Matches in Nanopublications for { ?s <http://www.w3.org/2000/01/rdf-schema#label> ?o ?g. }
- out1 label "out1" assertion.
- LinguisticSystem label "python" assertion.
- image label "image" assertion.
- LinguisticSystem label "python" assertion.
- text label "text" assertion.
- out1 label "out1" assertion.
- image label "image" assertion.
- step label "Add an awesome Watermark to your image (licence:cc0,author:rsiebes, date:06-05-2021 )" assertion.
- cohort label "Adults" assertion.
- association label "Pitolisant and sodium oxybate show promising results in two retrospective studies. The efficacy of γ-aminobutyric acid-A receptor antagonists on objective EDS needs to be clarified. All these medications are used off-label for the management of EDS in IH." assertion.
- HP_0001262 label "Excessive day time somnolence" assertion.
- cohort label "Children" assertion.
- association label "Dextroamphetamine-containing extended-release formulations (n = 180) and atomoxetine (n = 103) were also frequently prescribed off-label medications for children ages 3 to 5 years (8.1% and 4.6%, respectively)." assertion.
- cohort label "Children" assertion.
- association label "The 2 other medications for which off-label prescriptions were written for children ages 3 to 5-years included dexmethylphenidate, both immediate (20/2233) and extended release (20/2233), and lisdexamfetamine (42/2233)." assertion.
- association label "The most commonly prescribed off-label prescriptions for children ages 3 to 5 years were methylphenidate and alpha agonist formulations" assertion.
- cohort label "Children" assertion.
- association label "lenvima is a kinase inhibitor that is indicated for the treatment of patients with locally recurrent or metastatic progressive radioactive iodine refractory differentiated thyroid cancer dtc 1 1 in combination with everolimus for the treatment of patients with advanced renal cell carcinoma rcc following one prior anti angiogenic therapy 1 2 for the first line treatment of patients with unresectable hepatocellular carcinoma hcc 1 3 lenvima is indicated for the treatment of patients with locally recurrent or metastatic progressive radioactive iodine refractory differentiated thyroid cancer dtc lenvima is indicated in combination with everolimus for the treatment of patients with advanced renal cell carcinoma rcc following one prior anti angiogenic therapy lenvima is indicated for the first line treatment of patients with unresectable hepatocellular carcinoma hcc" assertion.
- comment label "This comment" assertion.
- ReferredObject label "identifier of the object that is reviewed (e.g. a text or nanopublication)" assertion.
- reviewComment label "The content of this comment as free text" assertion.
- ReferredMentioning label "identifier of a thing mentioned in the object that is reviewed" assertion.
- impact label "integer value from 1 (low impact) to 5 (high impact)" assertion.
- assertion label "Making a review comment according to the LinkFlows model" assertion.
- refersToMentioningOf label "refers to the mentioning of" assertion.
- refersToMentioningOf label "refers to the mentioning of" assertion.
- refersToMentioningOf label "refers to the mentioning of" assertion.
- refersToMentioningOf label "refers to the mentioning of" assertion.
- refersToMentioningOf label "refers to the mentioning of" assertion.
- refersToMentioningOf label "refers to the mentioning of" assertion.
- image label "image" assertion.
- step label "Put here a name of your awesome step (include the word awesome so others will find it)" assertion.
- LinguisticSystem label "python" assertion.
- out1 label "out1" assertion.
- step label "AWESOME upside down flipper" assertion.
- out1 label "out1" assertion.
- LinguisticSystem label "python" assertion.
- image label "image" assertion.
- list-rest label "a rest-list" assertion.
- class2 label "URI of existing class 2" assertion.
- name label "the name of the class" assertion.
- class1 label "URI of existing class 1" assertion.
- newclass label "short ID of new class" assertion.
- list label "a list" assertion.
- intersectionOrUnion label "select intersection or union" assertion.
- description label "description of the class" assertion.
- assertion label "Defining a new class by intersection or union" assertion.
- step label "add awesome filters" assertion.
- image_path label "image_path" assertion.
- LinguisticSystem label "python" assertion.
- out1 label "out1" assertion.
- association label "activase is a tissue plasminogen activator tpa indicated for the treatment of acute ischemic stroke ais 1 1 acute myocardial infarction ami to reduce mortality and incidence of heart failure 1 2 limitation of use in ami 1 2 acute massive pulmonary embolism pe for lysis 1 3 activase is indicated for the treatment of acute ischemic stroke exclude intracranial hemorrhage as the primary cause of stroke signs and symptoms prior to initiation of treatment see contraindications 4 1 activase is indicated for use in acute myocardial infarction ami for the reduction of mortality and reduction of the incidence of heart failure limitation of use activase is indicated for the lysis of acute massive pulmonary embolism defined as acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments acute pulmonary emboli accompanied by unstable hemodynamics e g failure to maintain blood pressure without supportive measures" assertion.
- association label "pulmozyme r in cf patients with an fvc 4 of predicted daily administration of pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics pulmozyme is a recombinant dnase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis cf patients to improve pulmonary function 1" assertion.
