Deflazacort tablets

What is this medication?

Deflazacort (de FLAZ a kort) is a corticosteroid. This medicine is used for the treatment of Duchenne muscular dystrophy. It is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Emflaza

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cushing's syndrome
• diabetes
• glaucoma
• heart problems or disease
• high blood pressure
• infection such as herpes, measles, or chickenpox
• kidney disease
• liver disease
• mental problems
• myasthenia gravis
• osteoporosis
• seizures
• stomach ulcer or intestine disease including colitis and diverticulitis
• thyroid problem
• an unusual or allergic reaction to deflazacort, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. You can crush and mix it with applesauce or swallow the tablets whole. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice. If your doctor wants you to stop the medicine, the dose may be slowly lowered over time to avoid any side effects.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• carbamazepine
• efavirenz
• phenytoin
• rifampin

This medicine may also interact with the following medications:

• clarithromycin
• diltiazem
• fluconazole
• grapefruit juice
• medicines that relax muscles for surgery
• vaccines
• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medicine.

This medicine may increase your risk of getting an infection. Tell your doctor or health care professional if you are around anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in emotions or moods
• eye pain
• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.
• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine
• slow growth in children (if used for longer periods of time)
• swelling of ankles, feet
• trouble sleeping
• weak bones (if used for longer periods of time)

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• nausea
• upset stomach
• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.