um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
1.1 Major Depressive Disorder
Escitalopram is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [
see Clinical Studies (
14.1)
].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [
see Clinical Studies (
14.2)
].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
1 INDICATIONS AND USAGE
CYSTADANE
is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are:
Cystathionine beta-synthase (CBS) deficiency
5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency
Cobalamin cofactor metabolism (cbl) defect
CYSTADANE is a methylating agent indicated in pediatric and adult patients for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations. Included within the category of homocystinuria are (
1):
Cystathionine beta-synthase (CBS) deficiency
5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency
Cobalamin cofactor metabolism (cbl) defect
INDICATIONS AND USAGE
Mirtazapine Tablets USP are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders-3rd edition (DSM-lll) category of major depressive disorder (see
CLINICAL PHARMACOLOGY
).
A major depressive episode (DSM-lV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
The effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8-12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (See
CLINICAL PHARMACOLOGY
).
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (
see
WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation
).
Mefenamic acid is indicated:
For relief of mild to moderate pain in patients
14 years of age, when therapy will not exceed one week (7 days).
For treatment of primary dysmenorrhea.
1 INDICATIONS AND USAGE
SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of:
Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate (1.1)
Active Psoriatic Arthritis (PsA) in patients 2 years of age and older (1.2)
Adult patients with active Ankylosing Spondylitis (AS) (1.3)
Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older (1.4)
1.1
Rheumatoid Arthritis (RA)
SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
1.2	Psoriatic Arthritis (PsA)
SIMPONI ARIA is indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older.
1.3	Ankylosing Spondylitis (AS)
SIMPONI ARIA is indicated for the treatment of adult patients with active ankylosing spondylitis.
1.4	Polyarticular Juvenile Idiopathic Arthritis (pJIA)
SIMPONI ARIA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.
1
INDICATIONS AND USAGE
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)].
Limitations of Use
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.
Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1)
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1)
1 INDICATIONS AND USAGE
Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.
Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.s Bridion
(Sugammadex Injection). However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. (1)
INDICATIONS AND USAGE
Levsin is effective as adjunctive therapy in the treatment of peptic ulcer. In acute episodes, Levsin injection can be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Parenterally administered Levsin is also effective in reducing gastrointestinal motility to facilitate diagnostic procedures such as endoscopy or hypotonic duodenography. Levsin may be used to reduce pain and hypersecretion in pancreatitis, in certain cases of partial heart block associated with vagal activity, and as an antidote for poisoning by anticholinesterase agents.
In Anesthesia:
Levsin injection is indicated as a pre-operative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions, to reduce the volume and acidity of gastric secretions, and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. Levsin protects against the peripheral muscarinic effects such as bradycardia and excessive secretions produced by halogenated hydrocarbons and cholinergic agents such as physostigmine, neostigmine, and pyridostigmine given to reverse the actions of curariform agents.
In Urology:
Levsin injection may also be used intravenously to improve radiologic visibility of the kidneys. It is also indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic.
INDICATIONS AND USAGE
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a 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 conjunctivitides 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 drug in this product is active against the following common bacterial eye pathogens:
Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species
, and
Pseudomonas aeruginosa. This product does not provide adequate coverage against:
Serratia marcescens and Streptococci, including
Streptococcus pneumoniae.
1 INDICATIONS & USAGE
Methadone hydrochloride tablets are indicated for the:
1.Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations 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 long-acting opioids [see Warnings and Precautions (5.1)], reserve methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic.
2.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
3.Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)].
Methadone hydrochloride tablets are an opioid agonist indicated for the: 1.Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations 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 long-acting opioids, reserve methadone hydrochloride tablets 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.
Methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic.
2.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
3.Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (1)
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 (2.1).
1 INDICATIONS AND USAGE
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults
[see
Clinical Studies (14)]
.
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults. (
1)
INDICATIONS AND USAGE
Levorphanol tartrate tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve levorphanol tartrate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
1 INDICATIONS AND USAGE
PULMICORT RESPULES is an inhaled corticosteroid indicated for:
Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1)
Limitations of Use:
Not indicated for the relief of acute bronchospasm (1)
1.1 Maintenance Treatment of Asthma
PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.
Limitations of Use:
PULMICORT RESPULES is NOT indicated for the relief of acute bronchospasm.
INDICATIONS AND USAGE
Sucralfate is indicated in:
Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
INDICATIONS AND USAGE
ELINESTTM
is indicated for use by females of reproductive potential to prevent pregnancy.
In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15 to 40 years was approximately 1 pregnancy per 100 women-years of use.
1 INDICATIONS AND USAGE
Glycopyrrolate oral solution is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy)
INDICATIONS ANDUSAGE
Triamcinolone acetonide cream, USP 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Indomethacin extended-release 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)
Indomethacin extended-release capsules are a nonsteroidal anti-inflammatory drug 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) (
1)
1.4 Usage
Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Daptomycin for Injection and other antibacterial drugs, Daptomycin for Injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information is available, it 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. Empiric therapy may be initiated while awaiting test results.
1 INDICATIONS AND USAGE
Ifosfamide Injection is indicated for use in combination with certain other approved antineoplastic agentsfor third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.
Ifosfamide Injection is an alkylating drug indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. (1)
1 INDICATIONS AND USAGE
Pioglitazone tablet is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (
1.1,
14)
Important Limitation of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (
1.2)
1.1
Monotherapy and Combination Therapy
Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings
[see
Clinical Studies (14)]
.
1.2
Important Limitation of Use
Pioglitazone tablet exerts its antihyperglycemic effect only in the presence of endogenous insulin.
Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease
[see
Warnings and Precautions (5.3)].
1 INDICATIONS AND USAGE
Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea.
Vancomycin Hydrochloride Capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.
Limitations of Use
Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections.
Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride Capsules and other antibacterial drugs, Vancomycin Hydrochloride Capsules 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.
Vancomycin Hydrochloride Capsules are a glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: (1)
Clostridioides difficile-associated diarrhea
Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains)
Limitations of Use: (1) (5.1)
Parenteral administration of vancomycin is not effective for the above infections; therefore, Vancomycin Hydrochloride Capsules must be given orally for these infections.
Orally administered Vancomycin Hydrochloride Capsules are not effective for other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride Capsules and other antibacterial drugs, Vancomycin Hydrochloride Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)
INDICATIONS AND USAGE:
Folic Acid Injection, USP alone is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or nontropical sprue, in anemias of nutritional origin, pregnancy, infancy or childhood.
INDICATIONS AND USAGE
Prednisone tablets 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, acute rheumatic carditis.
Dermatologic diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, 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 dematitis, 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, eythroblastopenia (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.
Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.
In addition to the above indications, prednisone tablets are indicated for systemic dermatomyositis (polymyositis).
INDICATIONS AND USAGE
Zinc 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition. Administration helps to maintain zinc serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
INDICATIONS:
10% Sodium Sulfacetamide 5% Sulfur Cleanser (in a Urea vehicle) is indicated in the topical control of acne vulgaris, acne rosacea
and seborrheic dermatitis.
1 INDICATIONS AND USAGE
Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age
[see
Clinical Studies (14)]
.
Methylphenidate hydrochloride extended-release capsule is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age.