um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major
Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (
1.1)
Acute Treatment of Generalized Anxiety
Disorder (GAD) in adults (
1.2)
1.1 Major Depressive Disorder
Escitalopram Tablets, USP are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [
see Clinical Studies (
14.1)
].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [
see Clinical Studies (
14.2)
].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least six months and which the person finds difficult to control. It must be associated with at least three of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
1 INDICATIONS AND USAGE
FORFIVO XL (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [seeClinical Studies (14)].
The physician who elects to use FORFIVO XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
FORFIVO XL is an aminoketone antidepressant indicated for the treatment of major depressive disorder (MDD) (1). The efficacy was established in two 4-week trials, one 6-week trial with bupropion immediate-release formulation, and one maintenance trial with bupropion sustained-release formulation, all in adults (14). Periodically re-evaluate long-term usefulness for the individual patient (1).
1 INDICATIONS AND USAGE
Rosuvastatin tablets are an HMG Co-A reductase inhibitor indicated for:
adult patients with hypertriglyceridemia as an adjunct to diet (1.3 )
adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4 )
adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.5 )
Limitations of use (1.8):
Rosuvastatin tablets have not been studied in
Fredrickson Type I and V dyslipidemias.
Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.3 Hypertriglyceridemia
Rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias.
INDICATIONS AND USAGE
Tc99m Sulfur Colloid is used in lymphoscintigraphy studies in breast cancer patients, for liver, spleen and bone marrow imaging and gastric transit studies and gastroesophageal reflux.
1 INDICATIONS AND USAGE
Metoclopramide tablets are indicated for the:Metoclopramide tablets are indicated for the:
Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy.
Relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
Limitations of Use:
Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [
see Use in Specific Populations (
8.4)
].
Metoclopramide tablets are indicated for the:
Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. (
1)
Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. (
1)
Limitations of Use:
Metoclopramide tablets are not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. (
1,
8.4)
1 INDICATIONS AND USAGE
Nateglinide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
Nateglinide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Nateglinide is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (
1)
Limitation of use: Not for treating type 1 diabetes mellitus or diabetes ketoacidosis (
1)
INDICATIONS AND USAGE
Vincristine Sulfate Injection is indicated in acute leukemia.
Vincristine Sulfate Injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, nonHodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor.
Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see DOSAGE AND ADMINISTRATION (2)]
1.1 Adult Patients
Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis. or Streptococcus pneumoniae.
Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.
Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
1.2 Pediatric Patients
[see USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.2)]
Acute otitis media (> 6 months of age) caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
Community-acquired pneumonia (> 6 months of age) due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumonia, or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis (> 2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
1.3 Limitations of Use
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
patients with cystic fibrosis,
patients with nosocomial infections,
patients with known or suspected bacteremia,
patients requiring hospitalization,
elderly or debilitated patients, or
patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
1.4 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should 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 & USAGE SECTION
Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Associations Diagnostic and Statistical Manual, III1 as follows:
Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
1. Motor tension:
Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
2. Autonomic hyperactivity:
Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
3. Apprehensive expectation:
Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
4. Vigilance and scanning:
Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.
The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.
The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS & USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, Cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Adults and Adolescents
Community-Acquired Pneumonia
Caused by
Haemophilus influenzae (including -lactamase producing strains),
Haemophilus parainfluenzae (including -lactamase producing strains),
Streptococcus pneumoniae (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains) (see
CLINICAL STUDIES
).
Acute Exacerbations of Chronic Bronchitis
Caused by
Haemophilus influenzae (including -lactamase producing strains),
Haemophilus parainfluenzae (including -lactamase producing strains),
Streptococcus pneumoniae (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains).
Acute Maxillary Sinusitis
Caused by
Haemophilus influenzae (including -lactamase producing strains),
Streptococcus pneumonia (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains).
NOTE: For information on use in pediatric patients, see
Pediatric Use
and
DOSAGE AND ADMINISTRATION
.
Pharyngitis/Tonsillitis
Caused by
Streptococcus pyogenes
(see
CLINICAL STUDIES).