- association label "oncaspar is an asparagine specific enzyme indicated as a component of a multi agent chemotherapeutic regimen for treatment of pediatric and adult patients with first line acute lymphoblastic leukemia 1 1 acute lymphoblastic leukemia and hypersensitivity to asparaginase 1 2 oncaspar r is indicated as a component of a multi agent chemotherapeutic regimen for the first line treatment of pediatric and adult patients with all oncaspar is indicated as a component of a multi agent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of l asparaginase" assertion.
- association label "ninlaro is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy ninlaro is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy 1" assertion.
- association label "portrazza tm is an epidermal growth factor receptor egfr antagonist indicated in combination with gemcitabine and cisplatin for first line treatment of patients with metastatic squamous non small cell lung cancer 1 1 limitation of use portrazza is not indicated for treatment of non squamous non small cell lung cancer 1 2 5 6 14 2 portrazza tm is indicated in combination with gemcitabine and cisplatin for first line treatment of patients with metastatic squamous non small cell lung cancer portrazza is not indicated for treatment of non squamous non small cell lung cancer see warnings and precautions 5 6 14 2" assertion.
- association label "zurampic is indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone s ee clinical studies 14 zurampic is a urat1 inhibitor indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone 1 limitations of use zurampic is not recommended for the treatment of asymptomatic hyperuricemia 1 1 zurampic should not be used as monotherapy 1 1 5 1 zurampic is not recommended for the treatment of asymptomatic hyperuricemia zurampic should not be used as monotherapy see warnings and precautions 5 1" assertion.
- association label "kineret is an interleukin 1 receptor antagonist indicated for rheumatoid arthritis ra reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs dmards 1 1 cryopyrin associated periodic syndromes caps treatment of neonatal onset multisystem inflammatory disease nomid 1 2 kineret is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis ra in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs dmards kineret can be used alone or in combination with dmards other than tumor necrosis factor tnf blocking agents see warnings and precautions 5 2 kineret is indicated for the treatment of neonatal onset multisystem inflammatory disease nomid" assertion.
- association label "somavert is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy or for whom these therapies are not appropriate the goal of treatment is to normalize serum insulin like growth factor i igf i levels somavert is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy or for whom these therapies are not appropriate the goal of treatment is to normalize serum insulin like growth factor i igf i levels 1" assertion.
- association label "genotropin is a recombinant human growth hormone indicated for pediatric 1 1 adult 1 2 genotropin is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone genotropin is indicated for the treatment of pediatric patients who have growth failure due to prader willi syndrome pws the diagnosis of pws should be confirmed by appropriate genetic testing see contraindications 4 genotropin is indicated for the treatment of growth failure in children born small for gestational age sga who fail to manifest catch up growth by age 2 years genotropin is indicated for the treatment of growth failure associated with turner syndrome genotropin is indicated for the treatment of idiopathic short stature iss also called non growth hormone deficient short stature defined by height standard deviation score sds 2 25 and associated with growth rates unlikely to permit attainment of adult height in the normal range in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means genotropin is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria adult onset ao childhood onset co patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults according to current standards confirmation of the diagnosis of adult growth hormone deficiency in both" assertion.
- association label "aldurazyme r aldurazyme has been shown to improve pulmonary function and walking capacity aldurazyme has not been evaluated for effects on the central nervous system manifestations of the disorder aldurazyme is a hydrolytic lysosomal glycosaminoglycan gag specific enzyme indicated for patients with hurler and hurler scheie forms of mucopolysaccharidosis i mps i and for patients with the scheie form who have moderate to severe symptoms the risks and benefits of treating mildly affected patients with the scheie form have not been established aldurazyme has been shown to improve pulmonary function and walking capacity aldurazyme has not been evaluated for effects on the central nervous system manifestations of the disorder 1" assertion.
- association label "enbrel is a tumor necrosis factor tnf blocker indicated for the treatment of rheumatoid arthritis ra 1 1 polyarticular juvenile idiopathic arthritis jia in patients aged 2 years or older 1 2 psoriatic arthritis psa 1 3 ankylosing spondylitis as 1 4 plaque psoriasis pso in patients 4 years or older 1 5 enbrel is indicated for reducing signs and symptoms inducing major clinical response inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active rheumatoid arthritis ra enbrel can be initiated in combination with methotrexate mtx or used alone enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis jia in patients ages 2 and older enbrel is indicated for reducing signs and symptoms inhibiting the progression of structural damage of active arthritis and improving physical function in patients with psoriatic arthritis psa enbrel can be used with or without methotrexate enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis as enbrel is indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis pso who are candidates for systemic therapy or phototherapy" assertion.
- association label "brovana inhalation solution is a long acting beta 2 2 long term twice daily morning and evening administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease copd including chronic bronchitis and emphysema 1 1 important limitations of use brovana inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease 1 2 5 2 brovana inhalation solution is not indicated to treat asthma 1 2 brovana arformoterol tartrate inhalation solution is indicated for the long term twice daily morning and evening maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease copd including chronic bronchitis and emphysema brovana inhalation solution is for use by nebulization only brovana inhalation solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease see warnings and precautions 5 2 brovana inhalation solution is not indicated to treat asthma the safety and effectiveness of brovana inhalation solution in asthma have not been established" assertion.
