Decortin H50

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.

Posology

Adults and the elderly

The lowest effective dose should be used for the minimum period.

Children

If there is lack of a satisfactory clinical response to Decortin H50e Tablets, the drug should be gradually discontinued and the patient transferred to alternative therapy.

Intermittent dosage regimen A single dose of Decortin H50e 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

Method of administration

Decortin H50e tablets should be taken following a meal to reduce the risk of gastric irritation.

- 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.

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 H50e on the ability to drive or use machinery has not been evaluated. There is no evidence to suggest that Decortin H50e may affect these abilities.

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 Overdose The information provided in Overdose of Decortin H50 is based on data of another medicine with exactly the same composition as the Decortin H50. . Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Decortin H50 directly from the package or from the pharmacist at the pharmacy. more... 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. Pharmacodynamic properties The information provided in Pharmacodynamic properties of Decortin H50 is based on data of another medicine with exactly the same composition as the Decortin H50. . Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Decortin H50 directly from the package or from the pharmacist at the pharmacy. more... 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. Pharmacokinetic properties The information provided in Pharmacokinetic properties of Decortin H50 is based on data of another medicine with exactly the same composition as the Decortin H50. . Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Decortin H50 directly from the package or from the pharmacist at the pharmacy. more... Decortin H50e 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 H50e has a biological half-life lasting several hours, making it suitable for alternate-day administration regimens. Although peak plasma Decortin H50e levels are somewhat lower after administration of Decortin H50e and absorption is delayed, total absorption and bioavailability are the same as after plain Decortin H50e. Decortin H50e 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 H50e is metabolised primarily in the liver to a biologically inactive compound. Liver disease prolongs the half-life of Decortin H50e and, if the patient has hypoalbuminaemia, also increases the proportion of unbound drug and may thereby increase adverse effects. Decortin H50e is excreted in the urine as free and conjugated metabolites, together with small amounts of unchanged Decortin H50e. Significant differences in the pharmacokinetics of Decortin H50e amongst menopausal women have been described. The postmenopausal women had reduced unbound clearance (30%), reduced total clearance and increased half-life of Decortin H50e. Pharmacotherapeutic group The information provided in Pharmacotherapeutic group of Decortin H50 is based on data of another medicine with exactly the same composition as the Decortin H50. . Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Decortin H50 directly from the package or from the pharmacist at the pharmacy. more... glucocorticoid steroid, ATC code: H02A B06 Preclinical safety data The information provided in Preclinical safety data of Decortin H50 is based on data of another medicine with exactly the same composition as the Decortin H50. . Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Decortin H50 directly from the package or from the pharmacist at the pharmacy. more... There are no non-clinical data of relevance to the prescriber that are not already covered in other sections of the SmPC. Incompatibilities The information provided in Incompatibilities of Decortin H50 is based on data of another medicine with exactly the same composition as the Decortin H50. . Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Decortin H50 directly from the package or from the pharmacist at the pharmacy. more... None known Special precautions for disposal and other handling The information provided in Special precautions for disposal and other handling of Decortin H50 is based on data of another medicine with exactly the same composition as the Decortin H50. . Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Decortin H50 directly from the package or from the pharmacist at the pharmacy. more... Not available Decortin H50 price We have no data on the cost of the drug. However, we will provide data for each active ingredient The approximate cost of Prednisolone Acetate 1 % per unit in online pharmacies is from 3.43$ to 12.75$, per package is from 40$ to 115$. The approximate cost of Prednisolone Acetate 0.5 % per unit in online pharmacies is from 4.69$ to 4.69$, per package is from 94$ to 94$. References: https://www.drugs.com/search.php?searchterm=decortin-h50 https://pubmed.ncbi.nlm.nih.gov/?term=decortin-h50 Available in countries Russia Find in a country: A B C D E F G H I J K L M N O P Q R S T U V Y Z