um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Methotrexate Injection is a folate analog metabolic inhibitor indicated for:
The following neoplastic diseases for the:
oTreatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen (1.1)
oProphylaxis and treatment of adult and pediatric patients with meningeal leukemia (1.2)
oTreatment of adult and pediatric patients with non-Hodgkin lymphoma (1.3)
oTreatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen (1.4)
oTreatment of adults with breast cancer as part of a combination chemotherapy regimen (1.5)
oTreatment of adults with squamous cell carcinoma of the head and neck as single-agent (1.6)
oTreatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen (1.7)
Treatment of adults with rheumatoid arthritis (RA). (1.8)
Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). (1.9)
Treatment of adults with severe psoriasis. (1.10)
1.1	Acute Lymphoblastic Leukemia
Methotrexate Injection is indicated for the treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy regimen.
1.2	Meningeal Leukemia: Prophylaxis and Treatment
Methotrexate Injection is indicated for the prophylaxis and treatment of meningeal leukemia in adult and pediatric patients.
1.3	Non-Hodgkin Lymphoma
Methotrexate Injection is indicated for the treatment of adults and pediatric patients with Non-Hodgkin lymphoma.
1.4	Osteosarcoma
Methotrexate Injection is indicated for the treatment of adults and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen.
1.5	Breast Cancer
Methotrexate Injection is indicated for the treatment of adults with breast cancer as part of a combination chemotherapy regimen.
1.6	Squamous Cell Carcinoma of the Head and Neck
Methotrexate Injection is indicated for the treatment of adults with squamous cell carcinoma of the head and neck as a single-agent.
1.7	Gestational Trophoblastic Neoplasia
Methotrexate Injection is indicated for the treatment of adults with gestational trophoblastic neoplasia (GTN) as part of a combination chemotherapy regimen.
1.8	Rheumatoid Arthritis
Methotrexate Injection is indicated for the treatment of adults with rheumatoid arthritis (RA).
1.9	Polyarticular Juvenile Idiopathic Arthritis
Methotrexate Injection is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA).
1.10	Psoriasis
Methotrexate Injection is indicated for the treatment of adults with severe psoriasis.
1 INDICATIONS AND USAGE
Oxycodone HCl extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in:
Adults; and
Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.
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 extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve oxycodone HCl extended-release 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.
Oxycodone HCl extended-release tablets are not indicated as an as-needed (prn) analgesic.
Oxycodone HCl extended-release tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate in:
Adults; and
Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent.
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 extended-release opioid formulations, reserve oxycodone HCl extended-release 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. (1)
Oxycodone HCl extended-release tablets are not indicated as an as-needed (prn) analgesic. (1)
1 INDICATIONS & USAGE
Amiodarone Hydrochloride Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone Hydrochloride Injection also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with Amiodarone Hydrochloride Injection, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (
2)].
Use Amiodarone Hydrochloride Injection for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but Amiodarone Hydrochloride Injection may be safely administered for longer periods if necessary.
1 INDICATIONS & USAGE
Fluorouracil is indicated for the treatment of patients with:1.1Adenocarcinoma of the Colon and Rectum1.2Adenocarcinoma of the Breast1.3Gastric Adenocarcinoma1.4Pancreatic Adenocarcinoma
Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with
Adenocarcinoma of the Colon and Rectum (1.1)Adenocarcinoma of the Breast (1.2)Gastric Adenocarcinoma (1.3)Pancreatic Adenocarcinoma (1.4)
INDICATIONS AND USAGE
Pentoxifylline extended-release tablets, USP are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.
INDICATIONS AND USAGE
femhrt is indicated in women with an intact uterus for the:
Treatment of moderate to severe vasomotor symptoms associated with the menopause.
Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis. Non-estrogen medications should be carefully considered.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, previous fracture, small frame (low BMI), light skin color, smoking, and alcohol intake. Response to therapy can be predicted by pre-treatment serum estradiol, and can be assessed during treatment by measuring biochemical markers of bone formation/resorption, and/or bone mineral density.
Estrogen therapy reduces bone resorption and retards or halts postmenopausal bone loss. Studies have shown a risk ratio of about 0.4 for hip and wrist fractures in women whose estrogen therapy was begun within a few years of menopause, compared to women taking calcium and vitamin D alone. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen reduces further loss of bone mass for as long as treatment is continued. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period.
Data from the Women's Health Initiative study showed that use of estrogen-plus-progestin (dose equivalent to 0.625 mg CE and 2.5 mg MPA) resulted in about 5 less hip fractures per 10,000 women-years, compared to use of placebo (risk ratio about 0.66).
1 INDICATIONS AND USAGE
Nelarabine injection is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Nelarabine Injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. (1)
1 INDICATIONS AND USAGE
Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Information related usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.s
Rizatriptan Benzoate Tablets. However, due to Merck & Co., Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information.
Limitations of Use
Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.
Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate tablets has not been established for cluster headache.
Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1)
Limitations of Use:
Use only after clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
INDICATIONS AND USAGE
Dovonex (calcipotriene cream) Cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
INDICATIONS AND USAGE
Probenecid tablets are indicated for the treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.
1
INDICATIONS AND USAGE
Minastrin 24 Feis indicated for use by females of reproductive ageto prevent pregnancy [
see
Clinical Studies (14)
].
The efficacy of Minastrin 24 Fe in women with a body mass index (BMI) of more than35 kg/m2 has not been evaluated.
