um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
HIV-1 Treatment (1.1)
Emtricitabine and Tenofovir disoproxil fumarate tablet is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated:
in
combination with other antiretroviral agents for the treatment of
HIV-1 infection in adults and pediatric patients weighing at least 17
kg.
HIV-1 PreP (1.2):
Emtricitabine
and Tenofovir disoproxil fumarate tablets are indicated in at-risk adults
and adolescents weighing at least 35 kg for pre-exposure prophylaxis
(PrEP) to reduce the risk of sexually acquired HIV-1 infection.
Individuals must have a negative HIV-1 test immediately prior to
initiating Emtricitabine and Tenofovir disoproxil fumarate tablets for
HIV-1 PrEP.
1.1 Treatment of HIV-1 Infection
Emtricitabine and Tenofovir disoproxil fumarate tablet is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies (14)].
1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP)
Emtricitabine and Tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating Emtricitabine and Tenofovir disoproxil fumarate tablets for HIV-1 PrEP [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE
Finasteride tablets is a 5-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1):
Improve symptoms
Reduce the risk of acute urinary retention
Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
Finasteride tablets administered in combination with the alpha-blocker doxazosinis indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score) (1.2).
Limitations of Use: Finasteride tablets is not approved for the prevention of prostate cancer (1.3).
1.1 Monotherapy
Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- Improve symptoms- Reduce the risk of acute urinary retention- Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1.2 Combination with Alpha-Blocker
Finasteride tablets administered in combination with the alpha-blocker doxazosinis indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score).
1.3 Limitations of Use
Finasteride tablets are not approved for the prevention of prostate cancer.
1 INDICATIONS AND USAGE
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are an estrogen/progestin COC indicated for use by women to prevent pregnancy.
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy.
1 INDICATIONS AND USAGE
1.1 Partial Onset Seizures
Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets USP are indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
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)
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)
INDICATIONS AND USAGE
Attention Deficit Disorders, Narcolepsy
Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.Methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms:
moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physicians assessment of the chronicity and severity of the childs symptoms.
INDICATIONS AND USAGE
Dilantin is indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections).
INDICATIONS AND USAGE
Lithium Carbonate Extended-Release Tablets isindicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania.
Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, Lithium Carbonate Extended-Release Tablets may produce a normalization of symptomatology within 1 to 3 weeks.
INDICATION AND USAGE
LIDODERM is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
INDICATIONS AND USAGE
When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows:
Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.
Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia.
Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Neoplastic diseases: For the palliative management of leukemias and lymphomas.
Nervous System: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy.
Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.
1 INDICATIONS AND USAGE
Aripiprazole tablets are indicated for the treatment of:
Schizophrenia [see Clinical Studies (14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for:
Schizophrenia (14.1)
1 INDICATIONS AND USAGE
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)
Celecoxib capsules are indicated
1.1 Osteoarthritis
For the management of the signs and symptoms of OA [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis
For the management of the signs and symptoms of RA [see Clinical Studies (14.2)].
1.3 Juvenile Rheumatoid Arthritis
For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)].
1.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS [see Clinical Studies (14.4)].
1.5 Acute Pain (AP)
For the management of acute pain in adults [see Clinical Studies (14.5)].
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see Clinical Studies (14.5)].
1 INDICATIONS AND USAGE
Lacosamide is indicated for:
Treatment of partial-onset seizures in patients 4 years of age and older (1.1)
1.1	Partial-Onset Seizures
Lacosamide is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Additional pediatric use information is approved for UCB, Inc.s VIMPAT (lacosamide) oral solution. However, due to UCB, Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
Topiramate tablet is indicated for:
Epilepsy: initial monotherapy in patients
2 years
of age with partial onset or primary generalized tonic-clonic seizures (1.1);
adjunctive therapy for adults and pediatric patients (2 to 16 years of
age) with partial onset seizures or primary generalized tonic-clonic
seizures, and for patients 2 years of age with seizures associated
with Lennox-Gastaut syndrome (1.2)
Prophylaxis of migraine in patients 12 years of age and
older (1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
1.3 Migraine
Topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache.
1 INDICATIONS AND USAGE
DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
DANYELZA is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1)
INDICATIONS AND USAGE
Tranexamic acid injection is indicated in patients with
hemophilia for short-term use (two to eight days) to reduce or prevent
hemorrhage and reduce the need for replacement therapy during and
following tooth extraction.
1 INDICATIONS AND USAGE
Bupropion hydrochloride tablets, USP are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM .
)
The efficacy of bupropion hydrochloride tablets, USP in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD .
[see Clinical Studies (
14
)]
Bupropion hydrochloride, USP is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( )
1
1 INDICATIONS AND USAGE
Valproic Acid Capsules are an anti-epileptic drug indicated for:
Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (
1)
1.1 Epilepsy
Valproic Acid Capsules are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic Acid Capsules are 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 which 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.
See
Warnings and Precaution (
5.1)
for statement regarding fatal hepatic dysfunction.
1.2 Important Limitations
Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition
[see Warnings and Precautions (
5.2,
5.3,
5.4), Use in Specific Populations (
8.1), and Patient Counseling Information (
17)]
.
1 INDICATIONS AND USAGE
Phentermine hydrochloride Tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
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/m2
Weight (pounds)
Height (feet, inches)
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
The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)
] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine Hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1)
The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1)
INDICATIONS AND USAGE
Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:
Respiratory Tract Infectionscaused byStreptococcus pneumoniae,Staphylococcus aureus(penicillinase and nonpenicillinase-producing),H. influenzae, and Group A beta-hemolytic streptococci.
Bacterial Meningitiscaused byE. coli, Group B streptococci, and other Gram-negative bacteria (Listeria monocytogenes,N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.
Septicemia and Endocarditiscaused by susceptible Gram-positive organisms includingStreptococcusspp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused byE. coli,Proteus mirabilisandSalmonellaspp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis.
Urinary Tract Infectionscaused by sensitive strains ofE.coliandProteus mirabilis.
Gastrointestinal Infectionscaused bySalmonella typhi(typhoid fever), otherSalmonellaspp., andShigellaspp. (dysentery) usually respond to oral or intravenous therapy.
Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin 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.
Indicated surgical procedures should be performed.
INDICATIONS AND USAGE
A. Sedative
B. AnticonvulsantFor the treatment of generalized and partial seizures.
INDICATIONS AND USAGE
Ciprofloxacin extended-release tablets are indicated only for the treatment of urinary tract infections, including acute uncomplicated pyelonephritis, caused by susceptible strains of the designated microorganisms as listed below. Ciprofloxacin extended-release tablets and ciprofloxacin immediate-release tablets are not interchangeable. Please see
DOSAGE AND ADMINISTRATION
for specific recommendations.
Uncomplicated Urinary Tract Infections (Acute Cystitis) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticusTreatment of infections due to this organism in the organ system was studied in fewer than 10 patients..
Complicated Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, or Pseudomonas aeruginosa.
Acute Uncomplicated Pyelonephritis caused by Escherichia coli.
THE SAFETY AND EFFICACY OF CIPROFLOXACIN EXTENDED-RELEASE TABLETS IN TREATING INFECTIONS OTHER THAN URINARY TRACT INFECTIONS HAS NOT BEEN DEMONSTRATED.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with ciprofloxacin extended-release tablets may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin extended-release tablets and other antibacterial drugs, ciprofloxacin extended-release 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.