- association label "uloric is a xanthine oxidase xo inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol who are intolerant to allopurinol or for whom treatment with allopurinol is not advisable for the safe and effective use of allopurinol see allopurinol prescribing information uloric is a xanthine oxidase xo inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol who are intolerant to allopurinol or for whom treatment with allopurinol is not advisable 1 for the safe and effective use of allopurinol see allopurinol prescribing information limitations of use uloric is not recommended for the treatment of asymptomatic hyperuricemia 1 limitations of use uloric is not recommended for the treatment of asymptomatic hyperuricemia" assertion.
- association label "lantus is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus important limitations of use lantus is not recommended for the treatment of diabetic ketoacidosis intravenous short acting insulin is the preferred treatment for this condition lantus is a long acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus 1 important limitations of use not recommended for treating diabetic ketoacidosis use intravenous short acting insulin instead" assertion.
- association label "imraldi is a tumor necrosis factor tnf blocker indicated for treatment of rheumatoid arthritis ra 1 1 juvenile idiopathic arthritis jia 1 2 psoriatic arthritis psa 1 3 ankylosing spondylitis as 1 4 adult crohn s disease cd 1 5 ulcerative colitis uc 1 6 plaque psoriasis ps 1 7 imraldi is indicated for reducing signs and symptoms inducing major clinical response inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis imraldi can be used alone or in combination with methotrexate or other non biologic disease modifying anti rheumatic drugs dmards imraldi is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients from 4 to 17 years of age and 3 kg 66 lbs imraldi can be used alone or in combination with methotrexate imraldi is indicated for reducing signs and symptoms inhibiting the progression of structural damage and improving physical function in adult patients with active psoriatic arthritis imraldi can be used alone or in combination with non biologic dmards imraldi is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis imraldi is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn s disease who have had an inadequate response to conventional therapy imraldi is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab imraldi is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids azathioprine or 6 mercaptopurine 6 mp the effectiveness of adalimumab has not been established in patients who have lost response to or were intolerant to tnf blockers see clinical studies 14 7 imraldi is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate imraldi should only be administered to patients who will be closely monitored and have regular follow up visits with a physician see boxed warning 5" assertion.
- association label "imraldi is a tumor necrosis factor tnf blocker indicated for treatment of rheumatoid arthritis ra 1 1 juvenile idiopathic arthritis jia 1 2 psoriatic arthritis psa 1 3 ankylosing spondylitis as 1 4 adult crohn s disease cd 1 5 ulcerative colitis uc 1 6 plaque psoriasis ps 1 7 imraldi is indicated for reducing signs and symptoms inducing major clinical response inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis imraldi can be used alone or in combination with methotrexate or other non biologic disease modifying anti rheumatic drugs dmards imraldi is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients from 4 to 17 years of age and 3 kg 66 lbs imraldi can be used alone or in combination with methotrexate imraldi is indicated for reducing signs and symptoms inhibiting the progression of structural damage and improving physical function in adult patients with active psoriatic arthritis imraldi can be used alone or in combination with non biologic dmards imraldi is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis imraldi is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn s disease who have had an inadequate response to conventional therapy imraldi is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab imraldi is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids azathioprine or 6 mercaptopurine 6 mp the effectiveness of adalimumab has not been established in patients who have lost response to or were intolerant to tnf blockers see clinical studies 14 7 imraldi is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate imraldi should only be administered to patients who will be closely monitored and have regular follow up visits with a physician see boxed warning 5" assertion.
- association label "zydelig is a kinase inhibitor indicated for the treatment of patients with relapsed chronic lymphocytic leukemia cll in combination with rituximab in patients for whom rituximab alone would be considered appropriate therapy due to other co morbidities 1 1 relapsed follicular b cell non hodgkin lymphoma fl in patients who have received at least two prior systemic therapies 1 2 relapsed small lymphocytic lymphoma sll in patients who have received at least two prior systemic therapies 1 3 limitation of use zydelig is not indicated and is not recommended for first line treatment of any patient 1 1 1 2 1 3 zydelig is not indicated and is not recommended in combination with bendamustine and or rituximab for the treatment of fl 1 2 accelerated approval was granted for fl and sll based on overall response rate improvement in patient survival or disease related symptoms has not been established continued approval for these indications may be contingent upon verification of clinical benefit in confirmatory trials zydelig is indicated in combination with rituximab for the treatment of patients with relapsed chronic lymphocytic leukemia cll for whom rituximab alone would be considered appropriate therapy due to other co morbidities limitation of use zydelig is not indicated and is not recommended for first line treatment of patients with cll zydelig is indicated for the treatment of patients with relapsed follicular b cell non hodgkin lymphoma fl who have received at least two prior systemic therapies accelerated approval was granted for this indication based on overall response rate see clinical studies 14 2 limitation of use zydelig is not indicated and is not recommended for first line treatment of patients with fl zydelig is not indicated and is not recommended in combination with bendamustine and or rituximab for the treatment of fl zydelig is indicated for the treatment of patients with relapsed small lymphocytic lymphoma sll who have received at least two prior systemic therapies accelerated approval was granted for this indication based on overall response rate see clinical studies 14 3 limitation of use zydelig is not indicated and is not recommended for first line treatment of patients with sll" assertion.
