DEXAMETHASONE is a brand name for Dexamethasone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Neurology Cerebral oedema (only with symptoms of intracranial pressure evidenced by computerised tomography) caused by a brain tumour, neuro-surgical intervention, cerebral abscess. Pulmonary and respiratory diseases Acute asthma exacerbations when use of an oral corticosteroid (OCS) is appropriate. Croup. Dermatology…
Verbatim from this product's MHRA label. Tap a section to expand.
5 to 10 mg daily, depending on the disease being treated. In more severe disease conditions doses above 10 mg per day may be required. The dose should be titrated to the individual patient response and disease severity. In order to minimize side effects, the lowest effective possible dose should be used.
Unless otherwise prescribed, the following dosage recommendations apply:
The below mentioned dosing recommendations are given for guidance only. The initial and daily doses should always be determined based on individual patient response and disease severity. - Cerebral oedema: Initial dose and duration of treatment depending on the cause and severity, 6-16 mg (up to 24 mg)/day orally, divided into 3-4 individual doses.
- Acute asthma: Adults: 16 mg/day for two days. 6 mg/kg body weight for one or two days. 6 mg/kg in a single dose. - Acute skin diseases: Depending on the nature and extent of the disease daily doses of 8-40 mg, in some cases up to 100 mg, which should be followed by down titration according to clinical need.
- Active phase of rheumatic system disorders: Systemic lupus erythematosus 6-16 mg / day. - Active rheumatoid arthritis with severe progressive course form: running at fast destructive forms 12-16 mg/day, with extra-articular manifestations 6-12 mg/day.
- Idiopathic thrombocytopenic purpura: 40 mg for 4 days in cycles. 1 mg per kilogram per day for week 4) and then oral treatment for four weeks, starting at a total of 4 mg per day and decreasing by 1 mg each week. 1 mg per kilogram per day for week 3, then a total of 3 mg per day, decreasing by 1 mg each week).
- Palliative treatment of neoplastic diseases: Initial dose and duration of treatment depending on the cause and severity, 3-20 mg / day. Very high doses up to 96 mg may also be used for palliative treatment. - Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment: 8-20 mg dexamethasone prior to chemotherapy treatment, then 4-16 mg/day on day 2 and 3.
- Prevention and treatment of postoperative vomiting, within antiemetic treatment: single dose of 8 mg before the surgery. - Treatment of symptomatic multiple myeloma, acute lymphocytic leukemia, acute lymphoblastic leukemia, Hodgkin's disease and non- Hodgkin's lymphoma in combination with other medicinal products: the usual posology is 40 mg or 20 mg once per day.
4). During a short-term therapy, in compliance with the dosage recommendations and close monitoring of patients, the risk of side effects is low. The usual side effects of short-term dexamethasone treatment (days/weeks) include weight gain, psychological disorders, glucose intolerance and transitory adrenocortical insufficiency.
4 Special warnings and precautions for use). Tabulated list of adverse reactions Not known Infections and infestations Increased susceptibility to, or exacerbation of (latent) infections* (including septicaemia, recurrence of dormant tuberculosis, eye infections, chickenpox, measles, fungal and viral infections) with masking of clinical symptoms, opportunistic infections Blood and lymphatic system disorders Leukocytosis, lymphopenia, eosinopenia, polycythemia, abnormal coagulation Immune system disorders Hypersensitivity reactions including anaphylaxis and angioedema, immunosuppression (see also under “Infections and parasitic diseases”) Endocrine disorders Suppression of the hypothalamic-pituitary-adrenal axis and induction of Cushing's syndrome (typical symptoms: fullmoon face, plethora, truncal obesity), secondary adrenal and pituitary insufficiency* (especially in stress such as trauma or surgery), growth suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhoea, hirsutism Metabolism and nutrition disorders Weight gain, negative protein and calcium balance*, increased appetite, sodium and water retention*, potassium loss* (caution: rhythm disorders), hypokalemic alkalosis, manifestation of latent diabetes mellitus, impaired carbohydrate tolerance with increased dose requirements of antidiabetic therapy*, hypercholesterolemia, hypertriglyceridaemia Psychiatric disorders* Psychological dependence, depression, insomnia, aggravated schizophrenia, mental illness, from euphoria to manifest psychosis, 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 Reactions are common and may occur in both adults and children.
Adrenocortical insufficiency An adrenocortical insufficiency, which is caused by glucocorticoid treatment, can, depending on the dose and length of treatment, remain for many months, and in some cases more than a year, after discontinuation of treatment.
