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DEXAMETHASONE is a brand name for Dexamethasone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Dexamethasone is indicated as a treatment for certain endocrine and non-endocrine disorders, in certain cases of cerebral oedema, and for diagnostic testing of adrenocortical hyperfunction. Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia. Non-endocrine disorders:…
Verbatim from this product's MHRA label. Tap a section to expand.
General considerations:
Dosage must be individualised on the basis of the disease and the response of the patient. 8). 5 mg to 9 mg a day depending on the disease being treated. In more severe diseases, doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient’s response is satisfactory.
Both the dose in the evening, which is useful in alleviating morning stiffness, and the divided dosage regimen are associated with greater suppression of the hypothalamo- pituitary-adrenal axis. If satisfactory clinical response does not occur after a reasonable period of time, discontinue dexamethasone tablets and transfer the patient to other therapy.
After a favourable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response. 5 mg dexamethasone daily. g.
surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily. 4). The following equivalents facilitate changing to dexamethasone from other glucocorticoids: Milligram for milligram, dexamethasone is approximately equivalent to betamethasone, 4 to 6 times more potent than methylprednisolone and triamcinolone, 6 to 8 times more potent than prednisone and prednisolone, 25 to 30 times more potent than hydrocortisone, and about 35 times more potent than cortisone.
In acute, self-limiting allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested: First day: Dexamethasone injection, 4 mg or 8 mg (1 ml or 2 ml) intramuscularly Second day: Two 500 microgram dexamethasone tablets twice a day Third day: Two 500 microgram dexamethasone tablets twice a day Fourth day: One 500 microgram dexamethasone tablet twice a day Fifth day: One 500 microgram dexamethasone tablet twice a day Sixth day: One 500 microgram dexamethasone tablet Seventh day: One 500 microgram dexamethasone tablet Eighth day: Reassessment day This schedule is designed to ensure adequate therapy during acute episodes while minimising the risk of overdosage in chronic cases.
Dexamethasone suppression tests: 1. m. the following morning. For greater accuracy, 500 microgram dexamethasone is given orally every 6 hours for 48 hours. m. on the third morning. Twenty-four- hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.
4). 4).
Musculoskeletal effects:
Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis (especially in post-menopausal females), vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathological fracture of long bones, tendon rupture.
Gastro-intestinal:
Peptic ulcer with possible perforation and haemorrhage, perforation of the small and large bowel particularly in patients with inflammatory bowel disease, pancreatitis, abdominal distension, ulcerative oesophagitis, dyspepsia, oesophageal candidiasis.
Dermatological:
Impaired wound healing, thin fragile skin, petechiae and ecchymoses, erythema, striae, telangiectasia, acne, increased sweating, suppressed reaction to skin tests, other cutaneous reactions such as allergic dermatitis, urticaria, angioneurotic oedema.
Neurological:
Convulsions, vertigo, headache. Increased intracranial pressure with papilloedema (pseudotumour cerebri) may occur usually after treatment.
Psychiatric:
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.
Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions have been estimated to be 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown.
4. Each tablet contains 72 mg lactose (as monohydrate). 1. 3 PHARMACEUTICAL FORM Tablet. Round, white, biconvex tablets, 6 mm in diameter. 1 Therapeutic indications Dexamethasone is indicated as a treatment for certain endocrine and non-endocrine disorders, in certain cases of cerebral oedema, and for diagnostic testing of adrenocortical hyperfunction.
Endocrine disorders:
Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia.
Non-endocrine disorders:
Dexamethasone may be used in the treatment of non- endocrine corticosteroid responsive conditions, including: Allergy and anaphylaxis: Angioneurotic oedema, anaphylaxis.
Arteritis collagenosis:
Polymyalgia rheumatica, polyarteritis nodosa.
Blood disorders:
Haemolytic anaemia, leukaemia, myeloma.
Cardiovascular disorders:
Post-myocardial infarction syndrome.
Gastro-intestinal:
Crohn’s disease, ulcerative colitis.
Hypercalcaemia:
Sarcoidosis.
Infections (with appropriate chemotherapy):
Miliary tuberculosis.
Muscular disorders:
Polymyositis.
Neurological disorders:
Raised intra-cranial pressure secondary to cerebral tumours.
