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. Signs of existing or developing infection may be masked, thereby making diagnosis more difficult. Latent infections, such as tuberculosis or hepatitis B, may be reactivated. If certain stressful situations occur during treatment with DEXAMED (accident, surgery, childbirth, etc.), a temporary increase in dose may be necessary. In patients with COVID-19 who are already being treated with 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 undertaken only when strictly indicated and, if necessary, with concomitant 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 Strongyloides), glucocorticoids may lead to activation and massive proliferation of the parasites poliomyelitis lymphadenitis following BCG vaccination acute and chronic bacterial infections in cases of a history of tuberculosis, this medicinal product should be used only with concomitant antituberculosis 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 a history thereof), including suicidal tendencies. In this case, neurological or psychiatric evaluation 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. Owing to 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 after surgery) In patients receiving high doses of glucocorticoids, the signs of peritoneal irritation following gastrointestinal perforation may be unrecognisable. When using DEXAMED, the possibility of increasing the dose of insulin or oral antidiabetic agents should be considered in diabetic patients. During treatment with DEXAMED, regular monitoring of blood pressure is required, particularly in patients with hypertension who are receiving high doses and whose blood pressure is difficult to control. Patients with severe cardiac failure should be closely monitored, as there is a risk of deterioration of their condition. At high doses of dexamethasone, bradycardia may occur. 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. 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 restriction of sodium should be ensured, and serum potassium levels should be monitored. Abrupt discontinuation of treatment after more than 10 days may lead to exacerbation or recurrence of the original disease, as well as to acute adrenal insufficiency / corticosteroid withdrawal syndrome. Therefore, where discontinuation is required, the dose should be reduced gradually. Viral infections (chickenpox, measles) may follow a particularly severe course in patients treated with glucocorticoids. Particular caution is recommended in immunocompromised patients and in patients who have not had measles or chickenpox or who are in contact with persons who have either of these diseases. Following authorisation of the product, 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 rate of proliferation, a high tumour burden and a high sensitivity to cytostatics, should be closely monitored and appropriate preventive measures put in place. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient develops symptoms such as blurred vision or other visual disturbance, 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 following systemic and topical corticosteroid use. For intravenous administration, the injection should be given slowly (over 2–3 minutes), as too rapid administration may cause short-lived, harmless side effects lasting up to 3 minutes in the form of an unpleasant tingling or paraesthesia. DEXAMED is a medicinal product for short-term use. In the case 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 wear-related joint changes. This may be due to overuse of the affected joint once pain or other symptoms have subsided. Topical ophthalmic administration Cushing's syndrome and adrenal insufficiency may be associated with systemic absorption of ophthalmic dexamethasone after intensive or long-term 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 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 undertaken and cardiac function and structure monitored (section 4.8). Paediatric population Preterm infants Following early treatment (<96 hours after birth) in preterm infants with chronic lung disease, with starting doses of 0.25 mg/kg twice daily, available data suggest negative long-term effects on neuronal development. In children in the growth phase, the benefit-risk balance of treatment with DEXAMED should be carefully considered. Elderly patients In view of the increased risk of osteoporosis, an individual assessment of benefits and risks should be carried out in elderly patients. The use of DEXAMED may produce positive results in doping tests. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially "sodium-free".