Minastrin 24 Fe is an estrogen/progestin COC indicated for use by women to prevent pregnancy (1)
The efficacy in women with a body mass index of more than35kg/m2 has not been evaluated (1, 8.8)
1 INDICATIONS AND USAGE
Topiramate isindicated for:
Monotherapy epilepsy: Initial monotherapy in patients
2 years of age with partial onset or primary generalized tonic-clonic seizures (
1.1)
Adjunctive therapy epilepsy: 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 with seizures associated with Lennox-Gastaut syndrome (LGS) (
1.2)
1.1 Monotherapy Epilepsy
Topiramatetablets, USPare indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials
[see Clinical Studies (
14.1)]
.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets, USPare indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years 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
[see Clinical Studies (
14.2)]
.
Additional pediatric use information for patients ages 12 to 17 years is approved for Janssen Pharmaceuticals, Inc.s TOPAMAX (topiramate) Tablets and Sprinkle Capsules. However, due to Janssen Pharmaceuticals, Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin capsules, Ampicillin for Oral Suspension and other antibacterial drugs, Ampicillin capsules and Ampicillin for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting of modifying anitimicrobial therapy, in the absence of such data, local epidemiology and susceptibility patterns contribute to the empiric selection of therapy.
Ampicillin capsules and Ampicillin for oral suspension are indicated in the treatment of infections caused by susceptible strains of the designated organisms listed below:
Infections of the genitourinary tract including gonorrhea - E. coli, P. mirabilis, enterococci, Shigella
, S.
typhosa and other Salmonella and nonpenicillinase-producing N.
gonorrhoeae.
Infections of the respiratory tract - Nonpenicillinase-producing H.
influenzae and staphylococci, and streptococci including Streptococcus
pneumoniae.
Infections of the gastrointestinal tract -
Shigella
, S.
typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci.
Meningitis - N.
Meningitidis
Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to the results of susceptibility testing.
1. INDICATIONS AND USAGE
1.1 Maintenance Treatment of Asthma
Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.
Limitations of Use:
Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.
Budesonide inhalation suspension is an inhaled corticosteroid indicated for:
Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1)
Limitations of Use:
Not indicated for the relief of acute bronchospasm (1)
Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [seeWARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
INDICATIONS AND USAGE
Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.
INDICATIONS AND USAGE:
Fluorouracil Cream USP is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.
The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil Cream USP is approximately 93%, based on 113 lesions in 54 patients. Eighty-eight lesions treated with the cream produced 7 failures.
1 INDICATIONS AND USAGE
Oxaliplatin Injection, USP, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for:
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
treatment of advanced colorectal cancer.
Oxaliplatin Injection, USP is a platinum-based drug used in combination with infusional 5-fluorouracil /leucovorin, which is indicated for:
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.(1)
treatment of advanced colorectal cancer. (1)
1 INDICATIONS AND USAGE
Paliperidone is an atypical antipsychotic agent indicated forTreatment of schizophrenia (1.1)
Adults: Efficacy was established in three 6-week trials and one maintenance trial (14.1)
Adolescents (ages 12-17): Efficacy was established in one 6-week trial. (14.1)
Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (1.2)
Efficacy was established in two 6-week trials in adult patients. (14.2)
1.1 Schizophrenia
Paliperidone Extended-release Tablets are indicated for the treatment of schizophrenia [seeClinical Studies (14.1)].
The efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.
1.2 Schizoaffective Disorder
Paliperidone Extended-release Tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [seeClinical Studies (14.2)].
The efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults.
INDICATIONS AND USAGE
METROGEL-VAGINAL is indicated in the treatment of bacterial
vaginosis (formerly referred to as Haemophilus
vaginitis, Gardnerella vaginitis, nonspecific
vaginitis, Corynebacterium vaginitis, or anaerobic
vaginosis).
NOTE:For purposes of this indication, a clinical
diagnosis of bacterial vaginosis is usually defined by the presence of a
homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a
fishy amine odor when mixed with a 10% KOH solution, and (c) contains clue
cells on microscopic examination. Grams stain results consistent with a
diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood
cells.
Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia
trachomatis, N. gonorrhoeae, Candida albicans, and Herpes
simplex virus should be ruled out.
INDICATION AND USAGE
Fluocinolone acetonide topical oil is a low to medium potency corticosteroid indicated:
In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).
for temporary relief of minor aches and pains of the muscles and joints
associated with simple arthritis, sprains, bruises and simple backache.
1 INDICATIONS AND USAGE
PLENVU is indicated for cleansing of the colon in preparation for colonoscopy in adults.
PLENVU is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. (1)
INDICATIONS AND USAGE
VINCASAR PFS is indicated in acute leukemia.
VINCASAR PFS has also been shown to be useful in combination with other oncolytic agents in Hodgkins disease, non-Hodgkins malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms tumor.
1 INDICATIONS AND USAGE
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2)
Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3)
Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4)
1.1	Major Depressive Disorder
Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)].
The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see Dosage and Administration (2.1)].
1.2	Obsessive Compulsive Disorder
Fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
The effectiveness of fluoxetine in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)].
1.3	Bulimia Nervosa
Fluoxetine is indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
The physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].
1.4	Panic Disorder
Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)].
The effectiveness of fluoxetine in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.4)].
INDICATIONS AND USAGE
Metformin HCl Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
INDICATIONS AND USAGE
Droperidol Injection, USP is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.