fentanyl (buccal/sublingual)

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Pronunciation: FEN tan il BUK al / sub LIN gwal

Brand: Abstral, Fentora, Subsys

What is the most important information I should know about fentanyl buccal/sublingual?

Fentanyl can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose. Never share fentanyl with another person.

MISUSE OF NARCOTIC PAIN MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Keep out of the reach of children. The amount of fentanyl in this medicine can be fatal to a child.

What is fentanyl buccal/sublingual?

Fentanyl is an opioid pain medication. An opioid is sometimes called a narcotic. Fentanyl buccal or sublingual products are used in the mouth but not swallowed whole. Fentanyl buccal is placed inside the mouth between the cheek and gum. Fentanyl sublingual is placed under the tongue.

Fentanyl buccal/sublingual is used to treat "breakthrough" cancer pain that is not controlled by other medicines. This medicine is not for treating pain that is not cancer-related.

Fentanyl buccal/sublingual may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using fentanyl buccal/sublingual?

You should not use fentanyl if you are allergic to it. Do not use fentanyl unless you are already using an around-the-clock opioid medicine and are tolerant to it.

Some medicines can interact with fentanyl and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure this medicine is safe for you, tell your doctor if you have:

  • mouth sores or ulcers;
  • any type of breathing problem or lung disease;
  • a history of head injury, brain tumor, or seizures;
  • low blood pressure, slow heartbeats or other heart rhythm disorder;
  • mental illness such as depression, schizophrenia, or hallucinations;
  • liver or kidney disease;
  • a personal or family history of drug or alcohol addiction; or
  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Tell your doctor if there are children living in the home where you will store this medicine. The amount of fentanyl in this medicine can be fatal to a child.

If you use fentanyl while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed while you are using this medicine.

How should I use fentanyl buccal/sublingual?

Follow all directions on your prescription label. Fentanyl can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Fentanyl may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a person using the medicine without a prescription. Selling or giving away fentanyl is against the law.

If you have been using another form of fentanyl (injection, skin patch, "lollipop" device), your buccal or sublingual dose may be different.

Use only 1 tablet at a time. If your pain does not go away completely, use a second tablet only if your doctor has approved it.

You must wait at least 2 hours after your last dose of Abstral before you can treat a new pain episode. You must wait at least 4 hours after your last dose of Fentora or Subsys before you can treat a new pain episode.

Call your doctor if you have breakthrough pain more than 4 times in one day while using this medicine. Do not treat more than 4 pain episodes per day with this medicine.

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

Never crush or break a fentanyl pill to inhale the powder or mix it into a liquid to inject the drug into your vein.

Store at room temperature away from moisture and heat. Do not freeze. Keep track of the amount of medicine used from each new bottle. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Keep this medicine out of the reach of children or pets. The amount of fentanyl in each buccal or sublingual product can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

Carefully follow disposal instructions when this medicine is no longer needed. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, throw away any unused fentanyl tablets by removing them from the blister pack and flushing them down a toilet. Dispose of used sublingual spray units in the disposal bags provided with the medicine. Empty any unused spray units into the disposal bottle provided.

What happens if I miss a dose?

Since fentanyl is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include extreme weakness or drowsiness, weak pulse, cold and clammy skin, pinpoint pupils, and slow breathing (breathing may stop).

What should I avoid while using fentanyl buccal/sublingual?

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how fentanyl will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol. Dangerous side effects or death could occur.

Grapefruit and grapefruit juice may interact with fentanyl and lead to unwanted side effects. Avoid the use of grapefruit products while taking fentanyl.

What are the possible side effects of fentanyl buccal/sublingual?

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

Like other narcotic medicines, fentanyl can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

  • slow heart rate, weak or shallow breathing, sighing, severe drowsiness, feeling like you might pass out;
  • confusion, extreme fear, unusual thoughts or behavior;
  • pale skin, feeling short of breath, rapid heart rate, trouble concentrating;
  • infertility, missed menstrual periods, impotence, sexual problems, loss of interest in sex;
  • low cortisol levels -- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
  • dehydration symptoms --thirst, dry mouth, little or no urinating, hot and dry skin.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

  • headache, dizziness, drowsiness, pale skin, feeling weak or tired;
  • constipation, nausea, vomiting; or
  • swelling in your hands or feet.

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 buccal/sublingual?

Some drugs can raise or lower your blood levels of fentanyl, which may cause side effects or make fentanyl less effective. Tell your doctor if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Fentanyl can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • other narcotic medications --opioid pain medicine or prescription cough medicine;
  • drugs that make you sleepy or slow your breathing --a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or
  • drugs that affect serotonin levels in your body --medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with fentanyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about fentanyl buccal/sublingual.

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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