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. Because of immunosuppression, treatment with DEXAMED may increase the risk of bacterial, viral, parasitic, opportunistic and fungal infections. Symptoms of existing or developing infections may be masked, making diagnosis more difficult. Latent infections such as tuberculosis or hepatitis B may be reactivated. If certain stress situations occur during treatment with DEXAMED (accident, surgery, childbirth, etc.), a temporary increase in dosage 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 do not require supplemental oxygen therapy, systemic corticosteroids should not be discontinued. In the following conditions, treatment with DEXAMED should be undertaken 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 and 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 nematode parasite Strongyloides), glucocorticoids may lead to activation and massive proliferation of the parasites poliomyelitis lymphadenitis following BCG vaccination acute and chronic bacterial infections in the case of a history of tuberculosis, use this product only with concomitant antitubercular therapy Treatment with DEXAMED should be undertaken only when strictly indicated and, where appropriate, with additional specific therapy in the following conditions: gastrointestinal ulcers osteoporosis severe cardiac failure hypertension that is difficult to control diabetes mellitus that is difficult to control psychiatric disorders (including past history), including suicidal tendencies. Neurological or psychiatric evaluation is recommended in such cases. narrow- and wide-angle glaucoma. Ophthalmological monitoring and concomitant therapy are recommended. corneal ulceration and damage. Ophthalmological monitoring and concomitant therapy are recommended. Because of the risk of bowel perforation, DEXAMED should only be used when strictly indicated and under appropriate supervision in the following conditions: severe ulcerative colitis with imminent perforation, with or without peritoneal irritation diverticulitis enteroanastomoses (immediately after surgery) In patients receiving high doses of glucocorticoids, signs of peritoneal irritation following gastrointestinal perforation may be unrecognisable. When DEXAMED is used in diabetic patients, the possibility of an increased dose of insulin or oral antidiabetic agents should be considered. Regular monitoring of blood pressure is required during treatment with DEXAMED, particularly in patients with hypertension receiving high doses that is difficult to control. Patients with severe cardiac failure should be closely monitored because there is a risk of deterioration in their condition. Bradycardia may occur with high doses of dexamethasone. Severe anaphylactic reactions may also occur. When glucocorticoids are administered concomitantly 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. However, it should be noted that the immune response, and therefore the success of vaccination, may be impaired by higher doses of corticosteroids. When high doses are administered, adequate potassium intake and sodium restriction should be ensured, and serum potassium levels should be monitored. Abrupt discontinuation of treatment lasting more than 10 days may lead to exacerbation or recurrence of the underlying disease and to the occurrence of acute adrenal insufficiency/corticosteroid withdrawal syndrome. Therefore, when the medicinal product is to be discontinued, the dose should be tapered gradually. Viral infections (chickenpox, measles) may follow 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 either of these diseases. Following authorisation, tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies after the use of dexamethasone alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS, such as those with a high proliferation rate, high tumour burden and high sensitivity to cytostatic agents, should be closely monitored and appropriate preventive measures should be instituted. Visual disturbances Visual disturbances may be reported with systemic and topical use of corticosteroids. If a patient develops symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist for evaluation of possible causes should be considered, including cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR), which has been reported following systemic and topical use of corticosteroids. For intravenous administration, the injection should be given slowly (over 2–3 minutes), as administration that is too rapid may result in transient, harmless adverse effects of up to 3 minutes' duration in the form of unpleasant tingling or paraesthesia. DEXAMED is a medicinal product intended for short-term use. In the case of off-label use over a longer period, the additional guidance and precautions described for glucocorticoid-containing medicinal products for long-term use must be observed. With local use, possible systemic adverse 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 aggravate wear-related joint changes. This may be due to overuse of the affected joint after pain or other symptoms have already subsided. Local administration in ophthalmology Cushing's syndrome and adrenal insufficiency may be associated with systemic absorption of ophthalmic dexamethasone following intensive or prolonged treatment in predisposed patients, including children and patients receiving 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 administration of systemic corticosteroids. Corticosteroids should be administered to patients with suspected or known phaeochromocytoma only after appropriate assessment of the benefit-risk balance. 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 after discontinuation of treatment. In preterm infants treated with systemic dexamethasone, diagnostic evaluation should be performed and cardiac function and structure should be monitored (section 4.8). Paediatric population Preterm infants Following early treatment (<96 hours after birth) of preterm infants with chronic lung disease using initial doses of 0.25 mg/kg twice daily, 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 Because of the increased risk of osteoporosis, an individual benefit-risk assessment should be performed in elderly patients. Use of DEXAMED may produce positive results in doping tests. Excipients This medicinal product contains less than 1 mmol (23 mg) sodium per ampoule, i.e. it is essentially "sodium-free".