- association label "jardiance is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease limitations of use jardiance is a sodium glucose co transporter 2 sglt2 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease 1 limitations of use 1" assertion.
- association label "teriflunomide tablets are indicated for the treatment of patients with relapsing forms of multiple sclerosis teriflunomide tablets are a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis 1" assertion.
- association label "invokana r as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus to reduce the risk of major adverse cardiovascular events cardiovascular death nonfatal myocardial infarction and nonfatal stroke in adults with type 2 diabetes mellitus and established cardiovascular disease cvd invokana is a sodium glucose co transporter 2 sglt2 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 1 to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease 1 limitations of use not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis 1 limitations of use invokana is not recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis" assertion.
- association label "farxiga dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus see clinical studies 14 farxiga is a sodium glucose cotransporter 2 sglt2 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 1 limitation of use 1 1 farxiga is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis" assertion.
- association label "kyprolis is a proteasome inhibitor that is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy 1 14 as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy 1 14 kyprolis is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy kyprolis is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy" assertion.
- association label "bleomycin for injection should be considered a palliative treatment it has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents squamous cell carcinoma head and neck including mouth tongue tonsil nasopharynx oropharynx sinus palate lip buccal mucosa gingivae epiglottis skin larynx penis cervix and vulva the response to bleomycin is poorer in patients with previously irradiated head and neck cancer lymphomas hodgkin s disease non hodgkin s lymphoma testicular carcinoma embryonal cell choriocarcinoma and teratocarcinoma bleomycin has also been shown to be useful in the management of malignant pleural effusion bleomycin is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions" assertion.
- association label "otiprio is indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement the treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus otiprio is a fluoroquinolone antibacterial indicated for the following conditions the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement 1 the treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa staphylococcus aureus 1" assertion.
- association label "amphotericin b for injection usp should be administered primarily to patients with progressive potentially life threatening fungal infections this potent drug should not be used to treat noninvasive fungal infections such as oral thrush vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts amphotericin b for injection usp is specifically intended to treat potentially life threatening fungal infections aspergillosis cryptococcosis torulosis north american blastomycosis systemic candidiasis coccidioido mycosis histoplasmosis zygomycosis including mucormycosis due to susceptible species of the genera absidia mucor rhizopus conidiobolus basidiobolus amphotericin b may be useful in the treatment of american mucocutaneous leishmaniasis but it is not the drug of choice as primary therapy" assertion.
- association label "guanidine is indicated for the reduction of the symptoms of muscle weakness and easy fatigability associated with the myasthenic syndrome of eaton lambert it is not indicated for treating myasthenia gravis the eaton lambert syndrome is ordinarily differentiated from myasthenia gravis by the usual association of the syndrome with small cell carcinoma of the lung but myography may be necessary to make the diagnosis" assertion.
- association label "hydrocortisone tablets usp are indicated in the following conditions endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post traumatic osteoarthritis synovitis of osteoarthritis epicondylitis collagen diseases during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus systemic dermatomyositis polymyositis acute rheumatic carditis dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment seasonal or perennial allergic rhinitis serum sickness bronchial asthma contact dermatitis atopic dermatitis drug hypersensitivity reactions ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia respiratory diseases symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia neoplastic diseases for palliative management of leukemias and lymphomas in adults acute leukemia of childhood edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis nervous system acute exacerbations of multiple sclerosis miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
- association label "daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia myelogenous monocytic erythroid of adults and for remission induction in acute lymphocytic leukemia of children and adults" assertion.
- association label "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 the intravenous or intramusculat use of solu cortef sterile powder is indicated as follows allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions perennial or seasonal allergic rhinitis serum sickness transfusion reactions dermatologic diseases bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome 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 congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis systemic therapy and ulcerative colitis hematologic disorders acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia idiopathic thrombocytopenic purpura in adults intravenous administration only intramuscular administration is contraindicated pure red cell aplasia select cases of secondary thrombocytopenia miscellaneous trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy neoplastic diseases for the palliative management of leukemias and lymphomas nervous system acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy ophthalmic diseases sympathetic ophthalmia uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids renal diseases to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus respiratory diseases berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis temporal arteritis polymyositis and systemic lupus erythematosus" assertion.
