um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Vestura is an estrogen/progestin COC, indicated for use by women to:
Prevent pregnancy. (1.1)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. (1.2)
Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. (1.3)
1.1 Oral
Contraceptive
Vestura(drospirenone and ethinyl estradiol) tablets are indicated for use by women to prevent pregnancy.
1.2 Premenstrual
Dysphoric Disorder (PMDD)
Vestura is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of Vestura for PMDD when used for more than three menstrual cycles has not been evaluated.
The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.
Vestura has not been evaluated for the treatment of premenstrual syndrome (PMS).
1.3 Acne
Vestura is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Vestura should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
INDICATIONS AND USAGE
Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
1 INDICATIONS AND USAGE
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1)
Levetiracetam is indicated for adjunctive therapyfor the treatment of:
Myoclonic seizures in patients12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1 Partial-Onset Seizures
Levetiracetam tablets are indicated for the treatment of partial-onset seizuresin patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). (
1
)
INDICATIONS AND USAGE
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
Allopurinol Tablet is indicated in:
the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol should be discontinued when the potential for over production of uric acid is no longer present.
the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
INDICATIONS AND USAGE
Clorazepate dipotassium tablets are
indicated for the
management of anxiety
disorders or for the short-term relief of the
symptoms of anxiety.
Anxiety or
tension associated with the
stress of everyday
life usually
does not
require treatment with an
anxiolytic.
Clorazepate dipotassium tablets are indicated as
adjunctive therapy in
the management of
partial seizures.
The effectiveness of
Clorazepate dipotassium tablets in
long-term management of anxiety, that
is, more than 4
months, has not
been assessed by
systematic clinical studies. Long-term studies in
epileptic patients, however, have
shown continued therapeutic activity. The physician should
reassess periodically the
usefulness of the drug
for the
individual patient.
Clorazepate dipotassium tablets are indicated for the
symptomatic relief of acute
alcohol withdrawal.
1 INDICATIONS AND USAGE
Gabapentin is indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset
seizures, with and without secondary generalization, in adults and
pediatric patients 3 years and older with epilepsy (1)
Gabapentin capsules, USP are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Phentermine hydrochloride capsules 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 patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
BODY MASS INDEX (BMI), kg/m2
Height (feet, inches)
Weight
(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
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.
1 INDICATIONS AND USAGE
Fludeoxyglucose F18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings:
Fludeoxyglucose F 18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings:
Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures (1).
1.1 Oncology
For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1.2 Cardiology
For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3 Neurology
For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
INDICATIONS AND USAGE
Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules are indicated for the treatment of:
Major Depressive Disorder in adults
Generalized Anxiety Disorder in adults and pediatric patients 7 years of age and older
Diabetic Peripheral Neuropathic Pain in adults
Fibromyalgia in adults
Chronic Musculoskeletal Pain in adults.
Additional pediatric use information is approved for Eli Lilly and Company, Inc.'s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions:
Major Depressive Disorder (MDD) in adults
(1)
Generalized Anxiety Disorder (GAD) in adults and pediatric patients 7 years of age and older
(1)
Diabetic Peripheral Neuropathic Pain (DPNP) in adults
(1)
Fibromyalgia (FM) in adults
(1)
Chronic Musculoskeletal Pain in adults
(1)
INDICATIONS AND USAGE
For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
1 INDICATIONS AND USAGE
Pemetrexed for 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 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, non-small cell lung cancer (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 for 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 for Injection is indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous 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, non-small cell lung cancer (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 for 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 for 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.
1 INDICATIONS AND USAGE
Anastrozole is an
aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal
women with hormone receptor-positive early breast
cancer (1.1)
First-line treatment of postmenopausal
women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer (1.2)
Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets(1.3)
1.1 Adjuvant Treatment
Anastrozole
tablets are indicated for adjuvant
treatment of
postmenopausal women
with hormone receptor-positive early breast
cancer.
1.2 First-Line Treatment
Anastrozole
tablets are indicated
for the
first-line treatment of
postmenopausal women with hormone receptor-positive or
hormone receptor unknown locally advanced or
metastatic breast cancer.
1.3 Second-Line Treatment
Anastrozole
tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to
anastrozole
tablets.
