Abstral buccal / sublingual

Name: Abstral buccal / sublingual

What is Abstral?

Abstral (fentanyl) is an opioid pain medication. An opioid is sometimes called a narcotic.

Abstral sublingual tablets are used to treat "breakthrough" cancer pain that is not controlled by other medicines.

The sublingual tablet is placed on the floor of the mouth under your tongue (sublingual) and allowed to dissolve.

Abstral is not for treating pain that is not cancer-related.

Important information

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

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

How should I use Abstral?

Abstral dissolves under your tongue and will be absorbed by your body to help provide relief for your breakthrough cancer pain.

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 Abstral is against the law.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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

Abstral comes in a blister card with four blister units. Each blister unit contains an Abstral tablet. It is important that the tablet stays sealed in the blister unit until you are ready to use it.

When you get an episode of breakthrough pain, take the dose prescribed by your healthcare provider as follows:

  • If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water. Dry your hands if they are wet before you handle Abstral tablets.

  • When you are ready to take a tablet, pull apart one of the blister units from the blister card by tearing along the dotted lines (perforations) until it is fully separated.

  • When the blister unit is fully separated, peel back the foil starting at the unsealed area where indicated. Gently remove the tablet. Do not try to push Abstral tablets through the foil. This will damage the tablet.

  • As soon as you remove the Abstral tablet from the blister unit, place it on the floor of your mouth, under your tongue, as far back as you can. Do not suck, chew or swallow the tablet. Let the tablet dissolve completely. Do not drink or eat anything until the tablet has completely dissolved under your tongue and you can no longer feel it in your mouth.

  • If more than one tablet is required, spread them around the floor of your mouth under your tongue.

You must not use more than two doses of Abstral for each episode of breakthrough cancer pain.

Take one dose for an episode of breakthrough cancer pain. If your breakthrough pain does not get better within 30 minutes after taking the first dose of Abstral, you can take one more dose as instructed by your healthcare provider.

If your breakthrough pain does not get better after the second dose of Abstral, call your healthcare provider for instructions. Do not take another dose at this time.

Wait at least 2 hours before treating a new episode of breakthrough cancer pain with Abstral.

If you only need to take one dose of Abstral for an episode of breakthrough pain, you must wait 2 hours from the time of that dose to take a dose for new episode of breakthrough pain.

If you need to take two doses for an episode of breakthrough pain, you must wait 2 hours after the second dose to take a dose for a new episode of breakthrough pain.

It is important for you to keep taking your around-the-clock opioid pain medicine while taking Abstral.

Talk to your healthcare provider if you have more than four episodes of breakthrough cancer pain per day. The dose of your around- the-clock opioid pain medicine may need to be adjusted.

Talk to your healthcare provider if your dose of Abstral does not relieve your breakthrough cancer pain. Your healthcare provider will decide if your dose needs to be changed.

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

Never crush or break a Abstral tablet 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 sublingual tablet 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 Abstral tablets by removing them from the blister pack and flushing them down a toilet.

Abstral side effects

Get emergency medical help if you have signs of an allergic reaction to Abstral: 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. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

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; or

  • low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

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.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Abstral 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 Abstral?

Some drugs can raise or lower your blood levels of fentanyl, which may cause side effects or make Abstral 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.

In Summary

Common side effects of Abstral include: respiratory depression. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to fentanyl: film, lozenge/troche, spray, tablet

Other dosage forms:

  • injection injectable, injection solution
  • nasal spray
  • transdermal patch device assisted, transdermal patch extended release

Along with its needed effects, fentanyl (the active ingredient contained in Abstral) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fentanyl:

More common
  • Black, tarry stools
  • blurred vision
  • chest pain
  • confusion
  • convulsions
  • cough
  • decreased urine
  • difficult or labored breathing
  • dizziness
  • dry mouth
  • fainting
  • fever or chills
  • increased thirst
  • irregular heartbeat
  • lightheadedness
  • loss of appetite
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • pounding in the ears
  • rapid breathing
  • sneezing
  • sore throat
  • sunken eyes
  • swelling of the hands, ankles, feet, or lower legs
  • tightness in the chest
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • wrinkled skin
Less common
  • Abdominal or stomach pain
  • change in walking and balance
  • clumsiness or unsteadiness
  • decreased awareness or responsiveness
  • decreased frequency of urination
  • headache
  • muscle twitching or jerking
  • pounding in the ears
  • rhythmic movement of the muscles
  • seeing, hearing, or feeling things that are not there
  • seizures
  • severe constipation
  • severe sleepiness
  • shakiness in the legs, arms, hands, or feet
  • slow or fast heartbeat
  • thinking abnormalities
  • trembling or shaking of the hands or feet

Get emergency help immediately if any of the following symptoms of overdose occur while taking fentanyl:

Symptoms of overdose
  • Extremely shallow or slow breathing

Some side effects of fentanyl may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Back pain
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • discouragement
  • feeling sad or empty
  • irritability
  • lack or loss of strength
  • loss of interest or pleasure
  • muscle stiffness
  • pain in the joints
  • sleepiness or unusual drowsiness
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • weight loss
Less common
  • Changes in vision
  • excessive muscle tone
  • feeling of constant movement of self or surroundings
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • irritation, pain, or sores at the site of application
  • itching skin
  • muscle tension or tightness
  • rash
  • sensation of spinning
  • sweating
Incidence not known
  • Tooth pain
  • trouble with gums
  • trouble with teeth

Fentanyl Identification

Substance Name

Fentanyl

CAS Registry Number

437-38-7

Drug Class

Analgesics, Opioid

Narcotics

Anesthetics, Intravenous

Opiates

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