Abstral

Pronunciation: FEN-ta-nil
Generic Name: Fentanyl
Brand Name: Abstral

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

Abstral is only for breakthrough pain caused by cancer in patients 18 years old and older who are already using and are tolerant to around-the-clock narcotic pain medicine. Severe and sometimes fatal breathing problems can occur in patients using Abstral, especially in patients not already using other narcotic medicines or patients taking certain other medicines. Ask your health care provider if Abstral may interact with other medicines that you take. Do not use Abstral for short-term pain (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 2 hours after your last dose of Abstral before treating a NEW episode of breakthrough pain with Abstral.

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

Abstral is used for:

Managing breakthrough pain in cancer patients 18 years old and older who are already using and are tolerant to around-the-clock narcotic pain medicines.

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

Do NOT use Abstral if:

• you are allergic to any ingredient in Abstral or to any similar medicine (eg, sufentanil)


• you have not been taking any other narcotic pain medicine (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.

Before using Abstral:

Some medical conditions may interact with Abstral. 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, heart problems (eg, slow or irregular heartbeat, ventricle problems), liver or kidney problems, 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 been very ill, have a fever, have poor health or nutrition, or have had a recent surgery (eg, stomach or bowel surgery)


• if you have a history of mental or mood problems (eg, depression, schizophrenia), 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 stop taking your around-the-clock narcotic pain medicine

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

• 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


• Amiodarone, antihistamines (eg, diphenhydramine), aprepitant, azole antifungals (eg, ketoconazole), benzodiazepines (eg, diazepam), calcium channel blockers (eg, diltiazem, verapamil), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolides (eg, erythromycin, clarithromycin), 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 Abstral's side effects, including serious breathing problems, severe light-headedness or dizziness, or severe drowsiness


• Mixed agonist/antagonist analgesics (eg, buprenorphine, pentazocine, butorphanol), nalmefene, naloxone, or naltrexone because they may decrease Abstral'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 Abstral's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Abstral 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 Abstral:

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

• Abstral comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Abstral refilled.


• Do not use Abstral if the blister card is damaged in any way.


• Do not chew, suck, or swallow the tablet whole.


• If you have a dry mouth, take a sip of water to moisten it before you take Abstral.


• Do not remove the tablet from the blister unit until you are ready to take Abstral. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister unit to expose the tablet. Take the tablet right away after opening the blister pack. Do not store the removed tablet for future use.


• Place the tablet under the tongue as far back as you can. If more than 1 tablet is required for your dose, spread the tablets around the floor of your mouth under your tongue. Leave the tablet in place and allow it to dissolve. Do not eat, drink, or smoke while the tablet is dissolving.


• 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 30 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 2 hours after your last dose of Abstral 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 Abstral.


• If Abstral is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Abstral properly.


• Abstral is usually used as needed. If you forget to use a dose of Abstral 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 Abstral.

Important safety information:

• Abstral may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Abstral 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 Abstral.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Abstral; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Abstral 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 Abstral. Talk with your doctor about using laxatives or stool softeners while you take Abstral 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 Abstral without checking with your doctor.


• Tell your doctor or dentist that you take Abstral before you receive any medical or dental care, emergency care, or surgery.


• Contact your doctor if your pain is not relieved or if it worsens after you use Abstral. 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 Abstral so that your dose can be adjusted if needed.


• Do not switch brands of Abstral without first talking to your doctor. Different brands may release different amounts of Abstral into your body. This may cause severe and possibly fatal overdose. Discuss any questions or concerns with your doctor or pharmacist.


• Use Abstral with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, stomach pain, constipation, and vomiting.


• Abstral can be harmful, even fatal, if used in CHILDREN. Keep Abstral out of the reach of children.


• Use Abstral with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Abstral may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Abstral while you are pregnant. Abstral is found in breast milk. Do not breast-feed while taking Abstral.

When used for long periods of time or at high doses, Abstral 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 Abstral stops working well. Do not take more than prescribed.

Some people who use Abstral for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Abstral, 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 Abstral:

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.

See also: Abstral side effects (in more detail)

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 Abstral:

Store Abstral between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the original package, away from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate or freeze. Do not use if the blister card has been opened. Keep Abstral out of the reach of children and away from pets.

General information:

• If you have any questions about Abstral, please talk with your doctor, pharmacist, or other health care provider.


• Abstral 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 is a summary only. It does not contain all information about Abstral. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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