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Fentanyl (FEN ta nil)

Pediatric Medication

Brand Names: U.S.

Abstral; Actiq; Duragesic; Fentora; Lazanda; Onsolis; Subsys

Brand Names: Canada

Abstral; Apo-Fentanyl Matrix; Co-Fentanyl; Duragesic MAT; Fentanyl Citrate Injection, USP; Fentora; Mylan-Fentanyl Matrix Patch; PMS-Fentanyl MTX; RAN-Fentanyl Matrix Patch; Sandoz Fentanyl Patch; Teva-Fentanyl

Warning

All products:

  • This drug may cause very bad and sometimes deadly breathing problems. Call the doctor right away if your child has slow, shallow, or trouble breathing.
  • This drug is only for people who have been taking drugs like this one and are used to the effects. Use of this drug by people who have not been taking drugs like this one or by children may cause very bad and sometimes deadly breathing problems. If this happens, get medical help right away.
  • Even one dose of this drug may be deadly if it is taken by accident. Children are at higher risk. If this drug is taken by accident, get medical help right away.
  • Keep all drugs out of the reach of children and pets.
  • This drug is not for mild pain or pain that only lasts a short time (like headaches, toothaches, or pain after surgery).
  • This drug may be abused. It is habit-forming.
  • Do not give your child more of this drug than what the doctor told you to give. Giving more of this drug than you are told may raise the chance of very bad side effects.
  • Tell the doctor if your child or someone in your family has ever had drug abuse, alcohol abuse, or mental or mood problems.
  • Your child will be watched closely to make sure your child does not misuse, abuse, or become addicted to this drug.
  • Many other drugs interact with this drug. These drugs can raise the chance of side effects as well as very bad and sometimes deadly breathing problems. Talk with the doctor and pharmacist to make sure that it is safe for your child to use this drug with all of his/her other drugs.
  • This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled.

If your child is pregnant:

  • Using this drug for a long time during pregnancy may cause the unborn baby to become addicted. This can lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.

Skin patch:

  • Misuse or abuse of this drug by placing it in the mouth or chewing, swallowing, injecting, or snorting it can lead to overdose and death.
  • The chance of very bad and sometimes deadly breathing problems may be greater when your child first starts this drug or anytime the dose is raised. Talk with your child’s doctor.
  • Children and people who are not used to taking opioids who get this drug on the skin or in the mouth can have very bad and sometimes deadly breathing problems. The patch has a lot of drug in it even after it is used. Carefully follow how to handle, store, and throw out this drug. Talk with your doctor.
  • This drug is only for very bad, long-term pain that cannot be helped by other drugs.
  • Have your child avoid use of heat sources (such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, heated waterbeds). Avoid long, hot baths or sunbathing. Your child’s temperature may rise and cause too much drug to pass into your child’s body.
  • Have your child avoid activities like heavy exercise that can raise body temperature. Tell the doctor if your child gets a fever. Too much drug may pass into your child’s body. Talk with your child’s doctor.
  • Your child may only get this drug through a special program. Talk with the doctor.

All other products:

  • Misuse or abuse of this drug can lead to overdose and death.
  • Do not switch brands of this drug unless you talk with your child’s doctor. It may lead to deadly overdose.

What is this drug used for?

Skin patch:

  • It is used to ease very bad pain.
  • It is only to be used when around-the-clock (continuous) care is needed for a long time. It is also only to be used when other pain drugs do not treat your child’s pain well enough or your child cannot take them.

All other products:

  • It is used to ease pain.

Shot:

  • It is used during surgery.

Is it safe for my child to take this drug?

All products:

  • Not if your child has an allergy to fentanyl or any other part of this drug.
  • Be sure to let the doctor know if your child has any allergies or side effects to drugs, foods, or dyes. Make sure to tell about the allergy and what signs your child had. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • Not if your child has any of these health problems: Very bad asthma, trouble breathing, recent head injury, growths or tumors in the brain, raised pressure in the brain, or very bad bowel or stomach problems like bowel block.
  • Not if your child has taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine, or drugs used for certain other health problems in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure. Talk with your child’s doctor.
  • Not if your child is taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.

Skin patch:

  • Not if your child has any of these health problems: Kidney disease or liver disease.
Under the tongue (sublingual) spray:
  • Not if your child has sores in his/her mouth.

What are some things I need to know or do while my child takes this drug?

