Fentanyl oral transmucosal

generic for Actiq

Fentanyl oral transmucosal 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 lozenges 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 lozenges. 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 you are using without your doctor's approval.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. Properly throw away all opened units of this drug. 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 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.
  • CAUTION: Opioid. Risk of overdose and addiction.
  • CAUTION: Ask your doctor before using this drug with other opioids, sleep or anxiety drugs, or other drugs that can cause serious breathing problems/drowsiness.
  • Read the boxed warning information for this medication.
  • May cause drowsiness and dizziness. Alcohol and marijuana may intensify this effect. Use care when operating a vehicle, vessel (e.g., boat), or machinery.
  • If you are pregnant or of childbearing age, discuss the risks/benefits of this medication with your doctor and pharmacist.
  • Place in your mouth between the cheeks and gums and actively suck on the medicine.
  • Do not bite or chew medication.
  • Using more of this medication than recommended may cause serious breathing problems.
  • Do not drink alcoholic beverages when using this medication.
  • Do not share this drug with others. This amount of drug may cause serious toxicity or harm if used by someone not used to this much drug.
  • WARNING: Keep Out of the Reach of Children. Fatal Poisoning may occur if chewed or swallowed.

Lactation Warnings


Pregnancy Warnings

  • Neonatal opioid withdrawal syndrome may occur. Monitor neonates for opioid withdrawal syndrome and manage accordingly. Animal data suggest developmental toxicity. Consider maternal treatment benefits versus potential fetal/neonatal adverse outcomes.