um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for:
Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1)
1.1
Hypertension
Telmisartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Telmisartan tablets may be used alone or in combination with other antihypertensive agents [see Clinical Studies (14.1)].
1 INDICATIONS AND USAGE
LoSeasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl
estradiol tablets) is indicated for use by women to prevent pregnancy.
LoSeasonique is an estrogen/progestin COC indicated for use by women to prevent pregnancy. ( 1)
1. INDICATIONS AND USAGE
Celecoxib capsules are indicated
Celecoxib is a nonsteroidal 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)
For the management of the signs and symptoms of OA [
see
Clinical Studies (14.1)
]
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [
see
Clinical Studies (14.2)
]
1.3 Juvenile Rheumatoid Arthritis (JRA)
For the management of the signs and symptoms of JRA in patients 2 years and older [
see
Clinical Studies (14.3)
]
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [
see
Clinical Studies (14.4)
]
1.5 Acute Pain
For the management of acute pain in adults [
see
Clinical Studies (14.5)
]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [
see
Clinical Studies (14.5)
]
INDICATIONS & USAGE
Based on a review of this drug by the National Academy of Sciences
National Research Council and/or other information, FDA has classified the indications as follows:
Effective: Management of nausea and vomiting, and dizziness associated with motion sickness.
Possibly Effective: Management of vertigo associated with diseases affecting the vestibular system.
Final classification of the less than effective indications required further investigation.
INDICATIONS AND USAGE
Acetaminophen and codeine phosphate tablets are indicated for the relief of mild
to moderately severe pain.
1 INDICATIONS AND USAGE
Levalbuterol inhalation solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
Levalbuterol inhalation solution is a beta
2-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in adults, adolescents, and children 6
years of age and older with reversible obstructive airway disease.
(1)
INDICATIONS AND USAGE:
A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 DentaGel 1.1% Brush-On Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (SeeWARNINGS for exception.)
INDICATIONS AND USAGEMorphine sulfate extended-release tablets are an extended-release
oral formulation of morphine sulfate indicated for the management of moderate to
severe pain when a continuous, around-the-clock opioid analgesic is needed for
an extended period of time.
Morphine sulfate extended-release tablets are NOT intended for use as a prn
analgesic.
The morphine sulfate extended-release tablets 100 mg and 200 mg strengths are
high dose, extended-release, oral morphine formulations indicated for the relief
of pain in opioid-tolerant patients only.
Morphine sulfate extended-release tablets are not indicated for pain in the
immediate postoperative period (the first 12 to 24 hours following surgery) for
patients not previously taking the drug, because its safety in this setting has
not been established.
Morphine sulfate extended-release tablets are not indicated for pain in the
postoperative period if the pain is mild, or not expected to persist for an
extended period of time.
Morphine sulfate extended-release tablets are only indicated for
postoperative use if the patient is already receiving the drug prior to surgery
or if the postoperative pain is expected to be moderate to severe and persist
for an extended period of time. Physicians should individualize treatment,
moving from parenteral to oral analgesics as appropriate. (See American Pain
Society guidelines.)
INDICATIONS AND USAGE
MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See
WARNINGS.)
Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of MARCAINE in these patients.
MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See
WARNINGS
.
The routes of administration and indicated MARCAINE concentrations are:
local infiltration 0.25%peripheral nerve block
0.25% and 0.5%retrobulbar block 0.75%sympathetic block 0.25%lumbar epidural 0.25%, 0.5%, and 0.75%
(0.75% not for obstetrical anesthesia)caudal 0.25% and 0.5%
(See
DOSAGE AND ADMINISTRATION
for additional information).
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of MARCAINE.
1 INDICATIONS AND USAGE
Topotecan Injection is indicated for the treatment of:
small cell lung cancer sensitive disease after failure of first-line chemotherapy.
In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy
[see
Clinical Studies (
14)
]
.
Topotecan Injection in combination with cisplatin is indicated for the treatment of:
stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
Topotecan is a topoisomerase inhibitor indicated for:
small cell lung cancer sensitive disease after failure of first-line chemotherapy. (
1)
combination therapy with cisplatin for stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. (
1)
1 INDICATIONS AND USAGE
Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia.
Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters and should continue this diet during treatment with omega-3-acid ethyl esters capsules.
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 TG-lowering drug therapy.
Limitations of Use:
The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined.
The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined.
