um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*
, Klebsiella spp.* (including K. pneumoniae*
), Proteus mirabilis*,
Bacteroides fragilis*,
Enterobacter spp.*, and Acinetobacter calcoaceticus*.
NOTE: For information on use in pediatric patients see
PRECAUTIONS-Pediatric Use
and
CLINICAL STUDIES
sections.
Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*.
Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli*, and Bacteroides spp.* (including B. fragilis*).
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While ampicillin and sulbactam for injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection should not require the addition of another antibiotic.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection.
Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.
To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection and other antibacterial drugs, ampicillin and sulbactam for injection 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.
Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2 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 patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
BMI Index
The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below.
1 INDICATIONS AND USAGE
Erlotinib tablets are a kinase inhibitor indicated for:
The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1)
First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2)
Limitations of Use:
Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations. (1.1)
Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy. (1.1)
1.1 Non-Small Cell Lung Cancer (NSCLC)
Erlotinib tablets are indicated for:
The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen [see Clinical Studies (14.1, 14.3)].
Limitations of use:
Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations [see Clinical Studies (
14.1, 14.2
)].
Erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy [see Clinical Studies (14.4)].
1.2 Pancreatic Cancer
Erlotinib tablets in combination with gemcitabine are indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.5)].
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen tablets are indicated for relief of mild to moderate pain.
Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of Ibuprofen tablets in children have not been conducted.
1 INDICATIONSAND USAGE
Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.
Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.
Ciprofloxacin and dexamethasone otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa. (1)
Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa. (1)
INDICATIONS AND USAGE
Flavoxate HCl tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate HCl tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.
1 INDICATIONS AND USAGE
SAJAZIR (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
SAJAZIR (icatibant) injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. (1)
1 INDICATIONS AND USAGE
Potassium chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.
Potassium chloride is a potassium salt indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient
1 INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 15 years of age and older (
1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB): One 10 mg tablet at least 2 hours before exercise for patients 15 years of age and older (
1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 15 years of age and older, and perennial allergic rhinitis (PAR) in patients 15 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (
1.3).
Limitations of Use:
Not indicated to treat an acute asthma attack (
5.2).
1.1 Asthma
Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older. Because the benefits of Montelukast Sodium tablet may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis
[see Warnings and Precautions (5.1)], reserve use for patients who have an inadequate response or intolerance to alternative therapies.
1.4 Limitations of Use
Montelukast sodium tablets are not indicated for the treatment of an acute asthma attack.
INDICATIONS AND USAGE
For topical application to aid in the prevention of dental caries.
Treatment frequency should not exceed 4 treatments per year.
INDICATIONS AND USAGE:
Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (-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 hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
Vancomycin hydrochloride for injection, USP 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, and skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by
S. viridans or
S. bovis.
For endocarditis caused by enterococci (e.g.,
E. faecalis),
vancomycin hydrochloride for injection, USP has been reported to be effective only in combination with an aminoglycoside.
Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP 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 hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by
C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.
INDICATIONS AND USAGE
Citalopram tablets are indicated for the treatment of depression.The
efficacy of citalopram tablets in the treatment of depression was established in
4-6 week, controlled trials of outpatients whose diagnosis corresponded most
closely to the DSM-III and DSM-III-R category of major depressive disorder (see
CLINICAL
PHARMACOLOGY
).A major depressive episode (DSM-IV) implies a
prominent and relatively persistent (nearly every day for at least 2 weeks)
depressed or dysphoric mood that usually interferes with daily functioning, and
includes at least five of the following nine symptoms: depressed mood, loss of
interest in usual activities, significant change in weight and/or appetite,
insomnia or hypersomnia, psychomotor agitation or retardation, increased
fatigue, feelings of guilt or worthlessness, slowed thinking or impaired
concentration, a suicide attempt or suicidal ideation.The
antidepressant action of citalopram tablets in hospitalized depressed patients
has not been adequately studied.The efficacy of citalopram tablets in
maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks
of acute treatment was demonstrated in two placebo-controlled trials (see
CLINICAL PHARMACOLOGY
).Nevertheless,
the physician who elects to use citalopram tablets for extended periods should
periodically re-evaluate the long-term usefulness of the drug for the individual
patient.
