Abstral (Fentanyl) 30 pills per package

What is Abstral?

Abstral (fentanyl sublingual) is an opioid pain medication. An opioid is sometimes called a narcotic. Fentanyl sublingual is placed under the tongue.

Abstral 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.

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

Important information

Do not use Abstral to replace any other form of fentanyl, such as Actiq, Fentora, Onsolis, Duragesic, Lazanda, or generic brands of fentanyl (injection, skin patch, dissolving film, or “lollipop” device)

Abstral 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.

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.

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

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 Abstral unless you are already using an around-the-clock opioid medicine and are tolerant to it.

If you switch to Abstral 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 Abstral sublingual tablets can be fatal to a child.

Before taking this medicine

You should not use Abstral if you are allergic to fentanyl. 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 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 Abstral 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.

If you use Abstral while you are pregnant, your baby could become dependent on fentanyl. 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.

Fentanyl may also cause drowsiness, breathing problems, or addiction and withdrawal symptoms in a nursing infant. Do not breast-feed while you are using Abstral.

How should I use Abstral?

Use Abstral exactly as prescribed by your doctor. Follow all directions on your prescription label. Fentanyl can slow or stop your breathing. Take this medicine exactly as prescribed by your doctor. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not use Abstral to replace any other form of fentanyl, such as Actiq, Fentora, Onsolis, Duragesic, Lazanda, or generic brands of fentanyl (injection, skin patch, dissolving film, or “lollipop” device).

If you switch to Abstral from another form of fentanyl, you will not use the same dose. You must start with the lowest dose (100 micrograms). Your doctor may change your dose to make sure you get the best results.

Place the Abstral tablet under your tongue, as far back as you can. Do not break, chew, suck, or swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Do not drink or eat anything during this time.

You may use a second dose of Abstral 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 taking the second tablet. Do not take more than 2 doses for each episode of breakthrough cancer pain.

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

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

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

Never crush or break a Abstral 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 in the original carton at room temperature, away from heat and moisture. Keep track of the amount of medicine used from each carton. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Keep out of the reach of children. The amount of fentanyl in each Abstral tablet can be fatal to a child.

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. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.

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 Abstral?

Abstral 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.

Abstral side effects

Get emergency medical help if you have any signs of an allergic reaction to Abstral: 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, 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 – feeling very thirsty or hot, being unable to urinate, heavy sweating, or 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 Abstral 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 Abstral?

Some medicines can cause unwanted or dangerous effects when used with fentanyl. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Using Abstral 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, seizures, high blood pressure, heart rhythm disorders, or viral infections such as hepatitis or HIV.

You should not use Abstral if you have used a 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.