Uses of Deflazacort Oral Suspension:

• It is used to treat Duchenne muscular dystrophy (DMD).

What do I need to tell my doctor BEFORE I take Deflazacort Oral Suspension?

• If you are allergic to deflazacort oral suspension; any part of deflazacort oral suspension; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have an infection.
• If you have any of these health problems: Diverticulitis, hole in the GI (gastrointestinal) tract, stomach or bowel infection, or ulcers.
• If you have recently had stomach or bowel surgery.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with deflazacort oral suspension, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with deflazacort oral suspension.

This is not a list of all drugs or health problems that interact with deflazacort oral suspension.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take deflazacort oral suspension with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Deflazacort Oral Suspension?

• Tell all of your health care providers that you take deflazacort oral suspension. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.
• Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like deflazacort oral suspension. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
• 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 or glaucoma. Talk with the doctor.
• This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Tell your doctor if you get 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.
• High blood pressure has happened with deflazacort oral suspension. Have your blood pressure checked as you have been told by your doctor.
• Blood clots have happened with deflazacort oral suspension. Tell your doctor if you have ever had a blood clot. Talk with your doctor.
• Call your doctor right away if you have 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 type of cancer (Kaposi's sarcoma) has happened in people taking drugs like this one for a long time. Talk with the doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• This medicine has benzyl alcohol in it. Benzyl alcohol may cause very bad and sometimes deadly side effects in newborns or infants. If you have questions, talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Deflazacort Oral Suspension) best taken?

Use deflazacort oral suspension as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Shake well before use.
• Measure liquid doses carefully. Use the measuring device that comes with deflazacort oral suspension. If there is none, ask the pharmacist for a device to measure deflazacort oral suspension.
• 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, take your dose right away. Do not store for future use.
• Take with or without food.
• Keep taking deflazacort oral suspension as you have been told by your doctor or other health care provider, even if you feel well.
• This medicine may lower how much natural steroid is in your body. If you have a fever, an infection, surgery, or you are hurt, talk with your doctor. You may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you need extra steroids.
• Do not stop taking deflazacort oral suspension all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop deflazacort oral suspension, you will want to slowly stop it as ordered by your doctor.
• You may need to lower how much salt is in your diet and take extra potassium. Talk with your doctor.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• If you are not up to date with all of your vaccines, talk with your doctor. You may need to have some vaccines before treatment with this drug.
• Talk with your doctor before getting any vaccines. Use of some vaccines with deflazacort oral suspension may either raise the chance of an infection or make the vaccine not work as well.
• Have your eye pressure checked if you are on deflazacort oral suspension for a long time. Talk with your doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my 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 doctor or get medical help right away if you have 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 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 electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped deflazacort oral suspension.
• 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.
• Mental, mood, or behavior changes that are new or worse.
• 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 you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Deflazacort Oral Suspension?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Weight gain.
• More hungry.
• Signs of a common cold.
• Passing urine more often.
• Stomach pain.
• Constipation.
• Back pain.
• Upset stomach.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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.

How do I store and/or throw out Deflazacort Oral Suspension?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• After opening, throw away any part not used after 1 month.
• 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.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about deflazacort oral suspension, 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.

Frequently asked questions

• What are the new drugs for Duchenne muscular dystrophy?