Brands of Deflazacort in Kenya
Defcian, Cian Health Care Pvt. Ltd
Deflaz, Zuvan Limited
Deflozed, Zawadi Healthcare Ltd
Flazart, West-Coast Pharmaceuticals works Ltd
Safecort, Yash Pharma Laboratories Pvt Ltd
Yescort, Yash Pharma Laboratories Pvt . Ltd
MODE OF ACTION
Deflazacort is a corticosteroid prodrug, whose active metabolite, 21-desDFZ, acts through the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects. The precise mechanism by which deflazacort exerts its therapeutic effects in patients with DMD is unknown.
A wide range of conditions may sometimes need treatment with glucocorticoids. The indications include:
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
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 AND ADMINISTRATION
For acute disorders, up to 120 mg/day deflazacort may need to be given initially. Maintenance doses in most conditions are within the range 3 – 18 mg/day. The following regimens are for guidance only.
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 deflazacort depends on clinical need titrated to the lowest effective dose for maintenance. Starting doses may be estimated on the basis of ratio of 5mg prednisone or prednisolone to 6mg deflazacort.
In patients with hepatic impairment, blood levels of deflazacort may be increased. Therefore the dose of deflazacort should be carefully monitored and adjusted to the minimum effective dose.
In renally impaired patients, no special precautions other than those usually adopted in patients receiving glucocorticoid therapy are necessary.
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 (see Warnings and Precautions).
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 (see Warnings and Precautions).
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 deflazacort on alternate days.
In patients who have received more than physiological doses of systemic corticosteroids (approximately 9mg 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. Clinical assessment of disease activity may be needed during withdrawal. If the disease is unlikely to relapse on withdrawal of systemic corticosteroids but there is uncertainty about HPA suppression, the dose of systemic corticosteroids may be reduced rapidly to physiological doses. Once a daily dose equivalent to 9mg deflazacort is reached, dose reduction should be slower to allow the HPA-axis to recover.
Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Abrupt withdrawal of doses up to 48 mg daily of deflazacort, or equivalent for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less:
• Patients who have had repeated courses of systemic corticosteroids, particularly if taken for greater than 3 weeks.
• When a short course has been prescribed within one year of cessation of long-term therapy (months or years).
• Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy.
• Patients receiving doses of systemic corticosteroid greater than 48 mg daily of deflazacort (or equivalent),
• Patients repeatedly taking doses in the evening.
Systemic infection unless specific anti-infective therapy is employed.
Hypersensitivity to the active substance, deflazacort or any of the excipients .
Patients receiving live virus immunisation.
Deflazacort is metabolised in the liver. It is recommended to increase the maintenance dose of deflazacort if drugs which are liver enzyme inducers are co-administered, e.g. rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone and aminoglutethimide. For drugs which inhibit liver enzymes, e.g. ketoconazole it may be possible to reduce the maintenance dose of deflazacort.
In patients taking estrogens, corticosteroid requirements may be reduced.
The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives and diuretics are antagonised by corticosteroids and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics, beta 2-agonists, xanthines and carbenoxolone are enhanced.
The efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.
In patients treated with systemic corticosteroids, use of non-depolarising muscle relaxants can result in prolonged relaxation and acute myopathy. Risk factors for this include prolonged and high dose corticosteroid treatment, and prolonged duration of muscle paralysis. This interaction is more likely following prolonged ventilation (such as in the ITU setting).
The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication.
As glucocorticoids can suppress the normal responses of the body to attack by micro-organisms, it is important to ensure that any anti-infective therapy is effective and it is recommended to monitor patients closely. Concurrent use of glucocorticoids and oral contraceptives should be closely monitored as plasma levels of glucocorticoids may be increased. This effect may be due to a change in metabolism or binding to serum proteins. Antacids may reduce bioavailability; leave at least 2 hours between administration of deflazacort and antacids.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
Uncommon: Suppression of the hypothalamic-pituitary-adrenal axis, amenorrhoea, Cushingoid facies.
Not known: Growth suppression in infancy, childhood and adolescence.
Metabolism and nutrition disorders
Common: Weight gain.
Uncommon: impaired carbohydrate tolerance with increased requirement for anti-diabetic therapy, sodium and water retention with hypertension, potassium loss and hypokalaemic alkalosis when co-administered with beta 2-agonist and xanthines.
Not known: Negative protein and calcium balance, increased appetite.
Infections and Infestations
Uncommon: Increased susceptibility and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis (see section 4.4).
Not known: candidiasis.
Musculoskeletal and connective tissue disorders
Uncommon: Osteoporosis, vertebral and long bone fractures.
Rare: Muscle wasting.
Not known: avascular osteonecrosis, tendonitis and tendon rupture when co-administered with quinolones , myopathy (acute myopathy may be precipitated by non-depolarising muscle relaxants ), – negative nitrogen balance.
Reproductive system and breast disorders
Not known: Menstrual irregularity.
Not known: Heart failure, hypertrophic cardiomyopathy in preterm infants.
Nervous system disorders
Uncommon: Headache, vertigo.
Not known: restlessness, Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal, aggravation of epilepsy.
A wide range of psychiatric reactions including affective disorders such as:
Uncommon: depressed and labile mood.
Not known: irritable, euphoric, suicidal thoughts.
Psychotic reactions including:
Not known: mania, delusions, hallucinations, aggravation of schizophrenia
Other reactions including:
Uncommon: behavioural disturbances.
Not known: anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported.
Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.
Not known: Vision blurred , increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts especially in children, chorioretinopathy , corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases.
Uncommon: Dyspepsia, peptic ulceration, haemorrhage, nausea.
Not known: perforation of peptic ulcer, acute pancreatitis (especially in children), candidiasis.
Skin and subcutaneous tissue disorders
Uncommon: hirsutism, striae, acne.
Not known: Skin atrophy, telangiectasia.
General disorders and administration site conditions
Not known: impaired healing.
Immune system disorders
Uncommon: Hypersensitivity including anaphylaxis has been reported.
Blood and lymphatic system disorders
Not known: Leukocytosis.
Not known: Thromboembolism in particular in patients with underlying conditions associated with increased thrombotic tendency, rare incidence of benign intracranial hypertension.
Withdrawal symptoms and signs
Not known: Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death .
A ‘withdrawal syndrome’ may also occur including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight. This may occur in patients even without evidence of adrenal insufficiency.
Pheochromocytoma crisis has been reported with other systemic corticosteroids and is a known class effect
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, firstname.lastname@example.org or clicking below button:
Deflazacort in Kenya
Deflazacort in Kenya
Deflazacort in Kenya
Deflazacort in Kenya
Deflazacort in Kenya
Deflazacort in Kenya
Deflazacort in Kenya
Clinical | Pharmacokinetic data
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