um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamase-negative) strains of the designated microorganisms in the conditions listed below:
Infections of the ear, nose, and throat - due to Streptococcus spp. (- and - hemolytic strains only),
S. pneumoniae, Staphylococcus spp., or H. influenzae.
Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis.
Infections of the skin and skin structure - due to Streptococcus spp. (- and -hemolytic strains only), Staphylococcus spp., or E. coli.
Infections of the lower respiratory tract - due to Streptococcus spp. (- and -hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females).
H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
Triple Therapy
Amoxicillin/Clarithromycin/Lansoprazole
Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See
CLINICAL STUDIES
and
DOSAGE AND ADMINISTRATION
sections.)
Dual Therapy
Amoxicillin/Lansoprazole
Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See
CLINICAL STUDIES
and
DOSAGE AND ADMINISTRATION
sections.)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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.
Indicated surgical procedures should be performed.
INDICATIONS AND USAGE
For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angleclosure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide is also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.
1 INDICATIONSAND USAGE
Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of:
erectile dysfunction (ED) (1.1)
the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2)
ED and the signs and symptoms of BPH (ED/BPH) (1.3)
If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (1.4).
1.1	Erectile Dysfunction
Tadalafil tablets areindicated for the treatment of erectile dysfunction (ED).
1.2	Benign Prostatic Hyperplasia
Tadalafil tablets areindicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3	Erectile Dysfunction and Benign Prostatic Hyperplasia
Tadalafil tablets areindicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
1.4	Limitation of Use
If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see Clinical Studies (14.3)].
INDICATIONS AND USAGE
Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults withevidence of active viral replication and either evidence of persistent elevations in serumaminotransferases (ALT or AST) or histologically active disease.
The following points should be considered when initiating therapy with Entecavir tablets:
In adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-nave and lamivudine-resistant subjects with HBeAg-positive and HBeAg-negative HBV infection and compensated liver disease and a more limited number of subjects with decompensated liver disease[see Clinical Studies (14.1)].
Pediatric use information is approved for Bristol-Myers Squibb Companys Baraclude (entecavir)tablets. However, due to Bristol-Myers Squibb Companys marketing exclusivity rights, this drugproduct is not labeled with that information.
Entecavir tablets are a Hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (1)
1 INDICATIONS AND USAGE
LOTEMAX (loteprednol etabonate ophthalmic gel) 0.5% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
LOTEMAX is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery. (1)
INDICATIONS & USAGE SECTION
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol Tablet is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (
14.2)].
1.3 Hypertension
Carvedilol Tablet is indicated for the management of essential hypertension [see Clinical Studies (
14.3,
14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (
7.2)].
1 INDICATIONS AND USAGE
Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.
Levalbuterol Inhalation Solution, USP is a beta
2-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. (
1)
INDICATIONS AND USAGE
Ipratropium bromide nasal solution 0.06% (Nasal Spray) is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Ipratropium bromide nasal solution 0.06% (Nasal Spray) does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis.
The safety and effectiveness of the use of ipratropium bromide nasal solution 0.06% (Nasal Spray) beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.
1 INDICATIONS AND USAGE
Sildenafil tablets are 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 tablets were added to background epoprostenol therapy [see
Clinical Studies (1
4)
].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Limitation of Use
Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity
[see Clinical Studies (14
)
].
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 II-III 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)
INDICATIONS AND USAGE
Aminocaproic Acid Injection, is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other emergency measures may be required.
Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures), and portacaval shunt; hematological disorders such as aplastic anemia; acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.
Urinary fibrinolysis, usually a normal physiological phenomenon, may frequently be associated with life-threatening complications following severe trauma, anoxia, and shock. Symptomatic of such complications is surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See
WARNINGS
.)
INDICATIONS AND USAGE
Mirtazapine tablets,USPare indicated for the treatment of major depressive disorder.
The efficacy of mirtazapine in the treatment of major depressive disorder was established in6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders-3rd edition (DSM-III) 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 least5 of the following9 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 effectiveness of mirtazapine in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see
CLINICAL PHARMACOLOGY).
