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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: Dermatology Pemphigus vulgaris. Autoimmune disorders/rheumatology Myositis. Haematological disorder Idiopathic thrombocytopenic purpura in adults. Oncology Metastatic spinal cord compression. Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment. Treatment of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Please be aware that this is a high dosage medical product. Dexamethasone is recommended to be used at the lowest effective dose. 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. - Pemphigus: Initial dose of 300 mg for three days followed by down titration according to clinical need.
- Myositis: 40 mg for 4 days in cycles. - Idiopathic thrombocytopenic purpura: 40 mg for 4 days in cycles. - Metastatic spinal cord compression: Initial dose and duration of treatment depending on the cause and severity. Very high doses up to 96 mg may be used for palliative treatment.
For optimal dosing and reduction of the number or tablets the combination of lower dose strengths (4 and 8 mg) and higher dose strengths (20 mg or 40 mg) can be used. - Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment: 8-20 mg (one 20 mg tablet or one half of 40 mg tablet) prior to chemotherapy treatment, then 4-16 mg/day on day 2 and 3.
- 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.
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.
Summary of the safety profile The incidence of anticipated adverse effects correlates with the relative potency of the substance, dose, time of day of administration and duration of treatment. 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. Long-term dexamethasone treatment (months/years) usually causes central obesity, skin fragility, muscle atrophy, osteoporosis, growth retardation and long-term suprarenal insufficiency.
4) 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, nausea, vomiting Skin and subcutaneous tissue disorders Hypertrichosis, skin atrophy, 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 Reproductive system and breast disorders Impotence General disorders and administration site conditions Reduced response to vaccination and skin tests.
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 Anaphylactic reaction Serious anaphylactic reactions may occur.
1. Systemic infection unless specific anti-infective therapy is employed. Stomach ulcer or duodenal ulcer. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. Paediatric population 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, 20 mg and 40 mg.
The tablets can be divided into equal halves and can provide additional 2 mg and 10 mg strengths and make it easier for the patient to swallow the tablet. When alternate-day therapy is not possible, the entire daily dose of glucocorticoid can usually be administered as a single morning dose; however, some patients will require divided daily doses of glucocorticoids.
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 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. (see […]
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 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 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 co-existing risk factors like familial disposition, increased age, after menopause, insufficient protein and calcium intake, heavy smoking, excessive alcohol intake, as well as insufficient exercise. Prevention consists of sufficient calcium and vitamin D intake and physical activity.
Additional medical treatment should be considered in the event of pre-existing osteoporosis. Corticosteroids should be used cautiously in patients with […]