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 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, in conjunction 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 parasitic infections (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 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 antituberculosis agents Treatment with DEXAMED should be administered only when strictly indicated and, where appropriate, in conjunction 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 these 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. 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 imminent perforation, including 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 DEXAMED is used in diabetic patients, the possibility of increasing the insulin dose 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, where 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 co-administered 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 administering high doses, attention should be paid to ensuring adequate potassium intake and restricting sodium, 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, as well as to acute adrenal insufficiency/corticosteroid withdrawal syndrome. Therefore, if 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 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. After authorisation, tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies following 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 cytotoxic agents, should be carefully monitored and appropriate preventive measures put in place. Visual disturbance Visual disturbance may be reported with systemic and topical use of corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, 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 has been reported after the use of systemic and topical corticosteroids. When administered intravenously, 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 unpleasant tingling or paraesthesia. DEXAMED is a medicinal product for short-term use. In the case of off-label use over an extended period, additional instructions and precautionary measures must be followed, as described for glucocorticoid medicinal products 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 changes associated with joint wear. This may be caused by overuse of the affected joint once 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 in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat). In such cases, treatment should be tapered gradually. Phaeochromocytoma crisis Phaeochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should be administered to patients with suspected or identified 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 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) in preterm infants with chronic pulmonary disease, with starting doses of 0.25 mg/kg twice daily, available data suggest adverse long-term effects on neurodevelopment. In children in the growth phase, the benefit-risk balance of treatment with DEXAMED should be carefully assessed. Elderly patients Owing to the increased risk of osteoporosis, an individual benefit-risk assessment should be performed in elderly patients. 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, i.e. it is essentially "sodium-free".