Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
dexamethasone sodium phosphate, Quantity: 4.4 mg (Equivalent: dexamethasone phosphate, Qty 4 mg)
Alphapharm Pty Ltd
Dexamethasone sodium phosphate
Injection
Excipient Ingredients: sodium citrate; creatinine; water for injections
Intrasynovial, Intramuscular, Intravenous
5, 10
(S4) Prescription Only Medicine
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. Refer to section 4.2 Dose and Method of Administration. Dexamethasone should not be used as a substitute for normal shock therapy.
Visual Identification: 2mL amber vial with rubber stopper and aluminium seal; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2011-03-25
DEXAMETHASONE MYLAN _dexamethasone sodium phosphate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DEXAMETHASONE MYLAN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given DEXAMETHASONE MYLAN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DEXAMETHASONE MYLAN IS USED FOR DEXAMETHASONE MYLAN is a glucocorticoid and belongs to a group of medicines called corticosteroids. It may be used to treat an inactive or underactive adrenal gland or to treat a number of different diseases such as certain immune disorders, skin problems, asthma or arthritis. Corticosteroids reduce inflammation, one of the body's reactions to injury. Except for its use in the treatment of an underactive adrenal gland, DEXAMETHASONE MYLAN does ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. BEFORE YOU ARE GIVEN DEXAMETHASONE MYLAN _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU SHOULD NOT BE GIVEN DEXAMETHASONE MYLAN IF YOU HAVE AN ALLERGY TO: • any medicine containing dexamethasone sodium phosphate • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin YOU SHOULD NOT BE GIVEN DEXAMETHASONE MYLAN IF YOU HAVE AN INTERNAL FUNGAL INFECTION OR ANY OTHER INFECTION. YOU SHOULD NOT BE GIVEN DEXAMETHASONE MYLAN IF YOU HAVE RECENTLY BEEN GIVEN A LIVE VACCINE UNLESS YOU ARE BEING GIVEN THIS MEDICINE FOR REPLACEMENT THERAPY. YOU SHOULD Read the complete document
AUSTRALIAN PRODUCT INFORMATION DEXAMETHASONE MYLAN _dexamethasone sodium phosphate solution for injection _ 1 NAME OF THE MEDICINE Dexamethasone sodium phosphate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of DEXAMETHASONE MYLAN INJECTION contains dexamethasone sodium phosphate 4.4 mg (equivalent to 4 mg dexamethasone phosphate) as the active ingredient. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Solution for injection. DEXAMETHASONE MYLAN is a clear, colourless solution, free from visible particulate matter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 adm Read the complete document