This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.
- 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.
- Your child will be watched closely to make sure your child does not misuse, abuse, or become addicted to this drug.
- 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.
- 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.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- This drug has an opioid drug in it. Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana or other forms of cannabis, or prescription or OTC drugs that may cause drowsiness or slowed actions. This includes slow or troubled breathing and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepines may be used to treat many health problems like anxiety, trouble sleeping, or seizures. If you have questions, 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.
If your child is 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.
- It is used to ease pain.
- If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
- If your child has an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
- If your child has gotten nasal polyps or had swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness; or trouble breathing with aspirin or NSAID use.
- 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 any of these health problems: Hemophilia or ulcer disease.
- If your child has any of these health problems: Kidney disease or liver disease.
- If your child has Reye’s syndrome.
- If your child has or is getting better from flu signs, chickenpox, or other viral infections.
- If your child is taking any of these drugs: Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
- If your child has taken certain drugs for depression or certain other health problems in the last 14 days. This includes isocarboxazid, phenelzine, or tranylcypromine. Very high blood pressure may happen.
- If your child is taking any other NSAID.
If your child is pregnant or breast-feeding a baby:
- Avoid giving this drug to your child if she is at 20 weeks or later in pregnancy unless the doctor tells you otherwise. Do not give this drug to your child if she is in the third trimester of pregnancy.
- Be sure your child does not breast-feed a baby while taking this drug.
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 to give this drug with all of your child’s other 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 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.
- Long-term or regular use of opioid drugs like this drug may lead to dependence. Lowering the dose or stopping this drug all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your child’s doctor before you lower the dose or stop giving this drug. You will need to follow the doctor’s instructions. Tell your child’s doctor if your child has more pain, mood changes, thoughts of suicide, or any other bad effects.
- Do not give this drug with other strong pain drugs or pain patches without talking to your child’s doctor first.
- Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
- If your child is taking aspirin to help prevent a heart attack, talk with the doctor.
- 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 may lead to lower sex hormone levels. Call your child’s doctor if your child has a lowered interest in sex, fertility problems, no menstrual period (females), or change in sex ability (males).
- 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.
- Very bad stomach ulcers or bleeding can happen with this drug. Taking it in high doses or for a long time, smoking, or drinking alcohol raises the chance of these side effects. Giving this drug with food will not lower the chance of these effects. Call your child’s doctor or get medical help right away if your child gets very bad stomach or back pain; black, tarry, or bloody stools; throwing up blood or throw up that looks like coffee grounds; or weight gain or swelling that is not normal.
- Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye’s syndrome. Reye’s syndrome causes very bad problems to the brain and liver.
If your child is pregnant:
- This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Very bad dizziness or passing out.
- Severe constipation or stomach pain. These may be signs of a severe bowel problem.
- Trouble breathing, slow breathing, or shallow breathing.
- Noisy breathing.
- Breathing problems during sleep (sleep apnea).
- Ringing in ears.
- Hearing loss.
- Dark urine or yellow skin or eyes.
- Not able to pass urine or change in how much urine is passed.
- Mood changes.
- Chest pain or pressure or a fast heartbeat.
- Feeling confused.
- Call the doctor right away if your child has any signs of bleeding problems, like bruising; black, tarry, or bloody stools; bleeding gums; blood in the urine; coughing up blood; cuts that take a long time to stop bleeding; feeling dizzy; feeling very tired or weak; nosebleeds; pain or swelling; throwing up blood or throw up that looks like coffee grounds; or very bad headache.
- A severe and sometimes deadly problem called serotonin syndrome may happen if your child takes this drug with certain other drugs. Call your child’s 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; severe diarrhea, upset stomach, or throwing up; or severe 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 dizzy, sleepy, tired, or weak.
- Stomach pain.
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.
- Give this drug with or without food. Give with food if it causes an upset stomach.
- If your child takes this drug on a regular basis, 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.
- Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
- Store at room temperature in a dry place. Do not store in a bathroom.
- Store this drug in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep this drug safe. Keep all drugs away from 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.
- 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.
- 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.
- A drug called naloxone can be used to help treat an overdose of this drug. Your child’s doctor may order naloxone for you to keep while your child takes this drug. If you have questions about how to get or use naloxone, talk with your child’s doctor or pharmacist. If you think there has been an overdose, call your poison control center or get medical care right away even if naloxone has been used. 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.
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