- Hepatitis B has gotten worse when this drug was stopped in some people with hepatitis B. Close follow-up for a few months is needed when therapy is stopped in people who have hepatitis B. Do not stop giving this drug to your child without calling your child’s doctor.
- This drug is not approved to treat hepatitis B. Hepatitis B testing needs to be done before your child takes this drug. Talk with the doctor.
- It is used to treat HIV infection.
- 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: Kidney disease or liver disease.
- If your child takes any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with this drug.
- If your child is taking St. John’s wort. Do not give St. John’s wort with this drug. This drug may not work as well.
- If your child is taking any other drugs to treat HIV.
- If your child is taking any drugs that can raise the chance of kidney problems. There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
If your child is pregnant or breast-feeding a baby:
- Do not give this drug to your child if she is pregnant.
- 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 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.
- If your child has a sulfa (sulfonamide) allergy, talk with the doctor.
- This drug interacts with many other drugs. The chance of this drug’s side effects may be raised or how well this drug works may be lowered. The chance of the other drugs’ side effects may also be raised. This may include very bad, life-threatening, or deadly side effects. Check with the doctor and pharmacist to make sure that it is safe for your child to take this drug with all of their other drugs (prescription or OTC, natural products, vitamins).
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- High blood sugar has happened with this drug. This includes diabetes that is new or worse. Talk with the doctor.
- Have your child’s blood sugar checked as you have been told by your child’s doctor.
- This drug may cause high cholesterol and triglyceride levels. Talk with the doctor.
- Some people with hemophilia have had times of more bleeding when taking drugs like this one. If your child has hemophilia, talk with the doctor.
- Kidney problems like kidney failure have happened with this drug. Tell your child’s doctor if your child has ever had kidney problems.
- This drug is not a cure for HIV. Be sure your child stays under the care of the doctor.
- This drug does not stop the spread of diseases like HIV or hepatitis that are passed through blood. Be sure needles and other things like toothbrushes or razors are not shared. Talk with the doctor.
- This drug may rarely cause swollen liver and an acid health problem in the blood. This may be deadly in some cases. The chance may be higher in women, in overweight people, and in people who have taken drugs like this one for a long time. Talk with your child’s doctor.
If your child is or may be sexually active:
- This drug does not stop the spread of diseases like HIV or hepatitis that are passed through having sex. Be sure your child does not have any kind of sex without using a latex or polyurethane condom. Talk with the doctor.
- Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Be sure your child uses some other kind of birth control also, like a condom, when taking this drug.
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 blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
- Muscle or joint pain.
- Feeling very tired or weak.
- Changes in your child’s immune system can happen when your child starts taking drugs to treat HIV. If your child has an infection that you did not know was there, it may show up when your child takes this drug. Tell your child’s doctor right away if your child has any new signs after starting this drug, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.
- Liver problems have rarely happened with this drug. Sometimes, this has been deadly. 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 skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
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 your child has any side effects that bother your child or do not go away.
- Loose stools (diarrhea).
- Feeling tired or weak.
- Upset stomach.
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 food.
- Have your child swallow whole. Do not let your child chew or crush.
- Some products may be broken in half. If you are not sure if you can break this product in half, talk with the doctor.
- Give this drug at the same time of day.
- Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
- It is important that your child does not miss or skip a dose of this drug during treatment.
- Give a missed dose as soon as you think about it, with food.
- 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.
- Store at room temperature.
- Store in the original container. Do not take out the antimoisture cube or packet.
- Keep lid tightly closed.
- 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.
- 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.
- 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.
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.