um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
ANCOBON is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.
Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.
Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.
ANCOBON should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to ANCOBON (see
MICROBIOLOGY
).
1
INDICATIONS AND USAGE
Tasigna is a kinase inhibitor indicated for the treatment of:
Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1)
Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2)
Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3)
1.1
Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP
Tasigna is indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
1.2
Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP
Tasigna is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib.
1.3
Pediatric Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP
Tasigna is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy.
1 INDICATIONS AND USAGE
Oxycodone Hydrochloride Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (
1
)
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
Butorphanol Tartrate Nasal Spray is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS] reserve Butorphanol Tartrate Nasal Spray for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Butorphanol Tartrate Nasal Spray should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
INDICATIONS AND USAGE
Lisinopril-hydrochlorothiazide tablets are indicated for the
treatment of hypertension.
These fixed-dose combinations are not indicated for initial therapy (see
DOSAGE AND ADMINISTRATION).
In using lisinopril-hydrochlorothiazide tablets, consideration should be
given to the fact that an 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
lisinopril does not have a similar risk. (See WARNINGS.)
In considering the use of lisinopril-hydrochlorothiazide tablets, 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, Angioedema).
1 INDICATIONS AND USAGE
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)
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.
INDICATIONS AND USAGE
Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see
WARNINGS ]
, reserve Oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
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
Metastatic Prostate Cancer
Nilutamide Tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2).
For maximum benefit, treatment with Nilutamide Tablets must begin on the same day as or on the day after surgical castration.
1 INDICATIONS AND USAGE
Clonidine hydrochloride (HCl) extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].
Clonidine hydrochloride (HCl) extended-release tablets are a centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. (1)
1.1 Erectile Dysfunction
Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED).
1.2 Benign Prostatic Hyperplasia
Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia
Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
1.4 Limitation of Use
If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see Clinical Studies ( 14.3)] .
1	INDICATIONS AND USAGE
Phentermine hydrochloride is 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/m
2, or
27 kg/m
2 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 patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows:
pounds
2.2 = kg; inches
0.0254 = meters.
BODY MASS INDEX (BMI), kg/m
2
The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [
see
Clinical Pharmacology (12.1,
12.2)
] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) 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/m
2, or
27 kg/m
2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (
1)
The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (
1)
BMI figure
INDICATIONS AND USAGE
Spironolactone has been shown to be a tumorigen in chronic
toxicity studies in rats (see PRECAUTIONS section).
Spironolactone and hydrochlorothiazide tablets should be used only in those
conditions described below. Unnecessary use of this drug should be avoided.
Spironolactone and Hydrochlorothiazide Tablets are Indicated for:
Edematous Conditions for Patients with:
Congestive Heart FailureFor the management of edema and sodium retention when the patient
is only partially responsive to, or is intolerant of, other therapeutic
measures. The treatment of diuretic-induced hypokalemia in patients with
congestive heart failure when other measures are considered inappropriate. The
treatment of patients with congestive heart failure taking digitalis when other
therapies are considered inadequate or inappropriate.
Cirrhosis of the Liver Accompanied by Edema and/or
AscitesAldosterone levels may be exceptionally high in this condition.
Spironolactone and hydrochlorothiazide tablets are indicated for maintenance
therapy together with bed rest and the restriction of fluid and sodium.
The Nephrotic SyndromeFor nephrotic patients when treatment of the underlying disease,
restriction of fluid and sodium intake, and the use of other diuretics do not
provide an adequate response.
Essential HypertensionFor patients with essential hypertension in whom other measures
are considered inadequate or inappropriate. In hypertensive patients for the
treatment of a diuretic-induced hypokalemia when other measures are considered
inappropriate.
Usage in PregnancyThe routine use of diuretics in an otherwise healthy woman is
inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do
not prevent development of toxemia of pregnancy, and there is no satisfactory
evidence that they are useful in the treatment of developing toxemia.
Edema during pregnancy may arise from pathologic causes or from the
physiologic and mechanical consequences of pregnancy. Spironolactone and
hydrochlorothiazide tablets are indicated in pregnancy when edema is due to
pathologic causes just as it is in the absence of pregnancy (however, see PRECAUTIONS: Pregnancy). Dependent edema in pregnancy,
resulting from restriction of venous return by the expanded uterus, is properly
treated through elevation of the lower extremities and use of support hose; use
of diuretics to lower intravascular volume in this case is unsupported and
unnecessary. There is hypervolemia during normal pregnancy which is not harmful
to either the fetus or the mother (in the absence of cardiovascular disease),
but which is associated with edema, including generalized edema, in the majority
of pregnant women. If this edema produces discomfort, increased recumbency will
often provide relief. In rare instances, this edema may cause extreme discomfort
which is not relieved by rest. In these cases, a short course of diuretics may
provide relief and may be appropriate.
