um-ids/dailymed-annotations huggingface dataset:
Benazepril hydrochloride tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
It may be used alone or in combination with thiazide diuretics.
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ?35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure. (See CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials.)
In using enalapril maleate, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate does not have a similar risk. (See WARNINGS.)
In considering use of enalapril maleate, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks. (See WARNINGS, Head and Neck Angioedema.)
1 INDICATIONS AND USAGE
Quetiapine
fumarate
tablet is an atypical antipsychotic indicated for the treatment of:
Schizophrenia ( )
1.1
Bipolar I disorder manic episodes
( )
1.2
Bipolar disorder, depressive episodes
( )
1.2
1.2 Bipolar Disorder
Quetiapine fumarate tablet is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex.
Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [ .
see (14.2)]
Clinical Studies
Quetiapine fumarate tablet is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [ .
see (14.2)]
Clinical Studies
Quetiapine fumarate tablet is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine fumarate tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials. [ .
see (14.2)]
Clinical Studies
1.3	Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
INDICATIONS AND USAGE
Topicort (desoximetasone ointment USP) 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Cinacalcet tablets are a positive modulator of the calcium sensing receptor indicated for:
Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidneydisease (CKD)on dialysis. (1.1)
Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis
Hypercalcemiain adult patientswith Parathyroid Carcinoma (PC). (1.2)
Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. (1.3)
1.1 Secondary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see CLINICAL STUDIES (14.1)].
Limitations of Use
Cinacalcet tablets are not indicated for use in adult patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see WARNINGS AND PRECAUTIONS (5.1)].
1.2 Parathyroid Carcinoma
Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see CLINICAL STUDIES (14.2)].
1.3 Primary Hyperparathyroidism
Cinacalcet tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy [see CLINICAL STUDIES (14.3)].
1 INDICATIONS AND USAGE
Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults.
Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for the relief of pain in opioid-tolerant adults.
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride Oral Solution 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
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, [see Warnings and Precautions (5.2)
], reserve Oxycodone Hydrochloride Oral Solution 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
INDICATIONS AND USAGE:
Magnesium sulfate in water for injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.
INDICATIONS AND USAGE
Sucralfate oral suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
INDICATIONS AND USAGE
Intravenous adenosine injection is indicated for the following.
Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine administration.
It is important to be sure the adenosine solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION).1
Adenosine injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection administration.
Indications and Usage
Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.
INDICATIONS AND USAGE:
Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.
For prolonged control of blood pressure, patients should be transferred to oral medication as soon as their clinical condition permits (see
DOSAGE AND ADMINISTRATION
).
1 INDICATIONS AND USAGE
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
Trazodone hydrochloride tablets are is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1).
INDICATIONS AND USAGE
Clindamycin is indicated in the treatment of serious infections
caused by susceptible anaerobic bacteria.
Clindamycin is also indicated in the treatment of serious infections due to
susceptible strains of streptococci, pneumococci, and staphylococci. Its use
should be reserved for penicillin-allergic patients or other patients for whom,
in the judgment of the physician, a penicillin is inappropriate. Because of the
risk of colitis, as described in the WARNING box, before
selecting clindamycin the physician should consider the nature of the infection
and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such
as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue
infections; septicemia; intra-abdominal infections such as peritonitis and
intra-abdominal abscess (typically resulting from anaerobic organisms resident
in the normal gastrointestinal tract); infections of the female pelvis and
genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic
cellulitis and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections;
serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections;
serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract
infections.
Bacteriologic studies should be performed to determine the causative
organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of clindamycin hydrochloride and other antibacterial drugs,
clindamycin hydrochloride 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
XPOVIO is a nuclear export inhibitor indicated:
In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (1.1).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (1.1).
For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s) (1.2).
1.1 Multiple Myeloma
XPOVIO in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
XPOVIO in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
1.2 Diffuse Large B-Cell Lymphoma
XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
This indication is approved under accelerated approval based on response rate [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
7. 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
INDICATIONS AND USAGE
Betaxolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly thiazide-type diuretics.
1	INDICATIONS AND USAGE
Pemetrexed for Injection is a folate analog metabolic inhibitor indicated:
In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). (1.1)
As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1)
As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1)
Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1)
Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2)
1.1	Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed for Injection is indicated:
In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.
Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies 14.1].
1.2	Mesothelioma
Pemetrexed for Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
Atrial Fibrillation
Propranolol hydrochloride tablets, USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.
1 INDICATIONS AND USAGE
Erlotinib tablets are a kinase inhibitor indicated for:
The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1)
First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2)
Limitations of Use:
Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. (1.1)
Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. (1.1)
1.1 Non-Small Cell Lung Cancer (NSCLC)
Erlotinib tablets are indicated for:
The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen [see Clinical Studies (14.1, 14.3)].
Limitations of use:
Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations [see Clinical Studies (14.1, 14.2)].
Erlotinib tablets are not recommended for usein combination with platinum-based chemotherapy [see Clinical Studies (14.4)].
1.2 Pancreatic Cancer
Erlotinib tablets in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.5)].
INDICATIONS & USAGE
Intravenous adenosine injection is indicated for the following:
Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine injection administration.
It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see
DOSAGE AND ADMINISTRATION).
Adenosine injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine injection administration.
INDICATIONS:
For staining the anterior segment of the eye when fitting contact lenses, in disclosing corneal injury and in applanation tonometry.
1	INDICATIONS AND USAGE
INVEGA is an atypical antipsychotic agent indicated for
Treatment of schizophrenia (1.1)
Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1)
Adolescents (ages 1217): Efficacy was established in one 6-week trial. (14.1)
Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (1.2)
Efficacy was established in two 6-week trials in adult patients. (14.2)
1.1	Schizophrenia
INVEGA (paliperidone) Extended-Release Tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1)].
The efficacy of INVEGA in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.
1.2	Schizoaffective Disorder
INVEGA (paliperidone) Extended-Release Tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy
[see Clinical Studies (14.2)].
The efficacy of INVEGA in schizoaffective disorder was established in two 6-week trials in adults.
INDICATIONS: SodiumSulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheicdermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
1 INDICATIONS AND USAGE
Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.
Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older (1)
1 INDICATIONS AND USAGE
Gabapentin is indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin is indicated for:
Postherpetic neuralgia in adults (
1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
(1)
1 INDICATIONS AND USAGE
Darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
Darifenacin extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency (1).
1 INDICATIONS AND USAGE
Karbinal ER is indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of:
Seasonal and perennial allergic rhinitis
Vasomotor rhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
Dermatographism
As therapy for anaphylactic reactions
adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled
Amelioration of the severity of allergic reactions to blood or plasma
Karbinal ER is indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of:
Seasonal and perennial allergic rhinitis (
1)
Vasomotor rhinitis (
1)
Allergic conjunctivitis due to inhalant allergens and foods (
1)
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema (
1)
Dermatographism (
1)
As therapy for anaphylactic reactions
adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled (
1)
Amelioration of the severity of allergic reactions to blood or plasma (
1)