um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Famotidine tablets are indicated in:
1. Short-term treatment of active duodenal ulcer
Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.
2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer
Controlled studies in adults have not extended beyond one year.
3. Short-term treatment of active benign gastric ulcer
Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
4. Short-term treatment of gastroesophageal reflux disease (GERD)
Famotidine tablets are indicated for short-term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
Famotidine tablets are also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
1 INDICATIONS AND USAGE
Epirubicin Hydrochloride Injection, USPis indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1)].
Epirubicin Hydrochloride Injection, USPis an anthracycline topoisomerase II inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer (1).
1 INDICATIONS AND USAGE
Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Limitation of Use
Carisoprodol should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see Dosage and Administration (2)
].
Carisoprodol is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
(1)
Limitations of Use
Should only be used for acute treatment periods up to two or three weeks (1)
1 INDICATIONS AND USAGE
PROAIR HFA inhalation aerosol is a beta2-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease (1.1)
Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2)
1.1 Bronchospasm
PROAIR HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
PROAIR HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
1 INDICATIONS AND USAGE
Famotidine for oral suspension is indicated in adults for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive
gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD,
diagnosed by biopsy.
treatment of
pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome,
multiple endocrine neoplasias).
reduction of the risk of duodenal
ulcer recurrence.
Famotidine for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of:
peptic ulcer disease.
GERD with or without esophagitis and
ulcerations.
Famotidine for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of:
GERD.
Famotidine is a histamine-2 (H2) receptor antagonist indicated (1):
In adults for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of DU recurrence.
In pediatric patients 1 year of age and older for the treatment of:
peptic ulcer
GERD with or without esophagitis and ulcerations
In pediatric patients from birth to less than 1 year of age for the treatment of:
GERD.
INDICATIONS & USAGE
Diabetic Gastroparesis (Diabetic Gastric
Stasis). Metoclopramide is indicated for the relief of symptoms
associated with acute and recurrent diabetic gastric stasis.
The Prevention of Nausea and Vomiting Associated with
Emetogenic Cancer Chemotherapy. Metoclopramide Injection, USP is
indicated for the prophylaxis of vomiting associated with emetogenic cancer
chemotherapy.
The Prevention of Postoperative Nausea and Vomiting.
Metoclopramide Injection, USP is indicated for the prophylaxis of
postoperative nausea and vomiting in those circumstances where nasogastric
suction is undesirable.
Small Bowel Intubation. Metoclopramide Injection, USP
may be used to facilitate small bowel intubation in adults and pediatric
patients in whom the tube does not pass the pylorus with conventional
maneuvers.
Radiological Examination. Metoclopramide Injection,
USP may be used to stimulate gastric emptying and intestinaltransit of barium in
cases where delayed emptying interferes with radiological examination of the
stomach and/or small intestine.
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules are indicated for the treatment of:
Major Depressive Disorder [see Clinical Studies (14.1)]
Generalized Anxiety Disorder [see Clinical Studies (14.2)]
Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]
Chronic Musculoskeletal Pain [see Clinical Studies (14.5)]
Duloxetine delayed-release capsules USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
INDICATIONS AND USAGE
Mirtazapine tablets,USPare indicated for the treatment of major depressive disorder. The efficacy of mirtazapine in the treatment of major depressive disorder was established in6-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 ). 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 least5 of the following9 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 in hospitalized depressed patients has not been adequately studied. The efficacy of mirtazapine 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see ).
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
5. Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions
1
INDICATIONS AND USAGE
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants. (1)
1 INDICATIONS AND USAGE
IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to:
Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS) [see Dosage and Administration (2.1)
Bardet-Biedl syndrome (BBS) [see Dosage and Administration (2.2)].
Limitations of Use:
IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:
Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR
variants classified as benign or likely benign
Other types of obesity not related to POMC, PCSK1 or LEPR deficiency or BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity
IMCIVREE is a melanocortin 4 (MC4) receptor agonist indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to:
Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). (1)
Bardet-Biedl syndrome (BBS). (1)
Limitations of Use:
IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:
Obesity due to suspected POMC, PCSK1, or LEPR-deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign. (1)
Other types of obesity not related to POMC, PCSK1 or LEPR deficiency, or BBS, including obesity associated with other genetic syndromes and general (polygenic) obesity. (1)
Indications and Usage
Lidothol 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.
