- A larger number of deaths happened in people taking this drug compared to people taking other drugs used to treat infections. The cause of this risk is not known. This drug is only for use when other drugs cannot be used.
- Some products have maltose in them, which may affect certain glucose tests. False results of glucose tests may cause problems when treating high or low blood sugar. This may lead to long-lasting effects or death. Talk with the doctor about which blood sugar tests are best to use.
- It is used to treat bacterial infections.
- 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 a hole in the GI (gastrointestinal) tract.
- 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.
- Unsafe allergic effects may rarely happen.
- Do not give to your child longer than you have been told. A second infection may happen.
- This drug may make your child sunburn more easily. Use care if your child will be in the sun. Tell your child’s doctor if your child sunburns easily while taking this drug.
- If your child is taking warfarin, talk with the doctor. Your child may need to have blood work checked more closely while taking it with this drug.
- Do not give to a child younger than 18 years of age unless other drugs cannot be used or have not worked. Talk with the doctor.
- Do not give to a child younger than 8 years of age.
- This drug may cause a change in tooth color to yellow-gray-brown in children younger than 8 years old. If this change of tooth color happens, it will not go away. Talk with the doctor.
If your child is or may be sexually active:
- 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 pregnant or breast-feeding a baby:
- 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.
- Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
- 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 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 acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat the does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
- Feeling very tired or weak.
- Very bad headache.
- Change in eyesight, eye pain, or very bad eye irritation.
- Not able to pass urine or change in how much urine is passed.
- It is common to have diarrhea when taking this drug. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)-associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while your child is taking this drug or within a few months after he/she stops taking it. Call your child’s doctor right away if your child has stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with the doctor.
- Very bad and sometimes deadly pancreas problems (pancreatitis) have happened with this drug. This could happen at any time during care. Call the doctor right away if your child has signs of pancreatitis like very bad stomach pain, very bad back pain, or very upset stomach or throwing up.
- Upset stomach or throwing up.
- Loose stools (diarrhea).
- Belly pain.
- It is given as an infusion into a vein over a period of time.
- Call your 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 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.