- association label "loteprednol etabonate is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva cornea and anterior segment of the globe such as allergic conjunctivitis acne rosacea superficial punctate keratitis herpes zoster keratitis iritis cyclitis selected infective conjunctivitides when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation loteprednol etabonate is less effective than prednisolone acetate 1 in two 28 day controlled clinical studies in acute anterior uveitis where 72 of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells compared to 87 of patients treated with prednisolone acetate 1 the incidence of patients with clinically significant increases in iop 1 mmhg was 1 with loteprednol etabonate and 6 with prednisolone acetate 1 loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indication loteprednol etabonate is also indicated for the treatment of post operative inflammation following ocular surgery" assertion.
- association label "for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms and as an adjunctive in systemic sulfonamide therapy of trachoma escherichia coli staphylococcus aureus streptococcus pneumoniae streptococcus viridans group haemophilus influenzae klebsiella species and enterobacter species topically applied sulfonamides do not provide adequate coverage against neisseria species serratia marcescens and pseudomonas aeruginosa a significant percentage of staphylococcal isolates are completely resistant to sulfa drugs" assertion.
- association label "prednisolone sodium phosphate oral solution 15 mg prednisolone per 5 ml is indicated in the following conditions 1 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with seasonal or perennial allergic rhinitis asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 2 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative erythroderma mycosis fungoides 3 edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations with idiopathic nephrotic syndrome without uremia 4 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis 5 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 6 hematologic disorders idiopathic thrombocytopenic purpura in adults selected cases of secondary thrombocytopenia acquired autoimmune hemolytic anemia pure red cell aplasia diamond blackfan anemia 7 neoplastic diseases for the treatment of acute leukemia and aggressive lymphomas in adults and children 8 nervous system acute exacerbations of multiple sclerosis 9 ophthalmic diseases uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids temporal arteritis sympathetic ophthalmia 1 respiratory diseases symptomatic sarcoidosis idiopathic eosinophilic pneumonias fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy asthma as distinct from allergic asthma listed above under allergic states hypersensitivity pneumonitis idiopathic pulmonary fibrosis acute exacerbations of chronic obstructive pulmonary disease copd and pneumocystis carinii pneumonia pcp associated with hypoxemia occurring in an hiv individual who is also under treatment with appropriate anti pcp antibiotics studies support the efficacy of systemic corticosteroids for the treatment of these conditions allergic bronchopulmonary aspergillosis idiopathic bronchiolitis obliterans with organizing pneumonia 11 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis epicondylitis for the treatment of systemic lupus erythematosus dermatomyositis polymyositis polymyalgia rheumatica sjogren s syndrome relapsing polychondritis and certain cases of vasculitis 12 miscellaneous tuberculous meningitis with subarachnoid block or impending block tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty and tuberculosis with pleural or pericardial effusion appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications trichinosis with neurologic or myocardial involvement acute or chronic solid organ rejection with or without other agents" assertion.
- association label "besivance tm besifloxacin ophthalmic suspension 6 is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria cdc coryneform group g corynebacterium pseudodiphtheriticum corynebacterium striatum haemophilus influenzae moraxella lacunata staphylococcus aureus staphylococcus epidermidis staphylococcus hominis staphylococcus lugdunensis streptococcus mitis group streptococcus oralis streptococcus pneumoniae streptococcus salivarius efficacy for this organism was studied in fewer than 1 infections besivance tm besifloxacin ophthalmic suspension 6 is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria cdc coryneform group g corynebacterium pseudodiphtheriticum corynebacterium striatum haemophilus influenzae moraxella lacunata staphylococcus aureus staphylococcus epidermidis staphylococcus hominis staphylococcus lugdunensis streptococcus mitis group streptococcus oralis streptococcus pneumoniae streptococcus salivarius efficacy for this organism was studied in fewer than 1 infections 1" assertion.
- association label "hydrocortisone tablets are indicated in the following conditions primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia non suppurative thyroiditis hypercalcemia associated with cancer as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in during an exacerbation or as maintenance therapy in selected cases of pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as symptomatic sarcoidosis loeffler s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired autoimmune hemolytic anemia erythroblastopenia rbc anemia congenital erythroid hypoplastic anemia for palliative management of to induce a diuresis or remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus to tide the patient over a critical period of the disease in acute exacerbations of multiple sclerosis tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement" assertion.
