um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Verapamil Hydrochloride Tablets are indicated for the treatment of the following:
Angina
1. Angina at rest including:
Vasospastic (Prinzmetals variant) angina
Unstable (crescendo, pre-infarction) angina
2. Chronic stable angina (classic effort-associated angina)
Arrhythmias
1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see
WARNINGS; Accessory bypass tract
)
2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia
Essential hypertension:
Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
1 INDICATIONS AND USAGE
Sodium Fluoride F 18 Injection is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.
Sodium Fluoride F 18 Injection is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity.
1 INDICATIONS AND USAGE
Sterile Talc Powder is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion.
STERILE TALC POWDER is a sclerosing agent indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion. (1)
1
INDICATIONS AND USAGE
Mesalamine is indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
Mesalamine is an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. (1)
INDICATIONS AND USAGE
Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
Vancomycin is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Vancomycin has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by Streptococcus viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside.
Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin 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.
INDICATIONS AND USAGE
Pilocarpine hydrochloride tablets, USP are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogrens Syndrome.
1 INDICATIONS AND USAGE
Rabeprazole Sodium Delayed-Release Tablets 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 the 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 is 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 is 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 is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults.
1.4 Healing of Duodenal Ulcers in Adults
Rabeprazole Sodium Delayed-Release Tablets is 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, is 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 [see Clinical Studies (14.5) and Dosage and Administration (2.5)
].
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 clarithromycin package insert,
Clinical Pharmacology (12.2)
].
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
Rabeprazole Sodium Delayed-Release Tablets is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
1.7 Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
Rabeprazole Sodium Delayed-Release Tablets is indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
1 INDICATIONS AND USAGE
MYCAMINE is indicated for:
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)].
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses
without
meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in
Specific Populations (8.4)]
.
Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical
Studies (14.2)]
.
Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see
Clinical Studies (14.3)]
.
Limitations of Use
The safety and effectiveness of MYCAMINE have
not
been established for the treatment of candidemia
with
meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed [see Use in Specific
Populations (8.4)]
.
MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to Candida.
The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.
MYCAMINE is an echinocandin indicated in adult and pediatric patients for (1):
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older.
Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses
without
meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age.
Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.
Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT).
Limitations of Use
The safety and effectiveness of MYCAMINE have not been established for the treatment of candidemia
with
meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age as a higher dose may be needed. (1, 2.3, 8.4)
MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis or meningoencephalitis due to Candida. (1)
The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established. (1)
1 INDICATIONS AND USAGE
SARCLISA is indicated:
in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
SARCLISA is a CD38-directed cytolytic antibody indicated:
in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. (1)
INDICATIONS AND USAGE
Tobramycin and dexamethasone ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:
Staphylococci, including
S. aureus and
S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some
Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most
Proteus vulgaris strains
, Haemophilus influenzae and
H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some
Neisseria species.
1. Indications and Usage
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see CLINICAL STUDIES (14)].
INDICATIONS AND USAGE
ARICEPT is indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild to moderate Alzheimer's Disease, as well as in patients with severe Alzheimer's Disease.
1 INDICATIONS AND USAGE
OMNIPAQUE Imaging Bulk Package is indicated for
Computed tomographic (CT) imaging of the head and body by intravenous administration in:
adults (300 and 350 mg iodine/mL)
pediatric patients (300 mg iodine/mL)
For use only with an automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with OMNIPAQUE Imaging Bulk Package.
OMNIPAQUE Imaging Bulk Package is a radiographic contrast agent indicated for intravenous computed tomographic (CT) imaging of the head and body in adult and pediatric patients. (
2.1)
For use only with an automated contrast injection system, contrast management system, or contrast media transfer set cleared for use with OMNIPAQUE Imaging Bulk Package.
INDICATIONS AND USAGE
Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures(See
WARNINGS
).
Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus.Diazepam injection is a useful adjunct in status epilepticus.Diazepam is a useful premedication (the intramuscular route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patient's recall of the procedure.
1 INDICATIONS AND USAGE
Potassium citrate is a citrate salt of potassium indicated for the management of:
Renal tubular acidosis (RTA) with calcium stones (
1.1)
Hypocitraturic calcium oxalate nephrolithiasis of any etiology (
1.2)
Uric acid lithiasis with or without calcium stones (
1.3)
1.1 Renal tubular acidosis (RTA) with calcium stones
Potassium citrate is indicated for the management of renal tubular acidosis
[see
Clinical Studies (14.1)].
1.2 Hypocitraturic calcium oxalate nephrolithiasis of any etiology
Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis
[see
Clinical Studies (14.2)].
1.3 Uric acid lithiasis with or without calcium stones
Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones
[see
Clinical Studies (14.3)].
1 INDICATIONS AND USAGE
Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma.
Limitations of Use: The relative bioavailability between Levothyroxine Sodium Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium Injection as accurate dosing conversion has not been studied.
Levothyroxine Sodium is an L-thyroxine product. Levothyroxine (T4) Sodium Injection is indicated for the treatment of myxedema coma. (1)
Important Limitations of Use:
The relative bioavailability of this drug has not been established. Use caution when converting patients from oral to intravenous levothyroxine. (1)
INDICATIONS AND USAGE
Fluconazole tablets are indicated for the treatment of:
Vaginal candidiasis (vaginal yeast infections due to Candida).
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relativelysmall numbers of patients, fluconazole tabletswere also effective for the treatment of Candidaurinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
Cryptococcal meningitis
. Before prescribing fluconazole tabletsfor AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole tabletsto amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis: Fluconazole tabletsare also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
Vigabatrin tablets are indicated for the treatment of:
Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; Vigabatrin tablets are not indicated as a first line agent (
1.1
)
Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss (
1.2
)
1.1 Refractory Complex Partial Seizures
(CPS)
Vigabatrin tablets are indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions (
5.1
)]. Vigabatrintablets are not indicated as a first line agent for complex partial seizures.
1.2 Infantile Spasms (IS)
Vigabatrintablets are indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see Warnings and Precautions (
5.1
)].
INDICATION AND USAGE
LIDOCAINE PATCH 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
INDICATIONS AND USAGE
Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.
THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K
+
LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION.
When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.
1 INDICATIONS AND USAGE
Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1)
1.1 Oral Contraception
Tri-Lo-Estarylla (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see
CLINICAL STUDIES (14)].
1 INDICATIONS AND USAGE
Tamsulosin hydrochloride capsules, USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
[see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
Tamsulosin hydrochloride capsules are an alpha
1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (
1)
Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (
1)
1.1Lower Respiratory Tract Infections
caused by betalactamaseproducing isolates of Haemophilusinfluenzae and Moraxella catarrhalis.
1 INDICATIONS AND USAGE
DRAXIMAGE DTPA, after radiolabeling with Technetium Tc 99m, is indicated for
DRAXIMAGE DTPA is a kit for the preparation of Technetium Tc 99m pentetate
injection.
Technetium Tc 99m pentetate is a radioactive diagnostic
agent indicated for:
Brain imaging in adults (1.1).
Renal visualization, assessment of renal perfusion, and
estimation of glomerular filtration rate in adult and pediatric patients
(1.2).
Lung ventilation imaging and evaluation of pulmonary embolism
when paired with perfusion imaging in adult and pediatric patients
(1.3).
1.1 Brain
Imaging
Brain imaging in adults by intravenous administration.
1.2 Renal
Scintigraphy
Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients by intravenous administration.
1.3 Lung
Ventilation Imaging
Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation.