or allergy medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by fentanyl citrate. Tell your doctor if you regularly use any of these medicines, or any other narcotic pain medicine.

Grapefruit and grapefruit juice may interact with fentanyl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

What are the possible side effects of fentanyl citrate?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fentanyl citrate and call your doctor at once if you have any of these serious side effects:

• shallow breathing, slow heart rate;
• extreme sleepiness; or
• feeling light-headed, fainting.

Less serious side effects may include:

• dry mouth;
• headache, dizziness, weakness, anxiety; or
• nausea, vomiting, or constipation.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect fentanyl citrate?

There are many other medicines that can cause serious medical problems if you take them together with fentanyl citrate, especially:

• aprepitant (Emend);
• diltiazem (Cardizem, Cartia, Dilacor, Tiazac);
• verapamil (Calan, Covera, Isoptin, Verelan);
• antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, Ery-Tab, E.E.S.), fluconazole (Diflucan), ketoconazole (Nizoral), itraconazole (Sporanox), or troleandomycin (Tao); or
• HIV medicines such as amprenavir (Agenerase), indinavir (Crixivan), fosamprenavir (Lexiva), nelfinavir (Viracept), or ritonavir (Norvir).

This list is not complete and there may be other drugs that can interact with fentanyl citrate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about fentanyl citrate.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Copyright 1996-2003 Cerner Multum, Inc. Version: 1.06. Revision date: 11/30/2007.