What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Emflaza (Deflazacort)
Prescription Required
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Product Details
Description
Emflaza (deflazacort is the Emflaza generic) is prescribed for treating Duchenne muscular dystrophy in patients who are at least 2 years of age.
Emflaza is available in 6 mg, 18 mg, 30 mg, and 36 mg oral tablets. It is also available in a 22.75 mg/mL oral suspension.
Fact Table
Formula
C25H31NO6
License
US FDA
Bioavailability
40-90%
Legal status
Prescription only (Rx)
Chemical Name
Deflazacort
Elimination half-life
1.1-1.9 hours
Dosage (Strength)
6 mg, 18 mg, 30 mg, 36 mg tablets; 22.75 mg/5 mL oral suspension
Pregnancy
Consult a doctor
Brands
Emflaza
Protein binding
40%
PubChem CID
31675
MedlinePlus
a617023
ChEBI
CHEBI:31473
ATC code
H02AB13
DrugBank
DB01234
KEGG
D03692
Routes of administration
Oral
Directions
Take Emflaza exactly as prescribed by your doctor. For further instructions for use, refer to the medication guide that accompanies your prescription.
The recommended dose is based on your weight, and the medication is taken one time a day. The dose should be gradually decreased if it has been given for more than a few days.
Keep Emflaza stored between 20°C to 25°C (68°F to 77°F) and away from children.
If you have any questions or concerns about Emflaza, tell your doctor or pharmacist.
Ingredients
The active ingredient in Emflaza is a corticosteroid called deflazacort.
Inactive ingredients in the tablet include colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized corn starch.
Inactive ingredients in the oral suspension include acetic acid, aluminum magnesium silicate, benzyl alcohol, carboxymethylcellulose sodium, polysorbate 80, purified water, and sorbitol.
Contraindications
Patients with an allergy to Emflaza or any of its ingredients should not take it.
Cautions
- Before you begin taking Emflaza, tell your doctor about:
- All the prescription and over-the-counter medications you use
- Your allergies
- Your current health problems and past medical history
- Your pregnancy or breastfeeding status
- Emflaza is associated with the following warnings and precautions:
- Changes in endocrine function, such as Cushing’s syndrome, high blood glucose, and suppression of the hypothalamic-pituitary-adrenal axis
- Weakened immune system and increased risk of infection
- Changes in cardiovascular and kidney function, including high blood pressure, elevated sodium levels in the blood, and decreased potassium levels in the blood
- Perforation of the stomach or intestines
- Changes in behavior or mood, including euphoria, trouble sleeping, mood swings, severe depression, psychosis, and altered personality
- Decreased bone mineral density
- Eye problems such as cataracts, infections, and glaucoma
- Patients on Emflaza should not receive live vaccines. If live vaccines are needed, they should be given at least 4-6 weeks prior to starting Emflaza therapy
- Skin rashes that are serious
Side Effects
Cushingoid appearance, increased appetite, weight gain, upper respiratory tract infection, cough, frequent urination during the day, excessive hair growth, abdominal obesity, and common cold are common Emflaza side effects; however, other side effects can also occur. Immediately inform your doctor of side effects that bother you or won’t resolve.
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Reference
Emflaza. South Plainfield, NJ: PTC Therapeutics, Inc.; 2021.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13838
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