INDICATIONS AND USAGE
Oxycodone and Acetaminophen Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
1 INDICATIONS AND USAGE
Sildenafil is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil was added to background epoprostenol therapy [see Clinical Studies (14)].
Studies establishing effectiveness were short-term (12 to 16 weeks), included predominately patients with New York Heart Association (NYHA) Functional Class IIIII symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Sildenafil is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class IIIII symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. (1, 14)
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)].
INDICATIONS AND USAGE
CARNITOR (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see
CLINICAL PHARMACOLOGY
). In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.
CARNITOR (levocarnitine) is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
1 INDICATIONS AND USAGE
STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (
1)
1	INDICATIONS AND USAGE
Mometasone furoate ointment USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.
Mometasone furoate ointment USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age. (1)
USES
Helps prevent sunburns
Higher SPF gives more sunburn protection
Apply liberally as needed 15 to 20 minutes before sun exposure
Reapply as needed or after swimming, perspiring or towel drying
Children under 6 months of age: ask doctor
1 INDICATIONS AND USAGE
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer(DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
Famotidine tablets are indicated in adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of duodenal ulcerrecurrence.
Famotidine is a histamine-2 (H2) receptor antagonist indicated (1):
In adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer(DU).
active gastriculcer.
symptomatic nonerosive gastroesophageal reflux disease(GERD).
erosive esophagitis due to GERD, diagnosed bybiopsy.
In adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrineneoplasias).
reduction of the risk of DUrecurrence.
1 INDICATIONS AND USAGE
HEPARIN SODIUM IN 5% DEXTROSE INJECTION is indicated for:
Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation;
Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism;
Anticoagulant use in blood transfusions, extracorporeal circulation and dialysis procedures.
HEPARIN SODIUM IN 5% DEXTROSE INJECTION is indicated for: (1)
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation
Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation)
Prevention of clotting in arterial and cardiac surgery
Prophylaxis and treatment of peripheral arterial embolism
Anticoagulant use in blood transfusions, extracorporeal circulation and dialysis procedures
1 INDICATIONS AND USAGE
Methadone hydrochloride tablets for oral suspension contain methadone, an opioid agonist indicated for the:
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)].
Methadone hydrochloride tablets for oral suspension are an opioid agonist indicated for the:
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). (1)
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (1)
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8. (1, 2.1)
1 INDICATIONS AND USAGE
Aripiprazole Oral Tablets are indicated for the treatment of:
Schizophrenia (
14.1)
Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (
14.2)
Adjunctive Treatment of Major Depressive Disorder (
14.3)
Irritability Associated with Autistic Disorder (
14.4)
Treatment of Tourette's disorder (
14.5)
Aripiprazole Oral Tablets are indicated for the treatment of:
Schizophrenia
[see
Clinical Studies (
14.1
)
]
Acute
Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder
[see
Clinical Studies (
14.2
)
]
Adjunctive
Treatment of Major Depressive Disorder
[see
Clinical Studies (
14.3
)
]
Irritability
Associated with Autistic Disorder
[see
Clinical Studies (
14.4
)
]
Treatment
of Tourette's Disorder
[see
Clinical Studies (
14.5
)
]
1 INDICATIONS AND USAGE
Montelukast sodium is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (
1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (
1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (
1.3).
Limitations of Use:
Not indicated to treat an acute asthma attack (
5.2).
1.1 Asthma
Montelukast sodium
is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium
is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium
is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. Because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis
[see Warnings and Precautions (
5.1)],
reserve use for patients who have an inadequate response or intolerance to alternative therapies.
1.4 Limitations of Use
Montelukast Sodium is not indicated for the treatment of an acute asthma attack..