), a temporary increase in dose may be required. Because of the possible risk in stressful conditions, a corticosteroid ID should be made for patients undergoing long-term treatment. Even in cases of prolonged adrenocortical insufficiency after discontinuation of treatment, the administration of glucocorticoids can be necessary in physically stressful situations.
An acute therapy-induced adrenocortical insufficiency can be minimized by slow dose reduction until a planned discontinuation time. Treatment with dexamethasone should only be implemented in the event of the strongest indications and, if necessary, additional targeted anti-infective treatment administered for the following illnesses: - Acute viral infections (Herpes zoster, Herpes simplex, Varicella, herpetic keratitis) - HBsAG-positive chronic active hepatitis - Approx.
g. Nematodes) - Poliomyelitis - Lymphadenitis after BCG vaccination - Acute and chronic bacterial infections - With a history of tuberculosis (reactivation risk) use only under tuberculostatic protection - Known or suspected Strongyloidiasis (threadworm infestation).
Treatment with glucocorticoids may lead to lead to Strongyloides hyperinfection and dissemination with widespread larval migration. In addition, treatment with dexamethasone should only be implemented under strong indications and, if necessary, additional specific treatment must be implemented for: - Gastrointestinal ulcers - Severe osteoporosis (as corticosteroids have a negative effect on the calcium balance) - Difficult to regulate high blood pressure - Difficult to regulate diabetes mellitus - Psychiatric disorders (including history) - Angle closure glaucoma and wide-angle glaucoma - Corneal ulcerations and corneal injuries - Severe heart failure Particular care is required when considering the use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary a.
1. Systemic infection unless specific anti-infective therapy is employed. Stomach ulcer or duodenal ulcer. 5). In general no contraindications apply in conditions where the use of glucocorticoids may be lifesaving.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For the treatment of Covid-19 - Adult patients 6 mg PO, once a day for up to 10 days. - Paediatric population: Paediatric patients (adolescents aged 12 years and older) are recommended to take 6mg/dose PO once a day for up to 10 days.
- Duration of treatment should be guided by clinical response and individual patient requirements. - Elderly, renal impairment, hepatic impairment: No dose adjustment is needed. The dose and administration frequency varies with the therapeutic protocol and the associated treatment(s).
Dexamethasone administration should follow instructions for dexamethasone administration when described in the Summary of Product Characteristics of the associated treatment(s). If this is not the case, local or international treatment protocols and guidelines should be followed.
Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient. Renal impairment Patients undergoing active hemodialysis may show an increased clearance of drug via the dialysate and thus require an adjustment of steroid dose.
Hepatic impairment In patients with severe liver disease dose adjustment may be necessary. In patients with a severe liver impairment, the biological effects of dexamethasone may be potentiated due to its slower metabolism (prolonged plasma half-life) and hypoalbuminaemia (increased plasma levels of free drug), which may also cause more side effects.
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 (osteoporosis, diabetes mellitus, hypertension, reduced immunity, psychological changes).
In such patients, the plasma concentrations of dexamethasone may be higher and its excretion slower than in younger patients, therefore its dose should be reduced accordingly. 1 mg/kg of body weight daily. The excretion of dexamethasone is approximately equal in children and adults if dosage is adjusted to their body area.
Dosage should be planned bearing in mind possible effects upon growth and development and for signs of adrenal suppression. Long term treatment For the long-term treatment of several conditions, after initial therapy, glucocorticoid treatment should be switched from dexamethasone to prednisone/prednisolone to reduce suppression on the function of the adrenal cortex.
Discontinuation of treatment Acute adrenocortical failure may occur after abrupt discontinuation of long- term treatment with large doses of glucocorticoids. Therefore, glucocorticoid doses should be gradually reduced in such cases and treatment should be discontinued gradually.
4) Method of administration Dexamethasone should be taken with or after food to minimise irritation to the gastrointestinal tract. Drinks containing alcohol or caffeine should be avoided. Dexamethasone is in the form of tablets 4 mg, 8 mg and 20 mg.
