- It is used to treat Duchenne muscular dystrophy (DMD).
- It may be given to your child for other reasons. Talk 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 an infection.
- If your child has any of these health problems: Diverticulitis, hole in the GI (gastrointestinal) tract, stomach or bowel infection, or ulcers.
- If your child has recently had stomach or bowel surgery.
- 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 HIV, infections, or seizures. There are many drugs that must not be taken with this drug.
- 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 blood work checked as you have been told by the doctor. Talk with the doctor.
- If your child has been taking this drug for many weeks, talk with your child’s doctor before stopping. You may want to slowly stop this drug.
- Your child may have more chance of getting an infection. Some infections have been deadly. Have your child wash hands often. Have your child stay away from people with infections, colds, or flu.
- Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this drug. Avoid having your child near anyone with chickenpox or measles if your child has not had these health problems before. If your child has been exposed to chickenpox or measles, talk with the doctor.
- This drug may lower how much natural steroid is in your child’s body. If your child has a fever, an infection, surgery, or is hurt, talk with the doctor. Your child may need extra doses of oral steroids. These extra steroids will help your child’s body deal with these stresses. Carry a warning card saying that there may be times when your child needs extra steroids.
- Very bad and sometimes life-threatening health problems can happen with drugs like this one, especially with long-term use. This includes changes in adrenal gland function and a tumor on the adrenal gland (pheochromocytoma). Talk with the doctor.
- Long-term use may raise the chance of cataracts, glaucoma, or weak bones (osteoporosis). Talk with your child’s doctor.
- Your child may need to have a bone density test. Talk with the doctor.
- Have your child’s eye pressure checked if your child is on this drug for a long time. Talk with the doctor.
- Talk with the doctor before your child gets any vaccines. Use with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
- If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
- High blood pressure has happened with this drug. Have your child’s blood pressure checked as you have been told by the doctor.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- You may need to lower how much salt is in your child’s diet and give your child extra potassium. Talk with your child’s doctor.
- If your child drinks grapefruit juice or eats grapefruit often, talk with your child’s doctor.
- Blood clots have happened with this drug. Tell the doctor if your child has ever had a blood clot.
- A type of cancer (Kaposi’s sarcoma) has happened in people taking drugs like this one for a long time. Talk with the doctor.
- This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
If your child is pregnant or breast-feeding a baby:
- Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks of using this drug.
- This drug has benzyl alcohol in it. Benzyl alcohol may cause very bad and sometimes deadly side effects in newborns or infants. Talk with the doctor.
- 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 infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- 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 Cushing’s disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
- Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
- Signs of low calcium levels like muscle cramps or spasms, numbness and tingling, or seizures.
- Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
- Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if a dose was missed or the drug was recently stopped.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Skin changes (pimples, stretch marks, slow healing, hair growth).
- Change in eyesight.
- Bone or joint pain.
- Very bad belly pain.
- Black, tarry, or bloody stools.
- Throwing up blood or throw up that looks like coffee grounds.
- Call the doctor right away if your child has signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
- A very bad skin reaction (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.
- Weight gain.
- More hungry.
- Signs of a common cold.
- Passing urine more often.
- Stomach pain.
- Hard stools (constipation).
- Back pain.
- Upset stomach.
- Have your child swallow whole with a full glass of water.
- The tablet may also be crushed and mixed with applesauce.
- After mixing, give the dose right away. Do not store for future use.
- Shake well before use.
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
- Slowly add the liquid to 3 to 4 ounces (90 to 120 mL) of juice or milk. Mix well. Do not mix with grapefruit juice.
- After mixing, give the dose right away. Do not store for future use.
- Give this drug with or without food.
- To gain the most benefit, do not miss giving your child doses.
- 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.
- 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.
- 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.
- After opening, throw away any part not used after 1 month.
- 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 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.