Omega-3-acid ethyl esters capsules are 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. (1)
Limitations of Use:
The effect of omega-3-acid ethyl esters on the risk for pancreatitis has not been determined. (1)
The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined. (1)
1 INDICATIONS & USAGE
Imatinib mesylate is a kinase inhibitor indicated for the treatment of:
Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (1.1)
Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy (1.2)
Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) (1.3)
Adult patients with myelodysplastic/ myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test (1.5)
Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation as determined with an FDA-approved test or with c-Kit mutational status unknown (1.6)
Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFR fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR fusion kinase negative or unknown (1.7)
Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) (1.8)
1.1
Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML)
Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
1.2	Ph+ CML in Blast Crisis (BC), Accelerated Phase (AP) or Chronic Phase (CP) After Interferon-alpha (IFN) Therapy
Patients with Philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
1.3	Adult patients with Ph+ Acute Lymphoblastic Leukemia (ALL)
Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
1.5	Myelodysplastic/Myeloproliferative Diseases (MDS/MPD)
Adult patients with myelodysplastic/ myeloproliferative diseases associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test [see Dosage and Administration (2.6)]
1.6	Aggressive Systemic Mastocytosis (ASM)
Adult patients with aggressive systemic mastocytosis without the D816V c-Kit mutation as determined with an FDA-approved test [see Dosage and Administration (2.7)]or with c-Kit mutational status unknown.
1.7	Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL)
Adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the FIP1L1PDGFR fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFR fusion kinase negative or unknown.
1.8	Dermatofibrosarcoma Protuberans (DFSP)
Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans.
INDICATIONS AND USAGE
In patients without structural heart disease, Flecainide Acetate Tablets USP are indicated for the prevention of:
paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms
paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms
Flecainide Acetate Tablets USP are also indicated for the prevention of:
documented ventricular arrhythmias, such as
sustained ventricular tachycardia (
sustained VT), that in the judgment of the physician are life-threatening.
Use of Flecainide Acetate Tablets USP for the treatment of
sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of Flecainide Acetate Tablets USP is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.
Because of the proarrhythmic effects of Flecainide Acetate Tablets USP, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.
Flecainide Acetate Tablets USP should not be used in patients with recent myocardial infarction. (See Boxed
WARNINGS
).
Use of Flecainide Acetate Tablets USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See Boxed
WARNINGS
).
As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of Flecainide Acetate Tablets USP favorably affects survival or the incidence of sudden death.
1 INDICATIONS AND USAGE
Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy.(1.1)
postoperative nausea and/or vomiting.(1.2)
1.1	Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy
Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.
Ondansetron Injection is approved for patients aged 6 months and older.
1.2	Prevention of Postoperative Nausea and/or Vomiting
Ondansetron Injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Injection and experience nausea and/or vomiting postoperatively, Ondansetron Injection may be given to prevent further episodes.
Ondansetron Injection is approved for patients aged 1 month and older.
INDICATIONS AND USAGE
Methylprednisolone Tablets are indicated in the following conditions:
1.Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2.Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Synovitis of osteoarthritis
Acute nonspecific tenosynovitis
Post-traumatic osteoarthritis
Psoriatic arthritis
Epicondylitis
Acute gouty arthritis
3.Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
4.Dermatologic Diseases
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Severe seborrheic dermatitis
Exfoliative dermatitis
Mycosis fungoides
Pemphigus
Severe psoriasis
5.Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Drug hypersensitivity reactions
Serum sickness
Contact dermatitis
Bronchial asthma
Atopic dermatitis
6.Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Sympathetic ophthalmia
Keratitis
Optic neuritis
Allergic conjunctivitis
Chorioretinitis
Iritis and iridocyclitis
7.Respiratory Diseases
Symptomatic sarcoidosis
Berylliosis
Loefflers syndrome not manageable by other means
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis
8.Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9.Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10.Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
11.Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
12.Nervous System
Acute exacerbations of multiple sclerosis
13.Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Trichinosis with neurologic or myocardial involvement.
1 INDICATIONS AND USAGE
YUPELRI is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
YUPELRI is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
1
INDICATIONS & USAGE
NARCAN Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
NARCAN Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
NARCAN Nasal Spray is not a substitute for emergency medical care.
Limitations of Use:
Restrict prescription of NARCAN Nasal Spray 2 mg to opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.
1 INDICATIONS AND USAGE
Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
For procedures in which a rapid and short-acting topical ophthalmic anesthetic is indicated such as in tonometry, gonioscopy, removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, suture removal from the cornea, other short corneal and conjunctival procedures.
INDICATIONS AND USAGE
Carbidopa and levodopa extended-release tablets are indicated in the treatment of the symptoms of idiopathic Parkinsons disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.
Uses
Caustic applicators are useful for cauterization of skin or mucous membrane and for the removal of granulation tissue, warts and verrucae.
1 INDICATIONS AND USAGE
Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.
Buprenorphine sublingual tablets, contain buprenorphine, a partial opioid agonist, and are indicated for the treatment of opioid dependence and are preferred for induction. (
1)
Buprenorphine sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. (
1)
1.2 Acute Maxillary Sinusitis
Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Haemophilus influenzae,
Moraxella catarrhalis, or
Streptococcus pneumoniae [see Indications and Usage
(1.9)]
.
1 INDICATIONS AND USAGE
EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection [see Dosage and Administration (2.2, 2.3, 2.4) and Clinical Studies (14)]:
without cirrhosis or with compensated cirrhosis
with decompensated cirrhosis for use in combination with ribavirin.
EPCLUSA is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection (1):
without cirrhosis or with compensated cirrhosis
with decompensated cirrhosis for use in combination with ribavirin.