um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Dexmedetomidine injection is an alpha2-adrenergic receptor agonist indicated for:
Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer dexmedetomidine injection by continuous infusion not to exceed 24 hours. (1.1)
Sedation of non-intubated patients prior to and/or during surgical and other procedures. (1.2)
1.1	Intensive Care Unit Sedation
Dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours.
Dexmedetomidine injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine injection prior to extubation.
1.2	Procedural Sedation
Dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
INDICATIONS AND USAGE
Azithromycin for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
As recommended dosages, durations of therapy, and applicable patient populations vary among these infections, please see
DOSAGE AND ADMINISTRATION
for dosing recommendations.
Community-acquired pneumonia due to
Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or
Streptococcus pneumoniae in patients who require initial intravenous therapy.
Pelvic inflammatory disease due to
Chlamydia trachomatis, Neisseria gonorrhoeae, or
Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin for Injection, USP.
Azithromycin for Injection, USP should be followed by azithromycin by the oral route as required (see
DOSAGE AND ADMINISTRATION
).
Appropriate culture and susceptibility tests should be performed before treatment to determine the causative microorganism and its susceptibility to azithromycin. Therapy with azithromycin may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Azithromycin for Injection, USP and other antibacterial drugs, Azithromycin 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.
INDICATIONS AND USAGE
Hypertension
Propranolol hydrochloride extended-release capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride extended-release capsules are not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Propranolol hydrochloride extended-release capsules are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Migraine
Propranolol hydrochloride extended-release capsules are indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use.
Hypertrophic Subaortic Stenosis
Propranolol hydrochloride extended-release capsules improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
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, USP areindicated for the treatment of erectile dysfunction (ED).
1.2	Benign Prostatic Hyperplasia
Tadalafil tablets, USP areindicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3	Erectile Dysfunction and Benign Prostatic Hyperplasia
Tadalafil tablets, USP 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
Carbidopa and levodopa tablets, USP are indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa.
Carbidopa may also reduce nausea and vomiting and permit more rapid titration of levodopa.
INDICATIONS
Butalbital, Aspirin, and Caffeine Tablets, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
1 INDICATIONS AND USAGE
Azithromycin is 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.
Azithromycin tablets, USP 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.
1.2 Mycobacterial Infections
Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease
Azithromycin tablet, USP taken alone or in combination with rifabutin at its approved dose, is 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 tablet, USP taken in combination with ethambutol, is 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 and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. Wh en 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
PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older
[see
Use in Specific Populations (8.4) and
Clinical Studies (14)]
.
PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. PREZISTA must be co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents. (
1)
1 INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients2 yearsof age and older (1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients6 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 (1.3).
1.1 Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients2 yearsof age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients2years 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 patients2 yearsof age and older.
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
INDICATIONS AND USAGE
To control severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.
1 INDICATIONS AND USAGE
MYCOPHENOLATE MOFETIL TABLETS are an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants. (1)
Mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.
1 INDICATIONS AND USAGE
Venlafaxine Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1.1)
Social Anxiety Disorder (SAD) (1.2)
1.1 Major Depressive Disorder
Venlafaxine Extended-Release Tablets (venlafaxine hydrochloride) are indicated for the treatment of major depressive disorder (MDD).
Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [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 mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure 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 Social Anxiety Disorder
Venlafaxine Extended-Release Tablets are indicated for the treatment of Social Anxiety Disorder (SAD), also known as Social Phobia, as defined in DSM-IV. Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.
Efficacy of venlafaxine extended release in the treatment of SAD was established in short-term SAD trials [see Clinical Studies (14.2)].
INDICATIONS AND USAGE
Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
UPPER RESPIRATORY TRACT
Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
NOTE: The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. Cefprozil is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, substantial data establishing the efficacy of cefprozil in the subsequent prevention of rheumatic fever are not available at present.
Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains). (See CLINICAL STUDIES.)
NOTE: In the treatment of otitis media due to -lactamase producing organisms, cefprozil had bacteriologic eradication rates somewhat lower than those observed with a product containing a specific -lactamase inhibitor. In considering the use of cefprozil, lower overall eradication rates should be balanced against the susceptibility patterns of the common microbes in a given geographic area and the increased potential for toxicity with products containing -lactamase inhibitors.
Acute Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains).
LOWER RESPIRATORY TRACT
Secondary Bacterial Infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including -lactamase-producing strains), and Moraxella (Branhamella) catarrhalis (including -lactamase-producing strains).
