Buprenorphine and Naloxone

Pediatric Medication

Brand Names: US

Bunavail; Suboxone; Zubsolv

Brand Names: Canada

Mylan-Buprenorphine/Naloxone; Suboxone; Teva-Buprenorphine/Naloxone


  • This drug has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make you drowsy or slow your actions has led to very bad side effects. Side effects that have happened include slowed or trouble breathing and deaths. Benzodiazepine drugs include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepine drugs are used to treat many health problems like anxiety, trouble sleeping, or seizures. Talk with the doctor.
  • 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.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Get medical help right away if your child does not respond, answer, or react like normal; feels very sleepy or dizzy; passes out; or will not wake up.
  • Get medical help right away if your child has slow breathing, shallow breathing, or trouble breathing.

What is this drug used for?

  • It is used to treat pain drug (opioid) addiction.

What do I need to tell the doctor BEFORE my child takes this drug?

  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has liver disease.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

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

  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • This drug may be habit-forming with long-term use.
  • 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.
  • 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.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of side effects. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • Long-term use of an opioid drug like this drug may lead to lower sex hormone levels. This may lead to signs like change in sex ability in males, no menstrual period in females, lowered interest in sex, or fertility problems. If any of these apply to your child, call your child’s doctor.
  • Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.

If your child is pregnant or breast-feeding a baby:

  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks of using this drug.
  • Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.

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.
  • Very bad dizziness or passing out.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Feeling very sleepy.
  • Feeling confused.
  • Very hard stools (constipation).
  • Change in eyesight.
  • Feeling very tired or weak.
  • Feeling nervous and excitable.
  • Change in balance.
  • Mood changes.
  • Extra muscle action or slow movement.
  • Slurred speech.
  • Very bad and sometimes deadly liver problems have happened with this drug. Call your child’s doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call the doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • Taking an opioid pain drug like this drug may lead to a rare but very bad adrenal gland problem. Call your child’s doctor right away if your child has very bad dizziness or passing out, very bad upset stomach or throwing up, or if your child feels less hungry, very tired, or very weak.

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:

All products:

  • Dizziness.
  • Feeling sleepy.
  • Belly pain.
  • Not able to sleep.
  • Feeling tired or weak.
  • Headache.
  • Upset stomach or throwing up.
  • Hard stools (constipation).
  • Sweating a lot.
  • Flushing.
Under the tongue (sublingual) film:
  • Burning.
  • Numbness or tingling in the mouth.
  • Pain where it was placed.
  • Redness.
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 all information given to you. Follow all instructions closely.

All products:

  • To gain the most benefit, do not miss giving your child doses.
  • Give this drug at the same time of day.
  • Do not let your child chew or swallow.
  • Do not let your child eat, drink, smoke, or talk while this drug is melting.
  • Give this drug by mouth only. Very bad and sometimes deadly side effects may happen if this drug is injected.

All film products:

  • Open right before use.
  • Be sure your hands are dry before you touch this drug.
  • This drug must be taken whole. Do not cut or tear this drug. Do not touch the film with your tongue or finger once it has been placed.
Under the tongue (sublingual) film:
  • Place this drug under the tongue or on the inside of the cheek.
  • If your child is using under the tongue, have your child wet mouth with water. Place film under the tongue and have your child let it melt.
  • If your child is using on the inside of the cheek, have your child wet the inside of the cheek with the tongue or water. Place the film inside the mouth on a wet cheek and have your child let it melt.
  • If using 2 films, place on opposite sides. Try not to let films touch.
  • If using 3 films, place the third film under the tongue after the first 2 films have melted.

Cheek film:

  • Have your child wet the inside of the cheek with the tongue or water.
  • Place the film inside the mouth on a wet cheek. Hold for 5 seconds so it sticks to the cheek. Let it melt.
  • Place the side of the film with the writing against the inside of the cheek.
  • If using 2 films, place on opposite sides. If using many films, do not place more than 2 films on the inside of 1 cheek at a time.

Under the tongue (sublingual) tablet:

  • Place tablet under the tongue and let melt.
  • If the doctor tells you to give more than 1 tablet at a time, ask the doctor how to give them.

What do I do if my child misses a dose?

  • 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.
  • Do not give 2 doses at the same time or extra doses.
  • If you are not sure what to do if you miss giving your child a dose, call the doctor.

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

All products:

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

All film products:

  • Do not freeze.
  • Store in foil pouch until ready for use.

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, nurse, 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.

Last Reviewed Date



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