um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Naloxone Hydrochloride Injection, USP is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine. Naloxone Hydrochloride Injection, USP is also indicated for diagnosis of suspected or known acute opioid overdosage.
Naloxone Hydrochloride Injection, USP may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see
CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock
).
1. INDICATIONS AND USAGE
ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.
Limitations of Use
ASCOR is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.
ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.
Limitations of Use
ASCOR is not indicated for treatment of vitamin C deficiency that is not associated with signs and symptoms of scurvy.
1 INDICATIONS AND USAGE
Sildenafil tablet is indicated for the treatment of erectile dysfunction.
Sildenafil tablet is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)
1 INDICATIONS AND USAGE
Tramadol hydrochloride tablets are indicated in adults 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
[see
Warnings and Precautions (5.1)],
reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
Have not been tolerated or are not expected to be tolerated.
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
Tramadol hydrochloride is an opioid agonist indicated in adults for the management of 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 (
5.1), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:
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. Indications and Usage
1.1 Malignant Pleural Effusion
STERITALC is indicated to decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion.
1.2 Pneumothorax
STERITALC is indicated in adults to decrease the recurrence of pneumothorax.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of
meloxicam and other treatment options before deciding to use meloxicam. Use the
lowest effective dose for the shortest duration consistent with individual
patient treatment goals (see
WARNINGS
).
Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis
and rheumatoid arthritis.
1.5 Agitation Associated with Schizophrenia or Bipolar Mania
ABILIFY Injection is indicated for the acute treatment of agitation associated with schizophrenia or bipolar disorder, manic or mixed. Psychomotor agitation is defined in DSM-IV as excessive motor activity associated with a feeling of inner tension. Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care (eg, threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior), leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation. Efficacy was established in three short-term (24-hour) trials in adults .
[see CLINICAL STUDIES ]
(14.5)
INDICATIONS AND USAGE
Pentamidine Isethionate is indicated for the prevention of
Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined by one or both of the following criteria:
i. a history of one or more episodes of PJP
ii. a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm
3.
These indications are based on the results of an 18-month randomized, dose-response trial in high risk HIV-infected patients and on existing epidemiological data from natural history studies.
The patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of PJP. The remaining patients without a history of PJP included 55 patients with Kaposis sarcoma and 116 patients with other AIDS diagnoses, ARC or asymptomatic HIV infection. Patients were randomly assigned to receive Pentamidine isethionate via the Respirgard
II nebulizer at one of the following three doses: 30 mg every two weeks (n=135), 150 mg every two weeks (n=134) or 300 mg every four weeks (n=139). The results of the trial demonstrated a significant protective effect (p<0.01) against PJP with the 300 mg every four week dosage regimen compared to the 30 mg every two week dosage regimen. The 300 mg dose regimen reduced the risk of developing PJP by 50 to 70% compared to the 30 mg regimen. A total of 293 patients (72% of all patients) also received zidovudine at sometime during the trial. The analysis of the data demonstrated the efficacy of the 300 mg dose even after adjusting for the effect of zidovudine.
The results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of Pentamidine Isethionate prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks.
No dose-response was observed for reduction in overall mortality; however, mortality from PJP was low in all three dosage groups.
1 INDICATIONS AND USAGE
VIVLODEX is indicated for management of osteoarthritis pain.
VIVLODEX is a non-steroidal anti-inflammatory drug indicated for management of osteoarthritis (OA) pain. (1)
INDICATIONS AND USAGE
Major Depressive Disorder: Bupropion
hydrochloride extended-release tablets (XL) are indicated for the treatment of
major depressive disorder.
The efficacy of bupropion in the treatment of a major depressive episode was
established in two 4-week controlled trials of inpatients and in one 6-week
controlled trial of outpatients whose diagnoses corresponded most closely to the
Major Depression category of the APA Diagnostic and Statistical Manual (DSM)
(see CLINICAL
TRIALS).
A major depressive episode (DSM-IV) implies the presence of 1) depressed mood
or 2) loss of interest or pleasure; in addition, at least 5 of the following
symptoms have been present during the same 2-week period and represent a change
from previous functioning: depressed mood, markedly diminished interest or
pleasure in usual activities, significant change in weight and/or appetite,
insomnia or hypersomnia, psychomotor agitation or retardation, increased
fatigue, feelings of guilt or worthlessness, slowed thinking or impaired
concentration, a suicide attempt, or suicidal ideation.
The efficacy of bupropion in maintaining an antidepressant response for up to
44 weeks following 8 weeks of acute treatment was demonstrated in a
placebo-controlled trial with the sustained-release formulation of bupropion
(see CLINICAL TRIALS).
Nevertheless, the physician who elects to use bupropion hydrochloride
extended-release tablets (XL) for extended periods should periodically
reevaluate the long-term usefulness of the drug for the individual patient.
Seasonal Affective Disorder: Bupropion hydrochloride
extended-release tablets (XL) are indicated for the prevention of seasonal major
depressive episodes in patients with a diagnosis of seasonal affective
disorder.
