um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Prednisone Tablets, USP 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; hypercalcemia associated with cancer; nonsuppurative thyroiditis.
Endocrine 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.
Rheumatic Disorders
During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.
Collagen Diseases
Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens- Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis.
Dermatologic Diseases
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.
Allergic States
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.
Ophthalmic Diseases
Symptomatic sarcoidosis; Loefflers syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis.
Respiratory Diseases
Idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia.
Hematologic Disorders
For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.
Neoplastic Diseases
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
Edematous States
To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis.
Gastrointestinal Diseases
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.
Miscellaneous
1 INDICATIONS AND USAGE
OMNIPAQUE Imaging Bulk Package is indicated for
Computed tomographic (CT) imaging of the head and body by intravenous administration in:
adults (300 and 350 mg iodine/mL)
pediatric patients (300 mg iodine/mL)
For use only with an automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with OMNIPAQUE Imaging Bulk Package.
OMNIPAQUE Imaging Bulk Package is a radiographic contrast agent indicated for intravenous computed tomographic (CT) imaging of the head and body in adult and pediatric patients. (
2.1
)
For use only with an automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with OMNIPAQUE Imaging Bulk Package.
INDICATIONS AND USAGE:
PAROEX(Chlorhexidine Gluconate Oral Rinse USP, 0.12%) is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Paroex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis,see
PRECAUTIONS.
1.4 Important Limitations
Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition , .
[see Warnings and Precautions , ,
(5.2
5.3
5.4)
Use in Specific Populations , and Patient Counseling Information ]
(8.1)
(17.3)
Divalproex sodium extended-release tablets are contraindicated for prophylaxis of migraine headaches in women who are pregnant.
Gentamicin sulfate ophthalmic solution is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms:
Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli; Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
INDICATIONS AND USAGE
Fluorouracil Cream is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.
The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil Cream is approximately 93%, based on 113 lesions in 54 patients. Eighty-eight lesions treated with the cream produced 7 failures.
INDICATIONS & USAGE
Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days).
The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
INDICATIONS
Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed.
Neurolite is not indicated for assessment of functional viability of brain tissue.
Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.
1 INDICATIONS AND USAGE
Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].
Desvenlafaxine extended-release tablet, is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).
Indomethacin capsules are indicated for:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
Acute gouty arthritis
1	INDICATIONS AND USAGE
Ziprasidone is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.2)
]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.2)].
Ziprasidone is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone to prolong the QT interval and may consider the use of other drugs first. (5.2)
Ziprasidone is indicated as an oral formulation for the:
Treatment of schizophrenia. (1.1)
Adults: Efficacy was established in four 46 week trials and one maintenance trial in adult patients with schizophrenia. (14.1)
Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder. (1.2)
Adults: Efficacy was established in two 3-week trials in adult patients with manic or mixed episodes. (14.2)
Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate. (1.2)
Adults: Efficacy was established in one maintenance trial in adult patients. (14.2)
1.1	Schizophrenia
Ziprasidone is indicated for the treatment of schizophrenia. The efficacy of oral ziprasidone was established in four short-term (4- and 6-week) controlled trials of adult schizophrenic inpatients and in one maintenance trial of stable adult schizophrenic inpatients [see Clinical Studies (14.1)].
1.2	Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
Ziprasidone is indicated as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Efficacy was established in two 3-week monotherapy studies in adult patients [see Clinical Studies (14.2)].
Ziprasidone is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder. Efficacy was established in a maintenance trial in adult patients. The efficacy of ziprasidone as monotherapy for the maintenance treatment of bipolar I disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
VERZENIO is a kinase inhibitor indicated:
in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (1.1, 14.1)
in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (1.2)
in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (1.2)
as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (1.2)
1.1 Early Breast Cancer
VERZENIO (abemaciclib) is indicated:
in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence [see Clinical Studies (14.1)].
1.2 Advanced or Metastatic Breast Cancer
VERZENIO (abemaciclib) is indicated:
in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitises is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drugs in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilusinfluenzae, Klebsiella/Enterobacterspecies, Niesseriaspecies, and Pseudomonas aeruginosa.
This product does not provide adequate coverage against: Serratiamarcescensand Streptococci, including Streptococcus pneumoniae.
1 INDICATIONS AND USAGE
Buprenorphine transdermal system is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
L
imitations of Use
Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risk of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve buprenorphine transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic
Buprenorphine transdermal system is a partial opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1)
L
i
mitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve buprenorphine transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1)
Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic. (1)
INDICATIONS & USAGE
Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
1 INDICATIONS AND USAGE
Dexmethylphenidate hydrochloride tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
[see Clinical Studies (14)].
Dexmethylphenidate hydrochloride tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (1).
INDICATIONS AND USAGE
Oxybutynin chloride syrup is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (ie, urgency, frequency, urinary leakage, urge incontinence, dysuria).
1 INDICATIONS AND USAGE
Linezolid is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.4)
Limitations of Use: (1.5)
Linezolid is not indicated for the treatment of Gram-negative infections.
The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.6)
1.1	Nosocomial Pneumonia
Linezolid is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14)
].
1.2 Community-acquired Pneumonia
Linezolid is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14)
].
1.3	Complicated Skin and Skin Structure Infections
Linezolid is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae. Linezolid has not been studied in the treatment of decubitus ulcers [see Clinical Studies (14)
].
1.4	Vancomycin-resistant Enterococcus faecium Infections
Linezolid is indicated for the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14)
].
1.5 Limitations of Use
Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [see Warnings and Precautions (5.4)
].
The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials [see Clinical Studies (14)
].
1.6	Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid and other antibacterial drugs, linezolid 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.
1. Indications and Usage
Trazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
1 INDICATIONS AND USAGE
Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. (
1.1)
1.1	Prophylaxis of Organ Rejection in Kidney, Heart, or Lung Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant
[see
Clinical Studies (14.1)]
, liver transplant
[see
Clinical Studies (14.2)],
heart transplant
[see
Clinical Studies (14.3)]
or lung transplant
[see
Clinical Studies (14.4)]
in combination with other immunosuppressants.
Additional pediatric use information is approved for Astellas Pharma US, Inc.s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
1 INDICATIONS AND USAGE
LYRICA is indicated for:
1.1 Management of neuropathic pain associated with diabetic peripheral neuropathy1.2 Management of postherpetic neuralgia1.3 Adjunctive therapy for adult patients with partial onset seizures1.4 Management of fibromyalgia
1 INDICATIONS AND USAGE
Rosuvastatin tablets are indicated:
To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP 2 mg/L, and at least one additional CV risk factor.
As an adjunct to diet to:
oReduce LDL-C in adults with primary hyperlipidemia.
oReduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.
oReduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to diet for the treatment of adults with:
oPrimary dysbetalipoproteinemia.
oHypertriglyceridemia.
Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Rosuvastatin tablets are an HMG Co-A reductase inhibitor (statin) indicated: (1)
To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP 2 mg/L, and at least one additional CV risk factor.
As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.
As an adjunct to diet to reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to diet for the treatment of adults with:
oPrimary dysbetalipoproteinemia.
oHypertriglyceridemia.
1 INDICATIONS AND USAGE
Fesoterodine fumarate is indicated for the treatment of:
Overactive bladder(OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1)
1.1
Adult Overactive Bladder
Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
Pediatric use information is approved for Pfizer Inc.s TOVIAZ (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.s marketing exclusivity rights, this drug product is not labeled with that information.