um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablet, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (
1)
Zolpidem tartrate extended-release tablets are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration
[see CLINICAL STUDIES (
14)].
INDICATIONS AND USAGE
EPINEPHRINE
Epinephrines cardiac effects may be of use in the treatment and prophylaxis of cardiac arrest due to various causes in the absence of ventricular fibrillation and attacks of transitory atrioventricular (AV) heart block with syncopal seizures (Stokes-Adams syndrome), but it is not used in cardiac failure or in hemorrhagic, traumatic or in cardiogenic shock. Epinephrine may be used to stimulate the heart in syncope due to complete heart block or carotid sinus hypersensitivity. Epinephrine is also used for resuscitation in cardiac arrest following anesthetic accidents. In cardiopulmonary resuscitation, intracardiac puncture and intramyocardial injection of epinephrine may be effective when external cardiac compression and attempts to restore the circulation by electrical defibillation or use of a pacemaker fail. Epinephrine is seldom used as a vasopressor except in the treatment of anaphylactic shock and under certain conditions in insulin shock.
INDICATIONS AND USAGE
GoLYTELY for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination.
1 INDICATIONS AND USAGE
Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (
1.1
1.5)
In combination for treatment of
H. pylori infection and duodenal ulcer disease. (
1.5)
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 infections that are proven or strongly suspected to be caused by bacteria. (
1.6)
1.1 Infections of the Ear, Nose, and Throat
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Streptococcus species. (- and -hemolytic isolates only),
Streptococcus pneumoniae,
Staphylococcus spp., or
Haemophilus
influenzae.
1.2 Infections of the Genitourinary Tract
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Escherichia coli, Proteus mirabilis, or
Enterococcus
faecalis.
1.3 Infections of the Skin and Skin Structure
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Streptococcus spp. (- and -hemolytic isolates only),
Staphylococcus spp., or
E. coli.
1.4 Infections of the Lower Respiratory Tract
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of
Streptococcus spp. (- and -hemolytic isolates only),
S. pneumoniae, Staphylococcus spp., or
H.
influenzae.
1.5
Helicobacter pylori Infection
Triple therapy for
Helicobacter pylori with clarithromycin and 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.
Dual therapy for
H. pylori with 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.) Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.6 Usage
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 infections that are proven or strongly suspected to be caused by 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
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( )
1.1
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( )
1.2
1.1 Major Depressive Disorder
Escitalopram is 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 is 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 six months and which the person finds difficult to control. It must be associated with at least three 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.
1 INDICATIONS AND USAGE
Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older.
Articaine HCl and Epinephrine is a combination of articaine HCl, an amide local anesthetic, and epinephrine, a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age or older (1).
1 INDICATIONS AND USAGE
Leflunomide tablets, USP are indicated for the treatment of adults with active rheumatoid arthritis (RA).
Leflunomide tablets, USP are a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis.
INDICATIONS & USAGE SECTION
Doxepin is recommended for the treatment of:
1.Psychoneurotic patients with depression and/or anxiety.2.Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).3.Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).4.Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to doxepin include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that doxepin is safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin is not recommended for use in children under 12 years of age.
1 INDICATIONS AND USAGE
Mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older 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.
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (1)
1 INDICATIONS AND USAGE
Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
Adapalene and benzoyl peroxide topical gel 0.3%/2.5%, is a combination of adapalene, a retinoid, and benzoyl peroxide and is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. (1)
INDICATIONS AND USAGE:
Central Cranial Diabetes Insipidus:
Desmopressin acetate nasal solution is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. It is ineffective for the treatment of nephrogenic diabetes insipidus.
The use of desmopressin acetate nasal solution in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality. This will allow the resumption of a more normal life-style with a decrease in urinary frequency and nocturia.
There are reports of an occasional change in response with time, usually greater than 6 months. Some patients may show a decreased responsiveness, others a shortened duration of effect. There is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the peptide.
Patients are selected for therapy by establishing the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or the response to antidiuretic hormone. Continued response to intranasal desmopressin acetate can be monitored by urine volume and osmolality.
Desmopressin acetate nasal solution is also available as a solution for injection when the intranasal route may be compromised. These situations include nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may also be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.
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 tablets are 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)
1 INDICATIONS AND USAGE
ZAFEMY is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
Limitations of Use:
ZAFEMY may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. ZAFEMY is contraindicated for use in women with BMI
30 kg/m2
[see Contraindications (4), Warnings and Precautions (5.1)and Clinical Studies (14)].
