um-ids/dailymed-annotations huggingface dataset:
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 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 favorably affects survival or the incidence of sudden death.
1 INDICATIONS AND USAGE
Tri-Lo-Marzia is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1)
1.1 Oral Contraception
Tri-Lo-Marzia Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)].
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)
1 INDICATIONS AND USAGE
PERTZYE is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
PERTZYE is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. (1)
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin extended-release 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).
Indomethacin extended-release capsules, USP are not recommended for the treatment of acute gouty arthritis.
Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.
The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (See PRECAUTIONS,Drug Interactions).
1 INDICATIONS AND USAGE
PHEXXI is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
PHEXXI is a combination of lactic acid, citric acid, and potassium bitartrate indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. (1)
Limitations of Use: PHEXXI is not effective for the prevention of pregnancy when administered after intercourse.
Limitations of Use
PHEXXI is not effective for the prevention of pregnancy when administered after intercourse [see Dosage and Administration (2.1)].
1 INDICATIONS AND USAGE
Ammonia N13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
Ammonia N13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease (1).
1	INDICATIONS AND USAGE
KIMYRSA is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. (1.1)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of KIMYRSA and other antibacterial drugs, KIMYRSA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2)
1.1	Acute Bacterial Skin and Skin Structure Infections
KIMYRSA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:
Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).
1.2	Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of KIMYRSA and other antibacterial drugs, KIMYRSA 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
Rabeprazole sodium delayed-release tablet is a proton-pump inhibitor (PPI) indicated in adults for:
Healing of Erosive or Ulcerative
Gastroesophageal Reflux Disease (GERD) (1.1).
Maintenance of Healing of Erosive or
Ulcerative GERD (1.2).
Treatment of Symptomatic GERD (1.3).
Healing of Duodenal Ulcers (1.4).
Helicobacter pylori
Eradication to Reduce Risk of Duodenal Ulcer Recurrence (1.5).
Treatment of Pathological Hypersecretory
Conditions, Including Zollinger-Ellison Syndrome (1.6).
In adolescent patients 12 years of age and older for:
Short-term Treatment of Symptomatic GERD
(1.7).
1.1 Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
1.4 Healing of Duodenal Ulcers in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
Rabeprazole sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see CLINICAL PHARMACOLOGY (12.2) and the full prescribing information for clarithromycin].
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
Zonisamide is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
1 INDICATIONS AND USAGE
Oxaliplatin for injection USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for:
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
treatment of advanced colorectal cancer.
Oxaliplatin for injection USP is a platinum-based drug used in combination with infusional 5-fluorouracil/leucovorin, which is indicated for:
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
treatment of advanced colorectal cancer. (1)
1 INDICATIONS AND USAGE
Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Metformin hydrochloride extended-release tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
(1)
1 INDICATIONS AND USAGE
Limitation of Use
Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodoltablets 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 tablets are a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults (1)
Limitations of Use:
Should only be used for acute treatment periods up to two or three weeks (1)
INDICATIONS AND USAGE:
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
1 INDICATIONS AND USAGE
Fluoxetine capsules, USP are indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder
[see
Clinical Studies (14.1)]
.
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)
[see
Clinical Studies (14.2)]
.
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa
[see
Clinical Studies (14.3)]
.
Acute treatment of Panic Disorder, with or without
agoraphobia [see
Clinical Studies (14.4)]
.
Fluoxetine capsules, USP and Olanzapine in Combinationare indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Fluoxetine capsules, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
When using fluoxetine capsules, USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax
.
Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (
1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (
1)
Acute and maintenance treatment of Bulimia Nervosa (
1)
Acute treatment of Panic Disorder, with or without agoraphobia (
1)
Fluoxetine capsules, USP and olanzapine in combination
for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder (
1)
1 INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:
Lower Respiratory Tract Infections - caused by betalactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
Acute Bacterial Otitis Media - caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
Sinusitis - caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections - caused by betalactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
Urinary Tract Infections - caused by betalactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium 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.
Amoxicillin and clavulanate potassium tablets and oral suspension are a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: (1)
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)
INDICATIONS AND USAGE
Clindamycin phosphate topical solution, clindamycin phosphate topical gel and clindamycin phosphate topical lotion are indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).
1 INDICATIONS AND USAGE
Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Rosuvastatin calcium tablets are an HMG Co-A reductase inhibitor indicated for:
adult patients with hypertriglyceridemia as an adjunct to diet (1.3)
adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4)
adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.5)
Limitations of use (1.8): Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1.3 Hypertriglyceridemia
Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatin calcium tablets are indicated as anadjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Indomethacin extended-release 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).
Indomethacin extended-release capsules, USP are not recommended for the treatment of acute gouty arthritis.
Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.
The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (See
PRECAUTIONS,Drug Interactions
).
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 hyperlipidemia. Niacin 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.
1. Niacin extended-release tablets are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia.
2. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
3. In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
4. Niacin extended-release tablets in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
5. Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
Limitations of Use
Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH)
[see Warnings and Precautions (
5.1
)].
Niacin extended-release tablets contain extended-release niacin (nicotinic acid), and are indicated:
To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. (
1)
To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. (
1)
In combination with a bile acid binding resin:
Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. (
1)
As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. (
1)
To reduce TG in adult patients with severe hypertriglyceridemia. (
1)
Limitations of use:
Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial. (
5.1)
INDICATIONS AND USAGE
Clindamycin Phosphate Topical Solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see
CONTRAINDICATIONS, WARNINGS and
ADVERSE REACTIONS).
INDICATIONS AND USAGE:
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by bacitracin susceptible organisms.
1 INDICATIONS AND USAGE
JENTADUETO is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate (1.1)
Important limitations of use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis (1.2)
Has not been studied in patients with a history of pancreatitis (1.2)
1.1 Indication
JENTADUETO tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate [see Dosage and Administration (2.1) and Clinical Studies (14.1)].
1.2 Important Limitations of Use
JENTADUETO should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
JENTADUETO has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO [see Warnings and Precautions (5.2)].
1.1
Nosocomial Pneumonia
Linezolid is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus(methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14)].