Flazacort 6

Rx

Indications

• 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.

Dosage

Adults

• 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 acute attack, high doses of 48 – 72 mg/ day may be needed depending on severity and gradually reduced once the attack has been controlled; 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.

Children
There has been limited exposure of children to deflazacort. It is important that the lowest effective dosage is used.

• Juvenile chronic arthritis: The usual maintenance dose is between 0.25 – 1.0 mg/kg/day.
• Nephrotic syndrome: 1.5 mg/kg/day followed by down titration according to clinical need.
• Bronchial asthma: 0.25 – 1.0 mg/kg on alternate days.

Usage

• Flazacort 6 is orally administered.

• Systemic infection unless specific anti-infective therapy is employed.
• Hypersensitivity to deflazacort or to any of the ingredients.
• Patients receiving live virus immunisation.

Common

• Weight gain.

Uncommon

• Suppression of the hypothalamic-pituitary-adrenal axis, amenorrhoea,
• Cushingoid facies;
• Osteoporosis, bone fractures;
• Headache, vertigo;
• Hirsutism, striae, acne.
• Dyspepsia, peptic ulceration, heamorrhage, nausea.

• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take Flazacort 6.
• Adrenal suppression: After prolonged therapy must therefore always be gradual to avoid acute adrenal insufficiency which could be fatal, being tapered off over weeks or months according to the dose and duration of treatment.
• Anti-inflammatory/immunosuppressive effects and infection.
• The following clinical conditions require special caution and frequent patient monitoring is necessary:
  Cardiac disease or congestive heart failure (except in the presence of active rheumatic carditis), hypertension, thromboembolic disorders. Dietary salt restriction and potassium supplementation may be necessary.
  Gastritis or oesophagitis, diverticulitis, ulcerative colitis if there is probability of impending perforation, abscess or pyogenic infections, fresh intestinal anastomosis, active or latent peptic ulcer.
  Diabetes mellitus or a family history, osteoporosis, myasthenia gravis, renal insufficiency.
  Emotional instability or psychotic tendency, epilepsy.
  Previous corticosteroid-induced myopathy.
  Liver failure.
  Hypothyroidism and cirrhosis, which may increase glucocorticoid effect.
  Ocular Herpes simplex because of possible corneal perforation.
• Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence which may be irreversible.
• The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid lifethreatening reactions.
• Extreme caution should be exercised when prescribe Flazacort 6 in pregnant and nursing women.
• Patients should be aware of how they react to Flazacort 6 before driving or operating machinery.