NOTE: Cefdinir is effective in the eradication of
S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following
S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
Caused by
Staphylococcus aureus (including -lactamase producing strains) and
Streptococcus pyogenes.
Pediatric Patients
Acute Bacterial Otitis Media
Caused by
Haemophilus influenzae (including -lactamase producing strains),
Streptococcus pneumonia (penicillin-susceptible strains only), and
Moraxella catarrhalis (including -lactamase producing strains).
Pharyngitis/Tonsillitis
Caused by
Streptococcus pyogenes (see
CLINICAL STUDIES
).
NOTE: Cefdinir is effective in the eradication of
S. pyogenes from the oropharynx. Cefdinir has not, however, been studied for the prevention of rheumatic fever following
S. pyogenes pharyngitis/tonsillitis. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever.
Uncomplicated Skin and Skin Structure Infections
Caused by
Staphylococcus aureus (including -lactamase producing strains) and
Streptococcus pyogenes.
1 INDICATIONS AND USAGE
Therapy
with lipid-altering agents
should be only one component of multiple risk factor
intervention in individuals at
significantly increased risk for
atherosclerotic vascular disease due to
hyperlipidemia. Niacin therapy is indicated as an adjunct to
diet when the
response to a
diet restricted in
saturated fat and cholesterol and
other nonpharmacologic measures alone has been inadequate.
Niacin extended-release tablets
are indicated to
reduce elevated TC, LDL-C,
Apo B and TG levels, and to
increase HDL-C in patients
with primary hyperlipidemia and mixed dyslipidemia.
In patients with a
history of myocardial infarction and
hyperlipidemia, niacin is
indicated to reduce the risk of recurrent nonfatal
myocardial infarction.
In patients with a
history of coronary artery
disease (CAD) and
hyperlipidemia, niacin, in
combination with a bile acid
binding resin, is indicated to
slow progression or promote regression of atherosclerotic
disease.
Niacin extended-release tablets in combination
with a
bile acid
binding resin is indicated to reduce elevated TC and LDL-C levels in adult
patients with primary hyperlipidemia.
Niacin is also indicated as adjunctive therapy for treatment of adult
patients with severe hypertriglyceridemia who present a risk of pancreatitis and
who do not respond adequately to a
determined dietary effort to control them.
Limitations of Use
Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions (5.1)].
Niacin extended-release tablets contain extended-release niacin (nicotinic acid), and is indicated:
To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. (1)
To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. (1)
In combination with a bile acid binding resin:
Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. (1)
As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. (1)
To reduce TG in adult patients with severe hypertriglyceridemia. (1)
Limitations of use:
Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial. (5.1)
Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (AK).
INDICATIONS AND USAGE
Benzonatate Capsule is indicated for the symptomatic relief of cough.
INDICATIONAND USAGE
Phenoxybenzamine hydrochloride capsules are indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta-blocking agent concomitantly.
INDICATIONS AND USAGE:
Neo-Polycin Ophthalmic Ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis, and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
INDICATIONS AND USAGE
Fluconazole Tablets USP are indicated for the treatment of:
Vaginal candidiasis (vaginal yeast infections due to Candida).
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
Cryptococcal meningitis. Before prescribing Fluconazole Tablets USP for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis
Fluconazole Tablets USP are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
Escitalopram oxalate USP is a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (
1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (
1.2)
1.1 Major Depressive Disorder
Escitalopram tablet USP is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [
see Clinical Studies (
14.1)
].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram tablet USP is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [
see Clinical Studies (
14.2)
].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
1 INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic indicated for:
Treatment of schizophrenia (1.1)
As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2)
Treatment of irritability associated with autistic disorder (1.3)
1.1
Schizophrenia
Risperidone is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)].
1.2
Bipolar Mania
Monotherapy
Risperidone is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)].
Adjunctive Therapy
Risperidone adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3)].
1.3 Irritability Associated with Autistic Disorder
Risperidone is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years)
[see Clinical Studies (14.4)].