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Fentanyl lozenge

Pronunciation

Generic Name: fentanyl (FEN-ta-nil)
Brand Name: Actiq

Fentanyl lozenge can be harmful or fatal if taken by children, patients for whom it was not been prescribed, or patients who are not tolerant to narcotic (opioid) pain medicine. Keep fentanyl lozenge out of the reach of children.

Fentanyl lozenge is only for breakthrough pain caused by cancer in patients who are already using and are tolerant to around-the-clock narcotic pain medicine. Severe, sometimes life-threatening, breathing problems can occur in patients using fentanyl lozenge, especially in patients not already using other narcotic medicines or patients taking certain other medicines. Ask your health care provider if fentanyl lozenge may interact with other medicines that you take. Do not use fentanyl lozenge for pain that is short-term (including headache, dental pain, or migraine) or for pain that occurs after surgery or injuries.

Do NOT take more than the recommended dose or use more often than prescribed. You must wait at least 4 hours after your last dose of fentanyl lozenge before treating a NEW episode of breakthrough pain with fentanyl lozenge.

Do not switch brands of fentanyl lozenge without first talking with your doctor. Different brands may release different amounts of fentanyl lozenge into your body. This may cause severe and possibly fatal overdose. Talk with your doctor or pharmacist for more information.


Fentanyl lozenge is used for:

Managing breakthrough pain in cancer patients 16 years old and older who are already receiving and are tolerant to around-the-clock narcotic (opioid) medicines.

Fentanyl lozenge is a narcotic (opioid) analgesic. It works in the brain to decrease pain.

Do NOT use fentanyl lozenge if:

  • you are allergic to any ingredient in fentanyl lozenge or any related medicine (eg, sufentanil)
  • you have not already been taking other prescription narcotic pain medicines (eg, morphine, codeine) on a regular schedule
  • you have mild or short-term pain, including pain from injuries, surgery, dental pain, headache, or migraine
  • you are taking sibutramine or sodium oxybate (GHB)
  • you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using fentanyl lozenge:

Some medical conditions may interact with fentanyl lozenge. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have severe drowsiness; lesions, growths, or increased pressure in the brain; or a recent head injury
  • if you have lung or breathing problems (eg, asthma, slow or difficult breathing, chronic obstructive pulmonary disease [COPD]), urinary blockage, diabetes, heart problems (eg, slow or irregular heartbeat, ventricle problems), liver or kidney disease, inflammation in the mouth, an enlarged prostate or benign prostatic hypertrophy (BPH), stomach or bowel problems (eg, constipation, inflammatory bowel disease, pseudomembranous colitis, stomach pain), an underactive thyroid, low blood pressure, or seizures
  • if you have a history of mental or mood problems (eg, depression), hallucinations, or suicidal thoughts or actions
  • if you or a family member has a history of alcohol, narcotic, or other substance abuse or dependence
  • if you have been very ill, have a fever, have poor health or nutrition, or have had recent surgery (eg, stomach or bowel surgery)
  • if you stop taking your around-the-clock narcotic pain medicine

Some MEDICINES MAY INTERACT with fentanyl lozenge. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, antihistamines (eg, diphenhydramine), aprepitant, azole antifungals (eg, fluconazole), benzodiazepines (eg, alprazolam), calcium channel blockers (eg, diltiazem, verapamil), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolides (eg, erythromycin), MAOIs (eg, phenelzine), nefazodone, other opioid medicines (eg, oxycodone), phenothiazines (eg, chlorpromazine), skeletal muscle relaxants (eg, cyclobenzaprine), sleep medicines (eg, zolpidem), sodium oxybate (GHB ), telithromycin, or troleandomycin because they may increase the risk of fentanyl lozenge's side effects, including serious breathing problems, severe light-headedness or dizziness, or severe drowsiness
  • Serotonin reuptake inhibitors (eg, fluoxetine) or sibutramine because a severe reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma may occur
  • Mixed agonist/antagonist analgesics (eg, buprenorphine, pentazocine, butorphanol), nalmefene, naloxone, or naltrexone because they may decrease fentanyl lozenge's effectiveness and withdrawal symptoms may occur
  • Barbiturates (eg, phenobarbital), carbamazepine, corticosteroids (eg, prednisone), efavirenz, modafinil, nevirapine, oxcarbazepine, phenytoin, pioglitazone, rifamycins (eg, rifampin), St. John's wort, or troglitazone because they may decrease fentanyl lozenge's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if fentanyl lozenge may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use fentanyl lozenge:

