Defzort^®

Dezfort is a preparation of Deflazacort which is a prednisolone derived glucocorticoid with anti-inflammatory and immunosuppressant used in treating variety of diseases comparable to treat other anti-inflammatory diseases. It is an inactive prodrug which is metabolized rapidly to the active drug 21-desacetyl Deflazacort. Deflazacort 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

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

Rheumotoidarthritis: 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 Dafzort® 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.

Hepatic impairment
In patients with hepatic impairment, blood levels of deflazacort may be increased. Therefore the dose of Delzort® should be carefully monitored and adjusted to the minimum effective dose.

Renal Impairment
In renal impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.

Elderly
In elderly patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary. The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age.

Children
There has been limited exposure of children to deflazacort in clinical trials. 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 Delzort® usually lie in the range 0.25 -1.5 mg/kg/day. Glucocorticoids cause growth retardation in infancy, childhood and adolescence, therefore long term administration of pharmacological doses should be avoided.

The following ranges provide general guidance:
Juvenilechronicarthritis:The usual maintenance dose is between 0.25 -1.0 mg/kg/day.
Nephrotic syndrome: Initial dose of deflazacort is usually 1.5 mg/kg/day followed by down titration according to clinical need.
Bronchial asthma: On the basis of the potency ratio, the initial dose should be between 0.25 -1.0 mg/kg on alternate days.

Deflazacort withdrawal: 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
Deflazacort cross the placenta. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. As with all drugs, corticoste­roids should only be prescribed when the benefits to the mother and child outweigh the risks.

Lactation
Corticosteroids are excreted in breast milk, although no data are available for deflazacort. Doses up to 50 mg daily of deflazacort are unlikely to cause systemic effects in the infant. Infants of mothers taking higher doses than this may have a degree of adrenal suppression but the benefits of breast feeding are likely to outweigh any theoretical risk.

The following clinical conditions require special caution and frequent patient monitoring is necessary:

• Alterations in endocrine function: Hypothalamic-pituitary-adrenal axis suppression, cushing's syndrome, and hyperglycemia can occur. Monitor patients for these conditions with chronic use of deflazacort.
• lmmunosuppression and increased risk of infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe and at times fatal. Signs and symptoms of infection may be masked.
• Alterations in cardiovascular and renal function: Monitor for elevated blood pressure and sodium, and for decreased potassium levels.
• Gastrointestinal perforation: Increased risk in patients with certain GI disorders. Signs and symptoms may be masked.
• Behavioral and mood disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis.
• Effects on bones: Monitor for decreases in bone mineral density with chronic use of deflazacort
• Ophthalmic effects: May include cataracts, infections, and glaucoma. Monitor intraocular pressure if deflazacort is continued for more than 6 weeks.
• Vaccination: Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids.
• Serious skin rashes: Discontinue at the first sign of rash, unless the rash is clearly not drug related.

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

Deflazacort is contraindicated in patients with hypersensitivity to deflazacort or any of its components.

CYP3A4 inhibitors and inducers
Moderate or strong CYP3A4 Inhibitors: The active metabolite of deflazacort, 21-desDFZ, is a substrate of CYP3A4. 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.

Moderate or strong CYP3M inducers: Co-administration of deflazacort with rifampin, a strong CYP3A4 inducer, significantly decreased the exposure of 21-desDFZ. Avoid concomitant use of strong (e.g., efavirenz) or moderate (e.g., carbamazepine, phenytoin) CYP3A4 inducers with deflazacort.

Neuromuscular blockers
Patients receiving corticosteroids, including deflazacort, and concomitant therapy with neuromuscular b

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.

Dalzort tablet: Each coated tablet contains Deflazacort INN 6 mg. 

Dalzort 24 tablet: Each coated tablet contains Deflazacort INN 24 mg.

Dalzort tablet: Carton of 30 tablets in blister pack.
Dalzort 24 tablet: Carton of 20 tablets in blister pack.