um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Major Depressive Disorder:
WELLBUTRINXL is 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 44weeks following 8weeks 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 WELLBUTRINXL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Seasonal Affective Disorder:
WELLBUTRINXL is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder.
The efficacy of WELLBUTRINXL for the prevention of seasonal major depressive episodes was established in 3controlled 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 6months 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 INDICATIONS AND USAGE
Pioglitazone tablet is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (
1,
14)
Important Limitations of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (
1)
Monotherapy and Combination Therapy
Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings
[see
Clinical Studies (14)]
.
Important Limitations of Use
Pioglitazone tablet exerts its antihyperglycemic effect only in the presence of endogenous insulin.
Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease
[see
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]
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)].
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 [see Clinical Studies (14)].
Bupropion hydrochloride extended-release tablets(SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (1)
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules are indicated for the treatment of:Duloxetine delayed-release capsules are indicated for the treatment of:
Major depressive disorder in adults
Generalized anxiety disorder in adults and pediatric patients 7 years of age and older
Diabetic peripheral neuropathic pain in adults
Fibromyalgia
in adults
in
Chronic musculoskeletal pain in adults
Additional pediatric use information is approved for Eli Lilly and Company, Inc.s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions:
Major depressive disorder (MDD) in adults (
1)
Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (
1)
Diabetic peripheral neuropathic pain (DPNP) in adults (
1)
Fibromyalgia (FM)(
1)
Chronic musculoskeletal pain in adults (
1)
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.
indications and usage
Terconazole Vaginal Cream is indicated for the local treatment
of vulvovaginal candidiasis (moniliasis). As this product is effective only
for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed
by KOH smears and/or cultures.
INDICATIONS AND USAGE:
Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.
The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties.
Methocarbamol does not directly relax tense skeletal muscles in man.
1.1 Limitations of Use
KOMBIGLYZE XR is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
INDICATIONS & USAGE
Hypertension
Acebutolol hydrochloride capsules, USP are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Ventricular Arrhythmias
Acebutolol hydrochloride capsules, USP are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension
and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy.
Urinary Tract Infections
For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media
For the treatment of acute otitis media in pediatric patients due to susceptible strains of
Streptococcus pneumoniae
or Haemophilus influenzae
when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension
in pediatric patients under two years of age.
Sulfamethoxazole and trimethoprim oral suspension is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults
For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of
Streptococcus pneumoniae
or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension could
offer some advantage over the use of a single antimicrobial agent.
Shigellosis
For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis jirovecii
Pneumonia
For the treatment of documented
Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii
pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia.
Travelers Diarrhea in Adults
For the treatment of travelers diarrhea due to susceptible strains of enterotoxigenic E. coli.
1 INDICATIONS AND USAGE
FRAGMIN is a low molecular weight heparin (LMWH) indicated for
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (1.1)
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness (1.2)
Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months (1.3)
Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month of age and older (1.4)
Limitations of Use
FRAGMIN is not indicated for the acute treatment of VTE (1.5)
1.1	Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction
FRAGMIN Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy [see Clinical Studies (14.1)].
1.2	Prophylaxis of Deep Vein Thrombosis
FRAGMIN is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
In patients undergoing hip replacement surgery [see Clinical Studies (14.2)];
In patients undergoing abdominal surgery who are at risk for thromboembolic
complications [see Clinical Studies (14.3)];
In medical patients who are at risk for thromboembolic complications due to severely
restricted mobility during acute illness [see Clinical Studies (14.4)].
1.3	Extended Treatment of Symptomatic Venous Thromboembolism (VTE) in Adult Patients with Cancer
FRAGMIN is indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months [see Clinical Studies (14.5)].
1.4	Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients
FRAGMIN is indicated for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients 1 month of age and older.
1.5	Limitations of Use
FRAGMIN is not indicated for the acute treatment of VTE.
1.1 Infections of the Ear, Nose, and Throat
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Streptococcus species. (- and
-hemolytic isolates only),Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
1.2 Infections of the Genitourinary Tract
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
1.3 Infections of the Skin and Skin Structure
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Streptococcus spp. (- and -hemolytic isolates only), Staphylococcusspp., or E. coli.
1.4 Infections of the Lower Respiratory Tract
Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Streptococcus spp. (- and -hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
1.5 Helicobacter pylori Infection
Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole:
Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pyloriinfection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat 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 or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS & USAGE
1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin
50 mg/m2.2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.3. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.4. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets, USP are recommended even where the incidence of postoperative nausea and/or vomiting is low.
INDICATIONS AND USAGE:
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain.
INDICATIONS AND USAGE
In Chronic Spasticity
Dantrolenesodium capsules are indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolenesodium capsulesis not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
If improvement occurs, it will ordinarily occur within the dosage titration (see
DOSAGE AND ADMINISTRATION
), and will be manifested by a decrease in the severity of spasticity and the ability to resume a daily function not quite attainable without dantrolenesodium capsules.
Occasionally, subtle but meaningful improvement in spasticity may occur with dantrolenesodium capsulestherapy.
In such instances, information regarding improvement should be solicited from the patient and those who are in constant daily contact and attendance with him.
Brief withdrawal of dantrolenesodium capsulesfor a period of 2 to 4 days will frequently demonstrate exacerbation of the manifestations of spasticity and may serve to confirm a clinical impression.
A decision to continue the administration of dantrolenesodium capsuleson a long-term basis is justified if introduction of the drug into the patient's regimen:
produces a significant reduction in painful and/or disabling spasticity such as clonus, or
permits a significant reduction in the intensity and/or degree of nursing care required, or
rids the patient of any annoying manifestation of spasticity considered important by the patient himself.
In Malignant Hyperthermia
Oral dantrolenesodium capsules is also indicated preoperatively to prevent or attenuate the development of signs of malignant hyperthermia in known, or strongly suspect, malignant hyperthermia susceptible patients who require anesthesia and/or surgery.
Currently accepted clinical practices in the management of such patients must still be adhered to (careful monitoring for early signs of malignant hyperthermia, minimizing exposure to triggering mechanisms and prompt use of intravenous dantrolene sodium and indicated supportive measures should signs of malignant hyperthermia appear); see also the package insert for intravenous dantrolene sodium.
Oral dantrolenesodium capsulesshould be administered following a malignant hyperthermic crisis to prevent recurrence of the signs of malignant hyperthermia.
1 INDICATIONS AND USAGE
Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:
Treatment of acute manic and mixed episodes in patients 7 years and older [see Clinical Studies (14)]
Maintenance treatment in patients 7 years and older [see Clinical Studies (14)]
Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder:
Treatment of acute manic and mixed episodes in patients 7 years and older (1)
Maintenance treatment in patients 7 years and older (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of meloxicam tablets and other treatment options before deciding to use meloxicam tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis.
INDICATIONS & USAGE
Lidocaine Ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.
1 INDICATIONS AND USAGE
Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck & Co., Inc.s Rizatriptan Benzoate Orally Disintegrating Tablets. However, due to Merck & Co., Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information.
Limitations of Use:
Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets are administered to treat any subsequent attacks.
Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.
Rizatriptan benzoate is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1)
Limitations of Use:
Use only after clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)