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 caused by brain tumours, neurosurgery, bacterial meningitis, brain abscess. Pulmonary and respiratory diseases Severe acute asthma attack. Dermatology Oral initial treatment of extensive, severe, acute skin diseases that respond to glucocorticoids, such as erythroderma, pemphigus, vulgaris,…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dosage depends on the nature and severity of the disease and the individual response of the patient to treatment. In general, relatively high initial doses are administered, and they should be significantly higher in acute severe forms than in chronic diseases.
, followed by 16–24 mg (up to 48 mg)/day orally, divided into 3–4 (up to 6) individual doses for 4–8 days. A longer-term, lower-dose administration of Dexamethasone may be required during irradiation and in the conservative treatment of inoperable brain tumours.
4 mg/kg body weight every 12 hours for 2 days, starting before the first antibiotics. – Severe acute asthma attack: Adults: 8–20 mg, then, if necessary, 8 mg every 4 hours. 3 mg/kg body weight. – Acute skin diseases: Depending on the nature and extent of the disease, daily doses of 8–40 mg.
Followed by treatment with decreasing doses. – Active phases of rheumatic systemic diseases: systemic lupus erythematosus 6–16 mg/day. g. tuberculosis, typhoid): 4–20 mg for a few days, only with concomitant anti-infective therapy. – Palliative treatment of malignant tumours: initially 8–16 mg/day, in prolonged treatment 4–12 mg/day.
75 mg/day as a single dose. If necessary, addition of a mineralcorticoid (fludrocortisone). g. g. birth) a 10-fold increase. – The tablets should not be split to adjust doses. 5mg, other appropriate formulations should be used. Method of administration The tablets should be taken during or after a meal.
They should be swallowed whole, with a sufficient amount of liquid. The daily dose should be administered as a single dose in the morning, if possible (circadian therapy). In patients who require a high- dose therapy because of their disease, multiple daily dosing is often required to achieve maximum effect.
Depending on the underlying disease, clinical symptoms and response to therapy, the dose can be reduced at a faster or slower rate and the therapy stopped, or the patient is stabilised on a maintenance dose as low as possible and, if necessary, adrenal axis monitored.
Basically, the dose and duration of treatment should be kept as high and long as necessary, but as low and short as possible. In principle, the dose should be reduced gradually. In long-term therapy which is deemed necessary following initial treatment, patients should be switched to prednisone/prednisolone, because this leads to lower adrenal suppression.
– 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) Hormone replacement therapy: Low risk of undesirable effects with the use of recommended doses.
Pharmacotherapy:
The following undesirable effects may occur; they are highly dependent on the dose and duration of treatment, so their frequency cannot be specified: Infections and infestations Masking of infections, manifestation and exacerbation of viral infections, fungal infections, bacterial, parasitic and opportunistic infections, activation of strongyloidiasis.
Blood and lymphatic system disorders Moderate leukocytosis, lymphocytopenia, eosinopenia, polycythemia. g. drug eruption), severe anaphylactic reactions, such as arrhythmias, bronchospasm, hypo- or hypertension, circulatory collapse, cardiac arrest, weakening of the immune system.
Endocrine disorders Adrenal suppression and induction of Cushing’s syndrome (typical symptoms: moon face, central obesity and plethora). Metabolism and nutrition disorders Sodium retention with oedema, increased potassium excretion (risk of arrhythmias), weight gain, reduced glucose tolerance, diabetes mellitus, hypercholesterolemia and hypertriglyceridemia, increased appetite.
Psychiatric disorders Depression, irritability, euphoria, increased drive, psychoses, mania, hallucinations, emotional lability, anxiety, sleep disorders, suicidality. Nervous system disorders Pseudotumor cerebri, manifestation of latent epilepsy, increase in seizure susceptibility in manifest epilepsy.
4). Vascular disorders Hypertension, increased risk of atherosclerosis and thrombosis, vasculitis (also as withdrawal syndrome after long-term therapy), increased capillary fragility. Gastrointestinal disorders Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis, stomach discomfort, hiccups.
In post-marketing experience tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies following the use of dexamethasone alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS such as patients with high proliferative rate, high tumour burden, and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precaution taken.
