Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. No specific antidote is available; treatment is supportive and symptomatic. Serum electrolytes should be monitored.
High systemic doses of corticosteroids caused by chronic use have been associated with adverse effects such as neuropsychiatric disorders (psychosis, depression, hallucinations), cardiac dysrhythmias and Cushing's syndrome.
- Systemic infections unless specific anti-infective therapy is employed.
- Ocular herpes simplex because of possible perforation.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
None known
A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood, and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations, and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported.'Special warnings and special precautions for use').
Undesirable effects are listed by MedDRA System Organ Classes.
Assessment of undesirable effects is based on the following frequency groupings:
Very common: >1/10
Common: >1/100 to <1/10
Uncommon: >1/1,000 to <1/100
Rare: >1/10,000 to <1/1,000
Very rare: <1/10,000
Not known: cannot be estimated from the available data
| System Organ Class | Frequency | Undesirable Effect |
| Infections and Infestations | Not known | Increases susceptibility to, and severity of infections1, opportunistic infections, recurrence of dormant tuberculosis2, oesophageal candidiasis. |
| Blood and lymphatic system disorders | Not known | Leucocytosis. |
| Immune system disorders | Not known | Hypersensitivity including anaphylaxis. |
| Endocrine disorders | Not known | Suppression of the hypothalamo-pituitary adrenal axis3, cushingoid facies, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy, manifestation of latent diabetes mellitus. |
| Metabolism and nutrition disorders | Not known | Sodium and water retention, hypokalaemic alkalosis, potassium loss, negative nitrogen and calcium balance, glucose intolerance and protein catabolism. Increase both high and low density lipoprotein cholesterol concentration in the blood. Increased appetite4. Weight gain, obesity, hyperglycaemia, dyslipidaemia. |
| Very rare | Calciphylaxis5 | |
| Psychiatric disorders | Common | Irritability, depressed and labile mood, suicidal thoughts, psychotic reactions, mania, delusions, hallucinations, and aggravation of schizophrenia. behavioural disturbances, irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia. |
| Not known | Euphoria, psychological dependence, depression. | |
| Nervous system disorders | Not known | Depression, insomnia, dizziness, headache, vertigo. Raised intracranial pressure with papilloedema (pseudotumor cerebri)6. Aggravation of epilepsy, epidural lipomatosis. vertebrobasilar stroke7 |
| Eye disorders | Not known Severe exacerbation of bullous exudative retinal detachment; central serous chorioretinopathy or lasting visual loss in some patients with idiopathic central serous chorioretinopathy.8 | |
| Ear and labyrinth disorders | Not known | Vertigo. |
| Cardiac disorders | Not known | Congestive heart failure in susceptible patients, hypertension, increased risk of heart failure. Increased risk of cardiovascular disease, including myocardial infarction.9 |
| Vascular disorders | Not known | Thromboembolism. |
| Gastrointestinal disorders | Not known | Dyspepsia, nausea, peptic ulceration with perforation and haemorrhage, abdominal distension, abdominal pain, diarrhoea, oesophageal ulceration, acute pancreatitis. |
| Skin and subcutaneous tissue disorders | Not known | Hirsutism, skin atrophy, bruising, striae, telangiectasia, acne, increased sweating, pruritis, rash, urticaria. |
| Musculoskeletal and connective tissue disorders | Not known | Proximal myopathy, osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, tendinopathies (particularly of the Achilles and patellar tendons), myalgia, growth suppression in infancy, childhood and adolescence. |
| Renal and urinary disorders | Not known | Scleroderma renal crisis10 |
| Reproductive system and breast disorders | Not known | Menstrual irregularity, amenorrhoea. |
| General disorders and administration site conditions | Not known | Fatigue, malaise, impaired healing |
| Investigations | Not known | Increased intra-ocular pressure, may suppress reactions to skin tests. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard |
There are no non-clinical data of relevance to the prescriber that are not already covered in other sections of the SmPC.
Allergy and anaphylaxis: bronchial asthma, drug hypersensitivity reactions, serum sickness, angioneurotic oedema, anaphylaxis, incapacitating allergies unresponsive to conventional treatment.
Arteritis/collagenosis: giant cell arteritis/polymyalgia rheumatica, mixed connective tissue disease, polyarteritis nodosa, polymyositis.
Blood disorders: haemolytic anaemia (auto-immune), leukaemia (acute and chronic lymphocytic), lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura.
Cardiovascular disorders: post-myocardial infarction syndrome, rheumatic fever with severe carditis.
Endocrine disorders: primary and secondary adrenal insufficiency, congenital adrenal hyperplasia.
Gastro-intestinal disorders: regional ileitis (Crohn's disease), ulcerative colitis, persistent coeliac syndrome (coeliac disease unresponsive to gluten withdrawal), auto-immune chronic active hepatitis, multisystem disease affecting liver, biliary peritonitis.
Hypercalcaemia: sarcoidosis, vitamin D excess.
Infections (with appropriate chemotherapy): helminthic infestations, Herxheimer reaction, infectious mononucleosis, miliary tuberculosis, mumps orchitis (adult), tuberculous meningitis, rickettsial disease.
