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EMFLAZA

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Overview

What is EMFLAZA?

The active ingredient in EMFLAZA is deflazacort (a corticosteroid).  Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic.  The molecular formula for deflazacort is CHNO.  The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:

Deflazacort is a white to off white, odorless fine powder and has a molecular weight of 441.517.  Deflazacort is freely soluble in acetic acid and dichloromethane and soluble in methanol and acetone.

EMFLAZA for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg and an immediate-release oral suspension in a strength of 22.75 mg/mL. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pre-gelatinized corn starch. The oral suspension contains deflazacort and the following inactive ingredients: acetic acid, aluminum magnesium silicate, benzyl alcohol, carboxymethylcellulose sodium, polysorbate 80, purified water, and sorbitol.



What does EMFLAZA look like?



What are the available doses of EMFLAZA?

Tablets

Oral Suspension

What should I talk to my health care provider before I take EMFLAZA?

How should I use EMFLAZA?

EMFLAZA is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.

The recommended oral dosage of EMFLAZA is approximately 0.9 mg/kg/day once daily.  If tablets are used, round up to the nearest possible dose. Any combination of the four EMFLAZA tablet strengths can be used to achieve this dose. If the oral suspension is used, round up to the nearest tenth of a milliliter (mL).


What interacts with EMFLAZA?

Sorry No Records found


What are the warnings of EMFLAZA?

Sorry No Records found


What are the precautions of EMFLAZA?

Sorry No Records found


What are the side effects of EMFLAZA?

Sorry No records found


What should I look out for while using EMFLAZA?

EMFLAZA 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 .


What might happen if I take too much EMFLAZA?

Treatment of acute overdosage is by immediate gastric lavage or emesis followed by supportive and symptomatic therapy.  For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of EMFLAZA may be reduced temporarily, or alternate day treatment may be introduced.


How should I store and handle EMFLAZA?

