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deflazacort (Oral route)

dee-FLAYZ-a-kort

Commonly used brand name(s)

In the U.S.

  • Emflaza

Available Dosage Forms:

  • Tablet
  • Suspension

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For deflazacort

Deflazacort is used to treat Duchenne muscular dystrophy (DMD). DMD is a rare, inherited muscle disease that occurs usually in children and young adults that is caused by absence of a protein called dystrophin, which helps keep muscle cells intact. Deflazacort is corticosteroid (cortisone-like medicine or steroid).

deflazacort is available only with your doctor's prescription.

Before Using deflazacort

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For deflazacort, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to deflazacort or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of deflazacort in children 5 years of age and older. However, safety and efficacy have not been established in children younger than 5 years of age. Because of deflazacort oral suspension containing benzyl alcohol, use in children younger than 5 years of age is not recommended.

Geriatric

No information is available on the relationship of age to the effects of deflazacort in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking deflazacort, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using deflazacort with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Adenovirus Vaccine Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Desmopressin
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

Using deflazacort with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Aldesleukin
  • Amtolmetin Guacil
  • Aprepitant
  • Atazanavir
  • Bemiparin
  • Boceprevir
  • Bosentan
  • Bromfenac
  • Bufexamac
  • Bupropion
  • Carbamazepine
  • Celecoxib
  • Choline Salicylate
  • Ciprofloxacin
  • Clarithromycin
  • Clonixin
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Diltiazem
  • Dipyrone
  • Dronedarone
  • Droxicam
  • Efavirenz
  • Enzalutamide
  • Erythromycin
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Etravirine
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Flurbiprofen
  • Fluvoxamine
  • Fosphenytoin
  • Ibuprofen
  • Idelalisib
  • Imatinib
  • Indinavir
  • Indomethacin
  • Itraconazole
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Lopinavir
  • Lornoxicam
  • Loxoprofen
  • Lumacaftor
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mitotane
  • Modafinil
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Nafcillin
  • Naproxen
  • Nefazodone
  • Nelfinavir
  • Nepafenac
  • Niflumic Acid
  • Nilotinib
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenobarbital
  • Phenylbutazone
  • Phenytoin
  • Piketoprofen
  • Piroxicam
  • Posaconazole
  • Pranoprofen
  • Primidone
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Rifampin
  • Ritonavir
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Saquinavir
  • Sodium Salicylate
  • St John's Wort
  • Sulindac
  • Telaprevir
  • Telithromycin
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib
  • Verapamil
  • Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using deflazacort with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use deflazacort, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of deflazacort. Make sure you tell your doctor if you have any other medical problems, especially:

  • Adrenal problems or
  • Amebiasis, inactive or
  • Blood clotting problems or
  • Cataracts or
  • Congestive heart failure or
  • Cushing's syndrome (adrenal gland problem) or
  • Diabetes or
  • Eye infection (eg, herpes infection of the eyes) or
  • Glaucoma or
  • Heart attack, recent or
  • Hepatitis B infection or
  • Hyperglycemia (high blood sugar) or
  • Hypertension (high blood pressure) or
  • Infection (eg, bacterial, virus, or fungal) or
  • Kidney disease, severe or
  • Mood changes, including depression or
  • Myasthenia gravis (severe muscle weakness) or
  • Osteoporosis (weak bones) or
  • Peptic ulcer, active or history of or
  • Personality changes or
  • Pheochromocytoma (adrenal tumor) or
  • Stomach or intestinal problems (eg, diverticulitis, ulcerative colitis) or
  • Thyroid problems or
  • Tuberculosis, inactive or
  • Weak immune system (eg, Kaposi sarcoma)—Use with caution. May make these conditions worse.
  • Fungal infections—Should not be used in patients with these conditions.

Proper Use of deflazacort

Take deflazacort exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

deflazacort should come with patient instructions leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take deflazacort with or without food.

You may swallow the tablet whole, or crush it and mix with applesauce which to be taken immediately.

Shake well the oral suspension before each use. Measure the dose with the oral dispenser that comes with the package. Add your dose with 3 or 4 ounces of juice or milk, mix well, and take it immediately.

Do not drink grapefruit juice while you are using deflazacort.

Dosing

The dose of deflazacort will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of deflazacort. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (suspension and tablets):
    • For treatment of Duchenne muscular dystrophy
      • Adults and children 5 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.9 milligrams (mg) per kilogram (kg) of body weight once a day.
      • Children younger than 5 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of deflazacort, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused oral suspension 1 month after the bottle is opened for the first time.

Precautions While Using deflazacort

If you will be taking deflazacort for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by deflazacort. Blood or urine tests may be needed to check for unwanted effects.

Using too much of deflazacort or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using deflazacort: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

deflazacort may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

While you are being treated with deflazacort, do not have any immunizations (vaccines) without your doctor's approval. Deflazacort may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

If you use deflazacort for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.

Using deflazacort may increase risk of gastrointestinal perforation. It usually occurs in patients with stomach ulcers or other digestive problems. Tell your doctor right away if you have severe abdominal or stomach pain, cramping, or burning, bloody, black, or tarry stools, or vomiting of material that looks like coffee grounds, severe and continuing.

deflazacort may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression, mood swings, a false or unusual sense of well-being, trouble with sleeping, or personality changes while taking deflazacort.

deflazacort might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using deflazacort, tell the doctor if you think your child is not growing properly.

Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Serious skin reactions can occur with deflazacort. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using deflazacort.

deflazacort may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using deflazacort.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

deflazacort Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Backache
  • blurred vision
  • body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • facial hair growth in females
  • fever
  • fractures
  • full or round face, neck, or trunk
  • headache
  • increased hair growth, especially on the face
  • increased thirst or urination
  • irritability
  • loss of sexual desire or ability
  • loss of voice
  • menstrual irregularities
  • muscle aches
  • muscle wasting
  • nasal congestion
  • sneezing
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
  • weight gain
Less common
  • Bladder pain
  • bloody or cloudy urine
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with moving
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • lower back or side pain
  • muscle pains or stiffness
  • nausea
  • shivering
  • sweating
  • swollen joints
  • trouble sleeping
  • vomiting
Rare
  • Difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or rash
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Incidence not known
  • Abdominal or stomach pain
  • blindness
  • blistering, peeling, loosening of the skin
  • changes in behavior
  • decreased vision
  • depression
  • dry mouth
  • eye pain
  • false or unusual sense of well-being
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • indigestion
  • loss of sexual desire or ability
  • muscular pain, tenderness, wasting, or weakness
  • pain in the bones
  • pain in the chest, groin, or legs, especially the calves
  • pounding in the ears
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • severe abdominal pain, cramping, or burning
  • severe, sudden headache
  • slow or fast heartbeat
  • slurred speech
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • tearing
  • thoughts of killing oneself
  • unexplained weight loss
  • vision changes
  • vomiting of material that looks like coffee grounds, severe and continuing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach discomfort
  • flushing or redness of the skin
  • increase appetite
  • unusually warm skin
Less common
  • Acid or sour stomach
  • belching
  • blemishes on the skin
  • hair loss or thinning of the hair
  • pimples
  • stomach upset or pain
  • watering of the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Side Effects (complete list)

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