Muscular disorders: polymyositis, dermatomyositis.
Neurological disorders: infantile spasms, Shy-Drager syndrome, sub-acute demyelinating polyneuropathy.
Ocular disease: scleritis, posterior uveitis, retinal vasculitis, pseudo-tumours of the orbit, giant cell arteritis, malignant ophthalmic Graves disease.
Renal disorders: lupus nephritis, acute interstitial nephritis, minimal change glomerulonephritis, nephrotic syndrome.
Respiratory disease: allergic pneumonitis, asthma, occupational asthma, pulmonary aspergillosis, pulmonary fibrosis, pulmonary alveolitis, aspiration of foreign body, aspiration of stomach contents, pulmonary sarcoid, drug induced lung disease, adult respiratory distress syndrome, spasmodic croup, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy.
Rheumatic disorders: rheumatoid arthritis, polymyalgia rheumatica, juvenile chronic arthritis, psoriatic arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease.
Skin disorders: pemphigus vulgaris, exfoliative dermatitis, bullous pemphigoid, systemic lupus erythematosus, pyoderma gangrenosum.
Miscellaneous: sarcoidosis, hyperpyrexia, Behçets disease, immunosuppression in organ transplantation.
Pharmacotherapeutic group: glucocorticoid steroid, ATC code: H02A B06
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt- retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.
Decortin H5e is rapidly and apparently almost completely absorbed after oral administration; it reaches peak plasma concentrations after 1-3 hours. There is however wide inter-subject variation suggesting impaired absorption in some individuals. Plasma half-life is about 3 hours in adults and somewhat less in children. Its initial absorption, but not its overall bioavailability, is affected by food. Decortin H5e has a biological half-life lasting several hours, making it suitable for alternate-day administration regimens.
Although peak plasma Decortin H5e levels are somewhat lower after administration of Decortin H5e and absorption is delayed, total absorption and bioavailability are the same as after plain Decortin H5e. Decortin H5e shows dose dependent pharmacokinetics, with an increase in dose leading to an increase in volume of distribution and plasma clearance. The degree of plasma protein binding determines the distribution and clearance of free, pharmacologically active drug. Reduced doses are necessary in patients with hypoalbuminaemia.
Decortin H5e is metabolised primarily in the liver to a biologically inactive compound. Liver disease prolongs the half-life of Decortin H5e and, if the patient has hypoalbuminaemia, also increases the proportion of unbound drug and may thereby increase adverse effects.
Decortin H5e is excreted in the urine as free and conjugated metabolites, together with small amounts of unchanged Decortin H5e.
Significant differences in the pharmacokinetics of Decortin H5e amongst menopausal women have been described. The postmenopausal women had reduced unbound clearance (30%), reduced total clearance and increased half-life of Decortin H5e.
Raised intracranial pressure Raised intracranial pressure with papilloedema (pseudotumour cerebri) associated with corticosteroid treatment has been reported in both children and adults.'Undesirable effects').
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Use in the elderly
Treatment of elderly patients, particularly if long term, should be undertaken with caution bearing in mind the more serious consequences of the common side-effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life threatening reactions.
Paediatric population
Corticosteroids cause growth retardation in infancy, childhood and adolescence, which may be irreversible, and therefore long-term administration of pharmacological doses should be avoided. If prolonged therapy is necessary, treatment should be limited to the minimum suppression of the hypothalamo-pituitary adrenal axis and growth retardation. The growth and development of infants and children should be closely monitored. Treatment should be administered where possible as a single dose on alternate days.
The effect of Decortin H5e on the ability to drive or use machinery has not been evaluated. There is no evidence to suggest that Decortin H5e may affect these abilities.
Posology
Adults and the elderly
The lowest effective dose should be used for the minimum period.
Children
''Special warnings and special precautions for use')If there is lack of a satisfactory clinical response to Decortin H5e Tablets, the drug should be gradually discontinued and the patient transferred to alternative therapy.
Intermittent dosage regimen A single dose of Decortin H5e Tablets in the morning on alternate days or at longer intervals is acceptable therapy for some patients. When this regimen is practical, the degree of pituitary-adrenal suppression can be minimised.
Specific dosage guidelines The following recommendations for some corticosteroid-responsive disorders are for guidance only. Acute or severe disease may require initial high dose therapy with reduction to the lowest effective maintenance dose as soon as possible. Dosage reductions should not exceed 5-7.5mg daily during chronic treatment.
Allergic and skin disorders Initial doses of 5-15mg daily are commonly adequate.
Collagenosis Initial doses of 20-30mg daily are frequently effective. Those with more severe symptoms may require higher doses.
Rheumatoid arthritis The usual initial dose is 10-15mg daily. The lowest daily maintenance dose compatible with tolerable symptomatic relief is recommended.
Blood disorders and lymphoma An initial daily dose of 15-60mg is often necessary with reduction after an adequate clinical or haematological response. Higher doses may be necessary to induce remission in acute leukaemia.
Special populations
''Undesirable effects'). Alternate day dosage is preferable where possible.Method of administration
Decortin H5e tablets should be taken following a meal to reduce the risk of gastric irritation.
Not available
