Deflazacort 6 mg/1
Deflazacort · TABLET · Upsher-Smith Laboratories, LLC
Deflazacort is a tablet containing deflazacort at 6 mg/1, taken oral. Manufactured by Upsher-Smith Laboratories, LLC.
Key Facts
- Brand Name
- Deflazacort
- Generic Name
- Deflazacort
- NDC Code (Product)
0832-0814- Manufacturer
- Upsher-Smith Laboratories, LLC
- Strength
- 6 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA216720
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 11/05/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Deflazacort oral suspension is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza™ (deflazacort) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information . Deflazacort oral suspension is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended once-daily dosage is approximately 0.9 mg/kg/day administered orally ( 2.2 ) Discontinue gradually when administered for more than a few days ( 2.3 ) 2.1 Assessments Prior to First Dose of Deflazacort Oral Suspension Administer all immunizations according to immunization guidelines prior to starting deflazacort oral suspension. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting deflazacort oral suspension [see Warnings and Precautions (5.8) ]. 2.2 Dosing Information The recommended oral dosage of deflazacort oral suspension is approximately 0.9 mg/kg/day once daily. If the oral suspension is used, round up to the nearest tenth of a milliliter (mL). 2.3 Discontinuation Dosage of deflazacort oral suspension must be decreased gradually if the drug has been administered for more than a few days [see Warnings and Precautions (5.1 )]. 2.4 Important Preparation and Administration Instructions Deflazacort oral suspension can be taken with or without food. Do not administer deflazacort oral suspension with grapefruit juice [see Drug Interactions (7.1) ]. Shake deflazacort oral suspension well before administration.…
Contraindications
4 CONTRAINDICATIONS Deflazacort oral suspension is contraindicated in patients with known hypersensitivity to deflazacort or to any of the inactive ingredients. Instances of hypersensitivity, including anaphylaxis, have occurred in patients receiving corticosteroid therapy [see Warnings and Precautions (5.15) and Adverse Reactions (6.2) ] . Hypersensitivity to deflazacort or any of the inactive ingredients in deflazacort oral suspension ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Moderate or strong CYP3A4 inhibitors: Give one third of the recommended dosage of deflazacort ( 7.1 ) Avoid use of moderate or strong CYP3A4 inducers with deflazacort, as they may reduce efficacy ( 7.1) Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza™ (deflazacort) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information . 7.1 CYP3A4 Inhibitors and Inducers Moderate or Strong CYP3A4 Inhibitors The active metabolite of deflazacort, 21-desDFZ, is a substrate of CYP3A4 [see Clinical Pharmacology (12.3) ] . Co-administration of deflazacort with clarithromycin, a strong CYP3A4 inhibitor, increased total exposure to 21-desDFZ by about 3-fold. Therefore, give one third the recommended dosage of deflazacort when moderate or strong CYP3A4 inhibitors (e.g., clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice) are used concomitantly with deflazacort [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] . Moderate or Strong CYP3A4 Inducers Co-administration of deflazacort with rifampin, a strong CYP3A4 inducer, signifi…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections: Alterations in Endocrine Function [see Warnings and Precautions (5.1) ] Immunosuppression and Increased Risk of Infection [see Warnings and Precautions (5.2) ] Alterations in Cardiovascular/Renal Function [see Warnings and Precautions (5.3) ] Gastrointestinal Perforation [see Warnings and Precautions (5.4) ] Behavioral and Mood Disturbances [see Warnings and Precautions (5.5) ] Effects on Bones [see Warnings and Precautions (5.6) ] Ophthalmic Effects [see Warnings and Precautions (5.7 )] Immunizations [see Warnings and Precautions (5.8) ] Serious Skin Rashes [see Warnings and Precautions (5.9) ] Effects on Growth and Development [see Warnings and Precautions (5.10) ] Myopathy [see Warnings and Precautions (5.11) ] Kaposi's Sarcoma [see Warnings and Precautions (5.12) ] Risk of Serious Adverse Reactions in Infants because of Benzyl Alcohol Preservative [see Warnings and Precautions (5.13) ] Thromboembolic Events [see Warnings and Precautions (5.14) ] Anaphylaxis [see Warnings and Precautions (5.15) ] The most common adverse reactions (≥10% for deflazacort and greater than plac…
Frequently Asked Questions
What is Deflazacort used for?
Deflazacort contains Deflazacort. It is a tablet taken oral. Consult your doctor for specific uses.
Is Deflazacort a controlled substance?
Deflazacort is not classified as a controlled substance by the DEA.
What is the generic name for Deflazacort?
The generic name for Deflazacort is Deflazacort. There are 5 other brand versions of Deflazacort.
What is the NDC code for Deflazacort 6 mg/1?
The NDC (National Drug Code) for Deflazacort 6 mg/1 is 0832-0814, listed by Upsher-Smith Laboratories, LLC.