um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Fluoxetine oral solution, USP is indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].
Fluoxetine oral solution, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (1)
Acute and maintenance treatment of Bulimia Nervosa (1)
Acute treatment of Panic Disorder, with or without agoraphobia (1)
1 INDICATIONS AND USAGE
ONIVYDE is indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
Limitation of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas [see Clinical Studies (14)].
ONIVYDE is a topoisomerase inhibitor indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. (1)
Limitation of Use: ONIVYDE is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas. (1)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP (amoxicillin/clavulanate potassium) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP 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 Powder for Oral Suspension, USP is 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-lactamase-producing isolates of Haemophilus influenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
- caused by beta-lactamase-producing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
- caused by beta-lactamase-producing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
- caused by beta-lactamase-producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
- caused by beta-lactamase-producing 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 Powder for Oral Suspension, USP should not be used.
INDICATIONS AND USAGE
Fluticasone Propionate Cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone Propionate Cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of Fluticasone Propionate Cream, 0.05% in pediatric patients below 3 months of age have not been established.
INDICATIONS AND USAGE
Metolazone is indicated for the treatment of salt and water retention including:
edema accompanying congestive heart failure;
edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.
Metolazone is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. Mykrox tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if Mykrox tablets are to be substituted for Zaroxolyn tablets and other formulations of metolazone that share its slow and incomplete bioavailability, in the treatment of hypertension.
Usage In Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequence of pregnancy. Metolazone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see
PRECAUTIONS
). Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.
1	INDICATIONS AND USAGE
ARCALYST (rilonacept) is an interleukin-1 blocker indicated for:
Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older (1.1, 14.1)
Maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more (1.2, 14.2)
Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older (1.3, 14.3)
1.1	Cryopyrin-Associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome
ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS), and Muckle-Wells Syndrome (MWS) in adults and pediatric patients 12 years and older.
1.2
Deficiency of IL-1 Receptor Antagonist
ARCALYST is indicated for the maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing at least 10 kg.
1.3
Recurrent Pericarditis
ARCALYST is indicated for the treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older.
INDICATIONS AND USAGE
Nizatidine capsules are indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.
Nizatidine capsules are indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with nizatidine for longer than 1 year are not known.
Nizatidine capsules are indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.
Nizatidine capsules are indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.
1 INDICATIONS AND USAGE
VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue Candida infections (1.2)
Esophageal candidiasis (1.3)
Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4)
1.1	Invasive Aspergillosis
VFEND is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus [see Clinical Studies (14.1, 14.5) and Microbiology (12.4)].
1.2	Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections
VFEND is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2, 14.5) and Microbiology (12.4)].
1.3 Esophageal Candidiasis
VFEND is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients 2 years of age and older [see Clinical Studies (14.3, 14.5) and Microbiology (12.4)].
1.4 Scedosporiosis and Fusariosis
VFEND is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see Clinical Studies (14.4) and Microbiology (12.4)].
1.5 Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
Diclona Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.
1 INDICATIONS AND USAGE
Tazarotene Foam, 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.
Tazarotene Foam is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years of age or older. (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen delayed-release tablets are indicated:
For the relief of the signs and symptoms of rheumatoid arthritis
For the relief of the signs and symptoms of osteoarthritis
For the relief of the signs and symptoms of ankylosing spondylitis
For the relief of the signs and symptoms of juvenile arthritis
Naproxen delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
1 INDICATIONS AND USAGE
ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of:
Head and Neck Cancer
Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. (1.1, 14.1)
Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. (1.1, 14.1)
Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. (1.1, 14.1)
Colorectal Cancer
K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test
in combination with FOLFIRI for first-line treatment,
in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy,
as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. (1.2, 5.7, 12.1, 14.2)
Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown. (5.7)
BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)
in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. (1.3)
1.1 Squamous Cell Carcinoma of the Head and Neck (SCCHN)
ERBITUX is indicated:
in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN).
in combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN.
as a single-agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed.
1.2 K-Ras Wild-type, EGFR-expressing Colorectal Cancer (CRC)
ERBITUX is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test [see
Dosage and Administration (2.2)]:
in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment,
in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy,
as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown [see Warnings and Precautions (5.7)].
1.3 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)
ERBITUX is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy [see Dosage and Administration (2.3)].
INDICATIONS AND USAGE
Clobetasol Propionate Cream, USP 0.05% is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended.
As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
INDICATIONS AND USAGE
Terbinafine Hydrochloride Tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium) (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES).
Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
INDICATIONS AND USAGE
Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder.
The efficacy of mirtazapine tablets, USP in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders
3rd edition (DSM-III) category of major depressive disorder (see
CLINICAL PHARMACOLOGY
).
A major depressive episode (DSM-IV) 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 five of the following nine symptoms: depressed mood, loss of interest 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 effectiveness of mirtazapine tablets, USP in hospitalized depressed patients has not been adequately studied.
The efficacy of mirtazapine tablets, USP in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 to 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use mirtazapine tablets, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see
CLINICAL PHARMACOLOGY
).
1 INDICATIONS AND USAGE
BRENZAVVY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
BRENZAVVY is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see
Warnings and Precautions (5.1)].
BRENZAVVY is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitation of Use:Not recommended in patients with type 1 diabetes mellitus. May increase the risk of diabetic ketoacidosis in these patients
1 INDICATIONS AND USAGE
Febuxostat Tablets are a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
For the safe and effective use of allopurinol, see allopurinol prescribing information.
Limitations of Use:
Febuxostat Tablets are not recommended for the treatment of asymptomatic hyperuricemia.
Febuxostat Tablets are a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. (
1)
For the safe and effective use of allopurinol, see allopurinol prescribing information.
Limitations of Use:
Febuxostat Tablets are not recommended for the treatment of asymptomatic hyperuricemia. (
1)
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are indicated for:
Pantoprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD). (1.1)
Maintenance of Healing of Erosive Esophagitis. (1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE)Syndrome. (1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
INDICATIONS AND USAGE
Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,*
Klebsiella spp.* (including K. pneumoniae
*), Proteus mirabilis,*
Bacteroides fragilis,*
Enterobacter spp.,* and Acinetobacter calcoaceticus.*
NOTE: For information on use in pediatric patients (see
PRECAUTIONSPediatric Use
and
CLINICAL STUDIES
sections).
Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae
*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*
Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis
*).
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While ampicillin and sulbactam for injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection should not require the addition of another antibacterial.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection.
Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.
To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection and other antibacterial drugs, ampicillin and sulbactam for injectionshould 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.
Uses
Treats and helps prevent acne
1
INDICATIONS AND USAGE
XENAZINE is indicated for the treatment of chorea associated with Huntingtons disease.
XENAZINE is a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntingtons disease. (1)