Betamethasone Tablets (Betamethasone)

Each tablet contains 500 micrograms (0.5mg) betamethasone as betamethasone sodium phosphate PhEur. Betnelan (Betamethasone) is a glucocorticoid which is about eight to ten times as active as prednisolone on a weight-for-weight basis. Betamethasone sodium phosphate is very soluble in water, and is therefore less likely to cause local gastric irritation than corticosteroids which are only slightly soluble. This is important when high doses are required, as in immuno-suppressive therapy. Betnesol does not normally cause retention of salt and water and the risk of inducing oedema and hypertension is almost negligible. A wide variety of diseases may sometimes require corticosteroid therapy. Some of the principal indications are: Bronchial asthma, severe hypersensitivity reactions, anaphylaxis, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (excluding systemic sclerosis), polyarteritis nodosa; Inflammatory skin disorders, including pemphigus vulgaris, bullous pemphigoid and pyoderma gangrenosum; Minimal change nephrotic syndrome, acute interstitial nephritis; Ulcerative colitis, Crohn's disease, sarcoidosis, rheumatic carditis; Haemolytic anaemia (autoimmune), acute and lymphatic leukaemia, malignant lymphoma, multiple myeloma, idiopathic thrombocytopenic purpura; Immunosuppression in transplantation.

The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment. (see “Special Warnings and Precautions for Use”) Endocrine/metabolic Suppression of the hypothalamic-pituitary-adrenal axis, growth suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhoea. Cushingoid facies, hirsutism, weight gain, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy. Negative protein, nitrogen and calcium balance. Increased appetite. Hyperhydrosis. . Increased high –density lipoprotein and low – density lipoprotein concentrations in the blood. Anti-inflammatory and immunosuppressive effects Increased susceptibility to and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis (see “Special Warnings and Precautions for Use”). Musculoskeletal Osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, proximal myopathy. Fluid and electrolyte disturbance Sodium and water retention, hypertension, potassium loss, hypokalaemic alkalosis. Neuropsychiatric Euphoria, psychological dependence, depression, psychosis, insomnia, and aggravation of schizophrenia. Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal. Aggravation of epilepsy. Ophthalmic Increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases. Cardiac Myocardial rupture following recent myocardial infarction. Gastrointestinal Abdominal distension, oesophageal ulceration, nausea, dyspepsia, peptic ulceration with perforation and haemorrhage, acute pancreatitis, candidiasis. Dermatological Impaired healing, skin atrophy, bruising, telangiectasia, striae, acne. General Hypersensitivity including anaphylaxis, has been reported. Leucocytosis. Thrombo-embolism. Malaise. Hiccups. Withdrawal symptoms and signs Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (see “Special Warnings and Precautions for Use”). A 'withdrawal syndrome' may also occur including; fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.