INDICATIONS AND USAGE
Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
Pediatric Patients:
(See PRECAUTIONSPediatric Use and CLINICAL STUDIES IN PEDIATRIC PATIENTS).
Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.(For specific dosage recommendation, see DOSAGE AND ADMINISTRATION).
Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy. (For specific dosage recommendation, see DOSAGE AND ADMINISTRATION).
NOTE: Azithromycin should not be used in pediatric patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:
patients with cystic fibrosis,
patients with nosocomially acquired infections,
patients with known or suspected bacteremia,
patients requiring hospitalization, or
patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.(For specific dosage recommendation, see DOSAGE AND ADMINISTRATION).
NOTE: Penicillin by the intramuscular route is the usual drug of choice in the treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever. Azithromycin tablet is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to azithromycin tablet, susceptibility tests should be performed when patients are treated with azithromycin tablet. Data establishing efficacy of azithromycin in subsequent prevention of rheumatic fever are not available.
Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with azithromycin tablet may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.
INDICATIONS & USAGE SECTION
Benzonatate is indicated for the symptomatic relief of cough.
1 INDICATIONS AND USAGE
Cardiomyopathy: Myocardial damage, including acute left ventricular failure can occur with doxorubicin. The risk of cardiomyopathy is proportional to the cumulative exposure with incidences from 1% to 20% for cumulative doses from 300 mg/m2 to 500 mg/m2 when doxorubicin is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess LVEF before and regularly during and after treatment with doxorubicin [see Warnings and Precautions (5.1)].
Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin [see Warnings and Precautions (5.2)].
Extravasation and Tissue Necrosis: Extravasation of doxorubicin can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting.Immediately terminate the drug, and apply ice to the affected area [see Warnings and Precautions (5.3)].
Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4)].
Doxorubicin is an anthracycline topoisomerase II inhibitor indicated:
as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer
(1.1).
for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma (1.2).
1.1 Adjuvant Breast Cancer
Adriamycin (DOXOrubicin HCl) Injection, USP and Adriamycin (DOXOrubicin HCl) for Injection, USP is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer [see Clinical Studies (14.1)].
1.2 Other Cancers
Doxorubicin is indicated for the treatment of
acute lymphoblastic leukemia
acute myeloblastic leukemia
Hodgkin lymphoma
non-Hodgkin lymphoma (NHL)
metastatic breast cancer
metastatic Wilms tumor
metastatic neuroblastoma
metastatic soft tissue sarcoma
metastatic bone sarcoma
metastatic ovarian carcinoma
Indications and Usage
INDICATIONS AND USAGE
Herpes Zoster Infections
Acyclovir is indicated for the acute treatment of herpes zoster (shingles).
Genital Herpes
Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.
Chickenpox
Acyclovir is indicated for the treatment of chickenpox (varicella)
Indications:
For the local management of painful skin wounds, including: Pressure ulcers Venus stasis ulcers Superficial wounds and scrapes 1st and 2nd degree burns
1 INDICATIONS AND USAGE
Cysteine hydrochloride injection, USP is indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition.
Cysteine hydrochloride injection, USP is a sulfur-containing amino acid indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition. (1)
1 INDICATIONS AND USAGE
Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.
Clotrimazole and Betamethasone Dipropionate Cream contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. (1)
INDICATIONS
AND USAGE
Benzonatate is indicated for the symptomatic relief of cough.
INDICATIONS AND USAGE
Quflora FE Pediatric Liquid Drops is a prescription dietary supplement providing essential vitamins, iron and fluoride.
1 INDICATIONS AND USAGE
Adenosine Injection is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
Adenosine Injection, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately (1)
INDICATIONS AND USAGE
The topical corticosteriods are indicated for the relief of the inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses.
1INDICATIONS AND USAGE
GILENYA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. (1)
INDICATIONS & USAGE
Each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
1 INDICATIONS AND USAGE
Indomethacin extended-release capsules are indicated for:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
Indomethacin extended-release capsules are a nonsteroidal anti-inflammatory drug indicated for:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease.
Moderate to severe ankylosing spondylitis.
Moderate to severe osteoarthritis.
Acute painful shoulder (bursitis and/or tendinitis). (1)