Dexametazon-BP (inj)

Dexamethasonum

Each 1 ml ampoule contains dexamethasone phosphate 4 mg (as dexamethasone sodium phosphate); each 2 ml ampoule contains dexamethasone phosphate 8 mg. Excipient with known effect: sodium (0.65 mg per 1 ml ampoule; 1.3 mg per 2 ml ampoule).

Indication: Indicated systemically in acute situations where oral glucocorticoid therapy is not possible: replacement therapy in adrenocortical insufficiency, pre- and post-operative support, anaphylactic/haemorrhagic/surgical/post-traumatic shock, severe acute allergic states, cerebral oedema, autoimmune connective-tissue disease and other acute conditions requiring parenteral corticosteroid therapy.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to dexamethasone or to any of the excipients listed in section 6.1. − Systemic infections (unless specific anti-infective therapy is used). − Administration of live-virus vaccines (see "Special warnings and precautions for use"). Intra-articular injection is contraindicated: − if there is infection in the joint to be treated or in its immediate vicinity − in bacterial arthritis − in instability of the joint to be treated − in a bleeding tendency (spontaneous or induced by anticoagulant therapy) − in periarticular calcification − in avascular necrosis − in tendon rupture − in Charcot's joint. Infiltrations without additional causal treatment are contraindicated if there is infection in the administration area.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use With the use of dexamethasone phosphate, isolated cases of severe anaphylactic reactions have been observed, associated with circulatory collapse, cardiac arrest, cardiac arrhythmias, bronchospasm and/or hypo-/hypertension. Severe anaphylactic reactions have been reported after parenteral administration of corticosteroids, particularly in patients with a history of allergies. In these cases, the following measures are recommended: immediate slow intravenous injection of 0.1-0.5 ml adrenaline (1:1000 solution: 0.1-0.5 mg adrenaline, depending on body weight) and artificial respiration if necessary. Appropriate precautions must be taken before starting treatment. Serious neurological events, some resulting in death, have been reported following epidural injection of corticosteroids. Specific reported events […]