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

fresenius kabi usa, llc - dexamethasone sodium phosphate (unii: ai9376y64p) (dexamethasone - unii:7s5i7g3jql) - - intravenous or intramuscular administration. when oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: endocrine disorders. primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is

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

juno pharmaceuticals pty ltd - dexamethasone sodium phosphate, quantity: 8.74 mg (equivalent: dexamethasone phosphate, qty 8 mg) - injection, solution - excipient ingredients: sodium citrate; water for injections; disodium edetate; sodium hydroxide; 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.

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

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

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.

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)

organon pharma pty ltd - alendronate sodium, quantity: 91.37 mg (equivalent: alendronic acid, qty 70 mg); colecalciferol, quantity: 0.1387 mg - tablet, uncoated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; lactose; croscarmellose sodium; purified water; gelatin; aluminium starch octenylsuccinate; aluminium sodium silicate; sucrose; medium chain triglycerides - the treatment of osteoporosis in select patients where vitamin d supplementation is recommended.

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

organon pharma pty ltd - alendronate sodium, quantity: 91.37 mg (equivalent: alendronic acid, qty 70 mg); colecalciferol, quantity: 0.0693 mg - tablet, uncoated - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; lactose; microcrystalline cellulose; magnesium stearate; purified water; gelatin; aluminium starch octenylsuccinate; aluminium sodium silicate; sucrose; medium chain triglycerides - the treatment of osteoporosis in select patients where vitamin d supplementation is recommended.

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

meda pharmaceuticals - butabarbital sodium (unii: 9wtd50i918) (butabarbital - unii:p0078o25a9) - butabarbital sodium 30 mg - butisol sodium® (butabarbital sodium tablets, usp and butabarbital sodium oral solution, usp) is indicated for use as a sedative or hypnotic. since barbiturates appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks, use of butisol sodium® in treating insomnia should be limited to this time (see clinical pharmacology above). barbiturates are contraindicated in patients with known barbiturate sensitivity. barbiturates are also contraindicated in patients with a history of manifest or latent porphyria. controlled substance: schedule iii. abuse and dependence: abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or ad

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

actavis pharma, inc. - risedronate sodium hemi-pentahydrate (unii: hu2yaq274o) (risedronic acid - unii:km2z91756z), risedronate sodium monohydrate (unii: f67l43ut5c) (risedronic acid - unii:km2z91756z) - risedronate sodium anhydrous 4.3 mg - risedronate sodium tablets is indicated for the treatment and prevention of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, risedronate sodium tablets reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see clinical studies (14.1, 14.2) ]. risedronate sodium tablets is indicated for treatment to increase bone mass in men with osteoporosis. risedronate sodium tablets is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin d. risedronate sodium tablets is indicated for treatment of paget’s disease of bone in men and women. the optimal duration of use has not been determined. the safety and effectiveness of

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

direct rx - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 20 mg - pantoprazole sodium delayed-release tablets are indicated for: 1.1 short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (gerd) pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. for those adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 maintenance of healing of erosive esophagitis pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. 1.3 pathological hypersecretory conditions including zollinger-ellis