um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Methotrexate Injection is a folate analog metabolic inhibitor indicated for:
The following neoplastic diseases for the:
oTreatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen (1.1)
oProphylaxis and treatment of adult and pediatric patients with meningeal leukemia (1.2)
oTreatment of adult and pediatric patients with non-Hodgkin lymphoma (1.3)
oTreatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen (1.4)
oTreatment of adults with breast cancer as part of a combination chemotherapy regimen (1.5)
oTreatment of adults with squamous cell carcinoma of the head and neck as single-agent (1.6)
oTreatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen (1.7)
Treatment of adults with rheumatoid arthritis (RA). (1.8)
Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9)
Treatment of adults with severe psoriasis. (1.10)
1.1	Acute Lymphoblastic Leukemia
Methotrexate Injection is indicated for the treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy regimen.
1.2	Meningeal Leukemia: Prophylaxis and Treatment
Methotrexate Injection is indicated for the prophylaxis and treatment of meningeal leukemia in adult and pediatric patients.
1.3	Non-Hodgkin Lymphoma
Methotrexate Injection is indicated for the treatment of adults and pediatric patients with Non-Hodgkin lymphoma.
1.4	Osteosarcoma
Methotrexate Injection is indicated for the treatment of adults and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen.
1.5	Breast Cancer
Methotrexate Injection is indicated for the treatment of adults with breast cancer as part of a combination chemotherapy regimen.
1.6	Squamous Cell Carcinoma of the Head and Neck
Methotrexate Injection is indicated for the treatment of adults with squamous cell carcinoma of the head and neck as a single-agent.
1.7	Gestational Trophoblastic Neoplasia
Methotrexate Injection is indicated for the treatment of adults with gestational trophoblastic neoplasia (GTN) as part of a combination chemotherapy regimen.
1.8	Rheumatoid Arthritis
Methotrexate Injection is indicated for the treatment of adults with rheumatoid arthritis (RA).
1.9	Polyarticular Juvenile Idiopathic Arthritis
Methotrexate Injection is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA).
1.10 Psoriasis
Methotrexate Injection is indicated for the treatment of adults with severe psoriasis.
1 INDICATIONS AND USAGE
Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings:
Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings:
Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. (1.1)
Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. (1.2)
Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. (1.3)
1.1	Oncology
For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1.2	Cardiology
For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3	Neurology
For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
1 INDICATIONS AND USAGE
Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of:
Mild to severe chronic heart failure (
1.1)
Left ventricular dysfunction following myocardial infarction in clinically stable patients (
1.2)
Hypertension (
1.3)
1.1 Heart Failure
Carvedilol Tablets is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Clinical Studies (
14.1)].
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol Tablet is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [
see Clinical Studies (
14.2)
].
1.3 Hypertension
Carvedilol Tablet is indicated for the management of essential hypertension [
see Clinical Studies (
14.3,
14.4)
]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [
see Drug Interactions (
7.2)
].
1 INDICATIONS AND USAGE
Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Limitation of Use
Carisoprodol should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [
see
Dosage and Administration (2)
].
Carisoprodol is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
(1)
Limitations of Use
Should only be used for acute treatment periods up to two or three weeks (
1)
INDICATIONS AND USAGE
QVAR is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. QVAR is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR may reduce or eliminate the need for the systemic corticosteroids.
Beclomethasone dipropionate is NOT indicated for the relief of acute bronchospasm.
1 INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]
Celecoxib is a non steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older(1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)
1.1
Osteoarthritis (OA)
Celecoxib is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)]
1.2
Rheumatoid Arthritis (RA)
Celecoxib is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)]
1.3
Juvenile Rheumatoid Arthritis (JRA)
Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]
1.4
Ankylosing Spondylitis (AS)
Celecoxib is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)]
1.5
Acute Pain (AP)
Celecoxib is indicated for the managementof AP in adults [see
Clinical Studies (14.5)]
1.6
Primary Dysmenorrhea (PD)
Celecoxib is indicated for the treatment of PD [see Clinical
Studies (14.5)]
1 INDICATIONS AND USAGE
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient. (1)
INDICATIONS AND USAGE
For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.
1 INDICATIONS AND USAGE
BEPREVE
(bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.
BEPREVE is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. (1)
INDICATIONS AND USAGE
Fluconazole Injection, USP is indicated for the treatment of:
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 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 Injection, USP is 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.
Indications and Usage
Sucralfate is indicated in:
Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
INDICATIONS AND USAGE
Levocarnitine is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see CLINICAL PHARMACOLOGY). In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.
