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, USP 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, USP may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules, USP 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, USP are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole magnesium delayed-release capsules, USP 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, USP 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, USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
1 INDICATIONS AND USAGE
ALOXI capsules are indicated in adults for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
ALOXI is a serotonin-3 (5-HT3) receptor antagonist indicated in adults for prevention of acute nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
INDICATIONS AND USAGE
Indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.
1.	INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [
see
Warnings and Precautions (5)
]
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (
1.1)
Rheumatoid Arthritis (
1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (
1.3)
Ankylosing Spondylitis (
1.4)
Acute Pain (
1.5)
Primary Dysmenorrhea (
1.6)
1.1 Osteoarthritis (OA)
Celecoxib capsules are indicated for relief of the signs and symptoms of OA [
see
Clinical Studies (14.1)
]
1.2 Rheumatoid Arthritis (RA)
Celecoxib capsules are indicated for relief of the signs and symptoms of RA [
see
Clinical Studies (14.2)
]
1.3 Juvenile Rheumatoid Arthritis (JRA)
Celecoxib capsules are 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 capsules are indicated for the relief of signs and symptoms of AS [
see
Clinical Studies (14.4)
]
1.5 Acute Pain (AP)
Celecoxib capsules are indicated for the management of AP in adults [
see
Clinical Studies (14.5)
]
1.6 Primary Dysmenorrhea (PD)
Celecoxib capsules are indicated for the treatment of PD [
see
Clinical Studies (14.5)
]
1 INDICATIONS & USAGE
Gabapentin is indicated for:
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin is indicated for:
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
1 INDICATIONS AND USAGE
Fabrazyme is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.
Fabrazyme is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS ).
Etodolac Capsules and Tablets, USP are indicated:
For acute and long-term use in the management of signs and symptoms of the following:
Osteoarthritis
Rheumatoid arthritis
For the management of acute pain
INDICATIONS AND USAGE
Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis - e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself.
Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial - e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.
1. Indications and Usage
Ondansetron is indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2
initial and repeat courses of moderately emetogenic cancer chemotherapy
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron is also indicated for the prevention of postoperative nausea and/or vomiting.
1 INDICATIONS AND USAGE
Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablets is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
Naproxen sodium tablets are also indicated for:
the relief of the signs and symptoms of:
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
INDICATIONS AND USAGE
Attention Deficit Disorders,
Narcolepsy
Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.
Methylphenidate Hydrochloride Chewable Tablets are indicated 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 a 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 this 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 may not be warranted.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.
Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.
Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.
1 INDICATIONS AND USAGE
Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.
Bimatoprost ophthalmic solution is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. (1)
1 INDICATIONS AND USAGE
Docetaxel Injection is a microtubule inhibitor indicated for:
Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1)
Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2)
Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3)
Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4)
Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5)
1.1 Breast Cancer
Docetaxel Injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Docetaxel Injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
1.2 Non-Small Cell Lung Cancer
Docetaxel Injection as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
Docetaxel Injection in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.
1.3 Prostate Cancer
Docetaxel Injection in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
1.4 Gastric Adenocarcinoma
Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.
1.5 Head and Neck Cancer
Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
1 INDICATIONS AND USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor and timolol maleate, a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of Dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (1)
Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of Dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5%timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
Allopurinol tablets reduce serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
Allopurinol tablets are indicated in:
1.
the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
2.
the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present.
3.
the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
Sucralfate tablets are 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
Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
1 INDICATIONS AND USAGE
VISTOGARD
is indicated for the emergency treatment of adult and pediatric patients:
following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or
who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.
VISTOGARD
is a pyrimidine analog indicated for the emergency treatment of adult and pediatric patients:
following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or
who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration. (1)
Limitations of use:
VISTOGARD is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine
because it may diminish the efficacy of these drugs. (1)
The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established. (1)
Limitations of Use
VISTOGARD is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine
because it may diminish the efficacy of these drugs.
The safety and efficacy of VISTOGARD initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established.
INDICATIONS AND USAGE
NitrofurantoinCapsules, USP(monohydrate/ macrocrystals)are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or
Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NitrofurantoinCapsules, USP(monohydrate/ macrocrystals) and other antibacterial drugs,NitrofurantoinCapsules, USP(monohydrate/ macrocrystals) 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated withNitrofurantoinCapsules, USP(monohydrate/ macrocrystals) are predisposed to persistence or reappearance of bacteriuria. (See
CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with NitrofurantoinCapsules, USP(monohydrate/ macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of NitrofurantoinCapsules, USP(monohydrate/ macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
1INDICATIONS AND USAGE
DUREZOL is a topical corticosteroid that is indicated for:
The treatment of inflammation and pain associated with ocular surgery. (1.1)
The treatment of endogenous anterior uveitis. (1.2)
1.1Ocular Surgery
DUREZOL (difluprednate ophthalmic emulsion) 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.
1.2Endogenous Anterior Uveitis
DUREZOL is also indicated for the treatment of endogenous anterior uveitis.
1 INDICATIONS AND USAGE
NUCYNTA is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older. (1)
1 INDICATIONS AND USAGE
Glucagon for Injection is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract.
Limitations of Use:
Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.
Glucagon for Injection is a gastrointestinal motility inhibitor indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal (GI) tract (1)
Limitations of Use:
Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia (1)
INDICATIONS AND USAGE
Diethylpropion hydrochloride extended release tablets, 75 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of BMI based on various heights and weights. BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches x 0.0254 = meters.
Body Mass Index (BMI), kg/m2
Weight(pounds)
Height (feet, inches)
50
53
56
59
60
63
140
27
25
23
21
19
18
150
29
27
24
22
20
19
160
31
28
26
24
22
20
170
33
30
28
25
23
21
180
35
32
29
27
25
23
190
37
34
31
28
26
24
200
39
36
32
30
27
25
210
41
37
34
31
29
26
220
43
39
36
33
30
28
230
45
41
37
34
31
29
240
47
43
39
36
33
30
250
49
44
40
37
34
31
The usefulness of agents of this class (See
CLINICAL PHARMACOLOGY
) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride extended release tablets, 75 mg are indicated for use as monotherapy only.