Generic

Deflazacort

Indications

Deflazacort is indicated in-

• Anaphylaxis, asthma, severe hypersensitivity reactions
• Rheumatoid arthritis, juvenile chronic arthritis, polymyalgia rheumatica
• Systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (other than systemic sclerosis), polyartritis 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

Pharmacology

Phospholipase A2, the enzyme responsible for prostaglandin synthesis, is inhibited by Deflazacort, which has anti-inflammatory properties. Aside from that, Deflazacort inhibits the release of specific molecules that are crucial to the immune system. Deflazacort suppresses the immune system by reducing the release of these substances.

Dosage & Administration

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 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 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.

Interaction

The liver is where Deflazacort is broken down. If you're taking Deflazacort with other medications that cause liver enzyme induction, such as rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, or aminoglutethimide, you should up your maintenance dose. It may be feasible to reduce the maintenance dose of Deflazacort when using medications that inhibit liver enzymes (e.g. ketoconazole).

Contraindications

Intolerance to one or more of the components. Patients who are being immunized with a live virus.

Side Effects

GI problems, musculoskeletal, endocrine, neuropsychiatric, ophthalmology, fluid and electrolyte disorders; infection susceptibility, impaired healing, hypersensitivity, skin atrophy, striae, telangiectasia, acne, myocardial rupture after recent Ml, thromboembolism

Pregnancy & Lactation

Deflazacort crosses the placenta during pregnancy. Corticosteroids, on the other hand, may raise the risk of intrauterine growth retardation when used for lengthy periods of time or repeatedly during pregnancy. Corticosteroids, like any other medicine, should only be used when the benefits to the mother and child outweigh the hazards.

Corticosteroids are secreted in breast milk by nursing mothers, yet no data on Deflazacort is available. Deflazacort doses of up to 50 mg daily are unlikely to have systemic effects in a newborn. Infants born to mothers who take higher dosages may experience some adrenal suppression, but the benefits of breastfeeding are likely to outweigh any potential danger.

Precautions & Warnings

The following clinical situations necessitate extra vigilance and close observation of the patient:

Hypertension, thromboembolic diseases, and cardiac illness or congestive heart failure (unless in the context of active rheumatic carditis). Glucocorticoids can promote salt and water retention, as well as increased potassium excretion. Potassium supplements and dietary salt limitation may be required.

Gastritis or esophagitis, diverticulitis, ulcerative colitis with a risk of perforation, abscess or pyogenic infections, new intestinal anastomosis, active or latent peptic ulcer

Diabetes mellitus or a family history of diabetes, osteoporosis, myasthenia gravis, and renal insufficiency are all possible causes of renal insufficiency.

Therapeutic Class

Glucocorticoids

Storage Conditions

Protect from light and moisture by storing in a cold (below 25°C) and dry location. Keep out of children's reach.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.