Brand Names: U.S.
Brand Names: Canada
- Unsafe and sometimes deadly allergic effects may happen with this drug. Tell your child’s doctor about any fever, rash, feeling tired, upset stomach, throwing up, loose stools, belly pain, flu-like signs, sore throat, cough, or trouble breathing. Do not restart this drug if your child has had an allergic effect.
- The chance of allergic effects is raised in people who have a certain gene called HLA-B*5701. The doctor may check your child’s blood work before starting this drug. Talk with the doctor.
- Read the warning card and carry it with you at all times. It tells the signs to watch for in case an allergy happens.
- 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.
- 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.
What is this drug used for?
- It is used to treat HIV infection.
What do I need to tell the doctor BEFORE my child takes 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 their drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking 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: Kidney disease or liver disease.
- If your child is taking another drug that has the same drug in it.
- If your child is taking emtricitabine.
What are some things I need to know or do while my child takes this drug?
- Tell dentists, surgeons, and other doctors that your child is using this drug.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- Use care if your child has risks for heart disease (high blood pressure, high cholesterol, overweight, high blood sugar [diabetes], cigarette smoking, other family members with early heart disease). Talk with the doctor.
- If this drug is stopped because your child has an allergy to it, do not restart it. It may not be safe to restart this drug.
- If this drug is stopped for any other reason, do not restart it without talking to the doctor. It could be very risky to restart on your own.
- Do not run out of this drug.
- Alcohol may interact with this drug. Be sure your child does not drink beer, wine, or mixed drinks.
- 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.
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.
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.
- Be sure your child does not breast-feed a baby if she has HIV disease unless the doctor tells her to.
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.
- 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.
- 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.
- Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Very bad dizziness or passing out.
- Chest pain or pressure.
- Not able to pass urine or change in how much urine is passed.
- Low mood (depression).
- Mouth sores.
- Muscle pain or weakness.
- A burning, numbness, or tingling feeling that is not normal.
- This drug may help the immune system work. 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 you see any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after you start this drug.
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:
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.
- Change in body fat.
- Not able to sleep.
- Feeling tired or weak.
- Upset stomach.
- Loose stools (diarrhea).
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.
- To gain the most benefit, do not miss giving your child doses.
- Give as you have been told, even if your child feels well.
- Give this drug with or without food.
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.
How do I store and/or throw out this drug?
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
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.
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Last updated: August 16, 2014