INDICATIONS AND USAGE
Hypertension
Losartan potassiumtablets USP areindicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics.
Hypertensive Patients with Left Ventricular Hypertrophy
Losartan potassium tablets USP areindicated 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 and
CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke, Race.)
Nephropathy in Type 2 Diabetic Patients
Losartan potassium tablets USP areindicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio 300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, Losartan potassium tablets USP arereduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (see
CLINICAL PHARMACOLOGY,
Pharmacodynamics and Clinical Effects).
1 INDICATIONS AND USAGE
Azithromycin tablets are 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.
Azithromycin tablets are a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria:
Mycobacterial Infections (1.2)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3)
1.2 Mycobacterial Infections
Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease
Azithromycin tablets, taken alone or in combination with rifabutin at its approved dose, are indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection [see Dosage and Administration (2)].
Treatment of Disseminated MAC Disease
Azithromycin tablets, taken in combination with ethambutol, are indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection [see Use in Specific Populations (8.4) and Clinical Studies (14.1)].
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat 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
Doxepin hydrochloride tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration [see Clinical Studies (14)
].
Doxepin hydrochloride tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. (1, 14)
1. Indications and Usage Section
1 INDICATIONS AND USAGE
Eszopiclone tablet is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
1. INDICATIONS AND USAGE
Mesalamine delayed-release tablets are indicated for the:
induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis.
Pediatric use information is approved for Takeda Pharmaceuticals U.S.A., Inc.'s LIALDA (mesalamine) delayed-release tablets. However, due to Takeda Pharmaceuticals U.S.A., Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
Mesalamine delayed-release tablets are an aminosalicylate indicated for the:
induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. (1)
1
INDICATIONS AND USAGE
Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocialsupport.
The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have
not undergone
detoxification and not achieved alcoholabstinenceprior to beginning acamprosate calcium delayed-release tablets treatment. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence from alcohol in polysubstance abusers has not been adequatelyassessed.
Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients withalcoholdependence who areabstinentattreatmentinitiation (1,14).
Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support(1).
INDICATIONS AND USAGE
Desoximetasone ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
NEXIUM I.V. is a proton pump inhibitor (PPI) indicated for the:
Short-term treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis (EE) in adults and pediatric patients 1 month to 17 years of age, as an alternative to oral therapy when oral NEXIUM is not possible or appropriate. (1.1)
Risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers in adults. (1.2)
1.1 Treatment of Gastroesophageal Reflux Disease (GERD) with Erosive Esophagitis (EE)
NEXIUM I.V. is indicated for the short-term treatment of GERD with EE in adults and pediatric patients 1 month to 17 years, inclusively as an alternative to oral therapy when oral NEXIUM is not possible or appropriate.
1.2 Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers following Therapeutic Endoscopy in Adults
NEXIUM I.V. is indicated for risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers in adults.
INDICATIONS AND USAGE
Clomipramine Hydrochloride capsules, USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are egodystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
The effectiveness of Clomipramine hydrochloride capsules, USP
for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.
The effectiveness of Clomipramine hydrochloride capsules, USP for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use Clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see
DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE
Clindamycin palmitate hydrochloride for oral solution (Pediatric) 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 palmitate hydrochloride for oral solution (Pediatric) and other antibacterial drugs, clindamycin palmitate hydrochloride for oral solution (Pediatric) 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
Rivastigmine tartrate is an acetylcholinesterase inhibitor indicated for treatment of:
Mild-to-moderate dementia of the Alzheimers type (AD) (1.1)
Mild-to- moderate dementia associated with Parkinsons disease (PD) (1.2)
1.1 Alzheimer's Disease
Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia of the Alzheimer's type (AD).
1.2 Parkinson's Disease Dementia
Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia associated with Parkinsons disease (PD).
Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].
1 INDICATIONS AND USAGE
Apremilast, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of:
Adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. (1.2)
1.2 Psoriasis
Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.