um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
BACTROBAN NASAL is indicated for the eradication of nasal colonization with methicillin-resistant S. aureus in adult patients and health care workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of methicillin-resistant S.aureus infection during institutional outbreaks of infections with this pathogen.
NOTE:
There are insufficient data at this time to establish that this product is safe and effective as part of an intervention program to prevent autoinfection of high-risk patients from their own nasal colonization with S. aureus.
There are insufficient data at this time to recommend use of BACTROBAN NASAL for general prophylaxis of any infection in any patient population.
Greater than 90% of subjects/patients in clinical trials had eradication of nasal colonization 2 to 4days after therapy was completed. Approximately 30% recolonization was reported in 1 domestic study within 4weeks after completion of therapy. These eradication rates were clinically and statistically superior to those reported in subjects/patients in the vehicle-treated arms of the adequate and well-controlled studies. Those treated with vehicle had eradication rates of 5% to 30% at 2 to 4days post-therapy with 85% to 100% recolonization within 4weeks.
All adequate and well-controlled trials of this product were vehicle-controlled; therefore, no data from direct, head-to-head comparisons with other products are available at this time.
1 INDICATIONS AND USAGE
Methotrexate Injection is a folate analog metabolic inhibitor indicated for
The following neoplastic diseases for the:
Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen (
1.1)
Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia (
1.2)
Treatment of adult and pediatric patients with non-Hodgkin lymphoma (
1.3)
Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen (
1.4)
Treatment of adults with breast cancer as part of a combination chemotherapy regimen (
1.5)
Treatment of adults with squamous cell carcinoma of the head and neck as single-agent (
1.6)
Treatment 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
Ketamine hydrochloride injection is indicated:
as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
for the induction of anesthesia prior to the administration of other general anesthetic agents.
as a supplement to other anesthetic agents.
Ketamine hydrochloride injection is a general anesthetic indicated:
as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation (1)
for the induction of anesthesia prior to the administration of other general anesthetic agents (1)
as a supplement to other anesthetic agents (1).
1 INDICATIONS AND USAGE
Methadone hydrochloride tablets, USP 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.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids
[see Warnings and Precautions (
5.1)],
reserve methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic.
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12
[see Dosage and Administration (
2.1)].
Methadone hydrochloride tablets, USP is 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.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids, reserve Methadone Hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone hydrochloride tablets, USP are not indicated as an as-needed (prn) analgesic.
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (
1)
INDICATIONS AND USAGE:
Cladribine Injection, USPis indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms.
1 INDICATIONS AND USAGE
ZOLEDRONIC ACID Injection is a bisphosphonate indicated for the treatment of:
Hypercalcemia of malignancy. (
1.1)
Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.(
1.2)
Limitations of Use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia.
1.1 Hypercalcemia of Malignancy
Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12mg/dL [3.0mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL+0.8 (4.0 g/dL - patient albumin [g/dL]).
1.2 Multiple Myeloma and Bone Metastases of Solid Tumors
Zoledronic Acid Injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.
Limitations of Use
The safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other nontumor-related conditions have not been established.
INDICATIONS AND USAGE
Trazodone hydrochloride is indicated for the treatment of depression. The efficacy of trazodone has been demonstrated in both inpatient and out-patient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Associations Diagnostic and Statistical Manual, III.aMajor Depressive Episode 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 four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.
INDICATIONS AND USAGE
Supplementation of the diet with ten essential vitamins.
Supplementation of the diet with fluoride for cariesprophylaxis.
Multivitamin with Fluoride 0.25 mg Chewable Tablets provide 0.25 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water contains0.3 through 0.6 ppm of fluoride.
Multivitamin with Fluoride
0.25
mg Chewable Tablets
supply significant amounts of Vitamins A, C, D, E,thiamine, riboflavin, niacin, vitamin B6, vitamin B12, andfolate to supplement the diet, and to help assure thatnutritional deficiencies of these vitamins will not develop.
