um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
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 has 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 average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III
1 as follows:
Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
Motor tension:
shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
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.
Apprehensive expectation:
anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
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.
1INDICATIONSAND USAGE
Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks.
Zolmitriptan tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache.
Zolmitriptan tablets are serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use:
Use only after a clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
1 INDICATIONS AND USAGE
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including Methylphenidate Hydrochloride, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [
see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3) ].
Methylphenidate Hydrochloride are indicated for the treatment of:
Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults
Narcolepsy
Methylphenidate Hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy.
1 INDICATIONS AND USAGE
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see
Clinical Studies (14.1) ]
.
Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (
1).
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (
1).
1 INDICATIONS AND USAGE
Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG).
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use:
The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined.
The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined.
Omega-3-acid ethyl esters, USP is a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia (HTG). (1)
Limitations of Use:
The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. (1)
The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined. (1)
1 INDICATIONS AND USAGE
Paroxetine is indicated in adults for the treatment of:
Major depressive disorder (MDD)
Panic disorder (PD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (
1
):
Major Depressive Disorder (MDD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Premenstrual Dysphoric Disorder (PMDD)
1 INDICATIONSAND USAGE
Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.
Vardenafil hydrochloride is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1)
INDICATIONS & USAGE
SALAGEN Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
1 INDICATIONS AND USAGE
Tranexamic acid tablets are indicated for the treatment of cyclic heavy menstrual bleedingin females of reproductive potential [see Clinical Studies(14)]
Tranexamic acid tablets are an antifibrinolytic indicated for the treatment of cyclic heavy menstrual bleeding in females of reproductive potential. (1)
1
INDICATIONS AND USAGE
Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimers type.
Memantine hydrochloridetablets are an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimers type.(1)
INDICATIONS AND USAGE
Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see
CLINICAL PHARMACOLOGY
,Microbiology
).
The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens:Staphylococcus aureus, streptococci, includingStreptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacterspecies,Neisseriaspecies, andPseudomonas aeruginosa. The product does not provide adequate coverage againstSerratia marcescens.
1 INDICATIONS AND USAGE
Mupirocin ointment is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).
Mupirocin ointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. (1)
1 INDICATIONS AND USAGE
Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD
[see
Clinical Studies (14)].
Bupropion hydrochloride tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (
1)
Uses
for preparation of skin prior to injection
1 INDICATIONSAND USAGE
Olopatadine hydrochloride ophthalmic solution USP, 0.2 % is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Olopatadine hydrochloride ophthalmicsolution USP, 0.2 % is a mast cell stabilizer indicated for the treatment of ocular itching associated with allergic conjunctivitis.
1 INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of:
Major Depressive Disorder (MDD)
[see
Clinical Studies (14.1)]
Generalized Anxiety Disorder (GAD)
[see
Clinical Studies (14.2)]
Social Anxiety Disorder (SAD)
[see
Clinical Studies (14.3)]
Panic Disorder (PD)
[see
Clinical Studies (14.4)]
Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with:
Major Depressive Disorder (
MDD) (
1)
Social Anxiety Disorder (
SAD) (
1)
Generalized Anxiety Disorder (
GAD) (
1)
Panic Disorder (
PD) (
1)
1 INDICATIONS & USAGE
Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14
)]. Silodosin is not indicated for the treatment of hypertension.
Silodosin, an alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin is not indicated for the treatment of hypertension (1).
INDICATIONS AND USAGE:
Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of
hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary
management with potassium-rich foods or diuretic dose reduction is insufficient.
1 INDICATIONS AND USAGE
ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]:
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Posttraumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Posttraumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
INDICATIONS AND USAGE
Ofloxacin otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus.
Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus.
Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa Staphylococcus aureus, and Streptococcus pneumoniae.
INDICATIONS AND USAGE
Citalopram tabletsare indicated for the treatment of depression.
The efficacy of citalopram in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R 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 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.
The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied.
The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see
CLINICAL PHARMACOLOGY
). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Erythromycin and Benzoyl Peroxide Topical Gel USP is indicated for the topical treatment of acne vulgaris.
1 INDICATIONS AND USAGE
Pemetrexed for injection is a folate analog metabolic inhibitor indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. (
1.1)
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, NSCLC). (
1.1)
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (
1.1)
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (
1.1)
Limitations of Use: Pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (
1.1)
initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (
1.2)
1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed for injection is indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
in combination with cisplatin for the initial treatment of patients with locally advanced ormetastatic, non-squamous, NSCLC.
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed afterfour cycles of platinum-based first-line chemotherapy.
as a single agent for the treatment of patients with recurrent, metastatic non-squamous,NSCLC after prior chemotherapy.
Limitations of Use: Pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer
[see
Clinical Studies (14.1)]
.
1.2 Mesothelioma
Pemetrexed for injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
INDICATIONS & USAGE
Diltiazem hydrochloride is indicated for the management of chronic stable angina and angina due to coronary artery spasm.
INDICATIONS AND USAGE
For the treatment of moderate to severe pain not responsive to non-narcotic
analgesics.
For detoxification treatment of opioid addiction (heroin or other
morphine-like drugs).
For maintenance treatment of opioid addiction (heroin or other morphine-like
drugs), in conjunction with appropriate social and medical services.
Note
Outpatient maintenance and
outpatient detoxification treatment may be provided only by Opioid Treatment
Programs (OTPs) certified by the Federal Substance Abuse and Mental Health
Services Administration (SAMHSA) and registered by the Drug Enforcement
Administration (DEA). This does not preclude the maintenance treatment of a
patient with concurrent opioid addiction who is hospitalized for conditions
other than opioid addiction and who requires temporary maintenance during the
critical period of his/her stay, or of a patient whose enrollment has been
verified in a program which has been certified for maintenance treatment with
methadone.
Alprazolam tablets are indicated for the:
acute treatment of generalized anxiety disorder (GAD) in adults.
treatment of panic disorder (PD), with or without agoraphobia in adults.
1 INDICATIONS AND USAGE
Adult Patients:
ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients (
1).
Pediatric Patients:
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg (
1).
ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg (
1).
Adult Patients:
ISENTRESS
and ISENTRESS
HD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.
Pediatric Patients:
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg.
ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg.
INDICATIONS AND USAGE
Evekeo (amphetamine sulfate tablets, USP) is indicated for:
Narcolepsy
Attention Deficit
Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted.
Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below.
1 INDICATIONS AND USAGE
Fluoxetine Capsules USP are indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].
Fluoxetine Capsules USP and Olanzapine in Combination are indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Fluoxetine Capsules USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
When using Fluoxetine Capsules USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
Fluoxetine Capsules USP are a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (1)
Acute and maintenance treatment of Bulimia Nervosa (1)
Acute treatment of Panic Disorder, with or without agoraphobia (1)
Fluoxetine Capsules USP and olanzapine in combination for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder (1)
1 INDICATIONS AND DOSAGE
NuLYTELY is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.
NuLYTELY is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater
INDICATIONS AND USAGE
Desoximetasone Cream USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
INDICATIONS AND USAGE
Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
INDICATIONS AND USAGE
Adapalene Cream, 0.1% is indicated for the topical treatment of acne vulgaris.