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Subsys

Generic Name: fentanyl (sublingual) (FEN tan il sub LIN gwal)
Brand Name: Abstral, Subsys

What is fentanyl sublingual?

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

Fentanyl sublingual tablets (Abstral) and sublingual spray (Subsys) are used to treat "breakthrough" cancer pain. Fentanyl sublingual is taken together with other non-fentanyl narcotic pain medicine that is used around the clock. This medication is not for treating pain that is not cancer-related, such as pain from surgery or dental work, migraine headaches, or back pain.

Fentanyl sublingual may also be used for purposes not listed in this medication guide.

What is the most important information I should know about fentanyl sublingual?

Do not use this medication 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). Fentanyl sublingual is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of taking this medication.

Do not take fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

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Fentanyl 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 can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take fentanyl in larger amounts, or for longer than prescribed.

Some medicines can interact with fentanyl and worsen the effects on your breathing. Before using fentanyl sublingual, 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.

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

Fentanyl may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

What should I discuss with my healthcare provider before taking fentanyl sublingual?

Do not take fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

You should not use this medicine if you are allergic to fentanyl.

Some medicines can interact with fentanyl and worsen the effects on your breathing. Before using fentanyl sublingual, 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.

Fentanyl may be habit-forming, even at regular doses. Never share fentanyl with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away fentanyl is against the law.

To make sure fentanyl sublingual is safe for you, tell your doctor if you have:

  • 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;

  • a personal or family history of drug or alcohol addiction;

  • liver or kidney disease; or

  • mouth sores or ulcers.

Tell your doctor if there are children living in the home where you will store this medicine. Keep fentanyl out of the reach of children. The amount of fentanyl in each Abstral tablet or Subsys spray unit can be fatal to a child.

Fentanyl is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

FDA pregnancy category C. It is not known whether fentanyl sublingual will harm an unborn baby. Fentanyl may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant.

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

How should I take fentanyl sublingual?

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 or Subsys 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 or Subsys 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.

Point the Subsys spray nozzle into your mouth, lift your tongue, and spray the medicine under your tongue. Hold the liquid under the tongue for 30 to 60 seconds. Do not spit, swallow, or rinse your mouth during this time.

You may use a second dose of fentanyl sublingual 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.

You must wait at least 4 hours after your last dose of Subsys before you can treat a new pain episode.

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

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 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 or Subsys spray unit can be fatal to a child.

Carefully follow disposal instructions when this medicine is no longer needed. Throw away any unused Abstral tablets by removing them from the blister pack and flushing them down a toilet. Dispose of used Subsys spray units in the disposal bags provided with this medication. 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 drowsiness, weak pulse, and slow breathing (breathing may stop).

What should I avoid while taking fentanyl sublingual?

This medication 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.

Fentanyl sublingual side effects

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;

  • confusion, extreme fear, unusual thoughts or behavior; or

  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • constipation, nausea;

  • drowsiness; or

  • headache.

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.

See also: Side effects (in more detail)

What other drugs will affect fentanyl 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 using fentanyl sublingual with 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 sublingual, 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 transdermal.

Where can I get more information?

  • Your pharmacist can provide more information about fentanyl 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.03. Revision Date: 2014-01-13, 6:20:20 PM.

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