Systemic fungal infections; systemic infection unless specific anti-infective therapy is employed; hypersensitivity to any component of the drug. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2. Test to distinguish Cushing’s syndrome caused by pituitary ACTH excess from the syndrome induced by other causes: 2 milligram dexamethasone is given orally every 6 hours for 48 hours. m. on the morning following the last dose. Twenty-four-hour urine collections are made for determination of 17- hydroxycorticosteroid excretion.
Use in children:
Dosage should be limited to a single dose on alternate days to lessen retardation of growth and minimise suppression of hypothalamo-pituitary-adrenal axis.
Use in the elderly:
Treatment of elderly patients, particularly if long term, should be planned 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.
8).
Endocrine:
Menstrual irregularities, amenorrhoea, development of Cushingoid state, suppression of growth in children and adolescents, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress as in trauma, surgery or illness), decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, hyperglycaemia, increased requirements for insulin or oral hypoglycaemic agents in diabetics, hirsutism.
Anti-inflammatory and immunosuppressive effects:
Increased susceptibility and severity of infections with suppression of clinical symptoms and signs. 4).
Eye disorders:
Posterior subcapsular cataracts, increased intra-ocular pressure, papilloedema, corneal or scleral thinning, exacerbation of ophthalmic viral disease, glaucoma, exophthalmos, chorioretinopathy.
Metabolic:
Negative nitrogen balance due to protein catabolism. Negative calcium balance. 4).
Other:
Hypersensitivity, including anaphylaxis has been reported, leucocytosis, thromboembolism, weight gain, increased appetite, nausea, malaise, hiccups. 4). In some instances, withdrawal symptoms may simulate a clinical relapse of the disease for which the patient has been undergoing treatment.
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. uk/yellowcard.
Ocular disorders:
Anterior and posterior uveitis, optic neuritis.
Renal disorders:
Lupus nephritis.
Respiratory disease:
Bronchial asthma, aspiration pneumonitis.
Rheumatic disorders:
Rheumatoid arthritis.
Skin disorders:
Pemphigus vulgaris. 2 Posology and method of administration General considerations: Dosage must be individualised on the basis of the disease and the response of the patient. 8). 5 mg to 9 mg a day depending on the disease being treated.
In more severe diseases, doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient’s response is satisfactory. Both the dose in the evening, which is useful in alleviating morning stiffness, and the divided dosage regimen are associated with greater suppression of the hypothalamo- pituitary-adrenal axis.
If satisfactory clinical response does not occur after a reasonable period of time, discontinue dexamethasone tablets and transfer the patient to other therapy. After a favourable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response.
5 mg dexamethasone daily. g. surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily. 4). The following equivalents facilitate changing to dexamethasone from other glucocorticoids: Milligram for milligram, dexamethasone is approximately equivalent to betamethasone, 4 to 6 times more potent than methylprednisolone and triamcinolone, 6 to 8 times more potent than prednisone and prednisolone, 25 to 30 times more potent than hydrocortisone, and about 35 times more potent than cortisone.
In acute, self-limiting allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested: First day: Dexamethasone injection, 4 mg or 8 mg (1 ml or 2 ml) intramuscularly Second day: Two 500 microgram dexamethasone tablets twice a day Third day: Two 500 microgram dexamethasone tablets twice a day Fourth day: One 500 microgram dexamethasone tablet twice a day Fifth day: One 500 microgram dexamethasone tablet twice a day Sixth day: One 500 microgram dexamethasone tablet Seventh day: One 500 microgram dexamethasone tablet Eighth day: Reassessment day This schedule is designed to ensure adequate therapy during acute episodes while minimising the risk of overdosage in chronic cases.
Dexamethasone suppression tests: 1. m. the following morning. For greater accuracy, 500 microgram dexamethasone is given orally every 6 hours for 48 hours. m. on the third morning. Twenty-four- hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.
2. Test to distinguish Cushing’s syndrome caused by pituitary ACTH excess from the syndrome induced by other causes: 2 milligram dexamethasone is given orally every 6 hours for 48 hours. m. on the morning following the last dose. Twenty-four-hour urine collections are made for determination of 17- hydroxycorticosteroid excretion.
Use in children:
Dosage should be limited to a single dose on alternate days to lessen retardation of growth and minimise suppression of hypothalamo-pituitary-adrenal axis.
Use in the elderly:
Treatment of elderly patients, particularly if long term, should be planned 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.
8). 3 Contraindications Systemic fungal infections; systemic infection unless specific anti-infective therapy is employed; hypersensitivity to any component of the drug. 4). 4 Special warnings and precautions for use There is an increased risk of systemic side-effects with CYP3A […]