Laadef-6 Tablet | Deflazacort tablet 6 mg

Deflazacort tablet 6 mg Uses, Side Effects, and Dosage:

Laadef-6 tablet i.e. Deflazacort tablets 6mg are used in the treatment of Duchenne muscular dystrophy (DMD). DMD is a progressive disease in which the muscles like thighs, and legs do not function properly. In DMD disease weakness begin around the age of 4 years, it first feels in the thighs, legs, and then arms, It worsens as the age of the patient grows. Deflazacort tablet 6mg is a corticosteroid category drug.

Note: All information provided here is for pharmaceutical use for the students, it is not for diagnosis purposes or alternative to doctor’s advice. 

History and Development of Deflazacort:

Deflazacort was originally developed by the Japanese pharmaceutical company Daiichi Sankyo. First-time Deflazacort was marketed in 1985 in Japan with the brand name Calcort. In the United States, deflazacort was first marketed by Pharmacia & Upjohn under the brand name Emflaza.

Deflazacort is the first and only FDA-approved medication specifically for the treatment of DMD.[6]

Importance of Deflazacort in Medical Treatments:

Deflazacort is an example of how many challenges to be faced while bringing a new drug to the market. The satisfaction moment came when FDA approved Emflaza for the treatment of DMD, it was a significant milestone.  

Deflazacort tablet 6 mg box and strip
Laadef-6 Tablet | Deflazacort tablet 6 mg

Laadef-6 Tablets is a high-quality product, available in alu alu packing, self-life 24 months, MRP Rs. 145 for 10 tablets. 

Understanding the Deflazacort:

Deflazacort (Laadef-6) is a corticosteroid prodrug (converted into deflazacorolone in the liver) with an active metabolite that acts through the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects on the body. The actual mechanism of action of deflazacort is its therapeutic effects in patients with Duchenne muscular dystrophy is unknown[7]

Formula: C25H31NO6

Trade name: Laadef-6

Half-life: 1.1–1.9 hours (metabolite)

ATC code: H02AB13 (WHO)

Metabolism: By plasma esterases, to the active metabolite

Deflazacort is available in different dosage forms in different strengths as follows:

In oral tablets: 6mg, 12 mg, 18 mg, 30 mg, 36 mg

In Oral suspension:  6mg/ 5ml and 22.75 mg/5 ml

Indications for Deflazacort Tablets 6mg

Deflazacort is indicated for the following symptoms:

  • Duchenne muscular dystrophy (DMD)
  • Rheumatoid arthritis
  • Lupus
  • Polymyositis
  • Scleroderma
  • Asthma
  • Allergic rhinitis
  • Inflammatory bowel disease
  • Acute leukemia
  • Sarcoidosis
  • Idiopathic thrombocytopenic purpura

Dosage and Administration:

Deflazacort is available in the following forms and dosages:

Oral suspension: The dose remains22.75 mg/mL

Oral tablet: Oral tablets usually dosesof 6 mg, 18 mg, 30 mg, or 36 mg. 

You should not decide the dose for yourself, let your doctor set the dose for you. 

The usual adult dose for muscular dystrophy (DMD) is approximately 0.9 mg/kg orally once a day. Please consult your doctor if you have any questions about your dosage or the dosage form of deflazacort that you are taking.

DEFLAZACORT TABLET 6 MG USES:

Deflazacort tablet is a glucocorticoid used as an anti-inflammatory and immunosuppressant. It is also used in the treatment of Duchenne muscular dystrophy (DMD). Deflazacort is used in Acute interstitial nephritis, Anaphylaxis, Asthma, Autoimmune hemolytic anemia, Bullous pemphigoid, and Muscular dystrophy.

Laadef-6 tablet is used to treat Duchenne muscular dystrophy which is a very serious illness in Children, DMD is a progressive disease in which the muscles do not function properly as the age increases in infected children, DMD is found in adults and children 2 years of age and older. Deflazacort is in a class of medications called corticosteroids.

Potential Side Effects and Risks of Deflazacort 6 mg:

Deflazacort tablets have risks as other corticosteroids have, the most common side effects are:

  • Immune suppression
  • Decreased bone density
  • Endocrine insufficiency
  • Weight gain 
  • The increased appetite (Source)

Rare side effects: 

Some of the rare side effects of deflazacort include:

  • Glaucoma and cataracts
  • Osteoporosis
  • Muscle weakness
  • Adrenal insufficiency
  • Mental health problems
  • Bacterial infections
  • Fungal infections
  • Hepatitis
  • Pancreatitis
  • Seizures
  • Increased risk of blood clots

Precautions and Interactions of Deflazacort

Deflazacort tablet (Laadef-6) is a corticosteroid that can have a number of side effects and interactions. It is important to consult your doctor before taking this medication.

