um-ids/dailymed-annotations huggingface dataset:
INDICATIONS & USAGE
Metronidazole vaginal gel USP, 0.75% is indicated in the treatment of bacterial vaginosis (formerly referred to as
Haemophilus vaginitis,
Gardnerella vaginitis, nonspecific vaginitis,
Corynebacterium vaginitis, or anaerobic vaginosis).
NOTE:	For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a fishy amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Grams stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent
Lactobacillus morphology, (b) predominance of
Gardnerella morphotype, and (c) absent or few white blood cells.
Other pathogens commonly associated with vulvovaginitis, e.g.,
Trichomonas vaginalis,
Chlamydia trachomatis,
N.
gonorrhoeae,
Candida albicans, and
Herpes simplex virus should be ruled out.
Hypertension:Captopril tablets, USP are indicated for the treatment of hypertension.
In using captopril, consideration should be given to the risk of neutropenia/agranulocytosis (see
WARNINGS
).
Captopril may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations.
Captopril is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.
1 INDICATIONS AND USAGE
AndroGel is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary Hypogonadism (Congenital or Acquired) (1.1)
Hypogonadotropic Hypogonadism (Congenital or Acquired) (1.1)
1.1 Testosterone Replacement Therapy
AndroGel, an androgen, is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary Hypogonadism (Congenital or Acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range.
Hypogonadotropic Hypogonadism (Congenital or Acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.
INDICATIONS AND USAGE
Hypertension
Losartan Potassium and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see CLINICAL PHARMACOLOGY,
Pharmacodynamics and Clinical Effects, and DOSAGE AND ADMINISTRATION).
Hypertensive Patients with Left Ventricular Hypertrophy
Losartan Potassium and Hydrochlorothiazide Tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. (See PRECAUTIONS,
Race,
CLINICAL PHARMACOLOGY,
Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke, Race, and DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE
Cefadroxil tablets are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:
Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species.
Skin and skin structure infections caused by staphylococci and/or streptococci.
Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).
Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil for the prophylaxis of subsequent rheumatic fever are not available.
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 cefadroxil tablets and other antibacterial drugs, cefadroxil tablets 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
Warfarin sodium tablets are indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use
Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
Warfarin sodium tablets are vitamin K antagonist indicated for:
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism.
(1)
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement.
(1)
Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
(1)
Limitations of Use
Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage.
(1)
INDICATIONS AND USAGE
Naloxone Hydrochloride Injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage.
Naloxone may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see
CLINICAL PHARMACOLOGY, Adjunctive Use in Septic Shock
).
1 INDICATIONS & USAGE
Digoxin is a cardiac glycoside indicated for:
Treatment of mild to moderate heart failure in adults. (
1.1)
Increasing myocardial contractility in pediatric patients with heart failure. (
1.2)
Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (
1.3)
1.1 Heart Failure in Adults
Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.
1.2 Heart Failure in Pediatric Patients
Digoxin increases myocardial contractility in pediatric patients with heart failure.
1.3 Atrial Fibrillation in Adults
Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
1 INDICATIONS & USAGE
Everolimus tablets are a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients: Kidney transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids. (1.1) Liver transplant: Administer no earlier than 30 days post-transplant. Use in combination with tacrolimus (reduced doses) and corticosteroids. (1.2, 5.5)
Limitations of Use (1.3) Safety and efficacy has not been established in the following: Kidney transplant patients at high immunologic risk. (1.3) Recipients of transplanted organs other than kidney or liver. (1.3, 5.7) Pediatric patients (less than 18 years). (1.3)
1.1 Prophylaxis of Organ Rejection in Kidney Transplantation
Everolimus tablets are indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant [see Clinical Studies (14.1)] Everolimus tabletsare to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. Therapeutic drug monitoring (TDM) of everolimus tablets and cyclosporine is recommended for all patients receiving these products. [see Dosage and Administration (2.2, 2.3)]
1.2 Prophylaxis of Organ Rejection in Liver Transplantation
Everolimus tabletsare indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. Everolimus tabletsare to be administered no earlier than 30 days post-transplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [see Warnings and Precautions (5.5), Clinical Studies (14.2)]. Therapeutic drug monitoring (TDM) of everolimus tablets and tacrolimus is recommended for all patients receiving these products [see Dosage and Administration (2.3, 2.5)].
1.3 Limitations of Use
The safety and efficacy of everolimus tablets has not been established in the following populations: Kidney transplant patients at high immunologic risk Recipients of transplanted organs other than kidney and liver [see Warnings and Precautions (5.7)] Pediatric patients (less than18 years).
INDICATIONS AND USAGE
Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relationship in such patients has not been defined.
