fentanyl (buccal/sublingual)

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. Never use this medicine in larger amounts, or for longer than prescribed. Fentanyl may be habit-forming, even at regular doses. Never share this medicine with another person.

Fentanyl buccal/sublingual is not for treating pain that isn't cancer-related. 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 the medicine in a place where others cannot get to it.

Some medicines can interact with fentanyl and worsen the effects on your breathing. Tell your doctor about all medicines you use.

You should not use fentanyl buccal/sublingual unless you are already using an around-the-clock opioid medicine and are tolerant to it. Do not use this medicine to replace any other form of fentanyl (injection, skin patch, "lollipop" device).

If you switch to fentanyl buccal/sublingual after using another form of fentanyl, you may not use the same dose.

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 used together with other non-fentanyl narcotic pain medicine that is given around the clock.

Fentanyl buccal/sublingual is not for treating pain that is not cancer-related, such as pain from surgery or dental work, migraine headaches, or back pain.

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. Ask your doctor if you are not sure you are opioid-tolerant.

Some medicines can interact with fentanyl and worsen the effects on your breathing. Tell your doctor if you are taking an antibiotic or any medicines to treat high blood pressure, heart rhythm disorders, depression, or viral infections such as hepatitis, HIV or AIDS.

To make sure fentanyl buccal/sublingual 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; or
  • a personal or family history of drug or alcohol addiction.

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.

FDA pregnancy category C. Tell your doctor if you are pregnant. Fentanyl may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy.

Fentanyl may also cause drowsiness, breathing problems, or addiction and withdrawal symptoms in a nursing infant. 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.

If you have been using another form of fentanyl (injection, skin patch, "lollipop" device), your buccal or sublingual dose may be different. Follow your doctor's dosing instructions very carefully.

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.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use only 1 tablet at a time. Do not swallow whole. Allow the tablet to dissolve in your mouth without breaking, chewing, or sucking on it.

If you feel dizzy, nauseated, or very sleepy while the Fentora tablet is still in your mouth, spit the medicine out into a sink or toilet and rinse your mouth with water to remove all remaining pieces of the tablet. Call your doctor for instructions.

To use Subsys, spray the medicine under your tongue and hold it there for 30 to 60 seconds. Do not spit, swallow, or rinse your mouth.

For fentanyl buccal tablets (Fentora): If your pain does not go away completely, use a second tablet only if your doctor has approved it. Wait at least 4 hours before treating a new pain episode.

You may use a second dose of Abstral or Subsys 30 minutes after the first. Use only the same strength and amount you used for the first dose. Call your doctor if you still have pain after the second dose. Do not take more than 2 doses for each pain episode.

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 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. This practice has resulted in death with the misuse of fentanyl and similar prescription drugs.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine in its original package until you are ready to take your dose. Do not use a Fentora tablet that has been left out of the blister pack for more than a few minutes. Flush the tablet down a toilet.

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. 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 can occur when alcohol is combined with fentanyl.

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 any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • slow heart rate, weak or shallow breathing, sighing, severe drowsiness;
  • a light-headed feeling, like you might pass out;
  • confusion, extreme fear, unusual thoughts or behavior;
  • pale skin, feeling short of breath, rapid heart rate, trouble concentrating; or
  • dehydration symptoms --feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Common side effects may include:

  • constipation, nausea, vomiting;
  • dizziness, drowsiness, pale skin, feeling weak or tired;
  • headache, dehydration (thirst, dry mouth, little or no urinating); 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?

Using this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, a sedative or tranquilizer, other narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not take fentanyl if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

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. Tell your doctor about all your medications and any you start or stop using during treatment with fentanyl.

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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