um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONSAND USAGE
Ondansetron tablets are 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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
Ondansetron tablets are a 5-HT3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 (1)
nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (1)
nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen (1)
postoperative nausea and/or vomiting (1)
1 INDICATIONS AND USAGE
Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the:
Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. (1.1)
Treatment of adults with mycosis fungoides. (1.1)
Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen. (1.1)
Treatment of adults with rheumatoid arthritis. (1.2)
Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.3)
Treatment of adults with severe psoriasis. (1.4)
1.1 Neoplastic Diseases
Methotrexate tablets are indicated for the:
treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen.
treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen.
1.2 Rheumatoid Arthritis
Methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis.
1.3 Polyarticular Juvenile Idiopathic Arthritis
Methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA).
1.4 Psoriasis
Methotrexate tablets are indicated for the treatment of adults with severe psoriasis.
1 INDICATIONS AND USAGE
DuoDote is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds).
DuoDote, a combination of atropine, a cholinergic muscarinic antagonist, and pralidoxime chloride, a cholinesterase reactivator, is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds). (1)
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules USP are indicated for the treatment of:
Major depressive disorder in adults
Generalized anxiety disorder in adults and pediatric patients 7 years of age and older
Diabetic peripheral neuropathic pain in adults
Fibromyalgia in adults
Chronic musculoskeletal pain in adults
Additional pediatric use information is approved for Eli Lilly and Company, Inc.s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions:
Major depressive disorder (MDD) in adults (1)
Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1)
Diabetic peripheral neuropathic pain (DPNP) in adults (1)
Fibromyalgia (FM) in adults (1)
Chronic musculoskeletal pain in adults(1)
INDICATIONS AND USAGE
Chlordiazepoxide hydrochloride and clidinium bromide capsules is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
1 INDICATIONS AND USAGE
SUPREP Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older.
SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult and pediatric patients 12 years of age and older. (
1)
1
INDICATIONS AND USAGE
IMLYGIC is ageneticallymodified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
Limitations
of use:IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.
IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
Limitations of use: IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.(1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of naproxen tablets other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Naproxen is indicated:
For the relief of the signs and symptoms of rheumatoid arthritis
For the relief of the signs and symptoms of osteoarthritis
For the relief of the signs and symptoms of ankylosing spondylitis
For the relief of the signs and symptoms of juvenile arthritis
Naproxen is indicated:
For relief of the signs and symptoms of tendonitis
For relief of the signs and symptoms of bursitis
For relief of the signs and symptoms of acute gout
For the management of pain
For the management of primary dysmenorrhea
1 INDICATIONS
AND USAGE
BREXAFEMME is a triterpenoid antifungal indicatedin adult and post-menarchal pediatric femalesfor:
Treatment of vulvovaginal candidiasis (VVC). (
1.1)
Reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC) (
1.1)
1.1 Vulvovaginal Candidiasis
BREXAFEMME
is indicated in adult and post-menarchal pediatric femalesfor:
Treatment of vulvovaginal candidiasis (VVC)
Reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).
1.2 Usage
If specimens for fungal culture are obtained prior to therapy,antifungal therapy may be instituted before the results of the cultures are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
1	INDICATIONS AND USAGE
JARDIANCE is indicated:
to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated:
To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. (1)
To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. (1)
As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. (1)
Limitations of Use:
Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. (1)
Not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2 (1)
Limitations of Use
JARDIANCE is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1)].
JARDIANCE is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2. JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.
1 INDICATIONS AND USAGE
Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for:
Ovarian cancer: After failure of platinum-based chemotherapy (1.1).
AIDS-related Kaposis Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy (1.2).
Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3).
1.1 Ovarian Cancer
Doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
1.2 AIDS-Related Kaposi's Sarcoma
Doxorubicin hydrochloride liposome injection is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.
1.3 Multiple Myeloma
Doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
INDICATIONS & USAGE
Flucytosine Capsules are indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.
Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.
Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.
Flucytosine Capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine Capsules (see MICROBIOLOGY).
INDICATIONS AND USAGE
NEO-SYNALAR cream is indicated for the treatment of corticosteroid-responsive dermatoses with secondary infection. It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment (see WARNINGS section).
INDICATIONS AND USAGE
Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use.
Colestipol hydrochloride tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Generally, colestipol hydrochloride tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients.
Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy (see NCEP guidelines). A minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. Shorter periods may be considered in patients with severe elevations of LDL-C or with definite CHD.
According to the NCEP guidelines, the goal of treatment is to lower LDL-C, and LDL-C is to be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy. The NCEP treatment guidelines are shown below.
LDL-Cholesterol mg/dL (mmol/L)
Definite Atheroschlerotic Disease
Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease).
Two or More Other Risk Factors
Other risk factors for coronary heart disease (CHD) include: age (males:
45 years; female:
55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is
60 mg/dL (1.6 mmol/L).
