- 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: Long QT on ECG or low potassium levels.
- 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 takes sildenafil to treat pulmonary arterial hypertension (PAH).
- If your child has kidney or liver disease and is also taking colchicine.
- If your child is taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
- Do not give St. John’s wort with this drug. This drug may not work as well.
- If your child is taking disulfiram.
- If your child is taking metronidazole.
- If your child is pregnant or may be pregnant. Do not give this drug to your child if she is pregnant.
- Tell dentists, surgeons, and other doctors that your child is using this drug.
- Keep a list of all the drugs that your child takes. Find out about drugs that are not to be taken while your child takes this drug.
- If your child has high blood sugar (diabetes), talk with the doctor. This drug can raise blood sugar.
- Have your child’s blood sugar checked as you have been told by your child’s 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.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- 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.
- Use with care in children. Talk with the doctor.
- If your child’s weight changes, talk with the doctor. The dose of this drug may need to be changed.
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.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby if she has HIV disease unless the doctor tells her to.
- 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.
- This drug has alcohol and propylene glycol in it. These may cause very bad and sometimes deadly side effects in newborns or young children. Do not use this drug in premature newborns right after birth or in newborns younger than 14 days old unless the doctor tells you to.
- If your child gets pregnant while taking this drug, call the doctor right away.
- 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 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 a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Chest pain or pressure or a fast heartbeat.
- A heartbeat that does not feel normal.
- Dizziness or passing out.
- Very upset stomach or throwing up.
- Any bruising or bleeding.
- Change in body fat.
- 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.
- 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 your child starts this drug.
- 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.
- Back pain.
- Belly pain.
- Loose stools (diarrhea).
- Feeling tired or weak.
- Upset stomach or throwing up.
- Muscle or joint pain.
- 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.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- Give this drug with food.
- Measure liquid doses carefully. Use the measuring device that comes with this drug.
- If your child is also taking didanosine, give it at least 1 hour before or 2 hours after this drug.
- 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.
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Store liquid (solution) in a refrigerator or at room temperature. If stored at room temperature, throw away any part not used after 2 months.
- Protect liquid (solution) from heat.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- 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.
If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.