um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for
Prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants (
1.1,
1.2,
1.3)
Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil (MMF) (
1.1,
1.2,
1.3)
Limitations of Use (
1.4):
Do not use simultaneously with cyclosporine
Intravenous use reserved for patients who can not tolerate capsules orally
Use with sirolimus is not recommended in liver and heart transplant; use with sirolimus in kidney transplant has not been established
1.1 Prophylaxis of Organ Rejection in Kidney Transplant
Tacrolimus Capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that tacrolimus be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids [ see Clinical Studies ( 14.1)] . Therapeutic drug monitoring is recommended for all patients receiving tacrolimus [ see Dosage and Administration ( 2.6)].
1.2 Prophylaxis of Organ Rejection in Liver Transplant
Tacrolimus Capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that tacrolimus be used concomitantly with adrenal corticosteroids [
see Clinical Studies (
14.2)]. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus[
see Dosage and Administration (
2.6)].
1.3 Prophylaxis of Organ Rejection in Heart Transplant
Tacrolimus Capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. It is recommended that tacrolimus capsules be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids [
see Clinical Studies (
14.3)]. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules [
see Dosage and Administration (
2.6)].
1.4 Limitations of Use
Tacrolimus Capsules should not be used simultaneously with cyclosporine [
see Dosage and Administration (
2.5)].
Use with sirolimus is not recommended in liver and heart transplant. The safety and efficacy of tacrolimus with sirolimus has not been established in kidney transplant [
see Warnings and Precautions (
5.12)].
Intravenous use reserved for patients who cannot tolerate capsules orally.
Uses
Aids in the removal of phlegm, mucus, or other secretions in the temporary relief of discomfort due to occasional sore throat and sore mouth.
1 INDICATIONS AND USAGE
LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
chronic IBS symptoms (generally lasting 6 months or longer),
had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
not responded adequately to conventional therapy.
Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:
frequent and severe abdominal pain/discomfort,
frequent bowel urgency or fecal incontinence,
disability or restriction of daily activities due to IBS.
Because of infrequent but serious gastrointestinal adverse reactions associated with LOTRONEX, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.
Clinical studies have not been performed to adequately confirm the benefits of LOTRONEX in men.
LOTRONEX is a selective serotonin 5-HT3 antagonist indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
chronic IBS symptoms (generally lasting 6 months or longer),
had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
not responded adequately to conventional therapy. (1)
Severe IBS includes diarrhea and 1 or more of the following:
frequent and severe abdominal pain/discomfort,
frequent bowel urgency or fecal incontinence,
disability or restriction of daily activities due to IBS. (1)
1 INDICATIONS AND USAGE
INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron.
INFeD, an iron replacement product, is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or an unsatisfactory response to oral iron. (1)
1 INDICATIONS AND USAGE
HIV-1 Treatment (1.1)
Emtricitabine and tenofovir disoproxil fumarate tablets are two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated:
in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.
HIV-1 PrEP (1.2):
Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP.
1.1 Treatment of HIV-1 Infection
Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies (14)].
1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP)
Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE
Clopidogrel tablet 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]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)
- For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. (1.1)
Recent MI, recent stroke,
or established peripheral arterial disease. Clopidogrel has been shown to
reduce the rate of MI and stroke. (1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel
tablet is indicated to reduce the rate of myocardial infarction (MI) and
stroke in 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 should be administered in conjunction with aspirin.
Clopidogrel
tablet is indicated to reduce the rate of myocardial infarction and stroke
in patients with acute ST-elevation myocardial infarction (STEMI) who are
to be managed medically. Clopidogrel tablets should be administered in
conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke Clopidogrel tablet is indicated to reduce the rate of MI and stroke.
INDICATIONS AND USAGE
Amantadine hydrochloride syrup (amantadine hydrochloride oral
solution, USP) is indicated for the prophylaxis and treatment of signs and
symptoms of infection caused by various strains of influenza A virus. Amantadine
hydrochloride is also indicated in the treatment of parkinsonism and
drug-induced extrapyramidal reactions.
