um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older.
Fluticasone propionate nasal spray is a corticosteroid indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. (1)
1 INDICATIONS AND USAGE
Ontruzant is a HER2/neu receptor antagonist indicated for:
The treatment of HER2-overexpressing breast cancer. (1.1, 1.2)
The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3)
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product (1, 2.1).
1.1 Adjuvant Breast Cancer
Ontruzant is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1)]) breast cancer
as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
as part of a treatment regimen with docetaxel and carboplatin
as a single agent following multi-modality anthracycline based therapy.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1)].
1.2 Metastatic Breast Cancer
Ontruzant is indicated:
In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1)].
1.3 Metastatic Gastric Cancer
Ontruzant is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [see Dosage and Administration (2.1)].
1 INDICATIONS & USAGE
Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:Nateglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Nateglinide is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use: Not for treating type 1 diabetes mellitus or diabetes ketoacidosis (1)
1 INDICATIONS AND USAGE
Quazepam Tablets are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of Quazepam Tablets has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of Quazepam Tablets has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of Quazepam Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered.
Quazepam Tablets, a gamma-aminobutyric (GABAA) agonist, is indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. (
1)
INDICATIONS
Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: "Possibly" Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); moniliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.
1 INDICATIONS & USAGE
Aspirin and Extended-Release Dipyridamole Capsule is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.
Aspirin and Extended-Release Dipyridamole Capsule is a combination antiplatelet agent indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis (1)
1 INDICATIONS AND USAGE
Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults the prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use
Fosaprepitant has not been studied for the treatment of established nausea and vomiting.
Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Fosaprepitant for injection is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults in combination with other antiemetic agents, for the prevention of (1):
acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin.
delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
Limitations of Use (
1
)
Fosaprepitant for injection has not been studied for treatment of established nausea and vomiting.
1 INDICATIONS AND USAGE
SYNJARDY
SYNJARDY is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
SYNJARDY XR
SYNJARDY XR is a combination of empagliflozin, a SGLT2 inhibitor and metformin HCl, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Empagliflozin
Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of:
Cardiovascular death in adults with established cardiovascular disease. (1)
Cardiovascular death and hospitalization for heart failure in adults with heart failure. (1)
Limitations of Use:
Not recommended for use in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. (1)
Because of the metformin component, SYNJARDY and SYNJARDY XR are not recommended for use in patients with heart failure without type 2 diabetes mellitus. (1)
SYNJARDY
SYNJARDY is a combination of empagliflozin and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
SYNJARDY XR
SYNJARDY XR is a combination of empagliflozin and metformin HCl indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Empagliflozin
Empagliflozin, when used as a component of SYNJARDY or SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of:
Cardiovascular death in adults with established cardiovascular disease.
Cardiovascular death and hospitalization for heart failure in adults with heart failure.
Limitations of Use
SYNJARDY and SYNJARDY XR are not recommended for use in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.2)].
Because of the metformin component, SYNJARDY and SYNJARDY XR are not recommended for use in patients with heart failure without type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
TOLSURA is indicated for the treatment of the following fungal infections in
immunocompromised and non-immunocompromisedadult patients:
Blastomycosis, pulmonary and extrapulmonary
Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and
Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.
Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-fungal therapy should be adjusted accordingly
TOLSURA is an azole antifungal indicated for the treatment of the following fungal infections in
immunocompromised and non-immunocompromisedadult patients (
1):
Blastomycosis, pulmonary and extrapulmonary
Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and
Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.
Limitations of Use:
TOLSURA is not indicated for the treatment of onychomycosis (
1)
TOLSURA is
NOTinterchangeable or substitutable with other itraconazole products (
1)
Limitations of Use:
TOLSURA is not indicated for the treatment of onychomycosis.
TOLSURA is NOT interchangeable or substitutable with other itraconazole products due to the differences in the dosing between TOLSURA and other itraconazole products. Therefore, follow the specific dosage recommendations for TOLSURA
[see
Dosage and Administration (2)].