INDICATIONS AND USAGE
Asacol tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.
1 INDICATIONS AND USAGE
OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency.
OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency. (1)
INDICATIONS AND USAGE
Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures.
Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.
Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
1 INDICATIONS AND USAGE
EPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV1) infection.
Limitations of Use:
The dosage of this product is for HIV1 and not for HBV.
EPIVIR is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV1 infection.Limitations of Use: The dosage of this product is for HIV1 and not for HBV. (1)
INDICATIONS & USAGE
Lidocaine Hydrochloride Injection, USP administered intravenously is specifically indicated in the acute management of 1) ventricular arrhythmias occurring during cardiac manipulation such as cardiac surgery, and 2) life-threatening arrhythmias, particularly those which are ventricular in origin, such as those which occur during acute myocardial infarction.
1. INDICATIONS AND USAGE
Celecoxib is indicated
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (
1.1)
Rheumatoid Arthritis (RA) (
1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (
1.3)
Ankylosing Spondylitis (AS) (
1.4)
Acute Pain (AP) (
1.5)
Primary Dysmenorrhea (PD) (
1.6)
1.1 Osteoarthritis(OA)
For the management of the signs and symptoms of OA [
see
Clinical Studies (14.1)
]
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [
see
Clinical Studies (14.2)
]
1.3 Juvenile Rheumatoid Arthritis (JRA)
For the management of the signs and symptoms of JRA in patients 2 years and older [
see
Clinical Studies (14.3)
]
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [
see
Clinical Studies (14.4)
]
1.5 Acute Pain
For the management of acute pain in adults [
see
Clinical Studies (14.5)
]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [
see
Clinical Studies (14.5)
]
1 INDICATIONS AND USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a carbonic anhydrase inhibitor with a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (1)
INDICATIONS AND USAGE
Doxepin hydrochloride capsules are recommended for the treatment of:
1. Psychoneurotic patients with depression and/or anxiety.2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).3.Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4.Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following:
1.Mild to moderate pain
2.Osteoarthritis
3.Rheumatoid arthritis
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.
1 INDICATIONS AND USAGE
PROCYSBI is indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.
PROCYSBI is a cystine-depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older. (1)
1 INDICATIONSAND USAGE
Febuxostat tablets are 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.
For the safe and effective use of allopurinol, see allopurinol prescribing information.
Limitations of Use:
Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.
Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in 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) For the safe and effective use of allopurinol, see allopurinol prescribing information.
Limitations of Use:
Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. (1)
INDICATIONS AND USAGE
Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*
, Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis*, Bacteroides fragilis*, Enterobacter spp.*, and Acinetobacter calcoaceticus*.
NOTE: For information on use in pediatric patients see
PRECAUTIONS-Pediatric Use
and
CLINICAL STUDIES
sections.
Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*
Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli*, and Bacteroides spp.* (including B. fragilis*).
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While Ampicillin and Sulbactam for Injection, USPis indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with Ampicillin and Sulbactam for Injection, USPdue to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to Ampicillin and Sulbactam for Injection, USPshould not require the addition of another antibacterial.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Ampicillin and Sulbactam for Injection, USP.
Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.
To reduce the development of drug-resistant bacteria and maintain effectiveness of Ampicillin and Sulbactam for Injection, USPand other antibacterial drugs, Ampicillin and Sulbactam for Injection, USPshould 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.
INDICATIONS AND USAGE
Acyclovir Ointment USP, 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.
1 INDICATIONS AND USAGE
Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies (14)].
Guanfacine extended-release tablets are a central alpha2A-adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications (1, 14).
INDICATIONS AND USAGE
NeutroSpecTM [Technetium (99m Tc) fanolesomab] is indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older.
Indications and Usage
Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Etodolac tablets, USP are indicated:
For acute and long-term use in the management of signs and symptoms of the following:
- Osteoarthritis
- Rheumatoid arthritis
For the management of acute pain