(Approval lapsed) DEXAMETHASONE MYLAN dexamethasone phosphate (as dexamethasone sodium phosphate) 4mg/1mL (Mylan USA)

Replacement Therapy: Adrenocortical insufficiency

Dexamethasone has predominantly glucocorticoid activity and, therefore is not a complete replacement therapy in cases of adrenocortical insufficiency. Dexamethasone should be supplemented with salt and/or a mineralocorticoid, such as deoxycorticosterone. When so supplemented, dexamethasone is indicated in the following:

• Acute adrenocortical insufficiency - Addison's disease; bilateral adrenalectomy.
• Relative adrenocortical insufficiency Prolonged administration of adrenocortical steroids can produce dormancy of the adrenal cortex. The reduced secretory capacity gives rise to a state of relative adrenocortical insufficiency which persists for a varying length of time after therapy is discontinued. Should a patient be subjected to sudden stress during this period of reduced secretion (for up to two years after therapy has ceased) the steroid output may not be adequate. Steroid therapy should, therefore be reinstituted to help cope with stress such as that associated with surgery, trauma, burns or severe infections where specific antibiotic therapy is available.
• Primary and secondary adrenocortical insufficiency.
• Disease Therapy - Dexamethasone is indicated for therapy of the following diseases:
  1. Collagen diseases. Systemic lupus erythematosus, polyarteritis nodosa, dermatomyositis, giant cell arteritis, adjunctive therapy for short-term administration during an acute episode or exacerbation, acute rheumatic carditis -during an exacerbation or as maintenance therapy.
  2. Pulmonary disorders. Status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency.
  3. Blood disorders. Leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia.
  4. Rheumatic diseases. Rheumatoid arthritis, osteoarthritis, adjunctive therapy for short-term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis.
  5. Skin diseases. Psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis.
  6. Gastrointestinal disorders. Ulcerative colitis, regional enteritis.
  7. Oedema. Cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis).
  8. Eye disorders. Allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy.
  9. Neoplastic states. Cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children.
  10. Endocrine disorders. Adrenal insufficiency.
• Preoperative and postoperative support - Dexamethasone may be used in any surgical procedure when the adrenocortical reserve is doubtful. This includes the treatment of shock due to excessive blood loss during surgery.
• Shock - Dexamethasone may be used as an adjunct in the treatment of shock