DEFNALONE (Calcort)6mg – 10 tablet

Deflazacort Information

Pronunciation

de FLAZE a kort

What is this drug used for?

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

Frequently reported side effects of this drug

• Increased hunger

• Common cold symptoms

• Passing a lot of urine

• Constipation

• Back pain

• Nausea

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Infection

• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit

• Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood

• Cushing disease like weight gain in upper back or abdomen; moon face; severe headache; or slow healing

• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss

• Severe headache

• Dizziness

• Passing out

• Vision changes

• Electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting

• Severe loss of strength and energy

• Irritability

• Tremors

• Fast heartbeat

• Confusion

• Sweating a lot

• Shortness of breath

• Excessive weight gain

• Swelling in the arms or legs

• Skin changes like acne, stretch marks, slow healing, or hair growth

• Bone pain

• Joint pain

• Severe abdominal pain

• Black, tarry, or bloody stools

• Vomiting blood

• Mood changes

• Behavioral changes

• Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Storage and Stability

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Discard unused suspension 1 month after opening the bottle.

Adverse Reactions

Cardiovascular: Cardiac arrhythmia

Central nervous system: Abnormal behavior, aggressive behavior, depression, dizziness, emotional disturbance, emotional lability, heat exhaustion, hypertonia (hypertonic bladder), insomnia, irritability, mood changes, myasthenia (associated with long-term use), psychomotor agitation, sleep disorder

Dermatologic: Acneiform eruption, acne vulgaris, alopecia, atrophic striae, erythema, impetigo, skin rash

Endocrine & metabolic: Cushingoid appearance, glycosuria, hirsutism, hot flash, increased thirst, obesity (central), weight gain

Gastrointestinal: Abdominal distress, abdominal pain (including upper abdominal pain), constipation, dyspepsia, gastrointestinal disease, increased appetite, nausea

Genitourinary: Dysuria, pollakiuria, testicular pain, urinary tract infection, urine discoloration

Hematologic & oncologic: Bruise

Infection: Influenza, tooth abscess, viral infection

Neuromuscular & skeletal: Back pain, back injury, bone fracture (long bones including the fibula as well as greenstick fractures), decreased bone mineral density, limb pain, muscle spasm, myalgia, neck pain, osteopenia (associated with long-term use), tendon disease (associated with long-term use)

Ophthalmic: Hordeolum, increased lacrimation

Otic: Otitis externa

Respiratory: Cough, epistaxis, hypoventilation, nasopharyngitis, pharyngitis, rhinorrhea, upper respiratory tract infection

Miscellaneous: Accidental injury (face), fever, mass (neck)