Dexamethasone Krka

Isolated cases of anaphylactic reactions with circulatory failure, cardiac arrest, cardiac arrhythmia, bronchospasm, and/or decreased or elevated blood pressure have been observed following administration of DEXAMED. Treatment with DEXAMED may, owing to immunosuppression, 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 occur during treatment with DEXAMED (accident, surgical procedure, 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 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, concomitantly 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 up to 2 weeks after immunisation with live vaccines systemic mycoses and parasitoses (e.g. nematode infections) in patients with confirmed or suspected strongyloidiasis (infection caused by the parasitic nematode of the genus Strongyloides), glucocorticoids may lead to parasite activation and massive proliferation poliomyelitis lymphadenitis following BCG vaccination acute and chronic bacterial infections in patients with a history of tuberculosis, use this medicinal product only with concomitant administration of antituberculosis drugs Treatment with DEXAMED should be administered only when strictly indicated and, where appropriate, concomitantly with other specific therapy for 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 those in the medical history), including suicidal tendencies. In such cases, a neurological or psychiatric assessment is recommended. narrow-angle and open-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, including without peritoneal irritation diverticulitis entero-anastomoses (immediately after surgery) In patients receiving high doses of glucocorticoids, signs of peritoneal irritation following gastrointestinal perforation may be undetectable. When DEXAMED is used in patients with diabetes, the possibility of increasing the dose of insulin or oral antidiabetic agents should be considered. During treatment with DEXAMED, regular blood pressure monitoring is required, particularly in patients with hypertension that is difficult to control when receiving high doses. Patients with severe cardiac 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 also 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. Vaccination with inactivated vaccines is in principle possible. However, it should be noted that the immune response, and therefore the success of vaccination, may be impaired by higher corticosteroid doses. 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 given for 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, when the medicinal product needs to be withdrawn, 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 those who have not had measles or chickenpox, and in those in contact with persons suffering from any 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 chemotherapy 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 carefully monitored and appropriate preventive measures should be instituted. 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, referral to an ophthalmologist should be considered for evaluation of possible causes, which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after systemic and topical corticosteroid use. For intravenous administration, the injection should be given slowly (over 2–3 minutes), since too rapid administration may produce short-lived, harmless side effects lasting up to 3 minutes in the form of unpleasant tingling or paraesthesia. DEXAMED is a medicinal product intended for short-term use. In the event of off-label use over a prolonged period, the additional instructions and precautions described for glucocorticoid medicinal products intended for long-term use must be observed. For topical use, possible systemic side effects and interactions should be taken into account. Intra-articular administration of glucocorticoids increases the risk of joint infection. Long-term, repeated use of glucocorticoids in weight-bearing joints may aggravate degenerative joint changes. 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 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 known phaeochromocytoma only after appropriate assessment of the benefit/risk balance. Hypertrophic cardiomyopathy Hypertrophic cardiomyopathy has been reported following systemic corticosteroid administration, including dexamethasone, in premature infants. In most reported cases, the condition was reversible after 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 After early treatment (<96 hours after birth) in premature infants with chronic lung disease starting at doses of 0.25 mg/kg twice daily, the 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 Owing to the increased risk of osteoporosis, an individual assessment of benefits and risks should be made in elderly patients. The use of DEXAMED may produce positive results in doping controls. Excipients This medicinal product contains less than 1 mmol (23 mg) of sodium per ampoule, that is to say, it is essentially "sodium-free".