um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1 Partial-Onset Seizures
Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
INDICATIONS AND USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled.
The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See
DOSAGE AND ADMINISTRATION section.)
1 INDICATIONS & USAGE
Carglumic acid tablets for oral suspension is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as:
Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. (1.1)
Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. (1.1)
1.1 Acute and Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency
Carglumic acid tablets for oral suspension are indicated in pediatric and adult patients as:
Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency.
Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.
Risperidone tabletsare an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults and adolescent aged 13-17 years (1.1)
Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults, and alone in children and adolescent aged 10-17 years (1.2)
Treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years (1.3)
1.1
Schizophrenia
Adults
Risperidone tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)].
Adolescents
Risperidone tabletsare indicated for the treatment of schizophrenia in adolescents aged 1317 years [see Clinical Studies (14.1)].
1.2 Bipolar Mania
Monotherapy - Adults and Pediatrics
Risperidone tabletsare indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults [see Clinical Studies (14.2)].
Combination Therapy
Adults
The combination of risperidone tablets with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder [see Clinical Studies (14.3)].
1.3
Irritability Associated with Autistic Disorder
Pediatrics
Risperidone tabletsare indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 516 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [see Clinical Studies (14.4)].
1 INDICATIONS AND USAGE
Febuxostat Tablets are a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
Limitations of Use:
Febuxostat Tablets are not recommended for the treatment of asymptomatic hyperuricemia.
Febuxostat Tablets are a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. (1)
Limitations of Use:
Febuxostat Tablets are not recommended for the treatment of asymptomatic hyperuricemia. (1)
INDICATIONS AND USAGE
Terbutaline Sulfate Injection, USP is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
1.3	Adjunctive Treatment of Major Depressive Disorder
ABILIFY is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode [see CLINICAL STUDIES (14.3)].
INDICATIONS AND USAGE
Hypertension: Captopril tablets, USP are indicated for the treatment of hypertension.
In using captopril, consideration should be given to the risk of neutropenia/agranulocytosis (see
WARNINGS
).
Captopril may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations.
Captopril is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.
Heart Failure: Captopril tablets are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment.
Left Ventricular Dysfunction After Myocardial Infarction: Captopril tablets are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction 40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients.
Diabetic Nephropathy: Captopril tablets are indicated for the treatment of diabetic nephropathy (proteinuria > 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril tablets decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis).
In considering use of captopril tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see
WARNINGS: Head and Neck Angioedema and Intestinal Angioedema
).
1 INDICATIONS AND USAGE
NAPROSYN (naproxen) Suspension is indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
NAPROSYN Suspension is a non-steroidal anti-inflammatory drug indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
1 INDICATIONS AND USAGE
Fluoxetine capsules are indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder
[see Clinical Studies (
14.1)]
.
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)
[see Clinical Studies (
14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa
[see Clinical Studies (
14.3)]
.
Acute treatment of Panic Disorder, with or without agoraphobia
[see Clinical Studies (
14.4)].
Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).
Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax
.
Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (
1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (
1)
Acute and maintenance treatment of Bulimia Nervosa (
1)
Acute treatment of Panic Disorder, with or without agoraphobia (
1)
Fluoxetine capsules and olanzapine in combination for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder (
1)
Treatment Resistant Depression (
1)
INDICATIONS AND USAGE
Etomidate Injection USP is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties (see
CLINICAL PHARMACOLOGY
) should be weighed against the high frequency of transient skeletal muscle movements (see
ADVERSE REACTIONS
).
Intravenous etomidate is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.
1 INDICATIONS AND USAGE
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VUSION Ointment is indicated for adjunctive treatment of diaper dermatitis
when complicated by documented candidiasis (microscopic evidence of pseudohyphae
and /or budding yeast) in immunocompetent pediatric patients 4 weeks and older.
(
1
)
VUSION Ointment should not be used as a substitute for frequent diaper
changes. (
1
)
VUSION Ointment should not be used to prevent the occurrence of diaper
dermatitis, since preventative use may result in the development of drug
resistance. (
1
)
1.1 Indication
VUSION Ointment is indicated for the adjunctive treatment of
diaper dermatitis only when complicated by documented candidiasis (microscopic
evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric
patients 4 weeks and older. A positive fungal culture for Candida albicans is not adequate evidence of candidal
infection since colonization with C. albicans can
result in a positive culture. The presence of candidal infection should be
established by microscopic evaluation prior to initiating treatment.