ZAFEMY is an estrogen/progestin combination hormonal contraceptive (CHC), indicated for the prevention of pregnancy in women with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. (1)
Limitations of Use: ZAFEMY may be less effective in preventing pregnancy in women at or above 198 lbs (90 kg). (1, 4, 14)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of
REPREXAIN and other treatment options before deciding to use REPREXAIN. Use
the lowest effective dose for the shortest duration consistent with individual
patient treatment goals (see WARNINGS). REPREXAIN
tablets are indicated for the short-term (generally less than 10 days)
management of acute pain. REPREXAIN is not indicated for the treatment of such
conditions as osteoarthritis or rheumatoid arthritis.
1 INDICATIONS AND USAGE
Donepezil hydrochloride tablets are an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers Disease (1.0).
Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
1 INDICATIONS AND USAGE
Tretinoin Gel is indicated for topical treatment of acne vulgaris.
Tretinoin Gel is a retinoid indicated for topical treatment of acne vulgaris. (1)
1 INDICATIONS AND USAGE
Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)].
The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are an estrogen/progestin COC indicated for use by women to prevent pregnancy(1)
The efficacy in women with a body mass index of more than 35 kg/m2 has not been evaluated(1,8.8)
1 INDICATIONS AND USAGE
Lopreeza is an estrogen and progestin combination indicated in a woman with a uterus for:
Lopreeza 1 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in a woman with a uterus for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1)
Prevention of Postmenopausal Osteoporosis (1.3)
Lopreeza 1 mg/0.5 mg is also indicated in a woman with a uterus for:
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (1.2)
1.1
Treatment of Moderate to Severe Vasomotor Symptoms due
to Menopause
1.2
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal
atrophy due to menopause, topical vaginal products should be considered.
1.3
Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should onlybeconsidered for women at significant risk of osteoporosis and non-estrogen medication should be
carefully considered.
1
INDICATIONS AND USAGE
Epinephrine injection, USP auto-injector is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes 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.
Epinephrine injection, USP auto-injector is 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.
Epinephrine injection, USP auto-injector is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.
Epinephrine injection, USP auto-injector contains epinephrine, a non-selective alpha and beta-adrenergic receptor agonist, indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis. (
1)
INDICATIONS AND USAGE
Citalopram tablets, USPare indicated for the treatment of depression.
The efficacy of citalopram tablets, USPin the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see
CLINICAL PHARMACOLOGY
).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms:depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets, USPin hospitalized depressed patients has not been adequately studied.
The efficacy of citalopram tablets, USPin maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see
CLINICAL PHARMACOLOGY
).Nevertheless, the physician who elects to use citalopram tablets, USPfor extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Mupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2in area) due to susceptible isolates ofStaphylococcus aureus (S. aureus)andStreptococcus pyogenes (S. pyogenes).
Mupirocin cream is an RNA synthetase inhibitor antibacterial indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. (1)
INDICATIONS AND USAGE
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are indicated for the relief of moderate to moderately severe pain.
1 INDICATIONS AND USAGE
PRASUGREL tablets is a P2Y12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with PCI as follows:
Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) (1.1).
Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI (1.1).
1.1 Acute Coronary Syndrome
Prasugrel tabletis indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).
Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.
Prasugrel tablet has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke compared to clopidogrel. The difference between treatments was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies (14)].
INDICATIONS AND USAGE
Herpes Simplex Infections in Immunocompromised Patients
Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients.
Initial Episodes of Herpes Genitalis
Acyclovir Sodium Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immuno-competent patients.
Herpes Simplex Encephalitis
Acyclovir Sodium Injection is indicated for the treatment of herpes simplex encephalitis.
Neonatal Herpes Simplex Virus Infection
Acyclovir Sodium Injection is indicated for the treatment of neonatal herpes infections.
Varicella-Zoster Infections in Immunocompromised Patients
Acyclovir Sodium Injection is indicated for the treatment of varicella-zoster (shingles) infections in immunocompromised patients.
1 INDICATIONS AND USAGE
Pemetrexed Injection is a folate analog metabolic inhibitor indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. (1.1)
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. (1.1)
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1)
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1)
Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1)
initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2)
1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed Injection is indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC.
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.
Limitations of Use: Pemetrexed Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies (14.1)].
1.2 Mesothelioma
Pemetrexed Injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
INDICATIONS AND USAGE
Proparacaine hydrochloride ophthalmic solution is indicated for
procedures in which a topical ophthalmic anesthetic is indicated: corneal
anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal
foreign bodies, and for short corneal and conjunctival procedures.