Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
dexamethasone sodium phosphate, Quantity: 8.75 mg (Equivalent: dexamethasone phosphate, Qty 8 mg)
Medsurge Pharma Pty Ltd
Injection, solution
Excipient Ingredients: water for injections; disodium edetate; sodium hydroxide; sodium citrate dihydrate; creatinine
Intramuscular, Intrasynovial, Intravenous
10 x 2 mL ampoules, 5 x 2 mL ampoules
(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:,? 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:,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.,Pulmonary disorders: Status asthmaticus, chronic asthma, sarcoidosis, respiratory insufficiency.,Blood disorders: Leukaemia, idiopathic thrombocytopaenic purpura in adults, acquired (autoimmune) haemolytic anaemia.,Rheumatic diseases: Rheumatoid arthritis, osteoarthritis, adjunctive therapy for short-term administration during an acute episode or exacerbation of rheumatoid arthritis or osteoarthritis.,Skin diseases: Psoriasis, erythema multiforme, pemphigus, neutrophilic dermatitis, localised neurodermatitis, exfoliative dermatitis, sarcoidosis of skin, severe seborrhoeic dermatitis, contact dermatitis.,Gastrointestinal disorders: Ulcerative colitis, regional enteritis.,Oedema: Cerebral oedema associated with primary or metastatic brain tumours, neurosurgery or stroke, oedema associated with acute non-infectious laryngospasm (or laryngitis).,Eye disorders: Allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, chorioretinitis, optic neuritis, anterior ischaemic optic neuropathy.,Neoplastic states: Cerebral neoplasms, hypercalcaemia associated with cancer, leukaemias and lymphomas in adults, acute leukaemia in children.,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. Dexamethasone should not be used as a substitute for normal shock therapy.
Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2023-04-04
Dexamethasone Medsurge CMI Edition 03 Mar 2023 1 DEXAMETHASONE MEDSURGE CONSUMER MEDICINE INFORMATION (CMI) SUMMARY 1. WHY AM I USING DEXAMETHASONE MEDSURGE? Dexamethasone Medsurge contains the active ingredient dexamethasone sodium phosphate. Dexamethasone (as sodium phosphate) 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 and skin problems, asthma or arthritis. Corticosteroids reduce inflammation, one of the body’s reactions to injury. Except for its use in the treatment of underactive adrenal glands, dexamethasone (as sodium phosphate) does not cure disease; it treats the symptoms. For more information, see Section 1. Why am I using Dexamethasone Medsurge? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DEXAMETHASONE? Do not use if you have ever had an allergic reaction to dexamethasone sodium phosphate or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Dexamethasone? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with dexamethasone and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE DEXAMETHASONE MEDSURGE? • The dose of dexamethasone Injection is variable, depending upon the condition being treated. It may be given as a course of injections or as a single dose. Your doctor will decide what dose will receive. This depends on your condition and other factors, such as your weight. • Dexamethasone Injection is given as a slow injection or infusion (intravenous drip) into the veins. It may also be given as an injection into an injured muscle or joint. Dexamethasone Injection should only Read the complete document
DEXAMETHASONE MEDSURGE Dexamethasone Medsurge, version 0.3, Mar 2023 Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION – DEXAMETHASONE MEDSURGE (DEXAMETHASONE SODIUM PHOSPHATE) SOLUTION FOR INJECTION 1. NAME OF THE MEDICINE Dexamethasone sodium phosphate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of Dexamethasone Medsurge injection contains dexamethasone sodium phosphate equivalent to 4 mg of dexamethasone phosphate. It does not contain preservatives or antioxidants. There are no excipients with known effect. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Dexamethasone Medsurge is a clear colourless solution for injection, 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: • 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. M medsurge DEXAMETHASONE MEDSURGE Dexamethasone Medsurge, version 0.3, Mar 2023 Page 2 of Read the complete document