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deflazacort

Pronunciation: de FLAZ a kort

Brand: Emflaza

What is the most important information I should know about deflazacort?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is deflazacort?

Deflazacort is a steroid that is used to treat Duchenne muscular dystrophy in adults and children at least 2 years old.

Deflazacort is not a cure for muscular dystrophy, but this medicine may improve muscle strength and slow the progression of disability.

Deflazacort may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking deflazacort?

You should not use deflazacort if you are allergic to it.

Deflazacort should not be given to a child younger than 2 years old. Deflazacort oral suspension (liquid) contains an ingredient that can cause serious side effects or death in very young or premature babies.

Tell your doctor if you have ever had:

  • any type of bacterial, fungal, viral, or parasite infection;
  • heart problems, high blood pressure;
  • a heart attack or stroke;
  • fluid retention;
  • kidney disease;
  • liver disease (especially hepatitis B);
  • a stomach or intestinal disorder;
  • a colostomy or ileostomy;
  • cataracts, glaucoma, or herpes infection of the eyes;
  • diabetes;
  • a nerve-muscle disorder, such as myasthenia gravis;
  • low bone mineral density; or
  • a problem with your thyroid, pituitary gland, or adrenal gland.

You should be current on all vaccines before you start taking deflazacort. Tell your doctor if you have recently received a vaccine or if you are scheduled for a booster dose.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.

Taking deflazacort during early pregnancy may increase the risk of cleft lip and palate in a newborn. Tell your doctor if you are pregnant or plan to become pregnant.

Taking deflazacort at any time during pregnancy may affect adrenal gland hormones in the newborn baby. If you have taken this medicine during pregnancy, tell your doctor if your baby has symptoms such as dry skin, weakness, feeding problems, or vomiting.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I take deflazacort?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take deflazacort with or without food.

You may need to take multiple tablets of different strengths to make up your correct dose. Follow your doctor's dosing instructions very carefully.

If you cannot swallow a tablet whole, crush it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Shake the oral suspension (liquid) before you measure a dose. Use only the dosing syringe provided (not a kitchen spoon) to measure your dose. Mix your measured dose with 3 to 4 ounces of milk or fruit juice (but not grapefruit juice). Drink this mixture right away and do not save it for later.

Deflazacort doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

Deflazacort can weaken (suppress) your immune system, and you may get an infection more easily. If you use this medicine long-term, you may need frequent medical tests. Your vision and bone mineral density may also need to be checked.

Tell your doctor if you have recently traveled. Certain infections are more common in certain parts of the world, and you may have been exposed during travel.

If you've ever had hepatitis B or if you are a carrier of hepatitis B, using deflazacort can cause this virus to become active or get worse. You may need frequent liver function tests.

If you need surgery, tell the surgeon ahead of time that you are using deflazacort.

Store at room temperature away from moisture and heat.

Throw away any deflazacort liquid that has not been used within 1 month after you first opened the bottle.

You should not stop using deflazacort suddenly. Follow your doctor's instructions about tapering your dose. You may need to restart deflazacort if you are under stress or if you have a medical emergency.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking deflazacort?

While taking deflazacort and for at least 4 to 6 weeks before you start taking it: Do not receive a "live" vaccine or you could develop a serious infection.

  • Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
  • You may still be able to receive a yearly flu shot, or an "inactivated" or other vaccine to prevent diseases such as hepatitis, meningitis, pneumonia, shingles, HPV, or whooping cough.
  • Ask your doctor before getting any vaccine.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Grapefruit and grapefruit juice may interact with deflazacort and lead to unwanted side effects. Avoid the use of grapefruit products while taking deflazacort.

What are the possible side effects of deflazacort?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may be more likely if you use deflazacort for a long period of time.

Call your doctor at once if you have:

  • fever, chills, sore throat, weakness;
  • severe or ongoing diarrhea;
  • the first sign of any skin rash, no matter how mild;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • swelling in your hands, feet, or lower legs;
  • severe muscle weakness;
  • decreased adrenal gland hormones --weakness, diarrhea, nausea, menstrual changes, skin discoloration, craving salty foods, and feeling light-headed;
  • increased adrenal gland hormones --weight gain in your face and upper back, slow wound healing, skin discoloration, acne, thinning skin, increased body hair, tiredness, mood changes, menstrual changes, sexual changes;
  • high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor; or
  • low potassium level --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Deflazacort can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

  • increased appetite;
  • weight gain;
  • increased growth of body hair;
  • sleep problems;
  • cold symptoms such as stuffy nose, sneezing, sore throat, cough;
  • frequent urge to urinate; or
  • changes in the shape or location of body fat (especially in your face and back).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect deflazacort?

Tell your doctor about all your current medicines. Many drugs can affect deflazacort, especially:

  • aprepitant, insulin, nefazodone;
  • thyroid medication;
  • St. John's wort;
  • an antibiotic, antifungal medicine;
  • an antidepressant;
  • antiviral medicine (such as medicine to treat hepatitis C or HIV/AIDS);
  • cancer medicine;
  • heart or blood pressure medicine;
  • other steroid medicine;
  • seizure medication;
  • tuberculosis medication; or
  • NSAIDs (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others.

This list is not complete and many other drugs may affect deflazacort. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about deflazacort.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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