um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Divalproex sodium delayed-release capsules are an anti-epileptic drug indicated for:
Monotherapy and adjunctive
therapy of complex partial seizures and simple and complex absence
seizures; adjunctive therapy in patients with multiple seizure types that
include absence seizures (
1)
1.1 Epilepsy
Divalproex sodium delayed-release capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release capsules are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
1.2 Important Limitations
Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable
[see Warnings and Precautions (
5.2,
5.3,
5.4), Use in Specific Populations (
8.1), and Patient Counseling Information (
17)]
.
For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception
[see Contraindications (
4)]
.
INDICATIONS AND USAGE:
Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Septicemia in the pediatric patient and adult caused by
P. aeruginosa
,
E. coli
, and
Klebsiella
sp.
Lower respiratory tract infections caused by
P. aeruginos
a,
Klebsiella
sp,
Enterobacter
sp,
Serratia
sp,
E. coli
, and
S. aureus
(penicillinase- and non-penicillinase-producing strains).
Serious central-nervous-system infections (meningitis) caused by susceptible organisms.
Intra-abdominal infections, including peritonitis, caused by
E. coli
,
Klebsiella
sp, and
Enterobacter
sp.
Skin, bone, and skin-structure infections caused by
P. aeruginosa
,
Proteus
sp,
E. coli
,
Klebsiella
sp,
Enterobacter
sp, and
S. aureus.
Complicated and recurrent urinary tract infections caused by
P. aeruginosa
,
Proteus
sp (indole-positive and indole-negative),
E. coli
,
Klebsiella
sp,
Enterobacter
sp,
Serratia
sp,
S. aureus
,
Providencia
sp, and
Citrobacter
sp.
Aminoglycosides, including tobramycin sulfate, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.
Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin sulfate may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the
WARNINGS
box above.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS AND USAGE
Estradiol vaginal cream, USP, 0.01% is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
1 INDICATIONS AND USAGE
Mycophenolate mofetil for oral suspension is 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 for oral suspension 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)
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Indomethacin has been found effective in active stages of the following:1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease.2. Moderate to severe ankylosing spondylitis.3. Moderate to severe osteoarthritis.4. Acute painful shoulder (bursitis and/or tendinitis).5. Acute gouty arthritis.
INDICATIONS AND USAGE
Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies.
The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. (1)
1 INDICATIONS & USAGE
Tranylcypromine tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine tablets are not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions
[see Contraindications (4), Warnings and Precautions (5), and Drug Interactions (7)].
Tranylcypromine tablets are a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants (1)
Tranylcypromine tablets are not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions (1,4, 5, 7)
INDICATIONS AND USAGE
Fluocinonide topical solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Fluoxetine capsules are indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].
Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).
Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (1)
Acute and maintenance treatment of Bulimia Nervosa (1)
Acute treatment of Panic Disorder, with or without agoraphobia (1)
Fluoxetine capsules and olanzapine in combination for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder (1)
Treatment Resistant Depression (1)
INDICATIONS AND USAGE
Caffeine citrate is indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.
Exercise-Induced Bronchospasm
FORADIL AEROLIZER is also indicated for the acute prevention of exercise-induced bronchospasm (EIB) in adults and children 5 years of age and older, when administered on an occasional, as-needed basis.
Use of FORADIL AEROLIZER as a single agent for the prevention of exercise-induced bronchospasm may be clinically indicated in patients who do not have persistent asthma.
In patients with persistent asthma, use of FORADIL AEROLIZER for the prevention of exercise-induced bronchospasm may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.
1 INDICATIONS AND USAGE
Montelukast sodium is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 12 months of age and older (1 .1).
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 6 months of age and older (1.3).
1.1 Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in
pediatric patients 12 months 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 patients 6 months of age and older.
INDICATIONS AND USAGE
Hypertension
Propranolol hydrochloride tablets, USP
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 is not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis
Propranolol hydrochloride tablets, USP
are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris.
Atrial Fibrillation
Propranolol hydrochloride tablets, USP
are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.
Myocardial Infarction
Propranolol is indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.
Migraine
Propranolol is 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.
Essential Tremor
Propranolol is indicated in the management of familial or hereditary essential tremor. Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement. Propranolol causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol is not indicated for the treatment of tremor associated with Parkinsonism.
