um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Esomeprazole magnesium is a proton pump inhibitor indicated for the following:
Treatment of gastroesophageal reflux disease (GERD). (1.1)
Risk reduction of NSAID-associated gastric ulcer. (1.2)
H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. (1.4)
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.
In infants 1 month to less than 1 year, esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD.
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 plus amoxicillin and clarithromycin): esomeprazole magnesium delayed-release capsules, in combination with amoxicillin and clarithromycin, are 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 & USAGE
Donepezil hydrochloride tablet USP is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
Donepezil hydrochloride tablet USP is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers Disease (1.0).
1 INDICATIONS AND USAGE
THYROGEN is a thyroid stimulating hormone indicated for:
Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer:
Use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. (1.1)
Limitations of Use:
THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with Tg levels after thyroid hormone withdrawal.
Even when THYROGEN-Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or underestimating the extent of the disease.
Anti-Tg Antibodies may confound the Tg assay and render Tg levels uninterpretable.
Adjunct for Thyroid Remnant Ablation in Well-Differentiated Thyroid Cancer: Use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer. (1.2)
Limitations of Use:
The effect of THYROGEN on thyroid cancer recurrence greater than 5 years post-remnant ablation has not been evaluated.
1.1	Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer
THYROGEN is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy.
Limitations of Use:
THYROGEN-stimulated Tg levels are generally lower than, and do not correlate with, Tg levels after thyroid hormone withdrawal [see Clinical Studies (14.1)].
Even when THYROGEN-stimulated Tg testing is performed in combination with radioiodine imaging, there remains a risk of missing a diagnosis of thyroid cancer or of underestimating the extent of disease.
Anti-Tg antibodies may confound the Tg assay and render Tg levels uninterpretable [see Clinical Studies (14.1)]. Therefore, in such cases, even with a negative or low-stage THYROGEN radioiodine scan, consideration should be given to further evaluating patients.
1.2	Adjunct for Thyroid Remnant Ablation in Well-Differentiated Thyroid Cancer
THYROGEN is indicated for use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer.
Limitations of Use:
The effect of THYROGEN on thyroid cancer recurrence greater than five years post-remnant ablation has not been evaluated [see Clinical Studies (14.2)].
INDICATIONS AND USAGE
Betamethasone dipropionate cream is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 13 years and older.
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for
the treatment of major depressive disorder (MDD)
(1.1)
prevention of seasonal affective disorder (SAD)
(1.2)
1.1 Major Depressive Disorder (MDD)
Bupropion hydrochloride extended-release tablets (XL) are 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
[see
Clinical Studies (14.1)
].
1.2 Seasonal Affective Disorder (SAD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM
[see
Clinical Studies (14.2)
].
INDICATIONS AND USAGE
Major Depressive Disorder
Sertraline is indicated for the treatment of major depressive disorder in adults.
The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied.
The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY).
Premenstrual Dysphoric Disorder (PMDD)
Sertraline is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults.
The efficacy of sertraline in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-III-R/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY).
The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant.
The effectiveness of sertraline in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
1 INDICATIONS AND USAGE
Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil for oral suspension was added to background epoprostenol therapy [see Clinical Studies (14)].
Studies establishing effectiveness were short-term (12 weeks to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Limitation of Use
: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)].
Sildenafil for oral suspension is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 weeks to 16 weeks), and included predominately patients with NYHA Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. (1, 14)
1 INDICATIONS AND USAGE
APLENZIN is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1)
1.1 Major Depressive Disorder
APLENZIN (bupropion hydrobromide) 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 [see Clinical Studies (14.1)].
1.2 Seasonal Affective Disorder
APLENZIN is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies (14.2)].
INDICATIONS AND USAGE
CORVERT Injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patients with atrial arrhythmias of longer duration are less likely to respond to CORVERT. The effectiveness of ibutilide has not been determined in patients with arrhythmias of more than 90 days in duration.
INDICATIONSAND USAGE
VANIQA (eflornithine hydrochloride) Cream, 13.9% is indicated for the reduction of unwanted facial hair in women.
VANIQA has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement.
1 INDICATIONS AND USAGE
Pantoprazole sodium for injection is a proton pump inhibitor (PPI) indicated in adults for the following:
Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1)
Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2)
1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis
Pantoprazole sodium for injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE).
Safety and efficacy of pantoprazole sodium for injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.
1.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome
Pantoprazole sodium for injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
1 INDICATIONS AND USAGE
Vasopressin injectionis indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. (1)
1	INDICATIONS AND USAGE
Magnesium Sulfate in 5% Dextrose Injection, USP is indicated for:
Prevention of eclampsia in patients with preeclampsia
Treatment of seizures and prevention of recurrent seizures in patients with eclampsia
Magnesium Sulfate in 5% Dextrose Injection, USP is indicated for (1):
Prevention of eclampsia in patients with preeclampsia (1)
Treatment of seizures and prevention of recurrent seizures in patients with eclampsia (1)
1 INDICATIONS AND USAGE
ISENTRESS
Registered trademark of MERCK & CO., Inc.COPYRIGHT
2007, 2009 MERCK & CO., Inc.All rights reserved
is indicated in combination with other anti-retroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.
This indication is based on analyses of plasma HIV-1 RNA levels up through 48 weeks in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults and one was conducted in treatment-nave adults.
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies (14)].
The safety and efficacy of ISENTRESS have not been established in pediatric patients.
ISENTRESS is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated:
In combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients (1).
The safety and efficacy of ISENTRESS have not been established in pediatric patients (1).
INDICATIONS AND USAGE
Chlordiazepoxide Hydrochloride and Clidinium Bromide is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide Hydrochloride and Clidinium Bromide may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
1INDICATIONSAND USAGE
VIGAMOX is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium species*
Micrococcus luteus*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus warneri*
Streptococcus pneumoniae
Streptococcus viridans group
Acinetobacter lwoffii*
Haemophilus influenza
Haemophilus parainfluenzae*
Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections.
VIGAMOX is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections. (1)
INDICATIONS AND USAGE
Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
The effectiveness of clomipramine for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.
The effectiveness of clomipramine for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see
DOSAGE AND ADMINISTRATION
).
Naproxen Naproxen tablets and naproxen sodium tablets are indicated for:
The relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
Polyarticular Juvenile Idiopathic Arthritis
1 INDICATIONS AND USAGE
Fluoxetine
is a a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years
(1.1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years
(1.2)
Acute and maintenance treatment of Bulimia Nervosa in adult patients
(1.3)
Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients
(1.4)
1.1 Major Depressive Disorder
Fluoxetine tablets are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [see
Clinical Studies (14.1)
].
The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated [see
Dosage and Administration (2.1)
].
1.2 Obsessive Compulsive Disorder
Fluoxetine tablets are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see
Clinical Studies (14.2)
].
The effectiveness of fluoxetine tablets in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine tablets for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see
Dosage and Administration (2.2)
].
1.3 Bulimia Nervosa
Fluoxetine tablets are indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see
Clinical Studies (14.3)
].
The physician who elects to use fluoxetine tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see
Dosage and Administration (2.3
)].
1.4 Panic Disorder
Fluoxetine tablets are indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see
Clinical Studies (14.4)
].
The effectiveness of fluoxetine tablets in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine tablets for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see
Dosage and Administration (2.4)
].
1 INDICATIONS AND USAGE
Fesoterodine fumarate extended-release tablets are indicated for the treatment of:
Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. (1.1)
1.1
Adult Overactive Bladder
Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.
Pediatric use information is approved for Pfizer Inc.s TOVIAZ (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.s marketing exclusivity rights, this drug product is not labeled with that information.