The efficacy of bupropion hydrochloride extended-release tablets (XL) for the
prevention of seasonal major depressive episodes was established in 3 controlled
trials of adult outpatients with a history of major depressive disorder with an
autumn-winter seasonal pattern as defined by Diagnostic and Statistical Manual
of Mental Disorders, 4th edition (DSM-IV) criteria (see CLINICAL TRIALS).
Seasonal affective disorder is characterized by recurrent major depressive
episodes, most commonly occurring during the autumn and/or winter months.
Episodes may last up to 6 months in duration, typically beginning in the autumn
and remitting in the springtime. Although patients with seasonal affective
disorder may have depressive episodes during other times of the year, the
diagnosis of seasonal affective disorder requires that the number of seasonal
episodes substantially outnumber the number of non-seasonal episodes during the
individual's lifetime.
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.
1 INDICATIONS AND USAGE
Paliperidone is an atypical antipsychotic agent indicated for
Treatment of schizophrenia (1.1)
Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1)
Adolescents (ages 12 to 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 [see Clinical Studies (14.1)].
The efficacy of paliperidone extended-release tablets 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 tabletsare indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy [see Clinical Studies (14.2)].
The efficacy of paliperidone extended-release tablets in schizoaffective disorder was established in two 6-week trials in adults.
INDICATIONS AND USAGE
CEDAX (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below (see
DOSAGE AND ADMINISTRATION
and
CLINICAL STUDIES
sections).
Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including -lactamase-producing strains), Moraxella catarrhalis (including -lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
NOTE:
In acute bacterial exacerbations of chronic bronchitis clinical trials where Moraxella catarrhalis was isolated from infected sputum at baseline, ceftibuten clinical efficacy was 22% less than control.
Acute Bacterial Otitis Media due to Haemophilus influenzae (including -lactamase-producing strains), Moraxella catarrhalis (including -lactamase-producing strains), or Streptococcus pyogenes.
NOTE:
Although ceftibuten used empirically was equivalent to comparators in the treatment of clinically and/or microbiologically documented acute otitis media, the efficacy against Streptococcus pneumoniae was 23% less than control. Therefore, ceftibuten should be given empirically only when adequate antimicrobial coverage against Streptococcus pneumoniae has been previously administered.
Pharyngitis and Tonsillitis due to Streptococcus pyogenes.
NOTE:
Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Ceftibuten is generally effective in the eradication of Streptococcus pyogenes from the oropharynx; however, data establishing the efficacy of the CEDAX product for the prophylaxis of subsequent rheumatic fever are not available.
INDICATIONS AND USAGE
Hypertension
Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol. Oral Metoprolol tartrate tablets therapy can be initiated after intravenous metoprolol therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event. (See
DOSAGE AND ADMINISTRATION,
CONTRAINDICATIONS, and
WARNINGS).
INDICATIONS AND USAGE
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 [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
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 INDICATIONS AND USAGE
Pemetrexed 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 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 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 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 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
Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with
Metastatic castration-resistant prostate cancer (CRPC)
Metastatic high-risk castration-sensitive prostate cancer (CSPC)
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)
metastatic high-risk castration-sensitive prostate cancer (CSPC). (1)
INDICATIONS & USAGE
Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts.
Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis.
Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.
1 INDICATIONS AND USAGE
Lurasidone hydrochloride tablets are indicated for:
Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (
14.2
)].
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (
14.2
)].
Lurasidonehydrochloride is anatypicalantipsychoticindicated forthetreatmentof:
DepressiveepisodeassociatedwithBipolarIDisorder(bipolar depression) in adultsand pediatric patients (10 to 17 years) as monotherapy(1,14.2)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctivetherapywithlithiumor valproate(1,14.2)
1
INDICATIONS AND USAGE
Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:
Fludeoxyglucose F18 Injection 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.
1 INDICATIONS AND USAGE
Teriflunomide tablets are 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 adults.
Teriflunomide is a pyrimidine synthesis inhibitor 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 adults. (1)
1 INDICATIONS AND USAGE
Desoximetasone Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.
Desoximetasone Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older (1).
1
INDICATIONS AND USAGE
Oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.
Oxcarbazepine isindicated for:
Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures
Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4-16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2-16 years (1)
Uses
For the treatment and/or prevention of diaper rash
Temporarily protects and helps relieve chapped or cracked skin
1 INDICATIONS AND USAGE
REYATAZ (atazanavir) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 5 kg.
Limitations of Use:
REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus.
Use of REYATAZ/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].
REYATAZ is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 5 kg. (1)
INDICATIONS & USAGE
Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques suchas percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus andintercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for thesetechniques as described in standard textbooks are observed.
INDICATIONS AND USAGE
Atenolol and chlorthalidone tablets are indicated in the treatment of hypertension. This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patients needs, it may be more convenient than the separate components.
INDICATIONS AND USAGE
Depression
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
Childhood Enuresis
May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.
1.2 Acute Maxillary Sinusitis
Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Haemophilus influenzae,
Moraxella catarrhalis, or
Streptococcus pneumoniae [see Indications and Usage
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.