Dexamethasoni phosphas

Isolated cases of anaphylactic reaction with circulatory failure, cardiac arrest, cardiac arrhythmia, bronchospasm and/or fall or rise in blood pressure have been observed following administration of DEXAMED. Owing to immunosuppression, treatment with DEXAMED may increase the risk of bacterial, viral, parasitic, opportunistic and fungal infections. Symptoms of an 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 parasite — nematode of the genus 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 tuberculosis in the medical history, this medicinal product should be used only with concomitant administration of antituberculous agents Treatment with DEXAMED should be carried out only when strictly indicated and, where appropriate, with concomitant 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 those in the medical history), including suicidal tendencies. In such cases, neurological or psychiatric examination is recommended. narrow-angle 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 following surgery) In patients receiving high doses of glucocorticoids, the symptoms of peritoneal irritation following gastrointestinal perforation may be unrecognisable. When using DEXAMED in diabetic patients, the possibility of needing to increase the dose of insulin or oral antidiabetic agents should be considered. During treatment with DEXAMED, regular monitoring of blood pressure is required, particularly in patients with hypertension on high doses, in whom blood pressure 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 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. It should, however, be noted that the immune response and thus the success of vaccination may be impaired by higher doses of corticoids. When administering high doses, attention should be paid to adequate potassium intake and sodium restriction, and serum potassium levels should be monitored. Abrupt discontinuation of treatment carried out for more than 10 days may lead to exacerbation or recurrence of the underlying disease and to acute adrenal insufficiency / corticoid withdrawal syndrome. Therefore, where discontinuation is required, the dose should be tapered slowly. Viral infections (chickenpox, measles) may follow a particularly severe course in patients treated with glucocorticoids. Particular caution is recommended in immunocompromised patients, in patients who have not had measles or chickenpox, or who are in contact with persons with one 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, high tumour burden and high sensitivity to cytostatic agents, should be carefully monitored, and appropriate preventive measures should be implemented. Visual disturbance Visual disturbance may be reported with both systemic and topical use of corticosteroids. If a patient develops symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of possible causes, which include cataract, glaucoma or rare disorders 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 to 3 minutes), since too rapid administration may cause short-lived, harmless side effects lasting up to 3 minutes in the form of unpleasant tingling or paraesthesia. DEXAMED is a medicinal product for short-term use. In the case of off-label use over a longer period, additional instructions and precautionary measures must be followed as described for medicinal products containing glucocorticoids intended for long-term use. 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 changes. This may be due to overuse of the affected joint after pain or other symptoms have already subsided. Local use 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 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 confirmed phaeochromocytoma only after appropriate evaluation 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 systemically administered 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) in preterm infants with chronic lung disease using initial doses of 0.25 mg/kg twice daily, the 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 evaluated. Elderly patients Owing to the increased risk of osteoporosis, an individual benefit/risk assessment should be made in elderly patients. The use of DEXAMED may lead to positive results in doping controls. Excipients This medicinal product contains less than 1 mmol (23 mg) of sodium per ampoule, that is to say essentially "sodium-free".