Levocarnitine is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
1 INDICATIONS AND USAGE
Amyvid is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate -amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.
Amyvid is a radioactive diagnostic agent for Positron Emission Tomography (PET) imaging of the brain to estimate -amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques, and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations (1).
Limitations of Use
A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder (1).
Safety and effectiveness of Amyvid have not been established for:
Predicting development of dementia or other neurologic condition;
Monitoring responses to therapies (1).
Limitations of Use:
A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder.
Safety and effectiveness of Amyvid have not been established for:
Predicting development of dementia or other neurologic condition;
Monitoring responses to therapies.
1	INDICATIONS AND USAGE
BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY.
BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY. (1)
1
INDICATIONS AND USAGE
Carisoprodol Tablets USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol Tablets USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [
see Dosage and Administration (
2
)].
Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (
1)
Limitations of Use:
Should only be used for acute treatment periods up to two or three weeks (
1)
INDICATIONS AND USAGE
Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: "Possibly" Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); monliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.
INDICATIONS AND USAGE
Modafinil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder.
In OSA, modafinil is indicated as an adjunct to standard treatment(s) for the underlying obstruction.
If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating modafinil.
If modafinil is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.
In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance.
Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.
The effectiveness of modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSA and SWD clinical trials) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe modafinil for an extended time in patients with Narcolepsy, OSA, or SWD should periodically reevaluate long-term usefulness for the individual patient.
INDICATIONS AND USAGE
Sulfasalazine tablets are indicated:
a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
b) for the prolongation of the remission period between acute attacks of ulcerative colitis.
INDICATIONS
Indications: For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.
1INDICATIONS AND USAGE
Mycophenolic acid delayed-release tablets arean antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1)
Use in combination with cyclosporine and corticosteroids. (1.1)
Limitations of Use:
Mycophenolic aciddelayed release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. (1.2)
1.1Prophylaxis of Organ Rejection in Kidney Transplant
Mycophenolic acid delayed-release tablets areindicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Mycophenolic acid delayed-release tablets areindicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.
Mycophenolic acid delayed-release tablets areto be used in combination with cyclosporine and corticosteroids.
1.2Limitations of Use
Mycophenolic aciddelayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
INDICATIONS & USAGE
Chromium 4 mcg/mL (Chromic Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain chromium serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.
1 INDICATIONS AND USAGE
Fluoxetine tablets are indicated for the treatment of:
Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1)].
Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2)].
Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see Clinical Studies (14.3)].
Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12-week trials in adults [see Clinical Studies (14.4)].
Fluoxetine is a selective serotonin reuptake inhibitor (SSRI ) indicated for the treatment of:
Major Depressive Disorder (MDD) (1)
Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study (14.1)
Pediatrics: Efficacy was established in two 8- to 9- week trials of patients aged 8 to 18 years (14.1)
Obsessive Compulsive Disorder (OCD) (1)
Adults: Efficacy was established in two 13-week trials (14.2)
Pediatrics: Efficacy was established in one 13-week trial in patients aged 7 to 17 years (14.2)
Bulimia Nervosa (1)
Adults: Efficacy was established in two 8-week trials and one 16-week trial (14.3)
Panic Disorder, with or without agoraphobia (1)
Adults: Efficacy was established in two 12-week trials (14.4)
INDICATIONS AND USAGE:
Clobetasol propionate topical solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis.
This product is not recommended for use in pediatric patients under 12 years of age.
1 INDICATIONS AND USAGE
Famotidine for oral suspension is indicated in adults for the treatment of:
active duodenal
ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due
to GERD, diagnosed by biopsy.
treatment of
pathological hypersecretory conditions
(e.g., Zollinger-Ellison syndrome,
multiple endocrine neoplasias).
reduction of the risk
of duodenal ulcer recurrence.
Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of:
peptic ulcer disease.
GERD with or
without esophagitis and
ulcerations.
Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of:
GERD.
Famotidine for oral suspension is a histamine-2 (H2) receptor antagonist indicated (1):
In adults for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of DU recurrence.
In pediatric patients 1 year of age and older for the treatment of:
peptic ulcer
GERD with or without esophagitis and ulcerations
In pediatric patients from birth to less than 1 year of age for the treatment of:
GERD.
1 INDICATIONS AND USAGE
ALTRENO (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
ALTRENO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1)
INDICATIONS AND USAGE
Desonide ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
It should not be used for longer than two weeks unless directed by a physician.