Store at 20°C to 25°C (68°F to 77°F). Excursion permitted between 15°C to 30°C (59°F to 86°F). See USP controlled room temperature.Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle. Store at 20°C to 25°C (68°F to 77°F). Excursion permitted between 15°C to 30°C (59°F to 86°F). See USP controlled room temperature.Discard any unused EMFLAZA Oral Suspension remaining after 1 month of first opening the bottle. Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with  on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-421-60), 100 (NDC 60429-421-01), 180 (NDC 60429-421-18) and 1000 (NDC 60429-421-10).75 mg — Each white, round, enteric-coated tablet printed with  on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-422-60), 100 (NDC 60429-422-01), 180 (NDC 60429-422-18) and 1000 (NDC 60429-422-10).Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/Packaged by:GSMS, IncorporatedCamarillo, CA 93012 USA40-9184Revised —  October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with  on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-421-60), 100 (NDC 60429-421-01), 180 (NDC 60429-421-18) and 1000 (NDC 60429-421-10).75 mg — Each white, round, enteric-coated tablet printed with  on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-422-60), 100 (NDC 60429-422-01), 180 (NDC 60429-422-18) and 1000 (NDC 60429-422-10).Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/Packaged by:GSMS, IncorporatedCamarillo, CA 93012 USA40-9184Revised —  October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with  on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-421-60), 100 (NDC 60429-421-01), 180 (NDC 60429-421-18) and 1000 (NDC 60429-421-10).75 mg — Each white, round, enteric-coated tablet printed with  on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-422-60), 100 (NDC 60429-422-01), 180 (NDC 60429-422-18) and 1000 (NDC 60429-422-10).Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/Packaged by:GSMS, IncorporatedCamarillo, CA 93012 USA40-9184Revised —  October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with  on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-421-60), 100 (NDC 60429-421-01), 180 (NDC 60429-421-18) and 1000 (NDC 60429-421-10).75 mg — Each white, round, enteric-coated tablet printed with  on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-422-60), 100 (NDC 60429-422-01), 180 (NDC 60429-422-18) and 1000 (NDC 60429-422-10).Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/Packaged by:GSMS, IncorporatedCamarillo, CA 93012 USA40-9184Revised —  October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with  on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-421-60), 100 (NDC 60429-421-01), 180 (NDC 60429-421-18) and 1000 (NDC 60429-421-10).75 mg — Each white, round, enteric-coated tablet printed with  on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-422-60), 100 (NDC 60429-422-01), 180 (NDC 60429-422-18) and 1000 (NDC 60429-422-10).Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/Packaged by:GSMS, IncorporatedCamarillo, CA 93012 USA40-9184Revised —  October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with  on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-421-60), 100 (NDC 60429-421-01), 180 (NDC 60429-421-18) and 1000 (NDC 60429-421-10).75 mg — Each white, round, enteric-coated tablet printed with  on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-422-60), 100 (NDC 60429-422-01), 180 (NDC 60429-422-18) and 1000 (NDC 60429-422-10).Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/Packaged by:GSMS, IncorporatedCamarillo, CA 93012 USA40-9184Revised —  October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with  on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-421-60), 100 (NDC 60429-421-01), 180 (NDC 60429-421-18) and 1000 (NDC 60429-421-10).75 mg — Each white, round, enteric-coated tablet printed with  on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-422-60), 100 (NDC 60429-422-01), 180 (NDC 60429-422-18) and 1000 (NDC 60429-422-10).Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/Packaged by:GSMS, IncorporatedCamarillo, CA 93012 USA40-9184Revised —  October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with  on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-421-60), 100 (NDC 60429-421-01), 180 (NDC 60429-421-18) and 1000 (NDC 60429-421-10).75 mg — Each white, round, enteric-coated tablet printed with  on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-422-60), 100 (NDC 60429-422-01), 180 (NDC 60429-422-18) and 1000 (NDC 60429-422-10).Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/Packaged by:GSMS, IncorporatedCamarillo, CA 93012 USA40-9184Revised —  October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with  on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-421-60), 100 (NDC 60429-421-01), 180 (NDC 60429-421-18) and 1000 (NDC 60429-421-10).75 mg — Each white, round, enteric-coated tablet printed with  on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-422-60), 100 (NDC 60429-422-01), 180 (NDC 60429-422-18) and 1000 (NDC 60429-422-10).Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/Packaged by:GSMS, IncorporatedCamarillo, CA 93012 USA40-9184Revised —  October 2017Diclofenac Sodium Delayed-Release Tablets, USP are available as follows:50 mg — Each white, round, enteric-coated tablet printed with  on one side and 550 on the other side with black ink contains 50 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-421-60), 100 (NDC 60429-421-01), 180 (NDC 60429-421-18) and 1000 (NDC 60429-421-10).75 mg — Each white, round, enteric-coated tablet printed with  on one side and 551 on the other side with black ink contains 75 mg of Diclofenac Sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-422-60), 100 (NDC 60429-422-01), 180 (NDC 60429-422-18) and 1000 (NDC 60429-422-10).Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.Manufactured by: Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/Packaged by:GSMS, IncorporatedCamarillo, CA 93012 USA40-9184Revised —  October 2017


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Deflazacort is a corticosteroid prodrug, whose active metabolite, 21-desDFZ, acts through the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects.  The precise mechanism by which deflazacort exerts its therapeutic effects in patients with DMD is unknown.

Non-Clinical Toxicology
EMFLAZA 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 for clinically significant drug interactions with diclofenac.

Corticosteroids, such as EMFLAZA, can cause serious and life-threatening alterations in endocrine function, especially with chronic use.  Monitor patients receiving EMFLAZA for Cushing’s syndrome, hyperglycemia, and adrenal insufficiency after EMFLAZA withdrawal.  In addition, patients with hypopituitarism, primary adrenal insufficiency or congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma may be at increased risk for adverse endocrine events.

Risk of Adrenal Insufficiency Following Corticosteroid Withdrawal

A steroid “withdrawal syndrome”, seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of corticosteroids.  This syndrome includes symptoms such as anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, and/or weight loss.  These effects are thought to be due to the sudden change in corticosteroid concentration rather than to low corticosteroid levels.

Cushing’s Syndrome

Hyperglycemia

Considerations for Use in Patients with Altered Thyroid Function

Pheochromocytoma Crisis

The following serious adverse reactions are discussed in more detail in other sections:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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