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  • fentanyl citrate (oral transmucosal)
 

fentanyl citrate (oral transmucosal)

Pronunciation: FEN ta nil SIT rayt

Brand: Actiq

What is the most important information I should know about 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. Talk with your doctor if you are not sure you are opioid-tolerant.

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Do not use fentanyl citrate 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. A dangerous drug interaction could occur, leading to serious side effects.

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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.

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Fentanyl citrate may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

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Do not use more than four Actiq units per day.

What is fentanyl citrate?

Fentanyl citrate is an opioid pain medication. An opioid is sometimes called a narcotic.

Fentanyl citrate treats "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for treating pain that is not cancer-related, such as migraine headaches or pain after surgery.

Fentanyl citrate is available only under a special program called Actiq REMS Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

Fentanyl citrate may also be used for 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 codeine (Tylenol #3), hydrocodone (Lortab, Vicodin, Vicoprofen), hydromorphone (Dilaudid, Exalgo), oxycodone (OxyContin, Combunox, Roxicodone, Percocet), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph), oxymorphone (Opana), and others. Talk with your doctor if you are not sure you are opioid-tolerant.

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Do not use fentanyl citrate 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. A dangerous drug interaction could occur, leading to serious side effects.

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

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

  • 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, mental illness, or drug or alcohol addiction.
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Fentanyl citrate may be habit forming and should be used only by the person for whom it was prescribed. Never share this medicine 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.

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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.

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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.

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?

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Use exactly as prescribed. Never use fentanyl in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. You will also receive instructions for using the medicine. Follow these instructions carefully. 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.

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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.

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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.

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

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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.

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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.

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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.

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 anyone is using your medicine improperly or without a prescription.

After you have stopped using this medication, use wire-cutting pliers to cut the handles off any unused Actiq lozenges. Flush the lozenges down the toilet. Follow the instructions provided with Actiq when disposing of unused medicine.

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 taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of fentanyl citrate can be fatal.

What should I avoid while taking fentanyl citrate?

Grapefruit and grapefruit juice may interact with fentanyl citrate and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of fentanyl citrate?

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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.

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

  • weak or shallow breathing, slow heart rate;
  • extreme sleepiness; or
  • feeling like you might pass out.

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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect fentanyl citrate?

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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.

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

  • diltiazem (Cardizem, Cartia, Dilacor, Diltia, Diltzac, Taztia, Tiazac);
  • verapamil (Calan, Covera, Isoptin, Verelan);
  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifater, Rifadin, Rifamate), or telithromycin (Ketek);
  • an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);
  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, Kaletra), saquinavir (Invirase), and others; or
  • seizure medication such as carbamazepine (Carbatrol, Tegretol), oxcarbazepine (Trileptal), phenytoin (Dilantin), and others.

This list is not complete and other drugs may interact with fentanyl citrate. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start 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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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