Fentanyl Sublingual Tablet

• It is used to ease pain.
• This medicine is not for mild pain or pain that only lasts a short time (like headaches, toothaches, or pain after surgery).

Use fentanyl sublingual tablet as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use right after opening.
• Place under tongue and let melt all the way. Do not chew, suck or swallow tablet.
• Do not eat or drink until this medicine has melted all the way.
• You may wet your mouth with water, if needed, before you take.

What do I do if I miss a dose?

• If you use fentanyl sublingual tablet on a regular basis, use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Dry mouth.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Headache.
• Feeling sleepy.
• Feeling tired or weak.
• Feeling cold.
• Not hungry.
• Not able to sleep.
• Sweating a lot.
• Belly pain.
• Irritation where fentanyl sublingual tablet is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Fentanyl is available as a transdermal patch, buccal tablet, sublingual tablet, lozenge, sublingual spray, and nasal solution, spray.

Fentanyl sublingual tablet is available as the brand-name drug Abstral. It isn’t available as a generic drug.

Do not use fentanyl if you’re not opioid tolerant. Opioid tolerant means that you currently take another opioid pain drug that no longer works as well to control your pain.

Do not use fentanyl for short-term pain, such as pain after surgery, headache or migraine, or pain from a dental procedure.

Fentanyl can cause serious breathing problems if doses are too high.

IMPORTANT INFORMATION

• FDA warning See Details

What is fentanyl?

Fentanyl is a prescription drug. It’s available in the following forms:

• Transdermal patch. A patch that you place on your skin.
• Buccal tablet. A tablet that you place between your cheek and gums, where it dissolves.
• Sublingual tablet. A tablet that you place under your tongue, where it dissolves.
• Sublingual spray. A solution that you spray under your tongue.
• A lozenge that you suck on until it dissolves.
• A solution that you spray in your nose.

This drug isn’t available as a generic drug.

Fentanyl may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

Fentanyl is used for severe pain.

How it works

Fentanyl belongs to a class of drugs called opioid agonists.

More Details

Fentanyl can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Alcohol interaction

The use of drinks that contain alcohol can increase your risk of serious side effects from fentanyl. It may even result in coma or death. You should not drink alcohol while taking fentanyl.

Medications that might interact with this drug

Drugs you should not take with fentanyl

• Do not take these drugs with fentanyl. Taking fentanyl with these drugs can cause dangerous effects in your body. Examples of these drugs include:
  • Buprenorphine
    • Taking this drug with fentanyl may lower the effect of fentanyl or cause withdrawal symptoms or both.
  • Depression drugs such as monoamine oxidase inhibitors (MAOIs)
    • Taking these drugs with fentanyl may cause anxiety, confusion, slowed breathing, or coma. Do not take fentanyl if you’re taking MAOIs or have taken MAOIs within the last 14 days.

Interactions that increase the risk of side effects

• Taking fentanyl with certain medications may result in an increase in adverse effects. Examples of these drugs include:
  • Muscle relaxants, such as baclofen, cyclobenzaprine, and methocarbamol.
    • You may experience increased breathing problems.

• Benzodiazepines, such as lorazepam, diazepam, temazepam, and estazolam.
  • you may experience increased breathing problems, low blood pressure, extreme drowsiness, coma, or death. Your doctor may prescribe a lower dose for you.
• Anticholinergic drugs, such as atropine, scopolamine, and benztropine.
  • You may experience increased problems urinating or severe constipation, which could lead to more serious bowel problems.
• Voriconazole, ketoconazole.
  • These drugs may increase fentanyl levels in your body, which may increase your risk of side effects. Your doctor may monitor you more frequently and adjust your dose as necessary.
• Erythromycin.
  • This medication may increase fentanyl levels in your body, which may increase your risk of side effects. Your doctor may monitor you more frequently and adjust your dose as necessary.
• Ritonavir.
  • This medication may increase fentanyl levels in your body, which may increase your risk of side effects. Your doctor may monitor you more frequently and adjust your dose as necessary.
• Serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs)
  • Taking these drugs with fentanyl may cause serotonin syndrome, which can be fatal. Symptoms can include agitation, sweating, muscle twitches, and confusion.

Interactions that can make drugs less effective

• When fentanyl is used with certain drugs, it may not work as well to treat your condition. This is because the amount of fentanyl in your body may be decreased from the interaction with these drugs. Examples of these drugs include:

• Rifampin.
  • This drug may decrease fentanyl levels in your body, making the fentanyl less effective in relieving your pain. Your doctor may monitor you more frequently and adjust your dose as necessary.
• Carbamazepine, phenobarbital and phenytoin.
  • These drugs may decrease fentanyl levels in your body, making the fentanyl less effective in relieving your pain. Your doctor may monitor you more frequently and adjust your dose as necessary.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking. Drug warnings

People with breathing problems

Fentanyl may decrease your breathing rate. Use this medication with extreme caution if you’ve been diagnosed with a breathing problem, such as chronic obstructive pulmonary disease (COPD). Do not use fentanyl if you have asthma.

People with intestinal blockage and constipation

Fentanyl can cause you to not notice symptoms of these conditions. This can make it difficult for doctors to diagnose or find the cause of these conditions.

People with head injury or seizures

Fentanyl may cause increased pressure in your brain and cause breathing problems.

People with liver disease

If you have liver disease, your body may process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This increases your risk of side effects. Your doctor may start you on a lower dose. This can help keep levels of this drug from building up too much in your body.

People with kidney disease

If you have kidney disease or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of fentanyl in your body and cause more side effects.

People with adrenal insufficiency

Taking this drug can reduce the amount of hormones your adrenal glands release. If you have this adrenal insufficiency, taking this drug can make it worse.

People with pancreas and gallbladder problems

Taking this drug can cause spasms that can make symptoms of conditions such as biliary tract disease and pancreatitis worse.

People with urination problems

Taking this drug can cause your body to retain urine. If you already have difficulty urinating, your doctor may prescribe a lowered dose.

People with slow heart rate

Taking this drug can slow your heart rate. If you already have a slow heart rate (bradycardia), this drug can make it worse. Use fentanyl with caution. Your doctor may prescribe a lowered dose and monitor you more closely for side effects.

Pregnant women

Fentanyl is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should be used only if the potential benefit justifies the potential risk to the fetus.

Using fentanyl for a long time during pregnancy can lead to neonatal withdrawal syndrome in your newborn child. Symptoms include irritability, overactive behaviors, abnormal sleep pattern, high-pitched crying, tremors, vomiting, diarrhea, and failure to gain weight.

Women who are breast-feeding

Fentanyl does pass into breast milk and causes side effects in a child who is breast-fed.

Talk to your doctor if you breast-feed your baby. You may need to decide whether to stop breast-feeding or stop taking this medication.

For children

The safety and effectiveness of this form of fentanyl hasn’t been established in people younger than 18 years.

When to call the doctor

Call your doctor if you feel as though your pain remains uncontrolled. Your doctor may want to change the dose of your medicine.

Allergies

Fentanyl can cause a severe allergic reaction. Symptoms can include:

• trouble breathing
• swelling of your throat or tongue

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).