um-ids/dailymed-annotations huggingface dataset:
Heart Failure
Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY, for details and limitations of survival trials).
Heart Failure, Mortality Trials
1 INDICATIONS AND USAGE
ACTEMRA (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:
Rheumatoid Arthritis (RA) (1.1)
Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
Giant Cell Arteritis (GCA) (1.2)
Adult patients with giant cell arteritis.
Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) (1.3)
Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Polyarticular Juvenile Idiopathic Arthritis (PJIA) (1.4)
Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
Systemic Juvenile Idiopathic Arthritis (SJIA) (1.5)
Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
Cytokine Release Syndrome (CRS) (1.6)
Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.
Coronavirus Disease 2019 (COVID-19) (1.7)
Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
1.1	Rheumatoid Arthritis (RA)
ACTEMRA (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
1.2	Giant Cell Arteritis (GCA)
ACTEMRA (tocilizumab) is indicated for the treatment of giant cell arteritis (GCA) in adult patients.
1.3	Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
ACTEMRA (tocilizumab) is indicated for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease.
1.4	Polyarticular Juvenile Idiopathic Arthritis (PJIA)
ACTEMRA (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
1.5	Systemic Juvenile Idiopathic Arthritis (SJIA)
ACTEMRA (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
1.6	Cytokine Release Syndrome (CRS)
ACTEMRA (tocilizumab) is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older.
1.7
Coronavirus Disease 2019 (COVID-19)
ACTEMRA (tocilizumab) is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
INDICATIONS AND USAGE
MALES
Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone.
a.Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome; or orchiectomy.
b.Hypogonadotrophic hypogonadism (congenital or acquired) - idiopathic or gonadotropic LHRH deficiency, or pituitary - hypothalamic injury from tumors, trauma or radiation.
If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.
c.Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An x-ray of the hand and wrist to determine bone age should be taken every 6 months to assess the effect of treatment on epiphyseal centers (see WARNINGS).
1 INDICATIONS AND USAGE
TORISEL is indicated for the treatment of advanced renal cell carcinoma.
TORISEL
is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. (1)
INDICATIONS AND USAGE
Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
1 INDICATIONS AND USAGE
Adults
REVATIO is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)].
Pediatric Patients (1 to 17 Years old)
REVATIO is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [see Clinical Studies (14)].
Adults
REVATIO is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. (1)
Pediatric Patients (1 to17 years old)
REVATIO is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underly improvements in exercise (1, 14)
1 INDICATIONS AND USAGE
Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.
Azelastine hydrochloride nasal spray is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. (1)
INDICATIONS AND USAGE
Because of its life-threatening side effects and the substantial management difficulties associated with its use (see
WARNINGS
below), amiodarone is indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated.
Recurrent ventricular fibrillation.
Recurrent hemodynamically unstable ventricular tachycardia.
As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone hydrochloride tablets favorably affects survival.
Amiodarone should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. Because of the life-threatening nature of the arrhythmias treated, potential interactions with prior therapy, and potential exacerbation of the arrhythmia, initiation of therapy with amiodarone should be carried out in the hospital.
1 INDICATIONS AND USAGE
Fenofibrate tablets are a peroxisome proliferator receptor alpha (PPAR) activator indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (
1.1).
For treatment of adult patients with severe hypertriglyceridemia (
1.2).
Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (
5.1).
1.1 Primary
Hypercholesterolemia
or Mixed Dyslipidemia
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus
[
see Warnings and Precautions (5.1)]
.
INDICATIONS AND USAGE:
Chlordiazepoxidehydrochloride and clidinium bromide capsule is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxidehydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
INDICATIONS & USAGE
Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.
1 INDICATIONS AND USAGE
Trospium chloride tablet is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Trospium chloride tablet is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)
1 INDICATIONS AND USAGE
VIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of:
Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (1.1)
Pediatric patients aged 1 month and older with newly diagnosed Juvenile Myelomonocytic Leukemia (JMML). (1.2)
1.1
Myelodysplastic Syndromes (MDS)
VIDAZA is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
1.2 Juvenile Myelomonocytic Leukemia (JMML)
VIDAZA is indicated for the treatment of pediatric patients aged one month and older with newly diagnosed JMML.