Minoxidil reduced supine diastolic blood pressure by 20 mmHg or to 90 mmHg or less in approximately 75% of patients, most of whom had hypertension that could not be controlled by other drugs.
1 INDICATIONS AND USAGE
Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A agonist, are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [
see
Clinical Studies (14)]
.
The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
1 INDICATIONS & USAGE
EpiPen and EpiPen Jr are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.
EpiPen and EpiPen Jr are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.
EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.
1 INDICATIONS AND USAGE
Dexmethylphenidate Hydrochloride Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].
Dexmethylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) (1).
9. Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults Acute leukemia of childhood
1
INDICATIONS AND USAGE
Alprazolam orally disintegrating tabletsare a benzodiazepine indicated for:
The treatment of generalized anxiety disorder (1.1). The efficacy of alprazolam was demonstrated in 5 short-term, placebo-controlled trials. (14).
The treatment of panic disorder, with or without agoraphobia (1.2).
The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials (14).
1.1 Generalized Anxiety Disorder
Alprazolam orally disintegrating tablets, USP are indicated for the treatment of generalized anxiety disorder.
The efficacy of alprazolam in the treatment of generalized anxiety disorder was demonstrated in 5 short-term, placebo-controlled trials [see Clinical Studies (
14.1
)].
1.2 Panic Disorder
Alprazolam orally disintegrating tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia.
The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials [see Clinical Studies (
14.2
)].
Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months in duration for generalized anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
-------------------------------------------------------------------------------------------------------------------------------------------------------
Escitalopram Tablets, USP are a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2)
1.1 Major Depressive Disorder
Escitalopram Tablets, USP are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age
[see Clinical Studies (14.1)].
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.
1.2 Generalized Anxiety Disorder
Escitalopram Tablets, USP are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults
[see Clinical Studies (14.2)].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
INDICATIONS FOR USE
Theramine is intended for the clinical dietary management of the metabolic processes of pain disorders and inflammatory conditions.
1.1 Adenocarcinoma of the Colon and Rectum
1 INDICATIONS AND USAGE
Tacrolimus capsule is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney, heart or lung transplants, and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants. (1.1)
1.1 Prophylaxis of Organ Rejection in Kidney, Liver, Heart, or Lung Transplant
Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)], liver transplants [see Clinical Studies (14.2)], heart transplant [see Clinical Studies (14.3)], or lung transplant [see Clinical Studies (14.4)]in combination with other immunosuppressants.
Additional pediatric use information is approved for Astellas Pharma US, Inc.'s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
INDICATIONS AND USAGETo reduce the development of drug-resistant bacteria and maintain
the effectiveness of clindamycin hydrochloride capsules and other antibacterial
drugs, clindamycin hydrochloride 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.
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 WARNING box, 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.
1
INDICATIONS AND USAGE
Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see WARNINGS AND PRECAUTIONS (5.1)], reserve morphine sulfate extended-release for use in patients for whom alternative treatment options (e.g., non- opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Morphine sulfate extended-release is not indicated as an as-needed (prn) analgesic.
Indication
Animi-3 Capsules are indicated for improving nutritional status in conditions requiring Essential Fatty Acids, Vitamin B12, Vitamin B6, Vitamin D3 and Folic Acid supplementation.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of salsalate tablets, USP and other treatment options before deciding to use Salsalate tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, and related rheumatic disorder.
1 INDICATIONS AND USAGE
Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with
Metastatic castration-resistant prostate cancer (CRPC)
Metastatic high-risk castration-sensitive prostate cancer (CSPC)
Abiraterone acetate tablet is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with
metastatic castration-resistant prostate cancer (CRPC). (1)
metastatic high-risk castration-sensitive prostate cancer (CSPC).(1)
INDICATIONS AND USAGE
Sterile Water for Injection, USP is indicated for use only as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced.
For intravenous administration, an osmolar concentration not less than two-fifths (0.4) of the normal osmolarity of the extracellular fluid (280 mOsmol/liter) is essential to avoid intravascular hemolysis.
INDICATIONS AND USAGE
Metronidazole Vaginal Gel is indicated in the treatment of bacterial vaginosis (formerly referred to as
Haemophilus vaginitis,
Gardnerella vaginitis, nonspecific vaginitis,
Corynebacterium vaginitis, or anaerobic vaginosis).
NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent
Lactobacillus morphology, (b) predominance of
Gardnerella morphotype, and (c) absent or few white blood cells.
Other pathogens commonly associated with vulvovaginitis, e.g.,
Trichomonas vaginalis,
Chlamydia trachomatis,
N. gonorrhoeae,
Candida albicans, and
Herpes simplex virus should be ruled out.