The tablets 20 mg can be divided into equal […]
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. Nervous system disorders Increased intracranial pressure with papilloedema in children (pseudotumor cerebri) usually following discontinuation of treatment; manifestation of latent epilepsy, increased seizures in overt epilepsy, vertigo, headache Eye disorders Elevated intraocular pressure, glaucoma*, papilloedema, cataract*, mainly with posterior subcapsular opacity, corneal and scleral atrophy, increased ophthalmic viral, fungal and bacterial infections, worsening of symptoms associated with corneal ulcers*, chorioretinopathy, vision blurred Cardiac disorders Cardiac muscle rupture after recent history of myocardial infarction, congestive heart failure in predisposed patients, cardiac decompensation* Vascular disorders Hypertension, vasculitis, increased atherosclerosis and risk of thrombosis/thromboembolism (increase in coagulability of blood may lead to thromboembolic complications) Respiratory, thoracic and mediastinal disorders Hiccough Gastrointestinal disorders Dyspepsia, abdominal distension*, gastric ulcers with perforation and bleeding, acute pancreatitis, ulcerative esophagitis, oesophageal candidiasis, flatulence, abdominal distension, nausea, vomiting Skin and subcutaneous tissue disorders Hypertrichosis, skin atrophy, bruising, telangiectasia, striae, erythema, steroid acne, petechiae, ecchymosis, allergic dermatitis, urticaria, angioneurotic oedema, thinning hair, pigment disorders, increased capillary fragility, perioral dermatitis, hyperhidrosis, tendency to bruise Musculoskeletal and connective tissue disorders Premature epiphyseal closure, osteoporosis, fractures of the spine and long bones, aseptic necrosis of the femoral and the humeral bones, tendon tears, proximal myopathy, muscle weakness, loss of muscle mass, avascular osteonecrosis Reproductive system and breast disorders Impotence General disorders and administration site conditions Reduced response to vaccination and skin tests.
Delayed wound healing, discomfort, malaise, steroid withdrawal syndrome: a too rapid reduction in corticosteroid dose after prolonged treatment can lead to acute adrenal insufficiency, hypotension, and death. A withdrawal syndrome may present with fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and weight loss.
4 Special warnings and precautions for use Description of selected adverse reactions Adrenocortical insufficiency An adrenocortical insufficiency, which is caused by glucocorticoid treatment, can, depending on the dose and length of treatment, remain for many months and in some cases more than a year, after discontinuation of treatment.
4 Special warnings and precautions for use) Psychological changes Psychological changes are manifested in various forms, the most common being euphoria. Depression, psychotic reactions and suicidal tendencies may also appear. These illnesses can be serious.
Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose […]
Osteoporosis (post-menopausal females are particularly at risk) b. Hypertension or congestive heart failure c. Existing or previous history of severe affective disorders (especially previous steroid psychosis) d. Diabetes mellitus (or a family history of diabetes) e.
History of tuberculosis f. Glaucoma (or a family history of glaucoma) g. Previous corticosteroid-induced myopathy h. Liver failure i. Renal insufficiency j. Hypothyroidism k. Epilepsy l. Peptic ulceration m. Migraine n. Certain parasitic infestations in particular amoebiasis o.
Incomplete natural growth since glucocorticoids on prolonged administration may accelerate epiphyseal closure Anaphylactic reaction After administration of glucocorticoids serious anaphylactoid reactions such as glottis oedema, urticaria and bronchospasm have occasionally occurred particularly in patients with a history of allergy.
5mg adrenaline dependent on body weight), intravenous administration of aminophylline and artificial respiration if necessary. Tendinitis The risk of tendinitis and tendon rupture is increased in patients treated concomitantly with glucocorticoids and fluoroquinolones.
Myasthenia gravis Pre-existing myasthenia gravis may initially deteriorate in the beginning of dexamethasone treatment. 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.
Prolonged use of corticosteroids may cause posterior subcapsular cataracts, glaucoma with possible damage to the optic nerve and can increase the risk of secondary ocular infections due to fungi or viruses. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
Intestinal perforation Because of the risk of an intestinal perforation, dexamethasone must only be used under urgent indication and under appropriate monitoring for: - Severe ulcerative colitis with threatened perforation - Diverticulitis - Entero-anastomosis (immediately postoperative) Signs of peritoneal irritation after gastrointestinal perforation may be absent in patients receiving high doses of glucocorticoids.
Diabetes The desired effects of hypoglycaemic agents (including insulin), antihypertensives and diuretics are antagonised by corticosteroids. A higher need for insulin, or oral antidiabetics, must be taken into consideration when administering dexamethasone to diabetics.
Cardiovascular disorders Regular blood pressure monitoring is necessary during treatment with dexamethasone, particularly during administration of higher doses and with patients with difficult to regulate high blood pressure. Because of the risk of deterioration, patients with severe cardiac insufficiency should be carefully monitored.
Bradycardia may occur in patients treated with high doses of dexamethasone. Caution should be exercised when using corticosteroids in patients who have recently suffered myocardial infarction as myocardial rupture has been reported.
Infections Treatment with dexamethasone can conceal […]