INDICATIONS AND USAGE
Endrate (Edetate Disodium Injection, USP) is indicated in
selected patients for the emergency treatment of hypercalcemia and for the
control of ventricular arrhythmias associated with digitalis toxicity.
INDICATIONS AND USAGE
Bupap (butalbital and acetaminophen) Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable.
Caution in this regard is required because butalbital is habit-forming and potentially abusable.
1 INDICATIONS AND USAGE
Fenofibric Acid Delayed-Release Capsules are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to:
Reduce TG in patients with severe hypertriglyceridemia (
1.1).
Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia (
1.2).
Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of Fenofibric Acid Delayed-Release Capsules did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (
5.1).
1.1 Treatment of Severe Hypertriglyceridemia
Fenofibric Acid Delayed-Release Capsules are indicated as adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Fenofibric Acid Delayed-Release Capsules therapy on reducing this risk has not been adequately studied.
1.2 Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibric Acid Delayed-Release Capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
1.3 Limitations of Use
Fenofibrate at a dose equivalent to 135 mg of Fenofibric Acid Delayed-Release Capsules did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus
[see Warnings and Precautions (
5.1)]
.
1.4 General Considerations for Treatment
Laboratory studies should be performed to establish that lipid levels are abnormal before instituting Fenofibric Acid Delayed-Release Capsules therapy.
Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.
INDICATIONS AND USAGE
Dehydrated Alcohol Injection is indicated for therapeutic neurolysis of nerves or ganglia for the relief of intractable chronic pain in such conditions as inoperable cancer and trigeminal neuralgia (ticdouloureux), in patients for whom neurosurgical procedures are contraindicated. Relief of trigeminal neuralgia usually is only temporary. Other conditions for which injection of alcohol has been reported include glossopharyngeal neuralgia, angina pectoris and severe claudication due to peripheral vascular insufficiency. Alcohol concentrations of 40 to 50% (prepared by appropriate dilution of dehydrated alcohol) have been used for epidural or individual motor nerve injections to control certain manifestations of cerebral palsy and spastic paraplegia. Similar concentrations also have been injected for celiac plexus block to relieve pain of inoperable upper abdominal cancer, and have been injected intra-and subcutaneously for relief of intractable pruritus ani.
1 INDICATIONS AND USAGE
Atomoxetine capsule is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (
1.1)
1.1
Attention-Deficit/Hyperactivity Disorder (ADHD)
Atomoxetine capsule is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
The efficacy of atomoxetine capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15)
[see Clinical Studies (
14)].
1.2
Diagnostic Considerations
A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder.
The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, on the go, excessive talking, blurting answers, cant wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met.
1.3
Need for Comprehensive Treatment Program
Atomoxetine capsule is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physicians assessment of the chronicity and severity of the patients symptoms.
1 INDICATIONS AND USAGE
Oseltamivir phosphate for oral suspensionis an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)
Prophylaxis of influenza A and B in patients 1 year and older.(1.2)
Limitations of Use:
Not a substitute for annual influenza vaccination. (1.3)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3)
Not recommended for patients with end-stage renaldisease not undergoing dialysis. (1.3)
1.1 Treatment of Influenza
Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2	Prophylaxis of Influenza
Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3	Limitations of Use
Oseltamivir phosphatefor oral suspension is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate for oral suspension
[see Microbiology (12.4)].
Oseltamivir phosphate for oral solution, are not recommended for patients with end-stage renal disease not undergoing dialysis [see Dosage and Administration (2.4)and Use in Specific Populations (8.6)].
INDICATIONS AND USAGE
I. Vasospastic Angina
Nifedipine is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers.
II. Chronic Stable Angina (Classical Effort-Associated Angina)
Nifedipine is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents. In chronic stable angina (effort-associated angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients are incomplete. Controlled studies in small numbers of patients suggest concomitant use of nifedipine and betablocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See ).
WARNINGS