um-ids/dailymed-annotations huggingface dataset:
1 Indications And Usage
KETALAR (ketamine hydrochloride) injection is indicated:
as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
for the induction of anesthesia prior to the administration of other general anesthetic agents.
as a supplement to other anesthetic agents.
KETALAR is a general anesthetic indicated:
as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation (1)
for the induction of anesthesia prior to the administration of other general anesthetic agents (1)
as a supplement to other anesthetic agents (1).
INDICATIONS AND USAGE
Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.
1 INDICATIONS AND USAGE
Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for:
Pantoprazole is a proton pump inhibitor indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance of Healing of Erosive Esophagitis (1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole is indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1 INDICATIONS AND USAGE
PREMARIN (conjugated estrogens) Vaginal Cream is a mixture of estrogens indicated for:
Treatment of Atrophic Vaginitis and Kraurosis Vulvae (1.1)
Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause (1.2)
1.1 Treatment of Atrophic Vaginitis and Kraurosis Vulvae
1.2 Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause
INDICATIONS AND USAGE
MYAMBUTOL is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in-vitro susceptibility studies. In patients who have not received previous antituberculous therapy, ie, initial treatment, the most frequently used regimens have been the following:
MYAMBUTOL plus isoniazid
MYAMBUTOL plus isoniazid plus streptomycin.
In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, MYAMBUTOL should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in-vitro studies. Antituberculous drugs used with MYAMBUTOL have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilized.
INDICATIONS AND USAGE
Promethazine hydrochloride tablets are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angiodema. Amelioration of allergic reactions to blood or plasma.
Dermographism.
Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled.
Preoperative, postoperative, or obstetric sedation.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.
Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
1. INDICATIONS AND USAGE
Clopidogrel is a P2Y12 platelet inhibitor indicated for:
Acute coronary syndrome
For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)] including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel tablets has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1)
For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary PCI is unknown. (1.1)
Recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease. Clopidogrel tablets has been shown to reduce the combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death. (1.2)
1.1 Acute Coronary Syndrome (ACS)
For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel tablet has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablet has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown.
The optimal duration of clopidogrel tablets therapy in ACS is unknown.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel tablet has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
INDICATIONS
Entacapone Tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose wearing-off in patients with Parkinsons disease (see CLINICAL PHARMACOLOGY, Clinical Studies).
Entacapone Tablets effectiveness has not been systematically evaluated in patients with Parkinsons disease who do not experience end-of-dose wearing-off.
1 INDICATIONS AND USAGE
XALKORI is a kinase inhibitor indicated for the treatment of
patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. (1.1, 2.1)
pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. (1.2, 2.2)
oLimitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. (1.3, 2.2)
1.1	ALK- or ROS1-Positive Metastatic Non-Small Cell Lung Cancer
XALKORI is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test [see Dosage and Administration (2.1)].
1.2	Relapsed or Refractory, Systemic ALK-Positive Anaplastic Large Cell Lymphoma
XALKORI is indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.
Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
1.3	Unresectable, Recurrent, or Refractory ALK-Positive Inflammatory Myofibroblastic Tumor
XALKORI is indicated for the treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive.
INDICATIONS & USAGE SECTION
1.1 Major Depressive Disorder
Escitalopram tablets, USP are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies (14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram tablets, USP are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [seeClinicalStudies(14.2)].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
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 an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Associations Diagnostic and Statistical Manual, III1 as follows:
Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
1.
Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting,
restlessness, easy startle.
2.
Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset
stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
3.
Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
4.
Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling on edge, irritability, impatience.
The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.
The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Mesalamine extended-release capsule is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults.
(1)
INDICATIONS AND USAGE
Cyanocobalamin is indicated for Vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions:
Addisonian (pernicious) anemia
Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy
Fish tapeworm infestation
Malignancy of pancreas or bowel
Folic acid deficiency
It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see
Drug/Laboratory Test Interactions
), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin.
Requirements of Vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.
Cyanocobalamin injection is also suitable for the Vitamin B12 absorption test (Schilling test).
1 INDICATIONS AND USAGE
Azacitidine for injectionisanucleosidemetabolicinhibitorindicatedforthetreatmentof:
Adult patients with the following FAB myelodysplastic syndrome(MDS)subtypes:Refractoryanemia(RA)orrefractoryanemiawithringed sideroblasts (RARS) (if accompanied by neutropenia orthrombocytopeniaorrequiringtransfusions),refractoryanemiawithexcess blasts (RAEB), refractory anemia with excess blasts intransformation (RAEB-T), and chronic myelomonocytic leukemia(CMMoL). (1.1)
1.1 Myelodysplastic Syndromes (MDS)
Azacitidine for injection is indicated for treatment of adult patients with the following French-American- British(FAB)myelodysplasticsyndromesubtypes:refractoryanemia(RA) orrefractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions),refractoryanemiawithexcessblasts(RAEB),refractoryanemiawithexcessblasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
Pediatric use information is approved for Celgene Corporation's Vidaza (azacitidine for injection).However,duetoCelgeneCorporation'smarketingexclusivityrights,thisdrug product is not labeled with that information.
1	INDICATIONS AND USAGE
Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Rosuvastatin calcium tablets are an HMG CoA reductase inhibitor indicated for:
adult patients with hypertriglyceridemia as an adjunct to diet
(1.3)
adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet
(1.4)
adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDLC, total-C, and ApoB
(1.5)
Limitations of use
(1.8): Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1.3 Hypertriglyceridemia
Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4	Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1 INDICATIONS AND USAGE
Donepezil hydrochloride tablets are acetylcholinesterase inhibitor 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 (1).
Donepezil hydrochloride tablets are 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.
1 INDICATIONS AND USAGE
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney
[see Clinical Studies (14.1)], heart
[see Clinical Studies (14.2)] or liver transplants
[see Clinical Studies (14.3)], in combination with other immunosuppressants.
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (1)
INDICATIONS AND USAGE
Diethylpropion hydrochloride tablets USP, 25 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 patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches
0.0254 = meters.
Body Mass Index (BMI), kg/m2
Weight (pounds)
Height (feet, inches)
5'0"
5'3"
5'6"
5'9"
6'0"
6'3"
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 tablets USP, 25 mg are indicated for use as monotherapy only.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Diclofenac sodium and misoprostol delayed-release tabletsare indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. See
WARNINGS
,
Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
for a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications.
1 INDICATIONS AND USAGE
Atovaquone and proguanil hydrochloride tablets are an antimalarial indicated for:
prophylaxis of
Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported (
1.1)
treatment of acute, uncomplicated
P. falciparum malaria (
1.2)
1.1 Prevention of Malaria
Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of
Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported.
1.2 Treatment of Malaria
Atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated
P. falciparum malaria.
Atovaquone and proguanil hydrochloride tablets have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance.
1 INDICATIONS & USAGE
ROBINUL and ROBINUL FORTE are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.
Limitations of Use
ROBINUL and ROBINUL FORTE are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.
ROBINUL and ROBINUL FORTE are anticholinergics indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. (1)
Limitations of Use:
Not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established. (1)
INDICATIONS AND USAGE
Kidney, Liver, and Heart Transplantation
Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids.
Rheumatoid Arthritis
Cyclosporine capsules (modified) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules (modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone.
Psoriasis
Cyclosporine capsules (modified) is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated.
While rebound rarely occurs, most patients will experience relapse with cyclosporine capsules (modified) as with other therapies upon cessation of treatment.