Dexamethasoni phosphas

Isolated cases of anaphylactic reaction with circulatory failure, cardiac arrest, cardiac arrhythmia, bronchospasm and/or a decrease or increase in blood pressure have been observed following administration of DEXAMED. Treatment with DEXAMED may, owing to immunosuppression, increase the risk of bacterial, viral, parasitic, opportunistic and fungal infections. Signs of existing or developing infection may be masked, making diagnosis more difficult. Latent infections such as tuberculosis or hepatitis B may be reactivated. If stressful situations occur during treatment with DEXAMED (accident, surgery, childbirth, etc.), a temporary dose increase may be necessary. In patients with COVID-19 who are already receiving systemic (oral) corticosteroids for other reasons (e.g. patients with COPD [chronic obstructive pulmonary disease]) but who do not require supplemental oxygen therapy, systemic corticosteroids should not be discontinued. In the following conditions, treatment with DEXAMED should be administered only when strictly indicated and, where necessary, concurrently with anti-infective therapy: acute viral infections (hepatitis B, herpes zoster, herpes simplex, varicella, herpetic keratitis) HBsAg-positive chronic active hepatitis approximately 8 weeks before to 2 weeks after vaccination with live vaccines systemic mycoses and parasitoses (e.g. Nematoda) in patients with confirmed or suspected strongyloidiasis (infection caused by the parasitic nematode of the genus Strongyloides), glucocorticoids may lead to activation and massive proliferation of the parasite poliomyelitis lymphadenitis following BCG vaccination acute and chronic bacterial infections in cases of tuberculosis in the patient's history, use this product only with concomitant antituberculous therapy Treatment with DEXAMED should be administered only when strictly indicated and, where appropriate, concurrently with further specific therapy in the following conditions: gastrointestinal ulcers osteoporosis severe heart failure hypertension that is difficult to control diabetes mellitus that is difficult to control psychiatric disorders (including a history thereof), including suicidal tendencies. In such cases, neurological or psychiatric assessment is recommended. narrow- and wide-angle glaucoma. Ophthalmological monitoring and concomitant therapy are recommended. corneal ulceration and damage. Ophthalmological monitoring and concomitant therapy are recommended. Given the risk of intestinal wall perforation, DEXAMED should be used only when strictly indicated and under appropriate supervision in the following conditions: severe ulcerative colitis with impending perforation, possibly even without peritoneal irritation diverticulitis enteroanastomoses (immediately following surgery) In patients receiving high doses of glucocorticoids, signs of peritoneal irritation following gastrointestinal perforation may be unrecognisable. When using DEXAMED in patients with diabetes, the possibility of an increased dose of insulin or oral antidiabetics should be considered. During treatment with DEXAMED, regular monitoring of blood pressure is necessary, particularly in patients with hypertension receiving high doses that is difficult to control. Patients with severe heart failure should be carefully monitored, as there is a risk of worsening of their condition. Bradycardia may occur with high doses of dexamethasone. Severe anaphylactic reactions may occur. When glucocorticoids are administered together with fluoroquinolones, the risk of tendon damage, inflammation and rupture is increased. Symptoms of myasthenia gravis may worsen at the start of treatment with DEXAMED. In principle, vaccination with inactivated vaccines is possible. It should be noted, however, that the immune response, and thereby the success of vaccination, may be impaired by higher doses of corticoids. At high doses, adequate potassium intake and sodium restriction must be ensured, and serum potassium levels should be monitored. Abrupt discontinuation of therapy carried out for more than 10 days may lead to exacerbation or recurrence of the underlying disease, as well as to acute adrenal insufficiency/corticoid withdrawal syndrome. Therefore, if the medicinal product needs to be discontinued, the dose should be tapered gradually. Viral infections (chickenpox, measles) may take a particularly severe course in patients treated with glucocorticoids. Particular caution is advised in immunocompromised patients, in patients who have not had measles or chickenpox, or in those in contact with persons with any of these conditions. Tumour lysis syndrome (TLS) has been reported in the post-marketing setting in patients with haematological malignancies following use of dexamethasone alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS, such as those with a high proliferative rate, high tumour burden and high sensitivity to cytotoxic agents, should be closely monitored and appropriate preventive measures introduced. Visual disturbance Visual disturbance may be reported with both systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist for assessment of possible causes should be considered, including cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported following the use of systemic and topical corticosteroids. For intravenous administration, the injection should be given slowly (over 2–3 minutes), as administration that is too rapid may give rise to short-lived (up to 3 minutes), harmless side effects in the form of unpleasant tingling or paraesthesia. DEXAMED is a medicinal product for short-term use. In the event of off-label use over a longer period, the additional instructions and precautions described for glucocorticoid medicinal products intended for long-term use must be observed. With local use, possible systemic side effects and interactions should be taken into account. Intra-articular administration of glucocorticoids increases the risk of joint infections. Long-term repeated use of glucocorticoids in weight-bearing joints may worsen changes associated with joint wear. This may be due to overuse of the affected joint once pain or other symptoms have subsided. Local administration in ophthalmology Cushing's syndrome and adrenal insufficiency may be associated with systemic absorption of ophthalmic dexamethasone after intensive or prolonged treatment of predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat). In such cases, treatment should be discontinued gradually. Phaeochromocytoma crisis Phaeochromocytoma crisis, which can be fatal, has been reported following the administration of systemic corticosteroids. Corticosteroids should be administered to patients with suspected or known phaeochromocytoma only after appropriate benefit/risk evaluation. Hypertrophic cardiomyopathy Hypertrophic cardiomyopathy has been reported following systemic administration of corticosteroids, including dexamethasone, to preterm infants. In most reported cases, the condition was reversible following discontinuation of treatment. Diagnostic evaluation and monitoring of cardiac function and structure should be performed in preterm infants treated with systemically administered dexamethasone (section 4.8). Paediatric population Preterm infants Following early treatment (<96 hours after birth) in preterm infants with chronic lung disease at initial doses of 0.25 mg/kg twice daily, the available data suggest adverse long-term effects on neuronal development. In children in the growth phase, the benefit/risk balance of treatment with DEXAMED must be carefully considered. Elderly patients Owing to the increased risk of osteoporosis, an individual benefit/risk assessment should be carried out in elderly patients. Use of DEXAMED may result in positive findings on doping control tests. Excipients This medicinal product contains less than 1 mmol (23 mg) sodium per ampoule, that is to say essentially "sodium-free".