um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Capecitabine is a nucleoside metabolic inhibitor indicated for:
Colorectal Cancer
adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. (
1.1)
perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. (
1.1)
treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. (
1.1)
Breast Cancer
treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. (
1.2)
treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. (
1.2)
Gastric, Esophageal, or Gastroesophageal Junction Cancer
treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. (
1.3)
treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. (
1.3)
Pancreatic Cancer
adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. (
1.4)
1.1 Colorectal Cancer
Capecitabine tablets are indicated for the:
adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen.
perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy.
treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen.
1.2 Breast Cancer
Capecitabine tablets are indicated for the:
treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated.
treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy.
1.3 Gastric, Esophageal, or Gastroesophageal Junction
Cancer
Capecitabine tablets are indicated for the:
treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen.
treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen.
1.4 Pancreatic Cancer
Capecitabine tablets are indicated for the adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of naproxen and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Naproxen tablets are indicated:
For the relief of the signs and symptoms of rheumatoid arthritis
For the relief of the signs and symptoms of osteoarthritis
For the relief of the signs and symptoms of ankylosing spondylitis
For the relief of the signs and symptoms of juvenilearthritis
Naproxen tablets are also indicated:
For relief of the signs and symptoms of tendonitis
For relief of the signs and symptoms of bursitis
For relief of the signs and symptoms of acute gout
For the management of pain
For the management of primary dysmenorrhea
INDICATIONS AND USAGE
Nitroglycerin in 5% Dextrose Injection is indicated for treatment of peri-operative hypertension; for control of heart failure in the setting of acute myocardial infarction; for treatment of angina pectoris in patients who have not responded to sublingual nitroglycerin and -blockers; and for induction of intraoperative hypotension.
1 INDICATIONS AND USAGE
Mometasone furoate nasal spray is a corticosteroid indicated for:
Prophylaxis of Nasal Symptoms of Seasonal Allergic Rhinitis in adult and pediatric patients 12 years of age and older (1.1)
Treatment of Chronic Rhinosinusitis with Nasal Polyps in adult patients 18 years of age and older (1.2)
1.1 Prophylaxis of Seasonal Allergic Rhinitis
Mometasone furoate nasal spray 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult andpediatric patients 12 years and older.
1.2 Treatment of Chronic
Rhinosinusitis with Nasal Polyps
Mometasone furoate nasal spray 50 mcg is indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients 18 years of age and older.
INDICATIONS AND USAGE
Diltiazem hydrochloride injection is indicated for the following:
Atrial Fibrillation or Atrial Flutter
Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome.
Paroxysmal Supraventricular Tachycardia
Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection.
The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium.
For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure. A defibrillator and emergency equipment should be readily available.
In domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients. Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. Following administration of one or two intravenous bolus doses of diltiazem injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. Heart rate reduction may last from 1 to 3 hours. If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours.
A 24-hour continuous infusion of diltiazem injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 20% heart rate reduction during the infusion in 83% of patients. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). Hypotension, if it occurs, may be similarly persistent.
In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection.
In domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose.
Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection.
1 INDICATIONS AND USAGE
Nebivolol tablets are a beta-adrenergic blocking agent 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. (1.1)
1.1 Hypertension
Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies (14.1)]. Nebivolol tablets may be used alone or in combination with other antihypertensive agents [see Drug Interactions (7)].
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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nebivolol tablets.
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 Program's 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
Aripiprazole tablets are indicated for the treatment of:
Schizophrenia [see Clinical Studies (14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole is an atypical antipsychotic. The oral formulationis indicated for:
Schizophrenia(14.1)
1 INDICATIONS AND USAGE
Fexofenadine hydrochloride is an H1-receptor antagonist indicated for:
Relief of symptoms associated with seasonal allergic rhinitis in patients 6 years of age and older (1.1)
Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 years of age and older (1.2)
1.1 Seasonal Allergic Rhinitis
Fexofenadine hydrochloride tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.
1.2 Chronic Idiopathic Urticaria
Fexofenadine hydrochloride tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 of age and older .
1 INDICATIONS AND USAGE
Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (
1)
Complex HQ Plus is indicated for the gradual lightening of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigenes, and other unwanted areas of melanin hyperpigmention.
1 INDICATIONS AND USAGE
ZORYVE is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.
ZORYVE is a phosphodiesterase 4 inhibitor indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. (1)
INDICATIONS AND USAGE
DIFFERIN Gel is indicated for the topical treatment of acne vulgaris.