- association label "doxycycline hyclate tablets are tetracycline class drugs indicated for rickettsial infections 1 1 sexually transmitted infections 1 2 respiratory tract infections 1 3 specific bacterial infections 1 4 ophthalmic infections 1 5 anthrax including inhalational anthrax post exposure 1 6 alternative treatment for selected infections when penicillin is contraindicated 1 7 adjunctive therapy for acute intestinal amebiasis and severe acne 1 8 prophylaxis of malaria 1 9 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria 1 1 doxycycline hyclate tablets are indicated for treatment of rocky mountain spotted fever typhus fever and the typhus group q fever rickettsial pox and tick fevers caused by rickettsiae doxycycline hyclate tablets are indicated for treatment of the following sexually transmitted infections uncomplicated urethral endocervical or rectal infections caused by chlamydia trachomatis nongonococcal urethritis caused by ureaplasma urealyticum lymphogranuloma venereum caused by chlamydia trachomatis granuloma inguinale caused by klebsiella granulomatis uncomplicated gonorrhea caused by neisseria gonorrhoeae chancroid caused by haemophilus ducreyi doxycycline hyclate tablets are indicated for treatment of the following respiratory tract infections respiratory tract infections caused by mycoplasma pneumoniae psittacosis ornithosis caused by chlamydophila psittaci because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline is indicated for treatment of infections caused by the following microorganisms when bacteriological testing indicates appropriate susceptibility to the drug respiratory tract infections caused by haemophilus influenzae respiratory tract infections caused by klebsiella species upper respiratory infections caused by streptococcus pneumoniae doxycycline hyclate tablets are indicated for treatment of the following specific bacterial infections relapsing fever due to borrelia recurrentis plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections caused by campylobacter fetus brucellosis due to brucella bartonellosis due to bartonella bacilliformis because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline culture and susceptibility testing are recommended doxycycline hyclate tablets are indicated for treatment of infections caused by the following gram negative microorganisms when bacteriological testing indicates appropriate susceptibility to the drug escherichia coli enterobacter aerogenes shigella acinetobacter urinary tract infections caused by klebsiella doxycycline hyclate tablets are indicated for treatment of the following ophthalmic infections trachoma caused by chlamydia trachomatis inclusion conjunctivitis caused by chlamydia trachomatis doxycycline hyclate tablets are indicated for the treatment of anthrax due to bacillus anthracis bacillus anthracis doxycycline hyclate tablets are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated syphilis caused by treponema pallidum yaws caused by treponema pallidum pertenue listeriosis due to listeria monocytogenes vincent s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii infections caused by clostridium in acute intestinal amebiasis doxycycline hyclate tablets may be a useful adjunct to amebicides in severe acne doxycycline hyclate tablets may be useful adjunctive therapy doxycycline hyclate tablets are indicated for the prophylaxis of malaria due to plasmodium falciparum see dosage and administration 2 4 patient counseling information 17 to reduce the development of drug resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy in the absence of such data local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy" assertion.
- association label "glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus see clinical studies 14 1 glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 1 1 important limitations of use not for treating type 1 diabetes mellitus or diabetic ketoacidosis 1 1 glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis as it would not be effective in these settings" assertion.
- association label "somatuline depot is a somatostatin analog indicated for the long term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and or radiotherapy 1 1 the treatment of adult patients with unresectable well or moderately differentiated locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors gep nets to improve progression free survival 1 2 the treatment of adults with carcinoid syndrome when used it reduces the frequency of short acting somatostatin analog rescue therapy 1 3 somatuline depot is indicated for the long term treatment of acromegalic patients who have had an inadequate response to surgery and or radiotherapy or for whom surgery and or radiotherapy is not an option the goal of treatment in acromegaly is to reduce growth hormone gh and insulin growth factor 1 igf 1 levels to normal somatuline depot is indicated for the treatment of adult patients with unresectable well or moderately differentiated locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors gep nets to improve progression free survival somatuline depot is indicated for the treatment of adults with carcinoid syndrome when used it reduces the frequency of short acting somatostatin analog rescue therapy" assertion.
- association label "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 the intramuscular use of methylprednisolone acetate injectable suspension is indicated as follows allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions seasonal or perennial allergic rhinitis serum sickness transfusion reactions dermatologic diseases bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome 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 congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis systemic therapy and ulcerative colitis hematologic disorders acquired autoimmune hemolytic anemia congenital erythroid hypoplastic anemia diamond blackfan anemia pure red cell aplasia select cases of secondary thrombocytopenia miscellaneous trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy neoplastic diseases for palliative management of leukemias and lymphomas nervous system acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy ophthalmic diseases sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids renal diseases to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus respiratory diseases berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis polymyositis and systemic lupus erythematosus see warnings methylprednisolone acetate injectable suspension is indicated as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute and subacute bursitis acute nonspecific tenosynovitis epicondylitis rheumatoid arthritis synovitis of osteoarthritis methylprednisolone acetate injectable suspension is indicated for intralesional use in alopecia areata discoid lupus erythematosus keloids localized hypertrophic infiltrated inflammatory lesions of granuloma annulare lichen planus lichen simplex chronicus neurodermatitis and psoriatic plaques necrobiosis lipoidica diabeticorum methylprednisolone acetate injectable suspension also may be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
- association label "alimta r in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic non squamous nsclc with no egfr or alk genomic tumor aberrations 1 1 in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non squamous non small cell lung cancer nsclc 1 1 as a single agent for the maintenance treatment of patients with locally advanced or metastatic non squamous nsclc whose disease has not progressed after four cycles of platinum based first line chemotherapy 1 1 as a single agent for the treatment of patients with recurrent metastatic non squamous nsclc after prior chemotherapy 1 1 limitations of use 1 1 initial treatment in combination with cisplatin of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery 1 2 alimta r in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non squamous non small cell lung cancer nsclc as a single agent for the maintenance treatment of patients with locally advanced or metastatic non squamous nsclc whose disease has not progressed after four cycles of platinum based first line chemotherapy as a single agent for the treatment of patients with recurrent metastatic non squamous nsclc after prior chemotherapy limitations of use see clinical studies 14 1 alimta is indicated in combination with cisplatin for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery" assertion.