1 INDICATIONS AND USAGE
Mesalamine delayed-release tablets are aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. (1)
Limitation of Use
Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established (1)
Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults.
Limitations of Use:
Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established.
1 INDICATIONS AND USAGE
Zoledronic Acid Injection is a bisphosphonate indicated for:
Treatment of Pagets disease of bone in men and women(1.5)
1.5 Paget's Disease of Bone
Zoledronic Acid Injection is indicated for treatment of Pagets disease of bone in men and women. Treatment is indicated in patients with Pagets disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see
Clinical Studies (14.5)
].
1 INDICATIONS AND USAGE
1.1 Trichomoniasis
Tinidazole is indicated for the treatment of trichomoniasis caused by
Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection
[see Clinical Studies (
14.1)].
1.2 Giardiasis
Tinidazole is indicated for the treatment of giardiasis caused by
Giardia duodenalis (also termed
G. lamblia) in both adults and pediatric patients older than three years of age
[see Clinical Studies (
14.2)]
.
1.3 Amebiasis
Tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by
Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage
[see Clinical Studies (
14.3,
14.4)]
.
1.4 Bacterial Vaginosis
Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as
vaginitis,
vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in
Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as
Haemophilus vaginitis,
Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in
adult women
[see Use in Specific Populations (
8.1) and Clinical Studies (
14.5)].
Other pathogens commonly associated with vulvovaginitis such as
and
virus should be ruled out.
Other pathogens commonly associated with vulvovaginitis such as
Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and
Herpes simplex virus should be ruled out.
1.5 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tinidazole and other antibacterial drugs, tinidazole should be used only to treat or prevent 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.
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 antimicrobial 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. Meningitides.
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
Quetiapine fumarate is an atypical antipsychotic indicated for the treatment of:
Schizophrenia (1.1)
Bipolar I disorder manic episodes (1.2)
Bipolar disorder, depressive episodes (1.2)
1.1 Schizophrenia
Quetiapine fumarate is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine fumarate for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.1)].
1.2 Bipolar Disorder
Quetiapine fumarate is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see Clinical Studies (14.2)].
Quetiapine fumarate is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [see Clinical Studies (14.2)].
Quetiapine fumarate is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine fumarate as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies (14.2)].
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
INDICATIONS AND USAGE
Based on a review of this drug by the National Academy of Sciences
National Research Council and/or other information, FDA has classified the indications as follows:"Possibly" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.Final classification of the less-than-effective indications required further investigation.
1 INDICATIONS AND USAGE
Venlafaxine hydrochloride extended-release tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (
1.1)
Social Anxiety Disorder (SAD) (
1.2)
1.1 Major Depressive Disorder
Venlafaxine hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder (MDD).
Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [
see
Clinical Studies (
14.1)
].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: 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.
1.2 Social Anxiety Disorder
Venlafaxine hydrochloride extended-release tablets are indicated for the treatment of Social Anxiety Disorder (SAD), also known as Social Phobia, as defined in DSM-IV.
Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.
Efficacy of venlafaxine hydrochloride extended-release tablets in the treatment of SAD was established in short-term SAD trials [
see Clinical Studies (
14.2
)].
1 INDICATIONS AND USAGE
Frovatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
Use only if a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks.
Frovatriptan succinate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache.
Frovatriptan succinate is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use:
Use only after a 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
Kinlytic is indicated in adults:For the lysis of acute massive pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments.For the lysis of pulmonary emboli accompanied by unstable hemodynamics, i.e., failure to maintain blood pressure without supportive measures.The diagnosis should be confirmed by objective means, such as pulmonary angiography or non-invasive procedures such as lung scanning.
INDICATIONS& USAGE
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.
Allopurinolreduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
Allopurinolis indicated in:
1) the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
2) the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinolshould be discontinued when the potential for overproduction of uric acid is no longer present.
3) the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
INDICATIONS AND USAGE
A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional.