Deflazacort is used for the treatment of a wide range of inflammatory, allergic, autoimmune, and malignant conditions, including:

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

Deflazacort produces its anti-inflammatory effect by inhibiting the enzyme phospholipase A2, which plays a key role in the synthesis of prostaglandins. In addition, it reduces the release of certain immune-related chemical mediators. By lowering the production of these substances, deflazacort also exerts an immunosuppressive effect.

Adults-

• For acute disorders: Up to 120 mg/day Deflazacort may need to be given initially. Maintenance doses in most conditions are within the range of 3-18 mg/day.
• Rheumatoid arthritis: The maintenance dose is usually within the range of 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 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 Deflazacort 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.

Children: There has been limited exposure of children to Deflazacort in clinical trials. In children, the indications for glucocorticoids arethe same as for adults, but it is important that the lowest effective dosage is used. Alternate day administration may be appropriate. Doses of Deflazacort usually lie in the range 0.25-1.5 mg/kg/day.

The following ranges provide general guidance:

• Juvenile chronic arthritis: The usual maintenance dose is between 0.25-1.0 mg/kg/day
• Nephrotic syndrome: Initial dose of 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 per 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.

Deflazacort is metabolized in the liver. When it is used together with drugs that induce hepatic enzymes, the maintenance dose of deflazacort may need to be increased. Such drugs include rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, and aminoglutethimide. Conversely, when co-administered with drugs that inhibit liver enzymes, such as ketoconazole, the maintenance dose of deflazacort may need to be reduced.

Contraindicated in patients with hypersensitivity to the drug or any of its components. It should also not be used in patients receiving live virus vaccines.

Adverse effects may include gastrointestinal disturbances, musculoskeletal, endocrine, neuropsychiatric, and ophthalmic disorders, as well as fluid and electrolyte imbalance. Patients may become more susceptible to infections and experience delayed wound healing. Other possible effects include hypersensitivity reactions, skin atrophy, striae, telangiectasia, acne, myocardial rupture following recent myocardial infarction, and thromboembolic events.

Pregnancy: Deflazacort can cross the placental barrier. However, prolonged or repeated use of corticosteroids during pregnancy may increase the risk of intrauterine growth restriction. As with all medicines, corticosteroids should be prescribed during pregnancy only when the expected benefits to the mother and fetus outweigh the potential risks.

Nursing Mother: Corticosteroids are excreted in breast milk, although specific data for deflazacort are not available. Daily doses up to 50 mg are unlikely to produce systemic effects in the infant. Infants of mothers receiving higher doses may experience some degree of adrenal suppression; however, the benefits of breastfeeding are generally considered greater than the potential theoretical risks.

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

• Cardiac conditions: Cardiac disease or congestive heart failure (except active rheumatic carditis), hypertension, and thromboembolic disorders. Glucocorticoids may cause sodium and water retention and increased potassium loss; dietary salt restriction and potassium supplementation may be needed.
• Gastrointestinal conditions: Gastritis, oesophagitis, diverticulitis, and ulcerative colitis (especially with risk of perforation, abscess, or infection), recent intestinal anastomosis, and active or latent peptic ulcer disease.
• Metabolic and systemic conditions: Diabetes mellitus (or family history), osteoporosis, myasthenia gravis, and renal impairment.
• Neuropsychiatric conditions: Emotional instability, psychotic tendencies, and epilepsy.
• Muscle disorders: Previous corticosteroid-induced myopathy.
• Hepatic conditions: Liver failure.
• Endocrine/liver-related conditions: Hypothyroidism and cirrhosis, which may enhance glucocorticoid effects.
• Ophthalmic condition: Ocular herpes simplex infection due to risk of corneal perforation.

• Hepatic impairment: In patients with liver dysfunction, blood levels of deflazacort may be elevated. Therefore, the dose should be carefully monitored and adjusted to the lowest effective level.
• Renal impairment: In patients with kidney impairment, no additional precautions are required beyond the usual measures followed in glucocorticoid therapy.
• Elderly patients: No special precautions are generally required other than standard glucocorticoid use guidelines. However, common adverse effects of systemic corticosteroids may have more serious consequences in older patients.

Glucocorticoids

Store in a cool, dry place below 25°C. Protect from light and moisture. Keep out of reach of children.