um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of:
Mild to moderate dementia of the Alzheimers type (1.1)
Mild to moderate dementia associated with Parkinsons disease (1.2)
1.1 Alzheimer's Disease
Rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.
1.2 Parkinson's Disease Dementia
Rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia associated with Parkinson's disease.
1 INDICATIONS AND USAGE
1.1 Intensive Care Unit Sedation
Dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours.
Dexmedetomidine injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine injection prior to extubation.
1.2 Procedural Sedation
Dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
Dexmedetomidine injection is a relatively selective alpha
2-adrenergic agonist indicated for:
Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer dexmedetomidine injection by continuous infusion not to exceed 24 hours. (
1.1)
Sedation of non-intubated patients prior to and/or during surgical and other procedures. (
1.2)
1 INDICATIONS AND USAGE
Atorvastatin Calcium Tablets are indicated:
To reduce the risk of:
Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD
MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD
Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:
Adults with primary hyperlipidemia.
Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia
Hypertriglyceridemia
Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated (
1):
Reduce the risk of:
Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.
As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in:
Adults with primary hyperlipidemia.
Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia.
As an adjunct to diet for the treatment of adults with:
Primary dysbetaliproteinemia.
Hypertriglyceridemia.
1
INDICATIONS & USAGE
Sodium Chloride Injection, USP, 0.9% is indicated for:
Dilution or Dissolving the drugs for intravenous, intramuscular or subcutaneous injections (
1.1).
1.1 Dilution or Dissolution of Drugs
Sodium Chloride Injection, USP, 0.9% is indicated for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
1	INDICATIONS AND USAGE
JARDIANCE is indicated:
to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated:
to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. (
1)
to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. (
1)
as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (
1)
Limitations of Use:
Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. (
1)
Not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m
2 (
1)
Limitations of Use
JARDIANCE is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients
[see
Warnings and Precautions (5.1)]
.
JARDIANCE is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m
2. JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.
1.11 Urinary Tract Infections
Urinary Tract Infections in Adults
Ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible
Staphylococcus epidermidis, Staphylococcus saprophyticus, or
Enterococcus faecalis.
Acute Uncomplicated Cystitis
Ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by
Escherichia coli or
Staphylococcus saprophyticus.
Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions [see
WARNINGS AND PRECAUTIONS (
5.1 to
5.16)] and for some patients acute uncomplicated cystitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options.
Complicated Urinary Tract Infection and Pyelonephritis in Pediatric Patients
Ciprofloxacin tablets are indicated in pediatric patients aged one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to
Escherichia coli [see
USE IN SPECIFIC POPULATIONS (
8.4)].
Although effective in clinical trials, ciprofloxacin tablets are not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. Ciprofloxacin tablets, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see
WARNINGS AND PRECAUTIONS (
5.13),
ADVERSE REACTIONS (
6.1),
USE IN SPECIFIC POPULATIONS (
8.4) and
NONCLINICAL TOXICOLOGY (
13.2)].
1 INDICATIONS AND USAGE
Extended phenytoin sodium capsules, USP are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. (1)
INDICATIONS AND USAGE
Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Upper Respiratory Tract:
Pharyngitis/Tonsillitis:
Caused by Streptococcus pyogenes.
NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present.
Otitis Media:
Caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains). (See
CLINICAL STUDIES.)
NOTE: In the treatment of otitis media due to -lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific -lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing -lactamase inhibitors.
Acute Sinusitis:
Caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains).
Lower Respiratory Tract:
Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis:
Caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains).
Skin and Skin Structure:
Uncomplicated Skin and Skin-Structure Infections:
Caused by Staphylococcus aureus (including penicillinase producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil tablets and other antibacterial drugs, cefprozil 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.
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 tablets (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
Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder.
The efficacy of mirtazapine tablets, USP 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-III) category of major depressive disorder (see
CLINICAL PHARMACOLOGY).
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.
The effectiveness of mirtazapine tablets, USP in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine tablets, USP in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine tablets, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see
CLINICAL PHARMACOLOGY).
Close
1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events
In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets, USP are indicated to:
Reduce the risk of total mortality by reducing CHD deaths.
Reduce the risk of non-fatal myocardial infarction and stroke.
Reduce the need for coronary and non-coronary revascularization procedures.
INDICATIONS AND USAGE
Nitrofurantoin Monohydrate/Macrocrystals Capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Monohydrate/Macrocrystals Capsules and other antibacterial drugs, Nitrofurantoin Monohydrate/Macrocrystals 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Monohydrate/Macrocrystals Capsules are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Monohydrate/Macrocrystals Capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Monohydrate/Macrocrystals Capsules, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
1 INDICATIONS AND USAGE
Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.
Solifenacin succinate tablets are a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. (1)
INDICATIONS AND USAGE
In patients without structural heart disease, flecainide is indicated for the prevention of
-
paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms
-
paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.
Flecainide is also indicated for the prevention of
-
documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician, are life-threatening.
Use of flecainide for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.
Because of the proarrhythmic effects of flecainide, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.
Flecainide should not be used in patients with recent myocardial infarction (see
Boxed WARNINGS
).
Use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended (see
Boxed WARNINGS
).
As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide favorably affects survival or the incidence of sudden death.
INDICATIONS AND USAGE
Promethazine HCl Suppositories, USP are useful for:
Perennial and seasonal allergic rhinitis.Vasomotor rhinitis.Allergic conjunctivitis due to inhalant allergens and foods.Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.Amelioration of allergic reactions to blood or plasma.Dermographism.Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.Preoperative, postoperative, or obstetric sedation.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.Active and prophylactic treatment of motion sickness.Antiemetic therapy in postoperative patients.
INDICATIONS & USAGE
In Anesthesia
Glycopyrrolate Injection, USP is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection, USP may be used intraoperatively to counteract surgically or drug induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.
In Peptic Ulcer
For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
Indications and Usage Section
1 INDICATIONS AND USAGE
Phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
Height (feet, inches)
Weight
(pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3"
140 27
25
23 21 19 18
150 29 27 24 22 20 19
160 31 28 26 24 22 20
170 33 30 28 25 23 21
180 35 32 29 27 25 23
190 37 34 31 28 26 24
200 39 36 32 30 27 25
210 41 37 34 31 29 26
220 43 39 36 33 30 28
230 45 41 37 34 31 29
240 47 43 39 36 33 30
250 49 44 40 37 34 31
The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
1 INDICATIONS AND USAGE
LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1)].
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
LYTGOBI is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. (1, 2.1)
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (seeWARNINGS).Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis.
1
INDICATIONS AND USAGE
MESALAMINE delayed-release capsulesis an aminosalicylate indicated for:
Treatment of mildly to moderately active ulcerative colitis in patients5 years of age and older. (1.1)
Maintenance of remission of ulcerative colitis in adults. (1.2)
1.1
Treatment of Mildly to Moderately Active Ulcerative Colitis
MESALAMINE delayed-release capsulesis indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.
1.2
Maintenance of Remission of Ulcerative Colitis
MESALAMINE delayed-release capsulesis indicated for the maintenance of remission of ulcerative colitis in adults.
INDICATIONS & USAGE SECTION
Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.*
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
SCENESSE is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
SCENESSE is a melanocortin 1 receptor (MC1-R) agonist indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from
erythropoietic protoporphyria (EPP)