Initiation Level
Goal
No
No
190
( 4.9)
< 160
(< 4.1)
No
Yes
160
( 4.1)
< 130
(< 3.4)
Yes
Yes or No
130
( 3.4)
100
( 2.6)
1 INDICATIONS AND USAGE
Phentermine Hydrochloride, USP 15 mg and 30 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index 30 kg/m
2, or27 kg/m
2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of Body Mass Index (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
2.2 = kg; inches x 0.0254 = meters.
The limited usefulness of agents of this class, including Phentermine hydrochloride, [
see CLINICAL PHARMACOLOGY (
12.1
,
12.2
)] should be measured against possible risk factors inherent in their use such as those described below.
91cf84db-figure-01
1 INDICATIONS AND USAGE
Olmesartan medoxomil 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. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets.
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.
It may be used alone or in combination with other antihypertensive agents.
Olmesartan medoxomil tablets are an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1).
Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin capsules have been found effective in active stages of the following:
1.
Moderate to severe rheumatoid arthritis including acute flares of chronic disease.
2.
Moderate to severe ankylosing spondylitis.
3.
Moderate to severe osteoarthritis.
4.
Acute painful shoulder (bursitis and/or tendinitis).
5.
Acute gouty arthritis.
1 INDICATIONS AND USAGE
CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
CLINIMIX E may be used to treat negative nitrogen balance in patients.
CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients. (1)
INDICATIONS AND USAGE
Dobutamine injection is indicated when parenteral therapy is
necessary for inotropic support in the short-term
treatment of adults with cardiac decompensation due to depressed contractility
resulting either from organic heart disease or from cardiac surgical
procedures.
In patients who have atrial fibrillation with rapid ventricular response, a
digitalis preparation should be used prior to institution of therapy with
dobutamine hydrochloride.
1
INDICATION
S
AND USAGE
TAYTULLAis indicated for use by females of reproductive age to prevent pregnancy [
see
Clinical Studies (14)
].
The efficacy of TAYTULLAin women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
TAYTULLAis a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy (1)
The efficacy of TAYTULLAin females of reproductive potential with a body mass index (BMI) of >35kg/m2 has not been evaluated (1, 8.8)
INDICATIONS AND USAGE
Nystatin oral suspension is indicated for the treatment of infections of the oral cavity caused by Candida albicans.
1
INDICATIONS AND USAGE
Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of:
Rheumatoid Arthritis (RA) (1.1)
Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2years or older (1.2)
Psoriatic Arthritis (PsA) (1.3)
Ankylosing Spondylitis (AS) (1.4)
Plaque Psoriasis (PsO) in patients 4years or older (1.5)
1.1
Rheumatoid Arthritis
Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA).
Enbrel can be initiated in combination with methotrexate (MTX) or used alone.
1.2
Polyarticular Juvenile Idiopathic Arthritis
Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.
1.3
Psoriatic Arthritis
Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA).
Enbrel can be used with or without methotrexate.
1.4
Ankylosing Spondylitis
Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).
1.5
Plaque Psoriasis
Enbrel is indicated for the treatment of patients 4years orolderwith chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
INDICATIONS AND USAGE
Quinapril hydrochloride
and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
This fixed combination is not indicated for the initial therapy of hypertension
(see DOSAGE AND ADMINISTRATION).
In using quinapril
hydrochloride and hydrochlorothiazide, consideration should be given to the fact
that another angiotensin-converting enzyme inhibitor, captopril, has caused
agranulocytosis, particularly in patients with renal impairment or
collagen-vascular disease. Available data are insufficient to show that
quinapril does not have a similar risk (see WARNINGS:
Neutropenia/Agranulocytosis).
Angioedema in Black Patients: Black patients receiving ACE
inhibitor monotherapy have been reported to have a higher incidence of
angioedema compared to non-blacks. It should also be noted that in controlled
clinical trials, ACE inhibitors have an effect on blood pressure that is less in
black patients than in non-blacks.
1 INDICATIONS AND USAGE
Varenicline tablets are indicated for use as an aid to smoking cessation treatment.
Varenicline tablets are a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. (
1 and
2.1)
1 INDICATIONS AND USAGE
Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
Memantine HCl is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (1)
INDICATIONS AND USAGE
Postherpetic Neuralgia
Gabapentin tablets, USP are indicated for the management of postherpetic neuralgia in adults.
Epilepsy
Gabapentin tablets, USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin tablets are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.
INDICATIONS AND USAGE
Carac is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.
1
INDICATIONS & USAGE
OFIRMEV (acetaminophen) injection is indicated for
the management of mild to moderate pain in adult and pediatric patients 2 years and older
the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older
the reduction of fever in adult and pediatric patients.
1 INDICATIONS AND USAGE
Lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Limitations of Use:
The dosage of this product is for HIV-1 and not for HBV.
Lamivudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Limitations of Use: The dosage of this product is for HIV-1 and not for HBV. (
1)