um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Rabeprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated in adults for:
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (
1.1).
Maintenance of Healing of Erosive or Ulcerative GERD (
1.2).
Treatment of Symptomatic GERD (
1.3).
Healing of Duodenal Ulcers (
1.4).
Helicobacter pyloriEradication to Reduce Risk of Duodenal Ulcer Recurrence (
1.5).
Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (
1.6).
In adolescent patients 12 years of age and older for:
Short-term Treatment of Symptomatic GERD (
1.7).
1.1 Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
1.4 Healing of Duodenal Ulcers in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.
1.5
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
Rabeprazole sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted
[see
Clinical Pharmacology (12.2)
and the full prescribing information for clarithromycin
].
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
1 INDICATION AND USAGE
ELIDEL (pimecrolimus) Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.
ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age
[seeWarnings and Precautions (5.1),Use in Specific Populations (8.4)].
ELIDEL Cream, 1% is a calcineurin inhibitor immunosuppressant indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. (1)
1 INDICATIONS AND 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 AND USAGE
Multrys is indicated in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
Multrys is a combination of trace elements (zinc sulfate, cupric sulfate, manganese sulfate, and selenious acid) indicated in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. (1)
1 INDICATIONS AND USAGE
Escitalopram oxalate USP 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 tablet, USP 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 tablet, USP 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 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 AND USAGE
Verapamil Hydrochloride Tablets are indicated for the treatment of the following:
Angina
1. Angina at rest including:
Vasospastic (Prinzmetals variant) angina
Unstable (crescendo, pre-infarction) angina
2. Chronic stable angina (classic effort-associated angina)
Arrhythmias
1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS; Accessory Bypass Tract)
2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia
Essential Hypertension
INDICATIONS AND USAGE
Carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion:
Failure of expulsion of the fetus during the course of treatment by another method;
Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity;
Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus;
Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.
Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.
INDICATIONS AND USAGE
Disopyramide Phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Disopyramide Phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of Disopyramide Phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
INDICATIONS AND USAGECarefully consider the potential benefits and risks of
flurbiprofen tablets and other treatment options before deciding to use
flurbiprofen tablets. Use the lowest effective dose for the shortest duration
consistent with individual patient treatment goals (see WARNINGS).
Flurbiprofen tablets are indicated:
For relief of the signs and symptoms of rheumatoid arthritis.
For relief of the signs and symptoms of osteoarthritis.
1. INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of and other treatment options
before deciding to use celecoxib. Use the lowest effective dose for the shortest durationconsistent with individual patient treatment goals [see Warnings and Precautions (5)]
Celecoxib is a non steroidal anti-inflammatory drug indicated for:Osteoarthritis (OA) (1.1)Rheumatoid Arthritis (RA) (1.2)Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older(1.3)Ankylosing Spondylitis (AS) (1.4)Acute Pain (AP) (1.5)Primary Dysmenorrhea (PD) (1.6)
1.1 Osteoarthritis (OA)
Celecoxib is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)]
1.2 Rheumatoid Arthritis (RA)
Celecoxib is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis (JRA)
Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older[see Clinical Studies (14.3)]
1.4 Ankylosing Spondylitis (AS)
Celecoxib is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)]
1.5 Acute Pain (AP)
Celecoxib is indicated for the management of AP in adults [see Clinical Studies (14.5)]
1.6 Primary Dysmenorrhea (PD)
Celecoxib is indicated for the treatment of PD [see Clinical Studies (14.5)]
1 INDICATIONS AND USAGE
Methadone Hydrochloride Tablets are indicated for the:
1.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 long-acting opioids [see Warnings and Precautions (5.1)], reserve Methadone Hydrochloride Tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone Hydrochloride Tablets are not indicated as an as-needed (prn) analgesic.
2.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
3.Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)].
Methadone Hydrochloride Tablets are an opioid agonist indicated for the:
4.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 long-acting opioids, reserve Methadone Hydrochloride Tablets 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.
Methadone Hydrochloride Tablets are not indicated as an as-needed (prn) analgesic.
5.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
6.Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (1)
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 (2.1).
1 INDICATIONS AND USAGE
CLOROTEKAL (chloroprocaine hydrochloride) is indicated for intrathecal injection for the production of subarachnoid block (spinal anesthesia) in adults undergoing surgical procedures. Indicated procedures include those suitable for CLOROTEKAL's short duration of action.
CLOROTEKAL is an ester local anesthetic indicated for intrathecal injection in adults for the production of subarachnoid block (spinal anesthesia). (1)
INDICATIONS AND USAGE
Kidney, Liver, and Heart Transplantation
Gengraf Oral Solution (cyclosporine oral solution, USP [MODIFIED]) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine (MODIFIED) has been used in combination with azathioprine and corticosteroids.
Rheumatoid Arthritis
Gengraf Oral Solution (cyclosporine oral solution, USP [MODIFIED]) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Gengraf can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone.
Psoriasis
Gengraf Oral Solution (cyclosporine oral solution, USP [MODIFIED]) is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated.
While rebound rarely occurs, most patients will experience relapse with Gengraf as with other therapies upon cessation of treatment.
INDICATIONS AND USAGE
Alendronate sodium tablets are indicated for:
Treatment and prevention of osteoporosis in postmenopausal women
For the treatment of osteoporosis, alendronate sodium tablets increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture (see CLINICAL PHARMACOLOGY, Pharmacodynamics).
For the prevention of osteoporosis, alendronate sodium tablets may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture. Bone loss is particularly rapid in postmenopausal women younger than age 60. Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; moderately low bone mass (for example, at least 1 standard deviation below the mean for healthy young adult women); thin body build; Caucasian or Asian race; and family history of osteoporosis. The presence of such risk factors may be important when considering the use of alendronate sodium for prevention of osteoporosis.
Treatment to increase bone mass in men with osteoporosis
Treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density (see PRECAUTIONS, Glucocorticoid-induced osteoporosis). Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
Treatment of Pagets disease of bone in men and women
Treatment is indicated in patients with Pagets disease of bone having alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
The safety and effectiveness of alendronate sodium tablets for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
1 INDICATIONS AND USAGE
Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimers type.
Memantine hydrochloride is a N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimers type. (1)
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, USPfor 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, USPfor 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 capsules, USPfor extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (
see
DOSAGE AND ADMINISTRATION
).
INDICATIONS AND USAGE
TPN Electrolytes (multiple electrolyte additive) is indicated for use as a supplement to nutritional solutions containing concentrated dextrose and amino acids delivered by central venous infusion, to help maintain electrolyte homeostasis in adult patients.
INDICATIONS
Entacapone tablets are indicated as an adjunct to levodopa/carbidopa to treat patients with idiopathic Parkinsons Disease who experience the signs and symptoms of end-of-dose "wearing-off" (see CLINICAL PHARMACOLOGY, Clinical Studies).
Entacapone tablets effectiveness has not been systematically evaluated in patients with idiopathic Parkinsons Disease who do not experience end-of-dose "wearing-off".
Indications and Usage
Adult Patients
Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
Pediatric Patients (aged 1 to 17)
Flumazenil Injection, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (see
Precautions: Pediatric Use).
1 INDICATIONSAND USAGE
Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidones greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]
Acute Treatment of Agitation in Schizophrenia
Ziprasidone mesylate for injection intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation.
Since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone, the practice of co-administration is not recommended.
Ziprasidone mesylate for injection is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone mesylate for injection to prolong the QT interval and may consider the use of other drugs first (5.3)Ziprasidone mesylate for injection as an intramuscular injection is indicated for the:
Acute treatment of agitation in schizophrenic patients. (1)