What is the Fentanyl Transdermal System?
Fentanyl Transdermal System (skin patch) is a prescription medicine that is a federally controlled substance (CII) because it is a strong pain medicine that can be abused by people who abuse prescription medicines or street drugs.
The fentanyl skin patch is only for patients with chronic (around the clock) pain that is moderate to severe and expected to last for weeks or longer.
The fentanyl skin patch should not be the first opioid (narcotic) pain medicine that is prescribed for your pain. You should ONLY use the fentanyl skin patch if you have been taking at least 60 milligrams (mg) of oral morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equally strong dose of another opioid for a week or longer before starting the fentanyl skin patch.
The fentanyl skin patch is not for patients who need opioid pain medicines for only a short time. This includes the pain that happens with surgery (such as tonsillectomies), medical, or dental procedures (such as wisdom tooth removal).
The fentanyl skin patch is not for occasional ("as needed") use.
The fentanyl skin patch is only for opioid tolerant children 2 years of age or older who are already using other opioid narcotic pain medicines. Pediatric patients 2 years of age or older are opioid tolerant if they are taking at least 60 milligrams (mg) of oral morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equally strong dose of another opioid for a week or longer before starting the fentanyl skin patch
Who Should Not Use the Fentanyl Skin Patch?
Do not use the fentanyl skin patch:
If you are NOT already using other opioid narcotic medicines.
If you need opioid pain medicines for only a short time.
For pain from surgery, medical or dental procedures.
If your pain can be taken care of by occasional use of other pain medicines.
In children who are less than 2 years of age.
In children 2 years of age or older who are not already using other opioid narcotic pain medicines (opioid tolerant).
If you have acute (sudden) or severe asthma.
If you have a gastrointestinal problem called paralytic ileus.
What are The Risks?
The following are the major possible risks and side effects of fentanyl skin patch therapy. This list is not complete.
The fentanyl skin patch can cause serious problems that you should tell your doctor or healthcare professional about immediately such as:
Trouble breathing, which can be fatal. Call your healthcare professional right away or get emergency medical help if you:
Have trouble breathing
Have extreme drowsiness with slowed breathing
Have shortness of breath (little chest movement with breathing)
Feel faint, dizzy, confused, or have other unusual symptoms . These can be symptoms that you have taken too much (overdose) fentanyl or the dose of fentanyl in the skin is too high for you. These symptoms may lead to serious problems or death if not treated right away.
Physical Dependence. Stopping the fentanyl skin patch suddenly can make you sick with withdrawal symptoms. Talk to your healthcare professional about slowly stopping the fentanyl skin patch.
Addiction. There is a chance you could get addicted to the fentanyl skin patch. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.
Drop in blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down.
Common side effects with the fentanyl skin patch are nausea, vomiting, constipation, dry mouth, sleepiness, confusion, weakness, and sweating.
Constipation is a very common side effect of opioids including the fentanyl skin patch and is unlikely to go away without treatment. Talk to your healthcare professional about the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while using the fentanyl skin patch.
Sleepiness. The fentanyl skin patch can make you sleepy. Do not drive, operate heavy machinery, or do any other possibly dangerous activities until you know how the fentanyl skin patch affects you.
Other: Although uncommon, trouble sleeping and seizures were reported in children.
Manufacturer link or canadian Pharmacy drug sources: na