um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Oseltamivir Phosphate capsule USP is an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)
Prophylaxis of influenza A and B in patients 1 year and older. (1.2)
Limitations of Use:
Not a substitute for annual influenza vaccination. (1.3)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3)
Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3)
1.1 Treatment of Influenza
Oseltamivir Phosphate capsule USP is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2 Prophylaxis of Influenza
Oseltamivir Phosphate capsule USP is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3 Limitations of Use
Oseltamivir Phosphate capsule USP 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 Capsule USP [see Microbiology (12.4)].
Oseltamivir Phosphate capsule USP 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
Clobetasol propionate lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older (1.1).
Limitations of Use:
Do not use on the face, axillae or groin. (1.2)
Do not use if atrophy is present at the treatment site. (1.2)
Do not use for rosacea or perioral dermatitis. (1.2)
1.1 Indication
Clobetasol propionate lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. Treatment should be limited to 2 consecutive weeks. For moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2 week treatment. Any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression before prescribing for more than 2 weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz) per week.
Patients should be instructed to use clobetasol propionate lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [see Dosage and Administration (2)].
Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
1.2 Limitations of Use
Clobetasol propionate lotion, 0.05% should not be used on the face, axillae, or groin and should not be used if there is atrophy at the treatment site. Clobetasol propionate lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.
1 INDICATIONS AND USAGE
HORIZANT is indicated for:
treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. (1.1)
management of postherpetic neuralgia (PHN) in adults. (1.2)
1.1	Treatment of Restless Legs Syndrome
HORIZANT is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults.
HORIZANT is not recommended for patients who are required to sleep during the daytime and remain awake at night.
1.2	Management of Postherpetic Neuralgia
HORIZANT is indicated for the management of postherpetic neuralgia (PHN) in adults.
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
PENNSAID is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).
PENNSAID is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). (1)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets 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.
Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see DOSAGE AND ADMINISTRATION (2)]
1.1 Adult Patients
Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae .
Acute bacterial sinusitis due to Haemophilus influenzae , Moraxella catarrhalis or Streptococcus pneumoniae .
Community-acquired pneumonia due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Uncomplicated skin and skin structure infections due to Staphylococcus aureus , Streptococcus pyogenes , or Streptococcus agalactiae .
Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae .
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
1.2 Pediatric Patients
[see USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.2)]
Acute otitis media (>6 months of age) caused by Haemophilus influenzae , Moraxella catarrhalis, or Streptococcus pneumoniae
Community-acquired pneumonia (>6 months ofage) due to Chlamydophila pneumoniae , Haemophilus influenzae , Mycoplasma pneumonia , or Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis (>2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
1.3 Limitations of Use
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
patients with cystic fibrosis,
patients with nosocomial infections,
patients with known or suspected bacteremia,
patients requiring hospitalization,
elderly or debilitated patients, or
patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
1 INDICATIONS AND USAGE
CAMRESE LO is indicated for use by females of reproductive potential to prevent pregnancy.
CAMRESE LO is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1)
DIGOXIN is a cardiac glycoside indicated for:
Treatment of mild to moderate heart failure in adults. (1.1)
Increasing myocardial contractility in pediatric patients with heart failure. (1.2)
Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3)
1.1 Heart Failure in Adults
DIGOXIN is indicated for the treatment of mild to moderate heart failure in adults. DIGOXIN increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, DIGOXIN should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.
1.2 Heart Failure in Pediatric Patients
Digoxin increases myocardial contractility in pediatric patients with heart failure.
1.3 Atrial Fibrillation in Adults
DIGOXIN is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
1 INDICATIONS AND USAGE
Lapatinib is a kinase inhibitor indicated in combination with: (1)
capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab.
Limitations of Use: Patients should have disease progression on trastuzumab prior to initiation of treatment with lapatinib tablets in combination with capecetabine.
letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.
Lapatinib tablets in combination with an aromatase inhibitor have not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.
Lapatinib tablet is a kinase inhibitor indicated in combination with: (1)
capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab.
Limitations of Use: Patients should have disease progression on trastuzumab prior to initiation of treatment with lapatinib tablets in combination with capecitabine.
letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.
Lapatinib tablets in combination with an aromatase inhibitor have not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.
1 INDICATIONS AND USAGE
Fenofibrate Tablets, USP is a peroxisome proliferator receptor alpha (PPAR) activator indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (
1.1).
For treatment of adult patients with severe hypertriglyceridemia (
1.2).
Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (
5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate Tablets, USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate Tablets, USP are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 145 mg of Fenofibrate Tablets, USP was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus
[see
Warnings and Precautions (5.1)]
.
1 INDICATIONS AND USAGE
Bismuth subcitrate potassium, metronidazole and tetracyclinehydrochloride capsule is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline, - a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole,for the treatment of patients with Helicobacter pylori infection andduodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. (1.1)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules and other antibacterial drugs, bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsule should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2)
1.1 Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease
Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules in combination with omeprazole are indicated for the treatment of patients withHelicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. The eradication of Helicobacter pylorihas been shown to reduce the risk of duodenal ulcer recurrence.
1.2 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules and other antibacterial drugs, bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules should be used to treat only indicated 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 tabletsis 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.
INDICATIONS AND USAGE:
Flunisolide nasal solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide nasal solution should not be used in the presence of untreated localized infection involving the nasal mucosa.
1 INDICATIONS AND USAGE
Carvedilol tablets are an alpha/beta-adrenergic blocking agent indicated for the treatment of:
mild to severe chronic heart failure (1.1)
left ventricular dysfunction following myocardial infarction in clinically stable patients (1.2)
hypertension (1.3)
1.1 Heart Failure
Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4), Clinical Studies (14.1)].
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)].
1.3 Hypertension
Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. They can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].
1	INDICATIONS AND USAGE
Phentermine hydrochloride 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/m2, or
27 kg/m2 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 patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows:
pounds
2.2 = kg; inches
0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [see Clinical Pharmacology (12.1, 12.2)
] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) 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/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1)
The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1)
BMI figure
INDICATIONSAND USAGE
For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.
INDICATIONS AND USAGE
Naftin Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsuransEfficacy for this organism in this organ system was studied in fewer than 10 infections. and Epidermophyton floccosum.
1 INDICATIONS & USAGE
Lacosamide Injection is indicated for:
Treatment of partial-onset seizures in patients 17 years of age and older (1.1)
1.1 Partial-Onset Seizures
Lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older.
Pediatric use information is approved for UCB, Inc.s VIMPAT (lacosamide) injection. However, due to UCB, Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
INDICATION
Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see
PRECAUTIONS.