All products:

  • Tell dentists, surgeons, and other doctors that your child is using this drug.
  • Do not run out of this drug.
  • This drug may be habit-forming with long-term use.
  • If your child has been taking this drug for many weeks, talk with your child’s doctor before stopping. You may want to slowly stop this drug.
  • If your child has heart disease, talk with the doctor.
  • If your child has kidney disease, talk with the doctor.
  • If your child has liver disease, talk with the doctor.
  • If your child has lung disease, talk with the doctor.
  • If your child has mental illness, talk with the doctor.
  • If your child has thyroid disease, talk with the doctor.
  • Check all drugs your child is taking with your child’s doctor. This drug may not mix well with some other drugs.
  • If your child drinks grapefruit juice or eats grapefruit often, talk with your child’s doctor.
  • Avoid giving your child other drugs and natural products that may slow your child’s actions.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Your child may get sunburned more easily. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects him/her from the sun.

Skin patch:

  • Have your child avoid use of heat sources (such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, heated waterbeds). Avoid long, hot baths or sunbathing. Your child’s temperature may rise and cause too much drug to pass into your child’s body.
  • Fever may cause too much drug to pass into your child’s body. Call our child’s doctor.
  • The patch may have metal. Take off your child’s patch before an MRI.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • If any of this news causes you to be worried, any of the unwanted side effects happen, or if your child is not better after taking this drug.
  • If your child is using the patch and has a fever.
  • If anyone else touches your child’s patch.
  • If your child shows signs of very bad dizziness or passes out.
  • If your child has trouble breathing, slow breathing, or shallow breathing.
  • If your child has a change in thinking clearly and with logic.
  • If your child is feeling very nervous and excitable.
  • If your child is feeling very tired or weak.
  • If your child has poor pain control.
  • If your child has a very bad upset stomach or is throwing up.
  • If your child has very hard stools (constipation).
  • If your child gets a rash.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Trouble breathing. Slow breathing, shallow breathing, or trouble breathing are all signs of this. Call your doctor right away.
  • Feeling lightheaded, sleepy, having blurred eyesight, or a change in thinking clearly. Have your child avoid tasks or actions that call for him/her to be alert or have clear eyesight until you see how this drug works.
  • To lower the chance of feeling dizzy or passing out, have your child get up slowly over a few minutes when sitting or lying down. Have your child be extra careful climbing stairs.
  • Upset stomach or throwing up. Many small meals and good mouth care may help. Older children may suck hard, sugar-free candy.
  • Not able to sleep.
  • Dry mouth. Good mouth care may help. Older children may suck hard, sugar-free candy. Have your child see a dentist often.
  • Hard stools (constipation). Drinking more liquids, working out, or adding fiber to your diet may help. Talk with your doctor about a stool softener or laxative.
  • Seizures may rarely happen.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read and follow the dosing on the label closely.

All products:

  • Do not give this drug with other strong pain drugs or pain patches without talking to your child’s doctor first.
  • Have your child drink lots of noncaffeine liquids every day unless told to drink less liquid by your child’s doctor.
  • Keep a pain diary.

Shot:

  • It is given as a shot into a vein.

Skin patch:

  • Do not use patches that are cut or do not look right.
  • You do not need to put the patch on or near where your child is having pain for it to work.
  • If you or anyone else touches the gel, wash the skin with lots of water. Do not use soap.
  • Wash your hands before and after use.
  • Take off old patch first.
  • Put patch on clean, dry, healthy skin on your child’s upper back. The chest, upper leg, or upper arm may also be used in older children.
  • Do not put the patch on the belt line, bra line, or skin folds.
  • Move the site with each patch.
  • Your child may bathe, shower, or swim for short periods after putting on the patch. Cover the patch with plastic wrap and tape to help keep it in place.
  • If the patch falls off, put a new one on.
  • If the patch loosens, put tape ONLY on the edges of the patch to hold it in place.

What do I do if my child misses a dose?

Skin patch:

  • Put on a missed patch as soon as you think about it after taking off the old one.
  • Do not apply double dose or extra doses.

Shot:

  • Call your child’s doctor to find out what to do.

All other products:

  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.

How do I store and/or throw out this drug?

All products:

  • Store at room temperature. Do not freeze.
  • Keep all drugs out of the reach of children and pets.
  • Follow the info that comes with this drug for throwing out doses that are not needed. Check with your pharmacist if you have questions about how to throw out this drug.

Patch:

  • After you take off a skin patch, be sure to fold the sticky sides of the patch to each other.

Shot:

  • The shot will be given to your child in a hospital or doctor’s office. You will not store it at home.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Copyright

Copyright © 2014 Clinical Drug Information, LLC and Lexi-Comp, Inc.