Defzort^®

Defzort is a preparation of Deflazacort which is a prednisolone derived glucocorticoid with anti-inflammatory and immunosuppressant activity. It is an inactive prodrug which is metabolized rapidly to the active drug 21-desacetyl Deflazacort. Defzort works by acting within the cells to prevent the release of certain chemicals that are important in the immune system. By decreasing the release of these chemicals in particular area, inflammation is reduced. This, along with the decrease in inflammatory chemicals, can prevent the rejection of organ transplants.

No Data

Defzort is indicated for the treatment of-

• Anaphylaxis, asthma, severe hypersensitivity reactions
• Rheumatoid arthritis,juvenile chronic arthritis, polymyalgia rheumatica
• Systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (other than systemic sclerosis), polyarteritis nodosa, sarcoidosis
• Pemphigus, bullous pemphigoid, pyoderma gangrenosum
• Minimal change nephrotic syndrome, acute interstitial nephritis
• Rheumatic carditis
• Ulcerative colitis, crohn's disease
• Uveitis, optic neuritis
• Autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura
• Acute and lymphatic leukaemia, malignant lymphoma, multiple myeloma
• Immune suppression in transplantation

Route of administration: Defzort should be taken in oral route.

Adults
For acute disorders, up to 120 mg/day Defzort may need to be given initially. Maintenance doses in most conditions are within the range 3-18 mg/day.

Rheumatoid arthritis: The maintenance dose is usually within the range 3-18 mg/day. The smallest effective dose should be used and increased if necessary.

Bronchial asthma: In the treatment of an acute attack, high doses of 48-72 mg/day may be needed depending on severity and gradually reduced once the attack has been controlled. For maintenance in chronic asthma, doses should be titrated to the lowest dose that controls symptoms.

Other conditions: The dose of Defzort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5 mg prednisone or prednisolone to 6 mg deflazacort.

Pediatric patients
In children, the indications for glucocorticoids are the same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate. Doses of Defzort usually lie in the range 0.25 - 1.5 mg/kg/day.

Juvenile chronic arthritis: The usual maintenance dose is between 0.25-1.0 mg/kg/day.

Nephrotic syndrome: Initial dose is usually 1.5 mg/kg/day followed by down titration according to clinical need.

Bronchial asthma: Initial dose should be between 0.25-1.0 mg/kg on alternate days.

In patients who have received more than physiological doses of systemic corticosteroids (approximately 9 mg/day or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as the dose of systemic corticosteroids is reduced.

Pregnancy: Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: There is no information regarding the presence of deflazacort in human milk, the effects on the breastfed infant or the effects on milk production.

Use in children and adolescents
Long term administration of glucocorticoids should be avoided in children and adolescents.

There's risk of alterations in endocrine function, immunosuppression and increased risk of infections, alterations in cardiovascular and renal function, gastrointestinal perforation, behavioral and mood disturbances, decrease in bone mineral density following administration of deflazacort. Monitor intraocular pressure if deflazacort is continued for more than 6 weeks. Don't administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids. Caution should be taken and dose should be adjusted if necessary in elderly patients and in patients with hepatic and renal impairment.

The most common side effects are cushingoid appearance, increased weight, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity and nasopharyngitis.

It is contraindicated in patients with hypersensitivity to deflazacort or any components of this product.

Drug interaction with medication: Give one third the recommended dosage of deflazacort when moderate or strong CYP3A4 inhibitors (e.g., clarithromycin, fluconazole, diltiazem, verapamil) are used concomitantly with deflazacort. Avoid concomitant use of strong (e.g., efavirenz) or moderate (e.g., carbamazepine, phenytoin) CYP3A4 inducers with deflazacort. Patients receiving corticosteroids, including deflazacort and concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium) may be at increased risk of developing an acute myopathy.

Drug interaction with food and others: Grapefruit juice increases the exposure of deflazacort.

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

No Data

• Keep away from the reach of the children.
• Store in a cool (below 25°C) and dry place protected from light.
• To be taken and sold only on the prescription of a registered physician.

Defzort tablet: Each coated tablet contains Deflazacort INN 6 mg.
Defzort 24 tablet: Each coated tablet contains Deflazacort INN 24 mg.
Defzort suspension: Each 5 ml suspension contains Deflazacort INN 6 mg.

Storage
Store below 25℃ in a dry place, protected from light. Keep away from the reach of children.

Packing
Defzort tablet: Carton of 30 tablets in blister pack.
Defzort 24 tablet: Carton of 20 tablets in blister pack.
Defzort suspension: Bottle of 60 ml.