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Cordef

Deflazacort INN

NAME STRENGTH PACK SIZE DOSAGE FORM
Cordef 6 mg 6 mg 5X10 Tablet
Cordef 24 mg 24 mg 2X10 Tablet

Description

Cordef (Deflazacort) is a glucocorticoid derived from Prednisolone and 6 mg of Deflazacort has approximately the same anti-inflammatory potency as 5 mg Prednisolone or prednisone.

Cordef 6 mg: Each film-coated tablet contains Deflazacort INN 6 mg. Cordef 24 mg: Each film-coated tablet contains Deflazacort INN 24 mg.

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

Adults: For acute disorders: up to 120 mg/day Cordef (Deflazacort) 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 Cordef (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. Hepatic Impairment: In patients with hepatic impairment, blood levels of may be increased. Therefore the dose of Cordef (Deflazacort) should be carefully monitored and adjusted to the minimum effective dose. Renal Impairment: In renally 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 Cordef (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 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.

GI disturbances, musculoskeletal, endocrine, neuropsychiatric, ophthalmic, fluid and electrolyte disturbances; susceptible to infection, impaired healing, hypersensitivity, skin atrophy, striae, telangiectasia, acne, myocardial rupture following recent MI, thromboembolism.

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. Glucocorticoids can cause salt and water retention and increased excretion of potassium. 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.

Pregnancy: Deflazacort does 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. Nursing Mother: Corticosteroids are excreted in breast milk, although no data are available for Deflazacort. Doses of 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 medicines may interact with Deflazacort- Antacids, ACE inhibitors, acetazolamide, adrenergic neuron blockers, antidiabetics, aspirin, barbiturate, β-blockers, calcium-channel blockers, carbamazepine, carbenoxolone, cardiac glycosides, clonidine, coumarins, diazoxide, diuretics, erythromycin, hydralazine, ketoconazole, methotrexate, methyldopa, mifepristone, minoxidil, moxonidine, nitrates, nitroprusside, NSAIDs, oestrogens, phenytoin, primidone, rifamycins, ritonavir, somatropin, β2 sympathomimetics, theophylline, vaccines.

Emergency medical attention is advised in case of acute overdosage.

Store in a cool (below 30º C) and dry place. Keep out of the reach of the children.

Cordef 6 mg Tablet: Each box contains 5 x 10 tablets in blister pack. Cordef 24 mg Tablet: Each box contains 2 x 10 tablets in blister pack.