- association label "thalomid in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma mm 1 1 thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum enl 1 2 thalomid in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma mm see clinical studies 14 1 thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum enl thalomid is not indicated as monotherapy for such enl treatment in the presence of moderate to severe neuritis thalomid is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of enl recurrence see clinical studies 14 2" assertion.
- association label "tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia apl french american british fab classification m3 including the m3 variant characterized by the presence of the t 15 17 translocation and or the presence of the pml rari gene who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline based chemotherapy is contraindicated tretinoin capsules are for the induction of remission only the optimal consolidation or maintenance regimens have not been defined but all patients should receive an accepted form of remission consolidation and or maintenance therapy for apl after completion of induction therapy with tretinoin capsules" assertion.
- association label "when oral therapy is not feasible the intramuscular use r r control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions perennial or seasonal allergic rhinitis serum sickness transfusion reactions bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis acquired autoimmune hemolytic anemia diamond blackfan anemia pure red cell aplasia selected cases of secondary thrombocytopenia trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy for palliative management of leukemias and lymphomas acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis rheumatic disorders the intra articular or soft tissue administration the intralesional administration celestone soluspan injectable suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.
- association label "candesartan cilexetil tablets are an angiotensin ii receptor blocker arb indicated for treatment of hypertension in adults and children 1 to 17 years of age to lower blood pressure lowering blood pressure reduces the risk of fatal and non fatal cardiovascular events primarily strokes and myocardial infarctions 1 1 treatment of heart failure nyha class ii iv candesartan reduces cardiovascular death and heart failure hospitalization 1 2 candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to 17 years of age to lower blood pressure lowering blood pressure reduces the risk of fatal and non fatal cardiovascular events primarily strokes and myocardial infarctions these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs control of high blood pressure should be part of comprehensive cardiovascular risk management including as appropriate lipid control diabetes management antithrombotic therapy smoking cessation exercise and limited sodium intake many patients will require more than one drug to achieve blood pressure goals for specific advice on goals and management see published guidelines such as those of the national high blood pressure education program s joint national committee on prevention detection evaluation and treatment of high blood pressure jnc numerous antihypertensive drugs from a variety of pharmacologic classes and with different mechanisms of action have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs that is largely responsible for those benefits the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmhg is greater at higher blood pressures so that even modest reductions of severe hypertension can provide substantial benefit relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk so the absolute benefit is greater in patients who are at higher risk independent of their hypertension for example patients with diabetes or hyperlipidemia and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal some antihypertensive drugs have smaller blood pressure effects as monotherapy in black patients and many antihypertensive drugs have additional approved indications and effects e g on angina heart failure or diabetic kidney disease these considerations may guide selection of therapy candesartan cilexetil tablets may be used alone or in combination with other antihypertensive agents candesartan cilexetil tablets are indicated for the treatment of heart failure nyha class ii iv in adults with left ventricular systolic dysfunction ejection fraction 4 to reduce cardiovascular death and to reduce heart failure hospitalizations see clinical studies 14 2 see drug interactions 7 4" assertion.
- association label "in adults digoxin is indicated for the treatment of mild to moderate heart failure and for the control of resting ventricular rate in patients with chronic atrial fibrillation 1 in pediatric patients with heart failure digoxin increases myocardial contractility digoxin oral solution usp is indicated for the treatment of mild to moderate heart failure digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by increased exercise capacity and decreased heart failure related hospitalizations and emergency care while having no effect on mortality where possible digoxin should be used with a diuretic and an angiotensin converting enzyme inhibitor but an optimal order for starting these three drugs cannot be specified digoxin increases myocardial contractility in pediatric patients with heart failure digoxin oral solution usp is indicated for the control of resting ventricular response rate in patients with chronic atrial fibrillation digoxin should not be used for the treatment of multifocal atrial tachycardia" assertion.
- association label "zaroxolyn is indicated for the treatment of salt and water retention including edema accompanying congestive heart failure edema accompanying renal diseases including the nephrotic syndrome and states of diminished renal function zaroxolyn is also indicated for the treatment of hypertension alone or in combination with other antihypertensive drugs of a different class mykrox tablets a more rapidly available form of metolazone are intended for the treatment of new patients with mild to moderate hypertension a dose titration is necessary if mykrox tablets are to be substituted for zaroxolyn in the treatment of hypertension see package circular for mykrox tablets ucb the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard diuretics do not prevent development of toxemia of pregnancy and there is no evidence that they are useful in the treatment of developed toxemia edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy zaroxolyn is indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy see dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose use of diuretics to lower intravascular volume in this case is illogical and unnecessary there is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother in the absence of cardiovascular disease but which is associated with edema including generalized edema in the majority of pregnant women if this edema produces discomfort increased recumbency will often provide relief in rare instances this edema may cause extreme discomfort which is not relieved by rest in these cases a short course of diuretics may be appropriate precautions" assertion.
