DEXAMETHASONE MEDICIANZ dexamethasone phosphate (as dexamethasone sodium phosphate) 8 mg/2 mL solution for injection ampoule

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
04-04-2023

유효 성분:

dexamethasone sodium phosphate, Quantity: 8.75 mg (Equivalent: dexamethasone phosphate, Qty 8 mg)

제공처:

Medsurge Pharma Pty Ltd

약제 형태:

Injection, solution

구성:

Excipient Ingredients: sodium citrate dihydrate; water for injections; sodium hydroxide; creatinine; disodium edetate

관리 경로:

Intramuscular, Intrasynovial, Intravenous

패키지 단위:

10 x 2 mL ampoules, 5 x 2 mL ampoules

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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.

제품 요약:

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

승인 상태:

Registered

승인 날짜:

2023-04-04