Influenza A ProphylaxisAmantadine hydrochloride is indicated for chemoprophylaxis
against signs and symptoms of influenza A virus infection when early vaccination
is not feasible or when the vaccine is contraindicated or not available. In the
prophylaxis of influenza, early vaccination on an annual basis as recommended by
the Centers for Disease Control's Immunization Practices Advisory Committee is
the method of choice. Because amantadine does not completely prevent the host
immune response to influenza A infection, individuals who take this drug may
still develop immune responses to natural disease or vaccination and may be
protected when later exposed to antigenically related viruses. Following
vaccination during an influenza A outbreak, amantadine prophylaxis should be
considered for the 2-to 4-week time period required to develop an antibody
response.
Influenza A TreatmentAmantadine hydrochloride is also indicated in the treatment of
uncomplicated respiratory tract illness caused by influenza A virus strains
especially when administered early in the course of illness. There are no
well-controlled clinical studies demonstrating that treatment with amantadine
will avoid the development of influenza A virus pneumonitis or other
complications in high risk patients.
There is no clinical evidence indicating that amantadine is effective in the
prophylaxis or treatment of viral respiratory tract illnesses other than those
caused by influenza A virus strains.
Parkinson's Disease/SyndromeAmantadine is indicated in the treatment of idiopathic
Parkinson's disease (Paralysis Agitans), postencephalitic parkinsonism, and
symptomatic parkinsonism which may follow injury to the nervous system by carbon
monoxide intoxication. It is indicated in those elderly patients believed to
develop parkinsonism in association with cerebral arteriosclerosis. In the
treatment of Parkinson's disease, amantadine is less effective than levodopa,
(-)-3-(3,4-dihydroxyphenyl)-L-alanine, and its efficacy in comparison with the
anticholinergic antiparkinson drugs has not yet been established.
Drug-Induced Extrapyramidal ReactionsAmantadine hydrochloride is indicated in the treatment of
drug-induced extrapyramidal reactions. Although anticholinergic-type side
effects have been noted with amantadine when used in patients with drug-induced
extrapyramidal reactions, there is a lower incidence of these side effects than
that observed with the anticholinergic antiparkinson drugs.
1 INDICATIONS AND USAGE
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for the prevention of:
acuteanddelayednauseaandvomitingassociatedwithinitialandrepeatcoursesofhighlyemetogenic cancer chemotherapy (HEC) including high-dosecisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)
Limitations ofUse
Fosaprepitant for injection has not been studied for the treatment of established nausea andvomiting.
Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Fosaprepitant for injection is a substance P/neurokinin-1 (NK1)receptorantagonist, indicated in adults, in combination with otherantiemetic agents, for the prevention of(1):
acute and delayed nausea and vomiting associated with initialandrepeatcoursesofhighlyemetogeniccancerchemotherapy(HEC) including high-dose cisplatin
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use(1)
Fosaprepitant for injectionhasnotbeenstudiedfortreatmentofestablishednauseaand vomiting.
1 INDICATIONS AND USAGE
Norgestimate and Ethinyl Estradiol Tablets USP are estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1)
Norgestimate and Ethinyl Estradiol Tablets USP are also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.
Norgestimate and Ethinyl Estradiol Tablets USP should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2)
1.1 Oral Contraceptive
Norgestimate and Ethinyl Estradiol Tablets USP are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)].
1.2 Acne
Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) are indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Norgestimate and Ethinyl Estradiol Tablets USP, (0.18 mg/0.035 mg, 0.215 mg/0.035 mg and 0.25 mg/0.035 mg) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14)].
1 INDICATIONS AND USAGE
Olopatadine hydrochloride nasal spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.
Olopatadine hydrochloride nasal spray is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 6 years of age and older.
1 INDICATIONS AND USAGE
PRECEDEX is a alpha2-adrenergic receptor agonist indicated for:
Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer PRECEDEX by continuous infusion not to exceed 24 hours. (1.1)
Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2)
Sedation of non-intubated pediatric patients aged 1 month to less than 18years prior to and during non-invasive procedures. (1.2)
1.1	Intensive Care Unit Sedation
PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. PRECEDEX should be administered by continuous infusion not to exceed 24 hours.