Thus, in a single easy-to-use preparation, children obtainten essential vitamins and the important mineral, fluoride.The American Academy of Pediatrics recommends thatchildren up to age 16, in areas where drinking watercontains less than optimal levels of fluoride, receive dailyfluoride supplements.
Children using
Multivitamin with Fluoride
0
.
25
mg
Chewable Tablets regularly should receive semiannualdental examinations. The regular brushing of teeth andattention to good oral hygiene practices are also essential.Multivitamin with Fluoride Chewable Tablets is aprescription product for the clinical dietary management ofthe metabolic processes of caries prophylaxis and providessupplementation of the diet with ten essential vitamins.
1 INDICATIONSAND USAGE
DSUVIA is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use:
Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting.
Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied.
Only to be administered by a healthcare provider.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see
Warnings and Precautions (
5.4)
], reserve DSUVIA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
-Have not been tolerated, or are not expected to be tolerated,
-Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
DSUVIA contains sufentanil, an opioid agonist, and is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting.
Not for use for more than 72 hours.
Only to be administered by a healthcare provider.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve DSUVIA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
-Have not been tolerated, or are not expected to be tolerated,
-Have not provided adequate analgesia, or are not expected to provide adequate analgesia. (
1
)
1 INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate is a proton pump inhibitor indicated for:
Short-term treatment of active duodenal ulcer (1.1)
Short-term treatment of active benign gastric ulcer (1.2)
Treatment of gastroesophageal reflux disease (GERD) (1.3)
Maintenance of healing of erosive esophagitis (1.4)
The safety and effectiveness of omeprazole and sodium bicarbonate capsules in pediatric patients (<18 years of age) have not been established. (8.4)
1.1 Duodenal Ulcer
Omeprazole and sodium bicarbonate is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. [See Clinical Studies (14.1)]
Gastric Ulcer
Omeprazole and sodium bicarbonate is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies (14.2)]
1.2 Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD
Omeprazole and sodium bicarbonate is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. [See Clinical Studies (14.3)]
Erosive Esophagitis
Omeprazole and sodium bicarbonate is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.
The efficacy of Omeprazole and sodium bicarbonate used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4-8 week courses of omeprazole and sodium bicarbonate may be considered. [See
Clinical Studies (14.3)]
1.3 Maintenance of Healing of Erosive Esophagitis
Omeprazole and sodium bicarbonate is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months. [See Clinical Studies (14.4)]
INDICATIONS AND USAGE
Apraclonidine ophthalmic solution 0.5% is indicated for short-term adjunctive therapy, in patients on maximally tolerated medical therapy, who require additional IOP reduction. Patients on maximally tolerated medical therapy, who are treated with apraclonidine ophthalmic solution 0.5% to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the IOP rises significantly.
The addition of apraclonidine ophthalmic solution 0.5% to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because apraclonidine ophthalmic solution 0.5% is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP.
The IOP lowering efficacy of apraclonidine ophthalmic solution 0.5% diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month.
1. Indications and Usage Section
1 INDICATIONS AND USAGE
1.1 Monotherapy Epilepsy
Topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets and topiramate capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.
1.3 Migraine
Topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.
INDICATIONS AND USAGE
Oxycodone and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.
1 INDICATIONS AND USAGE
RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.
RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous use. Rubidium Rb 82 chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.(1)
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium
tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat 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.
Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
1.1 Lower Respiratory Tract Infections
caused by beta-lactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by beta-lactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
caused by beta-lactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used.
INDICATIONS AND USAGE
Ketorolac tromethamine ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.
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 non-small cell lung cancer 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, 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 non-small cell lung cancer 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, 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
Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type. (
1)
Memantine hydrochloride tablets, USP are indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
1 INDICATIONS & USAGE
Oxymorphone Hydrochloride Tablets are indicated for the management of acute 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 [see Warnings and Precautions (5.1)], reserve Oxymorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Oxymorphone Hydrochloride Tablets are an opioid agonist indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxymorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia