United States - English - NLM (National Library of Medicine)

hospira, inc. - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (phosphate ion - unii:nk08v8k8hr, sodium cation - unii:lyr4m0nh37), sodium phosphate, dibasic, anhydrous (unii: 22ado53m6f) (phosphate ion - unii:nk08v8k8hr, sodium cation - unii:lyr4m0nh37) - sodium phosphate, monobasic, monohydrate 276 mg in 1 ml - sodium phosphates injection, usp, 3 mm p/ml is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. it is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. the concomitant amount of sodium (na+ 4 meq/ml) must be calculated into total electrolyte dose of such prepared solutions. sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.

United States - English - NLM (National Library of Medicine)

novel laboratories, inc. - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (sodium cation - unii:lyr4m0nh37), sodium phosphate, dibasic anhydrous (unii: 22ado53m6f) (sodium cation - unii:lyr4m0nh37) - sodium phosphate, monobasic, monohydrate 1.105 g - monobasic sodium phosphate and dibasic sodium phosphate tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in patients with biopsy-proven acute phosphate nephropathy. monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients. laxatives and purgatives (including monobasic sodium phosphate and dibasic sodium phosphate tablets) have the potential for abuse by bulimia nervosa patients who frequently have binge eating and vomiting.

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (phosphate ion - unii:nk08v8k8hr), sodium phosphate, dibasic, anhydrous (unii: 22ado53m6f) (phosphate ion - unii:nk08v8k8hr) - sodium phosphate, monobasic, monohydrate 276 mg in 1 ml - sodium phosphates injection, usp is indicated as a source of phosphate, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake.  it is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. the concomitant amount of sodium (4 meq/ml) must be calculated into total electrolyte dose of such prepared solutions. sodium phosphate is contraindicated in diseases where high phosphate or low calcium levels may be encountered, and in patients with hypernatremia.

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (phosphate ion - unii:nk08v8k8hr), sodium phosphate, dibasic, anhydrous (unii: 22ado53m6f) (sodium cation - unii:lyr4m0nh37) - sodium phosphates injection, usp, 3 mm p/ml is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. it is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. the concomitant amount of sodium (na+ 4 meq/ml) must be calculated into total electrolyte dose of such prepared solutions. sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.

United States - English - NLM (National Library of Medicine)

salix pharmaceuticals, inc. - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (phosphate ion - unii:nk08v8k8hr), sodium phosphate, dibasic, anhydrous (unii: 22ado53m6f) (phosphate ion - unii:nk08v8k8hr) - sodium phosphate, monobasic, monohydrate 1.102 g - osmoprep® is indicated for cleansing of the colon as a preparation for colonoscopy in adults. osmoprep is contraindicated in the following conditions: risk summary there are no available data on sodium phosphate use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. animal reproduction studies have not been conducted with sodium phosphate. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there are no data available to assess the presence of sodium phosphate in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determinat

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (sodium cation - unii:lyr4m0nh37), sodium phosphate, dibasic anhydrous (unii: 22ado53m6f) (sodium cation - unii:lyr4m0nh37) - sodium cation 1.102 g - osmoprep tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. osmoprep tablets are contraindicated in patients with biopsy-proven acute phosphate nephropathy. osmoprep tablets are contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients. laxatives and purgatives (including osmoprep) have the potential for abuse by bulimia nervosa patients who frequently have binge eating and vomiting.

Australia - English - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - dexamethasone sodium phosphate, quantity: 8.75 mg (equivalent: dexamethasone phosphate, qty 8 mg) - injection, solution - excipient ingredients: water for injections; disodium edetate; sodium hydroxide; sodium citrate dihydrate; creatinine - 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.

United States - English - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (sodium cation - unii:lyr4m0nh37), sodium phosphate, dibasic, anhydrous (unii: 22ado53m6f) (sodium cation - unii:lyr4m0nh37) - monobasic sodium phosphate and dibasic sodium phosphate tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults. monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in the following conditions: -   history of acute phosphate nephropathy [see warnings and precautions (5.1)] -   gastrointestinal (gi) obstruction [see warnings and precautions (5.7)] -   gastric bypass or stapling surgery -   bowel perforation -   toxic colitis -   toxic megacolon -   hypersensitivity to sodium phosphate salts or any component of monobasic sodium phosphate and dibasic sodium phosphate tablets[see warnings and precautions (5.7)]. risk summary there are no available data on sodium phosphate use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. animal reproduction studies have not been conducted with sodium phosphate. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there are no data available to assess the presence of sodium phosphate in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of monobasic sodium phosphate and dibasic sodium phosphate tablets to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for monobasic sodium phosphate and dibasic sodium phosphate tablets and any potential adverse effects on the breastfed child from monobasic sodium phosphate and dibasic sodium phosphate tablets or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the 599 patients in clinical trials receiving at least 48 grams of monobasic sodium phosphate and dibasic sodium phosphate tablets, 134 (22%) were 65 years of age or older, while 27 (5%) were 75 years of age or older. no overall differences in safety or effectiveness were observed between geriatric patients and younger patients. however, the mean phosphate levels in geriatric patients were greater than the phosphate levels in younger patients after monobasic sodium phosphate and dibasic sodium phosphate tablets administration. the mean colonoscopy-day phosphate levels in patients 18-64, 65-74, and ≥ 75 years old who received the recommended monobasic sodium phosphate and dibasic sodium phosphate tablets dosage regimen in study 1were 7.0, 7.3, and 8.0 mg/dl, respectively. after monobasic sodium phosphate and dibasic sodium phosphate tablets administration, the mean phosphate levels in patients 18-64, 65-74, and ≥ 75 years old were 7.4, 7.9, and 8.0 mg/dl, respectively. greater sensitivity of some older individuals cannot be ruled out; therefore, use monobasic sodium phosphate and dibasic sodium phosphate tablets with caution in geriatric patients. advise geriatric patients to adequately hydrate before, during, and after the use of monobasic sodium phosphate and dibasic sodium phosphate tablets. sodium phosphate is known to be substantially excreted by the kidney, and the risk of adverse reactions with sodium phosphate may be greater in patients with impaired renal function. since geriatric patients are more likely to have impaired renal function, consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and bun) in these patients [see warnings and precautions (5.1)]. sodium phosphate is substantially excreted by the kidney. use monobasic sodium phosphate and dibasic sodium phosphate tablets with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or patients taking concomitant medications that may affect renal function. these patients may be at risk for renal injury. advise these patients of the importance of adequate hydration before, during and after the use of monobasic sodium phosphate and dibasic sodium phosphate tablets, and consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and bun) in these patients [see warnings and precautions (5.1), drug interactions (7.1)] .

Australia - English - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - dexamethasone sodium phosphate, quantity: 4.37 mg (equivalent: dexamethasone phosphate, qty 4 mg) - injection, solution - excipient ingredients: sodium citrate dihydrate; creatinine; water for injections; sodium hydroxide; disodium edetate - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - dexamethasone sodium phosphate, quantity: 4.4 mg (equivalent: dexamethasone phosphate, qty 4 mg) - injection - excipient ingredients: sodium citrate; creatinine; water for injections - 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.