- 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.
- 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.
- This drug has an opioid drug in it. The use of opioid drugs along with a benzodiazepine drug or other drugs that may make your child drowsy or slow your child’s 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.
- Be sure your child does not drink alcohol or use products that have alcohol. Unsafe and sometimes deadly effects may happen.
- 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.
- It is used to ease pain.
- It may be given to your child for other reasons. Talk with the doctor.
- 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 any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood, or stomach or bowel block or narrowing.
- 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.
- If your child is taking any of these drugs: Linezolid or methylene blue.
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.
- 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.
- 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 rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
- If your child is addicted to pain drugs and is given this drug, your child may have signs of withdrawal. Talk with the doctor.
- This drug may be habit-forming with long-term use.
- This drug is a strong pain drug that can put your child at risk for addiction, abuse, and misuse. Misuse or abuse of this drug can lead to overdose and death. Talk with your child’s doctor.
- If your child has been taking this drug for a long time or at high doses, it may not work as well and your child may need higher doses to get the same effect. This is known as tolerance. Call the doctor if this drug stops working well. Do not give more than ordered.
- If your child has been taking this drug on a regular basis and stops taking it all of a sudden, your child may have signs of withdrawal. Do not stop giving this drug all of a sudden without calling the doctor. Tell the doctor if your child has any bad effects.
- This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
- 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.
- This drug may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to the doctor to see if your child has a greater chance of seizures while taking this drug.
- Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
If your child is pregnant or breast-feeding a baby:
- Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
- 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.
- Tell your child’s doctor if your child is breast-feeding a baby. This drug passes into breast milk and may harm your child’s baby.
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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Trouble breathing, slow breathing, or shallow breathing.
- Noisy breathing.
- Feeling very sleepy.
- Very bad dizziness or passing out.
- Feeling confused.
- Chest pain or pressure or a fast heartbeat.
- Mood changes.
- Very bad belly pain.
- Very bad constipation.
- 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.
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:
- Upset stomach or throwing up.
- Feeling sleepy.
- Sweating a lot.
- Belly pain.
- Feeling tired or weak.
- Dry mouth.
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.
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- It is given as a shot into a muscle, vein, or into the fatty part of the skin.
- Call your child’s doctor to find out what to do.
- If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
- 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.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- 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.
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.
© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.