Dexamethasoni phosphas

Isolated cases of anaphylactic reaction with circulatory failure, cardiac arrest, cardiac arrhythmias, bronchospasm and/or decreased or increased 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 an existing or developing infection may be masked, making diagnosis more difficult. Latent infections, such as tuberculosis or hepatitis B, may be reactivated. If certain stressful situations (accident, surgery, childbirth, etc.) occur during treatment with DEXAMED, 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 administered only when strictly indicated and, if necessary, with concurrent 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 up to 2 weeks after vaccination with live vaccines systemic mycoses and parasitoses (e.g. nematodes) in patients with confirmed or suspected strongyloidiasis (infection caused by the parasitic roundworm 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 a history of tuberculosis, use this medicinal product only with concurrent administration of antitubercular agents Treatment with DEXAMED should be administered only when strictly indicated and, where appropriate, with additional 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 patient's history), including suicidal tendencies. In such cases, 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. In view of 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 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 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 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 be noted, however, that the immune response, and therefore the success of vaccination, may be impaired by higher doses of corticosteroids. 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 after more than 10 days may lead to exacerbation or recurrence of the underlying disease, as well as the occurrence of acute adrenal insufficiency/corticosteroid withdrawal syndrome. Therefore, if the medicinal product needs to be discontinued, the dose should be tapered slowly. Viral infections (chickenpox, measles) may have 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 suffering from any of these diseases. Following authorisation, tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies treated with 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 cytotoxic agents, should be closely monitored, and appropriate preventive measures should be implemented. Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, consideration should be given to referring the patient 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 produce transient, harmless side effects in the form of unpleasant tingling or paraesthesia lasting up to 3 minutes. DEXAMED is a medicinal product intended for short-term use. In the case of off-label use over a longer period, further instructions and precautions must be followed as described for glucocorticoid medicinal products intended for long-term use. For 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 in the joint. This may be due to overuse of the affected joint after pain or other symptoms have subsided. Topical ophthalmic use Cushing's syndrome and adrenal insufficiency may be associated with systemic absorption of ophthalmic dexamethasone following 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 confirmed 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 premature infants. In most reported cases, it was reversible following discontinuation of treatment. In premature infants treated with systemic dexamethasone, diagnostic evaluation should be performed and cardiac function and structure should be monitored (section 4.8). Paediatric population Premature infants Following early treatment (<96 hours after birth) in premature infants with chronic lung disease, with starting doses of 0.25 mg/kg twice daily, available data suggest negative long-term effects on neurodevelopment. 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 the benefit/risk balance should be performed in elderly patients. Use of DEXAMED may result in 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".