Hypertrophic Subaortic Stenosis
Propranolol improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
Pheochromocytoma
Propranolol is indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.
1 INDICATIONS AND USAGE
Oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial- onset seizures.
Oxcarbazepine oral suspension is indicated for:
Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures
Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4-16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2-16 years (1)
INDICATIONS
Thiothixene is effective in the management of schizophrenia. Thiothixene has not been evaluated in the management of behavioral complications in patients with mental retardation.
1 INDICATIONS AND USAGE
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.
1
INDICATIONS AND USAGE
FludeoxyglucoseF18 Injection USPisindicatedfor positronemissiontomography(PET)imaginginthefollowingsettings:
FludeoxyglucoseF18Injection USPisindicatedforpositronemissiontomography (PET)imaginginthefollowingsettings:
Oncology:Forassessmentofabnormalglucosemetabolismtoassistinthe evaluationof malignancyinpatientswithknownorsuspectedabnormalities foundbyothertesting modalities,orin patientswithanexistingdiagnosisof cancer.
Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patientswith coronary artery disease and left ventricular dysfunction, when usedtogether with myocardial perfusion imaging.
Neurology:Fortheidentificationofregionsofabnormalglucose metabolismassociatedwithfociofepilepticseizures(
1).
1.1 Oncology
For assessmentof abnormalglucosemetabolismtoassistintheevaluationofmalignancy inpatientswithknown or suspectedabnormalitiesfound by othertestingmodalities,or in patientswithanexistingdiagnosisofcancer.
1.2 Cardiology
For theidentificationof leftventricularmyocardiumwithresidualglucosemetabolism andreversibleloss of systolicfunctioninpatientswithcoronaryarterydiseaseandleft ventriculardysfunction,when used togetherwithmyocardialperfusionimaging.
1.3 Neurology
For theidentificationof regionsof abnormalglucosemetabolismassociatedwithfociof epilepticseizures.
1 INDICATIONS AND USAGE
ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults [see Clinical Studies (14)].
Limitations of Use
This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated [see Warnings and Precautions (5.14)].
ZILXI is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults. (1)
Limitations of Use
This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated (1).
INDICATIONS AND USAGE
Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m
2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.
Below is a chart of Body Mass Index (BMI) based on various heights and weights.
BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared.
Metric conversions are as follows:
pounds
2.2 = kg; inches
0.0254 = meters.
BODY MASS INDEX (BMI), kg/m
2
Weight
Height (feet, inches)
(pounds)
5'0"
5'3"
5'6"
5'9"
6'0"
6'3"
140
27
25
23
21
19
18
150
29
27
24
22
20
19
160
31
28
26
24
22
20
170
33
30
28
25
23
21
180
35
32
29
27
25
23
190
37
34
31
28
26
24
200
39
36
32
30
27
25
210
41
37
34
31
29
26
220
43
39
36
33
30
28
230
45
41
37
34
31
29
240
47
43
39
36
33
30
250
49
44
40
37
34
31
Phendimetrazine tartrate is indicated for use as monotherapy only.
1 INDICATIONS AND USAGE
Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.2)
]. 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 (5.2)
]
Ziprasidone hydrochloride capsules are an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride capsules to prolong the QT interval and may consider the use of other drugs first (5.2) Ziprasidone hydrochloride capsules are indicated as an oral formulation for the:Treatment of schizophrenia. (1.1)
Adults: Efficacy was established in four 4 to 6 week trials and one maintenance trial in adult patients with schizophrenia. (14.1)
1.1 Schizophrenia
Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. The efficacy of oral ziprasidone was established in four short-term (4- and 6-week) controlled trials of adult schizophrenic inpatients and in one maintenance trial of stable adult schizophrenic inpatients [see Clinical Studies (14.1)
].
Diabetic Nephropathy: Captopril tablets, USP are indicated for the treatment of diabetic nephropathy (proteinuria 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis).
In considering use of captopril, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see
WARNINGS: Head and Neck Angioedema and Intestinal Angioedema
).
1 INDICATIONS AND USAGE
Risperidone tabletsare anatypical 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 tablets are 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 tabletsare 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 tablets 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
Risperidone tabletsare 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)].