INDICATIONS AND USAGE
MONUROL is indicated only for the treatment ofuncomplicated urinary tract infections (acute cystitis)in women due to susceptible strains ofEscherichia coli and Enterococcus faecalis.MONUROL is not indicated for the treatment ofpyelonephritis or perinephric abscess.
If persistence or reappearance of bacteriuria occursafter treatment with MONUROL,other therapeuticagents should be selected. (See
PRECAUTIONS
and
CLINICAL STUDIES
sections.)
INDICATIONS & USAGE SECTION
LYRICA is indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for adult patients with partial onset seizures
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
1.4 Superficial Papillary Carcinoma of the Urinary Bladder
TEPADINA is indicated for treatment of superficial papillary carcinoma of the urinary bladder.
INDICATIONS AND USAGE:
A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4Sodium Fluoride 5000 ppm Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze tube is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (SeeWARNINGS for exception.)
INDICATIONS AND USAGE
Famotidine is indicated in:
1.
Short-term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.
2.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year.
3.
Short-term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
4.
Short-term treatment of gastroesophageal reflux disease (GERD). Famotidine is indicated for short-term treatment of patients with symptoms of GERD (see
CLINICAL PHARMACOLOGY IN ADULTS,
Clinical Studies).
Famotidine is also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see
CLINICAL PHARMACOLOGY IN ADULTS,
Clinical Studies).
5.
Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see
CLINICAL PHARMACOLOGY IN ADULTS,
Clinical Studies)
.
INDICATIONS AND USAGE
Estropipate tablets are indicated in the:
Treatment of moderate to severe vasomotor symptoms associated
with the menopause.
Treatment of moderate to severe symptoms of vulval and vaginal
atrophy associated with the menopause. When prescribing solely for the treatment
of symptoms of vulvar and vaginal atrophy, topical vaginal products should be
considered.
Treatment of hypoestrogenism due to hypogonadism, castration or
primary ovarian failure.
Prevention of postmenopausal osteoporosis. When prescribing
solely for the prevention of postmenopausal osteoporosis, therapy should only be
considered for women at significant risk of osteoporosis and for whom
non-estrogen medications are not considered to be appropriate.
The mainstays for decreasing the risk of postmenopausal osteoporosis are
weight-bearing exercise, adequate calcium and vitamin D intake, and when
indicated, pharmacologic therapy. Postmenopausal women require an average of
1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium
supplementation may be helpful for women with suboptimal dietary intake. Vitamin
D supplementation of 400-800 IU/day may also be required to ensure adequate
daily intake in postmenopausal women.
INDICATIONS AND USAGE
Clobetasol Propionate Ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
INDICATIONS
NataFort is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
INDICATIONS AND USAGE:
Prednicarbate ointment 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. (1)
INDICATIONS AND USAGE
Antizolis indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis (see
DOSAGE AND ADMINISTRATION
).
1 INDICATIONS AND USAGE
My Way is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.
My Way is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. My Way is not indicated for routine use as a contraceptive.
My way is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. My way is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. My way is not intended for routine use as a contraceptive. (1)
Indications and Usage Section
Butalbital, acetaminophen and caffeine tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
Butalbital Caffeine Acetaminophen 50/325/40 Tablet Permanent Link: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a26775c2-cafb-4b13-99ac-d4e8248265fb
1 INDICATIONS AND USAGE
ILLUCCIX, after radiolabeling with Ga 68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
With suspected metastasis who are candidates for initial definitive therapy.
With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.
ILLUCCIX, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
With suspected metastasis who are candidates for initial definitive therapy
With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
For selection of patients with metastatic prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated (
1)
1.2 Percutaneous Coronary Intervention
Argatroban injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
1 INDICATIONS AND USAGE
Azithromycin for oral suspension USP is 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)
]
Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
Acute bacterial exacerbations of chronic bronchitis in adults (
1.1)
Acute bacterial sinusitis in adults (
1.1)
Uncomplicated skin and skin structure infections in adults (
1.1)
Urethritis and cervicitis in adults (
1.1)
Genital ulcer disease in men (
1.1)
Acute otitis media in pediatric patients (
1.2)
Community-acquired pneumonia in adults and pediatric patients (
1.1,
1.2)
Pharyngitis/tonsillitis in adults and pediatric patients (
1.1,
1.2)
Limitation 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. (
1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension USP and other antibacterial drugs, azithromycin for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. (
1.4)