VUSION should be used as part of a treatment regimen that includes measures
directed at the underlying diaper dermatitis, including gentle cleansing of the
diaper area and frequent diaper changes.
VUSION should not be used as a substitute for frequent
diaper changes. VUSION should not be used to prevent the occurrence of diaper
dermatitis, since preventative use may result in the development of drug
resistance.
1.2 Limitations of Use
The safety and efficacy of VUSION have not been demonstrated in
immunocompromised patients, or in infants less than 4 weeks of age (premature or
term).
The safety and efficacy of VUSION have not been evaluated in incontinent
adult patients.
VUSION should not be used
to prevent the occurrence of diaper dermatitis, such as in an adult
institutional setting, since preventative use may result in the development of
drug resistance.
1 INDICATIONS AND USAGE
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is a alpha2-adrenergic agonist indicated for:
Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride 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)
1.1 Intensive Care Unit Sedation
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride injection should be administered by continuous infusion not to exceed 24 hours.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Dexmedetomidine hydrochloride injection prior to extubation.
1.2 Procedural Sedation
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
Pediatric use information is approved for Hospira Inc.s PRECEDEXTM (dexmedetomidine hydrochloride) injection and PRECEDEXTM (dexmedetomidine hydrochloride) in sodium chloride injection. However, due to Hospira Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
1 INDICATIONS AND USAGE
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. (1)
1 INDICATIONS AND USAGE
Voriconazole is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue Candida infections (1.2)
Esophageal candidiasis (1.3)
Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4)
1.1Invasive Aspergillosis
Voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus
[see Clinical Studies (14.1, 14.5
) and Microbiology (12.4)].
1.2Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections
Voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2, 14.5
) and Microbiology (12.4)].
1.3Esophageal Candidiasis
Voriconazole is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients 2 years of age and older [see Clinical Studies (14.3, 14.5
) and Microbiology (12.4)].
1.4Scedosporiosis and Fusariosis
Voriconazole is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see Clinical Studies (14.4) and Microbiology (12.4)].
1.5Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
WELLBUTRINSR (bupropion hydrochloride) is 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 WELLBUTRINSR in maintaining an antidepressant response for up to 44weeks following 8weeks of acute treatment was demonstrated in a placebocontrolled trial [see Clinical Studies (14)].
WELLBUTRIN SR is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1)
1 INDICATIONS AND USAGE
Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)].
Bosentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%). (1)
INDICATIONS AND USAGE:
For treatment of ACUTE OTITIS MEDIA in children that is caused by susceptible strains of Haemophilus influenzae.
1.1 Nosocomial Pneumonia
Levofloxacinin 5% Dextrose Injectionis indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible
Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or
Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where
Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal -lactam is recommended
[see Clinical Studies (
14.1)].
1 INDICATIONS AND USAGE
Adapalene Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Adapalene Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. (1)
1 INDICATIONS AND USAGE
VOSEVI is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have [see Dosage and Administration (2.2) and Clinical Studies (14)]:
genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.
genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.
Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.
VOSEVI is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, velpatasvir, an HCV NS5A inhibitor, and voxilaprevir, an HCV NS3/4A protease inhibitor, and is indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have (1, 2.2, 14):
genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor.
genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.
Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor.
1INDICATIONS AND USAGE
TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
1 INDICATIONS AND USAGE
Metformin hydrochloride extended-release tabletsare indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablets are biguanide indicated as an adjunct to diet and exercise toimprove glycemic control in adults with type 2 diabetes mellitus. (1)
INDICATIONS AND USAGE
Edetate calcium disodium injection is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults.
Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.
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.
INDICATIONS AND USAGE
Diltiazem hydrochloride extended-release capsules (Once-a-day dosage)are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.Diltiazem hydrochloride extended-release capsules (Once-a-day dosage)are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
INDICATIONS AND USAGE
Quflora 0.5 mg/mL F* Pediatric Drops is a prescription dietary supplement providing essential vitamins, minerals and fluoride.