um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Atorvastatin calcium tablets are indicated:
To reduce the risk of:
Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD
MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD
Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:
Adults with primary hyperlipidemia.
Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia
Hypertriglyceridemia
Atorvastatin calcium tablets are HMG-CoA reductase inhibitor (statin) indicated (1):
To reduce the risk of:
Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.
As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in:
Adults with primary hyperlipidemia.
Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia.
As an adjunct to diet for the treatment of adults with:
Primary dysbetaliproteinemia.
Hypertriglyceridemia.
1 INDICATIONS AND USAGE
NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS are indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
NAPROSYN Tablets and ANAPROX DS are also indicated for:
the relief of signs and symptoms of:
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
NAPROSYN Tablets, EC-NAPROSYN, and ANAPROX DS are non-steroidal anti-inflammatory drugs indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
NAPROSYN Tablets and ANAPROX DS are also indicated for:
the relief of signs and symptoms of:
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
11. Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis Regional enteritis
1.3 Limitations of Use
Oseltamivir phosphate for oral suspension is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate for oral suspension [see
Microbiology (12.4)
].
Oseltamivir phosphate for oral suspension is not recommended for patients with end-stage renal disease not undergoing dialysis [see
Dosage and Administration (2.4) and Use in Specific Populations (8.6)].
1 INDICATIONS AND USAGE
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2)
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 is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies (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 & USAGE
Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diclofenac potassium tablets are indicated:
For treatment of primary dysmenorrhea
For relief of mild to moderate pain
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
1 INDICATIONS AND USAGE
Azithromycin for Injection, USP is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
Community-acquired pneumonia in adults (1.1)
Pelvic inflammatory disease (1.2)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3)
1.1 Community-Acquired Pneumonia
due to Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy.
1.2 Pelvic Inflammatory Disease
due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Azithromycin for Injection, USP should be followed by azithromycin the oral route as required [see Dosage and Administration (2)
].
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS AND USAGE
Treatment of Anaerobic Infections
Metronidazole Injection, USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole therapy. In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to metronidazole.
Metronidazole is effective in Bacteroides fragilis infections resistant to clindamycin, chloramphenicol and penicillin.
Intra-abdominal Infections, including peritonitis, intra-abdominal abscess and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus,
B. thetaiotaomicron, B. vulgatus).Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species.
Skin and Skin Structure Infections caused by Bacteroides species including B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species and Fusobacterium species.
Gynecologic Infections, including endometritis, endomyometritis, tubo-ovarian abscess, and post-surgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus speciesand Fusobacterium species.
Bacterial Septicemia caused by Bacteroides species including the B. fragilis group and Clostridium species.
Bone and Joint Infections, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group.
Central Nervous System (CNS) Infections, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group.
Lower Respiratory Tract Infections, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group.
Endocarditis caused by Bacteroides species including the B. fragilis group.
Prophylaxis
The prophylactic administration of Metronidazole Injection, USP preoperatively, intraoperatively, and postoperatively may reduce the incidence of postoperative infection in patients undergoing elective colorectal surgery which is classified as contaminated or potentially contaminated.
Prophylactic use of Metronidazole Injection, USP should be discontinued within 12 hours after surgery. If there are signs of infection, specimens for cultures should be obtained for the identification of the causative organism(s) so that appropriate therapy may be given (see
DOSAGE AND ADMINISTRATION
).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion.
Limitations of Use:
Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.
Cyclobenzaprine hydrochloride extended-release capsules are a muscle relaxant indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. (1)
Limitations of Use:
Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to 2 or 3 weeks) (1)
Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity or cerebral palsy (1)
1 INDICATIONS AND USAGE
Amlodipine and benazepril hydrochloride capsulesare a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsulesare indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.(1)
1.1 Hypertension
Amlodipine and benazepril hydrochloride capsulesare indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
Citalopram, is indicated for the treatment of depression.
The efficacy of citalopram hydrobromide, in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).
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. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied.
The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
1 INDICATIONSAND USAGE
Methadone Hydrochloride Tablets are indicated for the: 1. Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids, reserve Methadone Hydrochloride Tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone Hydrochloride Tablets are not indicated as an as-needed (prn) analgesic.
2. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
3. Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see
Dosage and Administration (2.1)] .
Methadone Hydrochloride Tabletsis an opioid agonistindicated for the:
Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids, reserve Methadone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone Hydrochloride Tablets are not indicated as an as-needed (prn) analgesic.
2. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
3. Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.(1)
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 (
2.1
).
INDICATIONS
For the topical application of fluoride to aid in the protection against dental caries. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information.
image of package insert
1 INDICATIONS AND USAGE
BRONCHITOL is indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years and older with Cystic Fibrosis. Use BRONCHITOL only for adults who have passed the BRONCHITOL Tolerance Test [see Dosage and Administration (2.1)].
BRONCHITOL is a sugar alcohol indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis. Use BRONCHITOL only in adults who have passed the BRONCHITOL Tolerance Test. (1)
INDICATIONS AND USAGE
Methimazole is indicated in the medical treatment of hyperthyroidism. Long-term therapy may lead to remission of the disease. Methimazole may be used to ameliorate hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy. Methimazole is also used when thyroidectomy is contraindicated or not advisable.
INDICATIONSAND USAGE
1. Ursodiol capsules, USP are indicated for patients with radiolucent, noncalcified gallbladder stones <20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol capsules, USP beyond 24 months is not established. 2. Ursodiol capsules, USP are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
1 INDICATIONS AND USAGE
Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Limitation of Use
Carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration
[see
Dosage and Administration (2)
].
Carisoprodol
is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
(1)
Limitation of Use
Should only be used for acute treatment periods up to two or three weeks
(1)
INDICATIONS AND USAGE
Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION ).
In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS .)
In considering use of lisinopril and hydrochlorothiazide tablets, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See WARNINGS
,
Lisinopril .)
1 INDICATIONS AND USAGE
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see
Clinical Studies (
14.1)
].
Glimepiride tablets are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (
1.1).
Important Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (
1.1).
1.1 Important Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules, USP are indicated for the treatment of:
Major Depressive Disorder
[see Clinical Studies (
14.1)]
Generalized Anxiety Disorder
[see Clinical Studies (
14.2)]
Diabetic Peripheral Neuropathy
[see Clinical Studies
(
14.3)]
Chronic Musculoskeletal Pain
[see Clinical Studies (
14.5)]
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of flurbiprofen tablets and other treatment options before deciding to use flurbiprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Flurbiprofen tablets are indicated:
For relief of the signs and symptoms of rheumatoid arthritis.
For relief of the signs and symptoms of osteoarthritis.
Revised 2011-11 N-BB-CA-A 5BB89X505+5
FULL PRESCRIBING INFORMATION
*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].
1. INDICATIONS AND USAGE
1.1.
Read these instructions carefully before use.1.2.
Rx ONLY1.3.
Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.
For the collection of 450 mL +/- 10% Whole Blood.1.5.
For further processing, use standard component processing techniques.
Image of Figure Sealing with tape
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
For the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Enterobacter species, and coagulase-negative Staphylococcus species, including S. saprophyticus.
Cultures and susceptibility tests should be performed to determine the susceptibility of the bacteria to trimethoprim. Therapy may be initiated prior to obtaining the results of these tests.