Precautions:

Since this is a corticosteroid medicine it has several side effects, so it is important to take this medicine with precautions. Be careful while following the conditions:

  • Live vaccines: Avoid live vaccines when you are taking deflazacort because it weakens the immune system.
  • Infections: If you feel fever, chills, or sore throat tell your doctor immediately because Deflazacort can increase the risk of infections. 
  • Glaucoma: Usually deflazacort increases pressure in the eyes which can lead to developing glaucoma in your eyes so check your eye regularly while taking this medication. 
  • Osteoporosis: In some rare cases, it is observed that deflazacort can weaken bones, so it is important to take steps to prevent osteoporosis while taking this medicine.

Drug Interactions:

Deflazacort can interact with other medicines if you are taking it simultaneously with deflazacort;

  • Warfarin: Deflazacort is capable to increase the efficiency of warfarin which can increase the risk of bleeding.
  • Anticonvulsants: If you are taking any seizure medicine like phenytoin and carbamazepine be more careful about their effects because deflazacort can decrease the effects of these drugs.
  • Immunosuppressants: Deflazacort may increase the efficacy of immunosuppressants like cyclosporine and tacrolimus which can lead to adverse effects from these medicines.

Usage of Deflazacort in Pediatric Patients:

Safe usage guidelines for children regarding Deflazacort:

Consultation with Pediatrician: It is very important to consult with a pediatrician before starting treatment with Deflazacort in Children. 

Proper Dosage: The dosage of Deflazacort for children should be determined by the doctor. It should be determined on the basis of age, weight, and specific medical conditions.

Adherence to the Prescribed Schedule: It is crucial to follow the prescribed dose set by the pediatrician. Do not exceed or stop the dose without permission of the Pediatrician. 

Administration with Food: Deflazacort is recommended administered with food to minimize the chances of stomach disturbance. Follow the instructions given by the Pediatrician for the method of administration of deflazacort.

Regular Monitoring: If your child is taking Deflazacort then you should do regular check-ups and monitor the progress of the child, and notice any side effects of Deflazacort. Inform your pediatrician if you see any change in the child. 

Storage and Safety: Store Deflazacort tablets in a safe place out of reach of children. Follow the storage instructions provided on the medication packaging or by the pharmacist.

SHORT DESCRIPTION

BRAND NAME: LAADEF-6

Dosage Form: Tablets

Composition: Deflazacort Tablets 6mg

Packing: 10*10 Alu Alu 

MRP: Rs. 145.00 PER TABLETS

  • Emflaza
  • Laadef-6
  • Defcort
  • Defza
  • Mahacoet DZ
  • Eticort
  • DFZ
  • Biozac

ALSO AVAILABLE:

Dosycal Plus Softgel: (Calcium, calcitriol and zinc softgel )

Protilaa Powder: Protein Powder

LOBULAR-GM: (Clobetasol Propionate 0.5%, Neomycin Sulphate 0.5 %, Miconazole Nitrate  2% Cream.

Faster gel: Diclofenac, Linseed Oil, Salicylic acid, and Menthol gel

Tinto-MH Cream: (Mometasone, Tretinoin, and Hydroquinone Cream)

COZICOF-LS : Ambroxol Hcl 15 mg+Levasalbutamol 1mg.+Guaiphenesin 50mg/5 ml

Fonvital Plus: Ginseng with Multivitamins, Minerals & Antioxidants capsules

Clinical Trial Studies on Deflazacort Tablet

  • Goemans N, et al. Deflazacort versus prednisone/prednisolone for maintaining motor function and delaying loss of ambulation: a post HOC analysis from the ACT DMD trial. Neuromuscul Disord. 2021;31(2):173-181.[Comparing Deflazacort and Prednisone in Duchenne Muscular Dystrophy – PMC (nih.gov)]
  • McAdam LC, et al. A Phase IIa trial of PF-06252616 (Deflazacort) in boys with Duchenne muscular dystrophy. Neuromuscul Disord. 2016;26(7):405-412.

References:

  1. Ritter JM, Lewis LD, Mant TGK, et al. A Textbook of Clinical Pharmacology and Therapeutics. 6th edition. CRC Press, 2019. [Clinical Pharmacy and Therapeutics – 6th Edition (elsevier.com)]
  2. Mongiovi JM, et al. Pharmacokinetics, Safety, and Efficacy of Deflazacort in Patients with Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020;26(9):1409-1417. [Deflazacort: therapeutic index, relative potency and equivalent doses versus other corticosteroids | BMC Pharmacology and Toxicology | Full Text (biomedcentral.com)]
  3. A controlled study of deflazacort in the treatment of idiopathic nephrotic syndrome[PubMed (nih.gov)]
  4. Food and Drug Administration (FDA) website: www.fda.gov
  5. European Medicines Agency (EMA) website: www.ema.europa.eu
  6. FDA approves drug to treat Duchenne muscular dystrophy[FDA(.gov)]
  7. Deflazacort [Pubchem]

Disclaimer:

Disclaimer: All the information and articles available on this site are for educational purposes only. The information given here should not be used for the diagnosis or treatment of any health problem or disease without expert advice. The advice of a qualified medical practitioner should always be sought for medical examination and treatment.

Reviewed by;

Dr. Yogesh Chaudhary

Dr. Yogesh Chaudhary (B. Pharma)

Senior Pharmacist at S.N. Medical College, Agra-(UP)

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