1 INDICATIONS AND USAGE
ADMELOG is indicated to improve glycemic control in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.
ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. (1)
INDICATIONS:
Prenaissance Plus is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
1 INDICATIONS AND USAGE
Acyclovir cream, 5% is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.
Acyclovir cream, 5% is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.(1)
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, USP should be used only to treat 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.
Amoxicillin and clavulanate potassium for oral suspension, USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
Amoxicillin and clavulanate potassium for oral suspension, USP is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following:
Lower respiratory tract infections (1.1)
Acute bacterial otitis media (1.2)
Sinusitis (1.3)
Skin and skin structure infections (1.4)
Urinary tract infections (1.5)
1.1 Lower Respiratory Tract Infections
caused by beta-lactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by beta-lactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5	Urinary Tract Infections
caused by beta-lactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium for oral suspension, USP should not be used.
INDICATIONS AND USAGE
Ustell capsules are indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.
1 INDICATIONS AND USAGE
Montelukast sodium chewable tablets are a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (
1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (
1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (
1.3).
Limitations of Use:
Not indicated to treat an acute asthma attack (
5.2).
1.1 Asthma
Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium chewable tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis
[see Warnings and Precautions (
5.1)]
, reserve use for patients who have an inadequate response or intolerance to alternative therapies.
1.4 Limitations of Use
Montelukast sodium chewable tablets are not indicated for the treatment of an acute asthma attack.
1 INDICATIONS AND USAGE
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
Famotidine tablets are indicated in adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of duodenal ulcer recurrence.
Famotidine is a histamine-2 (H2) receptor antagonist indicated (1):
In adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer.
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
In adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of DU recurrence.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets, (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD
[see Clinical Studies (
14)]
.
The efficacy of bupropion hydrochloride extended-release tablet (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial
[see Clinical Studies (
14)]
.
Bupropion hydrochloride extended-release tablets, (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (
1)
INDICATIONS AND
USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride capsules and other antibacterial drugs, tetracycline 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.
Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
Upper respiratory tract infections caused by Streptococcus
pyogenes, Streptococcus
pneumoniae and Haemophilus
influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.
Lower respiratory tract infections caused by Streptococcus
pyogenes, Streptococcus
pneumoniae, Mycoplasma
pneumoniae (Eaton agent, and Klebsiella sp.)
Skin and soft tissue infections caused by Streptococcus
pyogenes, Staphylococcus
aureus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.)
Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.
Psittacosis caused by Chlamydophila psittaci.
Infections caused by Chlamydia
trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum.
Granuloma inquinale caused by Klebsiella
granulomatis.
Relapsing fever caused by Borrelia sp.
Bartonellosis caused by Bartonella
bacill iformis.
Chancroid caused by Haemophilus ducreyi.
Tularemia caused by Francisella tularensis.
Plaque caused by Yersinia
pestis.
Cholera caused by Vibrio
cholerae.
Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside).
Infections due to Campylobacter
fetus.
As adjunctive therapy in intestinal amebiasis caused by Entamoeba
histolytica.
Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc.
Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp.
In severe acne, adjunctive therapy with tetracycline may be useful.
When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:
Syphilis and yaws caused by Treponema pallidum and pertenue, respectively,
Vincents infection caused by Fusobacterium fusiforme,
Infections caused by Neisseria gonorrhoeae,
Anthrax caused by Bacillus anthracis,
Infections due to Listeria monocytogenes,
Actinomycosis caused by Actinomyces species,
Infections due to Clostridium species.
INDICATIONS AND USAGE
Isoproterenol hydrochloride injection is indicated:
For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.
For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation). (see
CONTRAINDICATIONS
)
For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available. (see
CONTRAINDICATIONS
)
For bronchospasm occurring during anesthesia.
As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock. (see
WARNINGS
)