um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 15 years of age and older (
1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (
1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (
1.3).
1.1 Asthma
Montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium tablet is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium tablet is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. Because the benefits of montelukast sodium tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis
[see
Warnings and Precautions (5.1)]
, reserve use for patients who have an inadequate response or intolerance to alternative therapies.
1 INDICATIONS AND USAGE
Quetiapine Fumarate Tablets are an atypical antipsychotic indicated for the treatment of:
Schizophrenia (1.1)
Bipolar I disorder manic episodes (1.2)
Bipolar disorder, depressive episodes (1.2)
1.1 Schizophrenia
Quetiapine Fumarate Tablets are indicated for the treatment of schizophrenia. The efficacy of Quetiapine Fumarate Tablets in schizophrenia was established in three 6 week trials in adults and one 6 week trial in adolescents (13 to 17 years). The effectiveness of Quetiapine Fumarate Tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (
14.1
)].
1.2 Bipolar Disorder
Quetiapine Fumarate Tablets are 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 Clinical Studies (
14.2
)].
Quetiapine Fumarate Tablets are 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 Clinical Studies (
14.2
)].
Quetiapine Fumarate Tablets are 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 Clinical Studies (
14.2
)].
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.
1. Indications and Usage Section
1 INDICATIONS AND USAGE
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin): Esomeprazole magnesium delayed-release capsules, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see DOSAGE AND ADMINISTRATION (2) and CLINICAL STUDIES (14)].
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see CLINICAL PHARMACOLOGY (12.4) and the prescribing information for clarithromycin].
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Esomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
1 INDICATIONS AND USAGE
Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see
Warnings and Precautions (5.3)
]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)
]
Schizophrenia
Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
Ziprasidone hydrochloride capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)].
Ziprasidone hydrochloride capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].
Ziprasidone hydrochloride capsules are an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride capsules to prolong the QT interval and may consider the use of other drugs first (5.3) Ziprasidone hydrochloride capsules are indicated as an oral formulation for the:
Treatment of schizophrenia. (1.1)
Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder.
Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate.
1 INDICATIONS & USAGE
Lithium is a mood-stabilizing agent indicated for the treatment of manic episodes and as maintenance treatment for Bipolar I Disorder.
Lithium is a mood stabilizing agent indicated for the treatment of manic episodes and as maintenance treatment for Bipolar I Disorder (1)
INDICATIONS AND USAGE
Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder.
The efficacy of mirtazapine in the treatment of major depressive disorder was established in 6-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 5 of the following 9 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 in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient(see
CLINICAL PHARMACOLOGY
).
INDICATIONSAND USAGE
Desipramine Hydrochloride Tablets are indicated for the treatment of depression.
1 INDICATIONS AND USAGE
NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms (1):
Community-acquired bacterial pneumonia (CABP) (1.1)
Acute bacterial skin and skin structure infections (ABSSSI) (1.2)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3)
1.1 Community-Acquired Bacterial Pneumonia (CABP)
NUZYRA is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
1.2 Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
NUZYRA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA 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.
INDICATIONS ANDUSAGE
Atracurium Besylate Injection, USP is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
1 INDICATIONS AND USAGE
Indomethacin extended-release capsules are indicated for:
Moderate to severe rheumatoid arthritis including acute
flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
Indomethacin extended-release capsule is a nonsteroidal anti-inflammatory drug indicated for:
Moderate to
severe rheumatoid arthritis including acute flares of chronic disease
Moderate to
severe ankylosing spondylitis
Moderate to
severe osteoarthritis
Acute painful
shoulder (bursitis and/or tendinitis) (1)
INDICATIONS & USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP 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.
For the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Enterobacter species, and coagulase-negative Staphylococcus species, including S. saprophyticus.
Cultures and susceptibility tests should be performed to determine the susceptibility of the bacteria to trimethoprim. Therapy may be initiated prior to obtaining the results of these tests.
INDICATIONS AND USAGE
Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
Lower Respiratory Tract Infections -
caused by -lactamase-producing strains of H. influenzae and M. catarrhalis.
Otitis Media -
caused by -lactamase-producing strains of H. influenzae and M. catarrhalis.
Sinusitis -
caused by -lactamase-producing strains of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections -
caused by -lactamase-producing strains of S. aureus, E. coli and Klebsiella spp.
Urinary Tract Infections -
caused by -lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter spp.
While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible organisms and -lactamase-producing organisms susceptible to amoxicillin/clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin/clavulanate potassium. (See
Microbiology.)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin/clavulanate potassium and other antibacterial drugs, amoxicillin/clavulanate potassium 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.
Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin/clavulanate potassium, should be performed together with any indicated surgical procedures.
1 INDICATIONS AND USAGE
Pramipexole dihydrochloride is a non-ergot dopamine agonist indicated for the treatment of:
Parkinson's disease (PD) (1.1)
Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2)
1.1 Parkinsons Disease
Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease.
1.2 Restless Legs Syndrome
Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
INDICATIONS AND USAGE
Tramadol hydrochloride ER tablets are indicated for the management of moderate
to moderately severe chronic pain in adults who require around-the-clock
treatment of their pain for an extended period of time.
1 INDICATIONS AND USAGE
Levoleucovorin injection is indicated for:
rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma.
diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients.
the treatment of adults with metastatic colorectal cancer in combination with fluorouracil.
Limitations of Use:
Levoleucovorin injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B
12
, because of the risk of progression of neurologic manifestations despite hematologic remission.
Levoleucovorin injection is a folate analog indicated for:
Rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. (
1)
Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. (
1)
Treatment of adults with metastatic colorectal cancer in combination with fluorouracil. (
1)
Limitations of Use:
Levoleucovorin injection is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B
12, because of the risk of progression of neurologic manifestations despite hematologic remission. (
1)
1 INDICATIONS AND USAGE
VALCYTE is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:
Adult Patients (1.1)
Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.
Pediatric Patients (1.2)
Prevention of CMV disease in kidney and heart transplant patients at high risk.
1.1	Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis: VALCYTE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)].
Prevention of CMV Disease: VALCYTE is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) [see Clinical Studies (14.1)].
1.2	Pediatric Patients
Prevention of CMV Disease: VALCYTE is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies (14.2)].
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Naproxen Tablets, USP and other treatment options before deciding to use Naproxen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen as Naproxen Tablets, USP is indicated:
For the relief of the signs and symptoms of rheumatoid arthritis For the relief of the signs and symptoms of osteoarthritis For the relief of the signs and symptoms of ankylosing spondylitis For the relief of the signs and symptoms of juvenile arthritis For relief of the signs and symptoms of tendonitis For relief of the signs and symptoms of bursitis For relief of the signs and symptoms of acute gout For the management of pain For the management of primary dysmenorrhea
INDICATIONS AND USAGE
Erythromycin Topical Solution USP, 2% is indicated for the topical treatment of acne vulgaris.
1 INDICATIONS AND USAGE
BiDil is a combination of isosorbide dinitrate, a nitrate vasodilator, and hydralazine hydrochloride, an arteriolar vasodilator, indicated for:
the treatment of heart failure as an adjunct therapy to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status (1.1)
Limitations of use:
There is little experience in patients with NYHA class IV heart failure (1.2)
1.1
Treatment of Heart Failure in Self-identified Black Patients
BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status.
1.2
Limitations of Use
There is little experience in patients with NYHA class IV heart failure.
INDICATIONS AND USAGE
Fluphenazine hydrochloride tablets, USP are indicated in the management of manifestations of psychotic disorders.
Fluphenazine hydrochloride USP has not been shown effective in the management of behavioral complications in patients with mental retardation.