PRECEDEX has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue PRECEDEX prior to extubation.
1.2	Procedural Sedation
PRECEDEX is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
PRECEDEX is indicated for sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures.
1 INDICATIONS AND USAGE
PONVORY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
PONVORY is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. (
1)
INDICATIONS AND USAGE
Topex Fluoride Gels are indicated for topical application to teeth to aid in the prevention of dental caries.
The non-acidic nature of Neutral pH (NaF) is recommended for patients with ceramic or composite restorations.
Treatment frequency should not exceed 4 treatments per year.
1. INDICATIONS AND USAGE
GIAPREZA increases blood pressure in adults with septic or other distributive shock
[see Clinical Studies (14)]
.
GIAPREZA is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. (
1)
INDICATIONS AND USAGE
Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the use of this product in the treatment of other disorders have not been established.
1 INDICATIONS AND USAGE
Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for:
Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
Sedation for Adult Patients in Combination with Regional Anesthesia
Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients
Limitations of Use
Propofol is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use (8.4)].
Safety, effectiveness and dosing guidelines for propofol have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use (8.4)].
Propofol is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4)].
Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for:
Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients
Sedation for Adult Patients in Combination with Regional Anesthesia
Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients
Limitations of Use:
Propofol is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months
MAC sedation in the pediatric population is not recommended
Propofol is not indicated for use in Pediatric ICU sedation
1 INDICATIONS AND USAGE
Eplerenone is an aldosterone antagonist indicated for:
Improving survival of stable patients with LV systolic dysfunction (LVEF 40%) and CHF after an acute myocardial infarction. (1.2)
Hypertension, alone or combined with other agents. (1.3)
1.1 Patient Selection Considerations
Serum potassium levels should be measured before initiating eplerenone therapy and eplerenone should not be prescribed if serum potassium is >5.5 mEq/L. [See 4 CONTRAINDICATIONS].
1.2 Congestive Heart Failure Post-Myocardial Infarction
Eplerenone is indicated to improve survival of stable patients with left ventricular (LV) systolic dysfunction (ejection fraction 40%) and clinical evidence of congestive heart failure (CHF) after an acute myocardial infarction (MI).
1.3 Hypertension
Eplerenone is indicated for the treatment of hypertension. Eplerenone may be used alone or in combination with other antihypertensive agents.
Initial Treatment of Advanced Ovarian Carcinoma
Carboplatin Injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see
CLINICAL STUDIES
).
There is limited statistical power to demonstrate equivalence in overall pathologic complete response rates and long-term survival (3 years)because of the small number of patients with these outcomes: the small number of patients with residual tumor <2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.
1. INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.
1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events
In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets are indicated to:
Reduce the risk of total mortality by reducing CHD deaths.
Reduce the risk of non-fatal myocardial infarction and stroke.
Reduce the need for coronary and non-coronary revascularization procedures.
1.2 Hyperlipidemia
Simvastatin tablets are indicated to:
Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb).
Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type lV hyperlipidemia).
Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia).
Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3 Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH)
Simvastatin tablets are indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present:
LDL cholesterol remains 190 mg/dL; or
LDL cholesterol remains 160 mg/dL and
There is a positive family history of premature cardiovascular disease (CVD) or
Two or more other CVD risk factors are present in the adolescent patient.
The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C <130 mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined.
1.4 Limitations of Use
Simvastatin tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).
1 INDICATIONS AND USAGE
Abacavir and lamivudine tablets, a combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (
1
)
Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
1 INDICATIONS AND USAGE
Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for
Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT) for the diagnosis of coronary artery disease by localization of:
Non-reversible defects (myocardial infarction) which may have prognostic value regarding survival.
Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress.
Localization of sites of parathyroid hyperactivity pre- and post-operatively in patients with elevated serum calcium and parathyroid hormone levels.
Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for
Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT) for the diagnosis of coronary artery disease by localization of:
Non-reversible defects (myocardial infarction)
Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress. (1)
Localization of sites of parathyroid hyperactivity pre- and post-operatively in patients with elevated serum calcium and parathyroid hormone levels. (1)