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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. During treatment with dexamethasone for specific physical stress conditions (trauma, surgery, childbirth, etc.), 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. 8 weeks prior through 2 weeks after vaccinations with live vaccines (see Contraindications and Interactions); Systemic mycoses and parasitosis (e.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.
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 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 migraine, as corticosteroids may cause fluid retention.
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. However, if problems do happen, they might need treatment. In a few cases, mental health problems have happened when doses are being lowered or stopped.
Cerebral oedema or increased intracranial pressure: Corticosteroids should not be used in conjunction with a head injury since they will probably not be of benefit or may even do harm.
Discontinuation of treatment: Glucocorticoid doses should be gradually reduced.
The following risks should be considered upon interruption or discontinuation of long-term glucocorticoid administration: Exacerbation or recurrence of the underlying disease, acute adrenal insufficiency, corticosteroid withdrawal syndrome (A 'withdrawal syndrome' may include fever, muscle and joint pain, inflammation of the nose lining (rhinitis), weight loss, itchy skin and inflammation of the eye (conjunctivitis)).
Certain viral diseases (chickenpox, measles) in patients treated with glucocorticoids, may be very severe.
Children and immunocompromised persons without previous chickenpox or measles infection are particularly at risk. If these people have contact with people infected with measles or chickenpox while undergoing treatment with dexamethasone, a preventative treatment should be introduced if necessary.
Other: Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
Influence of diagnostic tests: Glucocorticoids can suppress skin reaction to allergy testing. They can also affect the nitroblue tetrazolium test for bacterial infections and cause false-negative results.
Note on doping: The use of doping tests when taking dexamethasone can lead to positive results.
Lactose: Dexamethasone contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Effects on ability to drive and use machines: There have been no studies on the effects on the ability to drive and use machines.
Dexamethasone may cause confusional state, hallucinations, dizziness, somnolence, fatigue, syncope and blurred vision (see Adverse Reactions). If affected, patients should be instructed not to drive, use machines or perform hazardous tasks while being treated with dexamethasone.
Use in Children: 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. Therefore, during long-term treatment with dexamethasone, the indication should be very strongly presented in children and their growth rate should be checked regularly.
Available evidence suggests long-term neurodevelopmental adverse events after early treatment (< 96 hours) of premature infants with chronic lung disease at starting doses of 0.25mg/hg twice daily.
Use in the 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. Close clinical monitoring is required to prevent life-threatening reactions.