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 steroid emergency card 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. g. nematodes) – In patients with suspected or confirmed strongyloidiasis (infection with threadworms), glucocorticoids can lead to activation and mass proliferation of these parasites – Poliomyelitis – Lymphadenitis after BCG vaccination – Acute and chronic bacterial infections – In 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 – Osteoporosis – Severe cardiac insufficiency – High blood pressure that is difficult to regulate – Diabetes mellitus that is difficult to regulate – Psychiatric disorders (also in the past), including suicidality: neurological or psychiatric monitoring is recommended – Narrow- and wide-angle glaucoma, ophthalmic monitoring and adjunctive therapy are recommended – Corneal ulcerations and corneal injuries, ophthalmic monitoring and adjunctive therapy are recommended Anaphylactic reaction Serious anaphylactic reactions may occur.
1. Systemic infection unless specific anti-infective therapy is employed. Stomach ulcer or duodenal ulcer. Avoid live vaccines in patients receiving immuno suppressive doses (serum antibody response diminished). In general no contraindications apply in conditions where the use of glucocorticoids may be life saving.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In hypothyroidism or liver cirrhosis, low doses may be sufficient or a dose reduction may be necessary.
Skin and subcutaneous tissue disorders Striae rubra, atrophy, telangiectasias, petechiae, ecchymosis, hypertrichosis, steroid acne, rosacea- like (perioral) dermatitis, changes in skin pigmentation. Musculoskeletal and connective tissue disorders Myopathy, muscle atrophy and weakness, osteoporosis (dose-dependent, possible also in short- term administration), aseptic bone necrosis, tendon disorders, tendinitis, tendon rupture, epidural lipomatosis, growth inhibition in children.
Note:
Too rapid dose reduction after long-term treatment may cause symptoms such as muscle and joint pain. Reproductive system and breast disorders Disorders of sexual hormone secretion (consequently: irregular menstruation up to amenorrhea, hirsutism, impotence).
General disorders and administration site conditions Delayed wound healing. 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 is lowered or the medicine is stopped. 4 Special warnings and precautions for use) Infections Treatment with dexamethasone can conceal the symptoms of an existing, or developing infection thereby making a diagnosis more difficult and can lead to an increased risk of infection.
4 Special warnings and precautions for use) Intestinal perforation Corticosteroids can be associated with an increased risk of colonic perforation in severe ulcerative colitis with threatened perforation, diverticulitis and entero- anastomosis (immediately postoperative).
Signs of peritoneal irritation after gastrointestinal perforation may be absent in patients receiving high doses of glucocorticoids. 4 Special warnings and precautions for use) Cardiovascular disorders Bradycardia, deterioration of severe cardiac insufficiency and difficult to regulate high blood pressure may occur.
Caution should be exercised when using corticosteroids in patients who have recently suffered myocardial infarction as myocardial rupture has been reported. 4 Special warnings and precautions for use) Paediatric population Corticosteroids cause a dose-dependent inhibition of growth in infancy, childhood, and adolescence since corticosteroids may give rise to early closing of the epiphyses, which may be irreversible.
4 Special warnings and precautions for use) Elderly The adverse effects of systemic corticosteroids can have serious consequences especially in old age, mainly osteoporosis, hypertension, hypokalemia, diabetes, susceptibility to infection and skin atrophy.
4 Special warnings and precautions for use) 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.
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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.
Ocular disorders Systemic treatment with glucocorticoids can induce chorioretinopathy which may result in impaired vision including loss of vision. 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 may only be used under urgent indication and under appropriate monitoring for: – Severe ulcerative colitis with threatened perforation, possibly without peritoneal irritation – Diverticulitis – Enteroenterostomy (immediately postoperatively) Signs of peritoneal irritation after gastrointestinal perforation may be absent in patients receiving high doses of glucocorticoids.
Diabetes The possibility of 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 in patients with high blood pressure that is difficult to regulate.
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 the symptoms of an existing, or developing infection thereby making a diagnosis more difficult. The prolonged use of even small amounts of dexamethasone leads to an increased risk of infection, even by microorganisms which otherwise rarely cause infections (so-called opportunistic infections).
Vaccination Vaccinations with inactivated vaccine are always possible. However, it should be noted that the immune reaction and thereby the success of inoculation, can be affected by higher doses of corticoids. Regular checkups with doctors (including vision checkups in three-month intervals) are advised during long-term treatment with dexamethasone.
Metabolic disorders At high doses, sufficient calcium intake and sodium restriction, as well as serum potassium levels should be monitored. Depending on the length and dosage of the treatment, a negative influence on calcium metabolism can be expected, so that an osteoporosis prophylaxis is recommended.
This applies, above all, to […]