Dexamethasone Krka

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. Treatment with DEXAMED may increase the risk of bacterial, viral, parasitic, opportunistic and fungal infections due to immunosuppression. Signs 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 only be used when strictly indicated and, where 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. Nematoda) in patients with confirmed or suspected strongyloidiasis (infection caused by a parasite — a 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 case of a history of tuberculosis, use this product only with concomitant administration of antituberculosis agents Treatment with DEXAMED should only be carried out when strictly indicated and, where appropriate, with concurrent 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 a history thereof), including suicidal tendencies. In this case, neurological or psychiatric evaluation 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, possibly even without peritoneal irritation diverticulitis entero-anastomoses (immediately postoperative) In patients receiving high doses of glucocorticoids, signs of peritoneal irritation following gastrointestinal perforation may be unrecognisable. When using DEXAMED in diabetics, the possibility of increasing 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 difficult-to-control hypertension on high doses. Patients with severe heart failure should be closely 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 beginning of treatment with DEXAMED. Vaccination with inactivated vaccines is in principle possible. However, it should be noted that the immune response, and thus the success of vaccination, may be impaired by higher doses of corticosteroids. When high doses are administered, 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, as well as to acute adrenal insufficiency / corticosteroid withdrawal syndrome. Therefore, if the medicinal product needs to be discontinued, the dose should be reduced slowly. Viral infections (chickenpox, measles) may follow a particularly severe course in patients treated with glucocorticoids. Particular care is advised in immunocompromised patients, in patients who have not had measles or chickenpox, and in those who are in contact with persons suffering from one 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 chemotherapeutic agents. Patients at high risk of TLS, such as those with a high rate of proliferation, a high tumour burden and high sensitivity to cytostatics, should be closely monitored and appropriate preventive measures should be implemented. 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 following systemic and topical use of corticosteroids. 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 unpleasant tingling or paraesthesia. DEXAMED is a medicinal product intended 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 administration, possible systemic side effects and interactions must 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 excessive use of the affected joint after the pain or other symptoms have subsided. Local ophthalmic administration 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 the administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or confirmed phaeochromocytoma after an appropriate risk-benefit assessment. Hypertrophic cardiomyopathy Hypertrophic cardiomyopathy has been reported following systemic administration of corticosteroids, including dexamethasone, to premature infants. In most cases reported, it was reversible after discontinuation of treatment. In premature infants treated with systemically administered dexamethasone, diagnostic evaluation should be performed and cardiac function and structures monitored (section 4.8). Paediatric population Premature infants Following early treatment (<96 hours after birth) of premature infants with chronic lung disease at starting 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 ratio of treatment with DEXAMED should be carefully considered. Elderly patients Owing to the increased risk of osteoporosis, an individual benefit-risk assessment should be performed 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".