Use fentanyl lozenge as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Fentanyl lozenge comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get fentanyl lozenge refilled.
  • Do not use fentanyl lozenge if the foil packaging is damaged in any way.
  • Open the foil packaging with scissors just before using fentanyl lozenge. If your mouth is dry, you may drink some water before you use the medicine.
  • Place the medicine between the cheek and lower gum, occasionally moving it from one side of the mouth to the other. Twirl the handle often.
  • Suck on the lozenge for 15 minutes. Do not chew or bite the lozenge. If you bite or chew the lozenge, you will get less pain relief.
  • Swallow excessive saliva. If the medicine dissolves too quickly, you will swallow more of the medicine and get less pain relief.
  • Do not eat, drink, or smoke while the lozenge is dissolving in your mouth.
  • If you begin to feel drowsy, dizzy, or sick to your stomach before you finish your dose, remove the medicine from your mouth and dispose of it right away by dissolving it in hot tap water.
  • If you cannot finish an entire dose of fentanyl lozenge and cannot immediately dissolve the medicine in hot tap water, immediately put it in the temporary storage bottle for safe keeping. Push the unit into the opening on the top until it falls completely into the bottle. Properly dispose of the unit as soon as possible according to your doctor's instructions. Do not save open or partially used lozenges for future use.
  • When you finish your dose and the medicine is completely gone, dispose of the handle in a place that is out of the reach of children. If any medicine is left on the handle when you are finished, put the handle under hot tap water until the medicine is gone. Dispose of the handle out of the reach of children and pets.
  • If you notice that your medicine is a different color or shape, check with your pharmacist to make sure that you have the right medicine strength.
  • If your breakthrough pain does NOT get better within 15 minutes after your first dose, you may take a second dose as directed by your doctor. If your breakthrough pain does not get better after the second dose, contact your doctor. Do NOT take more than 2 doses per episode of breakthrough pain.
  • Wait at least 4 hours after your last dose of fentanyl lozenge before treating a NEW episode of breakthrough pain. If you have more than 4 episodes of breakthrough pain per day, tell your doctor.
  • Check with your doctor before including grapefruit or grapefruit juice in your diet while you use fentanyl lozenge.
  • If fentanyl lozenge is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of fentanyl lozenge properly.
  • Fentanyl lozenge is usually used as needed. If you forget to use a dose of fentanyl lozenge and you still have pain, use it when you remember as directed by your doctor. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use fentanyl lozenge.

Important safety information:

  • Fentanyl lozenge may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use fentanyl lozenge with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using fentanyl lozenge.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using fentanyl lozenge; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Fentanyl lozenge contains sugar (about a half teaspoon of sugar per unit) and may increase the risk of dental cavities or tooth decay. The side effect of dry mouth may add to this risk. Ask your dentist about proper dental care while you are using fentanyl lozenge (eg, brushing and flossing your teeth).
  • Fentanyl lozenge may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Constipation is a common side effect of fentanyl lozenge. Talk with your doctor about using laxatives or stool softeners while you take fentanyl lozenge to prevent or treat constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation.
  • Do NOT take more than the recommended dose, use more often than prescribed, or suddenly stop taking fentanyl lozenge without checking with your doctor.
  • Tell your doctor or dentist that you take fentanyl lozenge before you receive any medical or dental care, emergency care, or surgery.
  • Do not switch brands of fentanyl lozenge without first talking to your doctor. Different brands may release different amounts of fentanyl lozenge into your body. This may cause severe and possibly fatal overdose. Discuss any questions or concerns with your doctor or pharmacist.
  • Fentanyl lozenge can be fatal to a child. Keep both the used and unused medicine out of the reach of children. Throw away fentanyl lozenge properly according to the instructions given to you by your health care provider. If a child accidentally takes fentanyl lozenge, remove the medicine from their mouth, keep them awake by calling their name and shaking their arm, and call the emergency room or poison control center immediately.
  • Secure the space where you keep fentanyl lozenge with the child-resistant lock included in your patient kit. You can keep a small supply of fentanyl lozenge in the portable locking pouch so that it is nearby for your immediate use. Keep the rest of the medicine in the locked storage space. Keep the pouch locked and away from the reach and sight of children.
  • Contact your doctor if your pain is not relieved or if it worsens after you use fentanyl lozenge. Contact your doctor if your usual dose stops providing pain relief. Be sure to tell your doctor or health care provider how your pain is responding to fentanyl lozenge so that your dose can be adjusted if needed.
  • Diabetes patients - Fentanyl lozenge contains about 2 grams of sugar per unit.
  • Use fentanyl lozenge with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, stomach pain, constipation, and vomiting.
  • Fentanyl lozenge should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Fentanyl lozenge may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using fentanyl lozenge while you are pregnant. Fentanyl lozenge is found in breast milk. Do not breast-feed while taking fentanyl lozenge.

When used for long periods of time or at high doses, fentanyl lozenge may not work as well and may require higher doses to obtain the same effect as when first taken. This is known as TOLERANCE. Talk with your doctor if fentanyl lozenge stops working well. Do not take more than is prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking fentanyl lozenge. This is known as DEPENDENCE or "addiction."

If you suddenly stop taking fentanyl lozenge, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of fentanyl lozenge:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; headache; nausea; vomiting; weakness or tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); blurred vision or other vision problems; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; hallucinations; mood or mental changes (eg, depression); mouth sores, ulcers, bleeding, or inflammation; seizures; severe drowsiness; severe dry eyes, mouth, or skin; severe or persistent dizziness or headache; severe or persistent stomach pain; shortness of breath; slowed or shallow breathing; trouble urinating; unusual or severe weakness or tiredness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include loss of consciousness; muscle rigidity; pinpoint pupils; severe drowsiness or dizziness; slow or shallow breathing; very slow or weak heartbeat.

Proper storage of fentanyl lozenge:

Store fentanyl lozenge at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the original package away from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate or freeze. Do not remove from package until ready to use. Do not store it above 77 degrees F (25 degrees C). Do not use if the foil pouch has been opened. Keep fentanyl lozenge out of the reach of children and away from pets.

General information:

  • If you have any questions about fentanyl lozenge, please talk with your doctor, pharmacist, or other health care provider.
  • Fentanyl lozenge is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take fentanyl lozenge or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about fentanyl lozenge. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to fentanyl lozenge. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using fentanyl lozenge.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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