SKIN AND SKIN STRUCTURE
Uncomplicated Skin and Skin-Structure Infections caused by Staphylococcus aureus (including penicillinase-producing strains) and Streptococcus pyogenes. Abscesses usually require surgical drainage.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil tablets and other antibacterial drugs, cefprozil 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
RISPERIDONE is an atypical antipsychotic indicated for:
Treatment
of schizophrenia (1.1)
As
monotherapy or adjunctive therapy with lithium or valproate, for the
treatment of acute manic or mixed episodes associated with Bipolar I
Disorder (1.2)
Treatment
of irritability associated with autistic disorder (1.3)
1.1 Schizophrenia
RISPERIDONE (risperidone) is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)].
1.2 Bipolar Mania
Monotherapy
RISPERIDONE is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)].
Adjunctive Therapy
RISPERIDONE adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3)].
1.3 Irritability Associated with Autistic Disorder
Pediatrics
RISPERIDONE is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4)].
1. INDICATIONS AND USAGE
Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
chronic IBS symptoms (generally
lasting 6 months or longer),
had anatomic or biochemical
abnormalities of the gastrointestinal tract excluded, and
not responded adequately to
conventional therapy.
Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:
frequent and severe abdominal
pain/discomfort,
frequent bowel urgency or fecal
incontinence,
disability or restriction of daily
activities due to IBS.
Because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.
Clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men.
Alosetron hydrochloride tablets are a selective serotonin 5-HT3 antagonist indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
chronic IBS symptoms (generally lasting 6 months or longer),
had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
not responded adequately to conventional therapy. (1)
Severe IBS includes diarrhea and 1 or more of the following:
frequent and severe abdominal pain/discomfort,
frequent bowel urgency or fecal incontinence,
disability or restriction of daily activities due to IBS. (1)
1.
INDICATIONS AND USAGE
Sotalol Hydrochloride Tablets are an antiarrhythmic indicated for: the treatment of life threatening ventricular arrhythmias (
1.1)
Limitations of Use
Avoid use in patients with asymptomatic ventricular premature contraction (
1.1)
1.1 Life-Threatening Ventricular Arrhythmias
Sotalol Hydrochloride Tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT).
Limitation of Use:
Sotalol Hydrochloride Tablets may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of Sotalol Hydrochloride Tablets, including a 1.5 to 2% rate of Torsade de Pointes (TdP) or new ventricular tachycardia/fibrillation (VT/VF) in patients with either non-sustained ventricular tachycardia (NSVT) or supraventricular arrhythmias (SVT), its use inpatientswith less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Avoid treatment of patients with asymptomatic ventricular premature contractions [
see
Warnings
and Precautions (
5.2
).]
1.2 Chronic Kidney Disease Stage 5
Paricalcitol capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
1 INDICATIONS AND USAGE
UZEDY is indicated for the treatment of schizophrenia in adults.
UZEDY is an atypical antipsychotic indicated for the treatment of schizophrenia in adults. (1)
1.
INDICATIONS AND USAGE
Lotensin is indicated for the treatment of hypertension, to lower blood pressure.Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarilystrokes and myocardial infarctions. These benefits have been seen in controlled trialsof antihypertensive drugs from a wide variety of pharmacologic classes including the classto which this drug principallybelongs.
Control of high blood pressure should be part of comprehensive cardiovascularrisk management, including, as appropriate, lipid control, diabetes management,antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will requiremore 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 EducationPrograms Joint National Committee on Prevention, Detection, Evaluation, and Treatment of HighBlood Pressure(JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and withdifferent mechanisms of action, have been shown in randomized controlled trials toreduce cardiovascular morbidity and mortality, and it can be concluded that it is bloodpressure reduction, and not some other pharmacologic property of the drugs, that is largelyresponsible for those benefits. The largest and most consistent cardiovascular outcome benefit has beena reduction in the risk of stroke, but reductions in myocardial infarction andcardiovascular mortality also have been seenregularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absoluterisk increase per mmHg is greater at higher blood pressures, so that even modest reductions ofsevere hypertension can provide substantial benefit. Relative risk reduction from bloodpressure reduction is similar across populations with varying absolute risk, so the absolute benefitis 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 frommore aggressive treatment to a lower blood pressuregoal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) inBlack 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 selectionof therapy.
It may be used alone or in combination with thiazidediuretics.
Lotensinisanangiotensin-convertingenzyme(ACE)inhibitorindicated for the treatment of hypertension, to lower blood pressure.Lowering blood pressure reduces the risk of fatal and nonfatalcardiovascular events, primarily strokes and myocardial infarctions.(
1
)
1 INDICATIONS AND USAGE
Piroxicam Capsules USP is a nonsteroidal anti-inflammatory drug indicated for
Relief of the signs and symptoms of osteoarthritis (OA)
Relief of the signs and symptoms of rheumatoid arthritis (RA)
Piroxicam Capsules USP is indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
INDICATIONS AND USAGE
Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease.
The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.