Warnings:

See also Uses section.

Fentanyl has a risk for abuse and addiction, which can lead to overdose and death. Fentanyl may also cause severe, possibly fatal, breathing problems. Do not use fentanyl sublingual tablets unless you have been regularly taking moderate to large amounts of opioid pain medication. Otherwise, it may cause overdose (even death). To lower your risk, your doctor should have you use the smallest dose of fentanyl that works, and use it for the shortest possible time. See also How to Use section for more information about addiction.

The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you use the wrong dose/strength. Using this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to use fentanyl and what other drugs you should avoid using with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Carefully follow the specific directions for using fentanyl sublingual tablets. Since they are not taken the same way, different forms of fentanyl (including lozenges, buccal tablets, patches) do not have the same effects at equal strengths and should not be substituted for each other. Tell your doctor or pharmacist of all medications that you use, especially of drugs that can affect how fentanyl works. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.

Because of the risk of misuse, abuse, and overdose, you will need to register with a special distribution program (ABSTRAL REMS) before receiving your prescription. Only doctors and pharmacies enrolled in this program may prescribe or dispense this medication. Ask your doctor or pharmacist for details.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.

Uses

This medication is used to help relieve sudden (breakthrough) pain in people who are already taking opioid medication around-the-clock for cancer pain. Fentanyl belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain.This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).

How to use Abstral Tablet, Sublingual

Read the Medication Guide provided by your pharmacist before you start using fentanyl and each time you get a refill. Learn all usage and disposal instructions. If you have any questions, ask your doctor or pharmacist.

Use fentanyl sublingual tablets as directed by your doctor. If your mouth is dry, take a sip of water to moisten it before using this medication. Spit out or swallow the water. With dry hands, open the blister pack unit just before using. Do not push the tablet through the foil of the blister pack because this could damage the tablet. Place the tablet in your mouth under your tongue, as far back as you can. If your dose is for more than one tablet, spread them around the floor of your mouth under your tongue. Do not break, bite, chew, suck, or swallow the tablet whole. Do not eat or drink anything until the tablet dissolves completely.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. If you need a second dose, wait 30 minutes after starting the first dose. Do not use more than 2 doses per episode of breakthrough pain. Wait at least 2 hours before using fentanyl sublingual tablets again for another episode of breakthrough pain. Do not increase your dose or use this drug more often or for longer than prescribed.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

You should continue to also take your around-the-clock opioid medication as directed by your doctor. Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using fentanyl safely with other drugs.

Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Use this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Tell your doctor if your pain does not get better or if it gets worse, or if you have more than 4 episodes of breakthrough pain daily, or if you need to use 2 doses of medication for each episode of pain.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.