um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
FLOMAX (tamsulosin hydrochloride, USP) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
[see
Clinical Studies (14)]
. FLOMAX capsules are not indicated for the treatment of hypertension.
1 INDICATIONS AND USAGE
Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes
(MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Decitabine for Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. (1)
INDICATIONS AND USAGE
Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified.
Atrial Fibrillation: Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation.
INDICATIONS AND USAGE
Ampicillin Capsules, USP are indicated in the treatment of infections caused by susceptible strains of the designated organism listed below:
INFECTIONS OF THE GENITOURINARY TRACT INCLUDING GONORRHEA:
E. coli, P. mirabilis, enterococci,
Shigella
, S.
typhosa
and other
Salmonella, and nonpenicillinase producing
N.
gonorrhoeae.
INFECTIONS OF THE RESPIRATORY TRACT: Nonpenicillinase- producing
H.
influenzae
and
staphylococci, and streptococci including
streptococcus
pneumoniae.
INFECTIONS OF THE GASTROINTESTINAL TRACT:
Shigella, S. typhosa and other
Salmonella, E. coli, P. mirabilis, and enterococci.
MENINGITIS:
N. Meningitides.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin and other antibacterial drugs, ampicillin 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.
Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to the results of susceptibility testing.
INDICATIONS AND USAGE
Metoprolol tartrate and hydrochlorothiazide tablets are indicated
for the management of hypertension.
This fixed-combination drug is not indicated for initial
therapy of hypertension. If the fixed combination represents the dose titrated
to the individual patient's needs, therapy with the fixed combination may be
more convenient than with the separate components.
Indications & Usage
Naltrexone Hydrochloride Tablets USP are indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.
Naltrexone Hydrochloride Tablets USP have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
1 INDICATIONS AND USAGE
Clindamycin phosphate foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older.
Clindamycin phosphate foam is a lincosamide product indicated for acne vulgaris in patients 12 years and older. (1)
INDICATIONS AND USAGE
Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics)
NaNHave not provided adequate analgesia, or are not expected to provide adequate analgesia,
INDICATIONS AND USAGE
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the
BOXED WARNING
, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes:Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Streptococci:Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci:Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci:Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules 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.
INDICATIONS AND USAGE
Isosorbide dinitrate oral tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral ISDN is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
INDICATIONS AND USAGE
Antizol is 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).
INDICATIONS & 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 oftherapy.
The parenteral form of Vancomycin Hydrochloride for Injection, USP 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 infection.
INDICATIONS AND USAGE
To obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy, and other anterior segment surgery where rapid miosis may be required.
INDICATIONS AND USAGE
Fluocinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
INDICATIONS AND USAGE
Buspirone hydrochloride tablets USP are indicated for the management of anxiety disorders or 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. The efficacy of buspirone hydrochloride tablets USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Associations Diagnostic and Statistical Manual, III
1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse, and respiration rate.
Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling on edge, irritability, impatience.
The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.
The effectiveness of buspirone hydrochloride tablets USP in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone for extended periods should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Lamivudine and Zidovudine Tablet, USP a combination of two nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection.
Lamivudine and Zidovudine Tablets USP, a combination of two nucleoside analogue reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
(1)
1 INDICATIONS AND USAGE
Allopurinol Sodium for Injection is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.
Allopurinol Sodium for Injection is a xanthine oxidase inhibitor indicated for the management of adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy. (1)
1 INDICATIONS & USAGE
Monotherapy and Combination Therapy
Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].
Important Limitations of Use
Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease [see Warnings and Precautions (5.3)].
Pioglitazone is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1, 14)
Important Limitations of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
1 INDICATIONS AND USAGE
Sertraline hydrochloride tablets are indicated for the treatment of the following [See
Clinical Studies (14)
]:
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic stress disorder (PTSD)
Social anxiety disorder (SAD)Premenstrual dysphoric disorder (PMDD)
Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
Treatment
Cefotetan for Injection, USP is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the designated organisms:
Urinary Tract Infections caused by
E. coli, Klebsiella
spp (including
K. pneumoniae
), Proteus mirabilis,Proteus
vulgaris,
Providencia rettgeri
, and
Morganella morganii
).
Lower Respiratory Tract Infections caused by
Streptococcus pneumoniae
,
Staphylococcus aureus
(methicillin-susceptible),
Haemophilus
influenzae
,
Klebsiella
species (including
K. pneumoniae
),
E. coli
,
Proteus mirabilis
, and
Serratia marcescens.*
Skin and Skin Structure Infections due to
Staphylococcus aureus
(methicillin-susceptible),Staphylococcus epidermidis (methicillin susceptible),
Streptococcus pyogenes
,
Streptococcus
species,
Escherichia coli
,
Klebsiella pneumoniae
,
Peptococcus niger
*,
Peptostreptococcus
species.
Gynecologic Infections caused by
Staphylococcus aureus
(methicillin susceptible),Staphylococcus epidermidis (methicillin susceptible), Streptococcus species,
Streptococcus agalactiae
,
E. coli
,
Proteus mirabilis
,
Neisseria
gonorrhoeae
,
Bacteroides
fragilis, Prevotella melaninogenica, Bacteroides vulgatus,
Fusobacterium
species*, and gram-positive anaerobic cocci (including
Peptococcus
niger
and
Peptostreptococcus
species).
Cefotetan, like other cephalosporins, has no activity against
Chlamydia trachomatis.
Therefore, when cephalosporins are used in the treatment of pelvic inflammatory disease, and
C. trachomatis
is one of the suspected pathogens, appropriate antichlamydial coverage should be added.
Intra-abdominal lnfections caused by
E. coli
,
Klebsiella
species (including
K.
pneumoniae
),
Streptococcus
species,
Bacteroides
fragilis, Prevotella melaninogenica, Bacteroides
vulgatus and
Clostridium
species (other than Clostridium difficile
[see WARNINGS])*.
Bone and Joint Infections caused by Staphylococcus aureus (methicillin susceptible)*.
* Efficacy for this organism in this organ system was studied in fewer than ten infections in clinical studies
Specimens for bacteriological examination should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to cefotetan. Therapy may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly.
In cases of confirmed or suspected gram-positive or gram-negative sepsis or in patients with other serious infections in which the causative organism has not been identified, it is possible to use cefotetan concomitantly with an aminoglycoside. Cefotetan combinations with aminoglycosides have been shown to be synergistic
in
vitro
against many Enterobacteriaceae and also some other gram-negative bacteria. The dosage recommended in the labeling of both antibiotics may be given and depends on the severity of the infection and the patient's condition.
NOTE: Increases in serum creatinine have occurred when cefotetan was given alone. If cefotetan and an aminoglycoside are used concomitantly, renal function should be carefully monitored, because nephrotoxicity may be potentiated.
1 INDICATIONS AND USAGE
Doxazosin tablets, USP are an alpha
1adrenergic antagonist indicated for:
Signs and symptoms of Benign Prostatic Hyperplasia (BPH)
Treatment of Hypertension
1.1 Benign Prostatic Hyperplasia (BPH)
Doxazosin tablets, USP are indicated for the treatment of the signs and symptoms of BPH.
1.2 Hypertension
Doxazosin tablets, USP are 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.
Doxazosin tablets, USP may be used alone or in combination with other antihypertensives.
INDICATIONS & USAGE SECTION
Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis
Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes
Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis
Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae
Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
IBSRELA is indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
IBSRELA is a sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults. (1)