- association label "tamiflu is an influenza neuraminidase inhibitor indicated for treatment of influenza in patients 1 year and older who have been symptomatic for no more than 2 days 1 1 prophylaxis of influenza in patients 1 year and older 1 2 important limitations of use efficacy not established in patients who begin therapy after 48 hours of symptoms 1 3 not a substitute for annual influenza vaccination 1 3 no evidence of efficacy for illness from agents other than influenza viruses types a and b 1 3 consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use 1 3 tamiflu is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days tamiflu is indicated for the prophylaxis of influenza in patients 1 year and older the following points should be considered before initiating treatment or prophylaxis with tamiflu efficacy of tamiflu in patients who begin treatment after 48 hours of symptoms has not been established tamiflu is not a substitute for early influenza vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices there is no evidence for efficacy of tamiflu in any illness caused by agents other than influenza viruses types a and b influenza viruses change over time emergence of resistance mutations could decrease drug effectiveness other factors for example changes in viral virulence might also diminish clinical benefit of antiviral drugs prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use tamiflu" assertion.
- association label "prednisolone sodium phosphate oral solution 15 mg prednisolone per 5 ml is indicated in the following conditions 1 allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with seasonal or perennial allergic rhinitis asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 2 dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme stevens johnson syndrome exfoliative erythroderma mycosis fungoides 3 edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations with idiopathic nephrotic syndrome without uremia 4 endocrine disorders primary or secondary adrenocortical insufficiency hydrocortisone or cortisone is the first choice synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis 5 gastrointestinal diseases to tide the patient over a critical period of the disease in ulcerative colitis regional enteritis 6 hematologic disorders idiopathic thrombocytopenic purpura in adults selected cases of secondary thrombocytopenia acquired autoimmune hemolytic anemia pure red cell aplasia diamond blackfan anemia 7 neoplastic diseases for the treatment of acute leukemia and aggressive lymphomas in adults and children 8 nervous system acute exacerbations of multiple sclerosis 9 ophthalmic diseases uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids temporal arteritis sympathetic ophthalmia 1 respiratory diseases symptomatic sarcoidosis idiopathic eosinophilic pneumonias fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy asthma as distinct from allergic asthma listed above under allergic states hypersensitivity pneumonitis idiopathic pulmonary fibrosis acute exacerbations of chronic obstructive pulmonary disease copd and pneumocystis carinii pneumonia pcp associated with hypoxemia occurring in an hiv individual who is also under treatment with appropriate anti pcp antibiotics studies support the efficacy of systemic corticosteroids for the treatment of these conditions allergic bronchopulmonary aspergillosis idiopathic bronchiolitis obliterans with organizing pneumonia 11 rheumatic disorders as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis epicondylitis for the treatment of systemic lupus erythematosus dermatomyositis polymyositis polymyalgia rheumatica sjogren s syndrome relapsing polychondritis and certain cases of vasculitis 12 miscellaneous tuberculous meningitis with subarachnoid block or impending block tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty and tuberculosis with pleural or pericardial effusion appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications trichinosis with neurologic or myocardial involvement acute or chronic solid organ rejection with or without other agents" assertion.
- association label "temozolomide capsules are an alkylating drug indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme gbm concomitantly with radiotherapy and then as maintenance treatment 1 1 refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine 1 2 temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma i e patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine" assertion.
- association label "when oral therapy is not feasible the intramuscular use control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma atopic dermatitis contact dermatitis drug hypersensitivity reactions perennial or seasonal allergic rhinitis serum sickness transfusion reactions bullous dermatitis herpetiformis exfoliative erythroderma mycosis fungoides pemphigus severe erythema multiforme stevens johnson syndrome congenital adrenal hyperplasia hypercalcemia associated with cancer nonsuppurative thyroiditis hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency synthetic analogs may be used in conjunction with mineralocorticoids where applicable in infancy mineralocorticoid supplementation is of particular importance to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis acquired autoimmune hemolytic anemia diamond blackfan anemia pure red cell aplasia selected cases of secondary thrombocytopenia trichinosis with neurologic or myocardial involvement tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy for palliative management of leukemias and lymphomas acute exacerbations of multiple sclerosis cerebral edema associated with primary or metastatic brain tumor or craniotomy sympathetic ophthalmia temporal arteritis uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy idiopathic eosinophilic pneumonias symptomatic sarcoidosis as adjunctive therapy for short term administration to tide the patient over an acute episode or exacerbation in acute gouty arthritis acute rheumatic carditis ankylosing spondylitis psoriatic arthritis rheumatoid arthritis including juvenile rheumatoid arthritis selected cases may require low dose maintenance therapy for the treatment of dermatomyositis polymyositis and systemic lupus erythematosus the intra articular or soft tissue administration the intralesional administration betamethasone sodium phosphate and betamethasone acetate injectable suspension may also be useful in cystic tumors of an aponeurosis or tendon ganglia" assertion.