um-ids/dailymed-annotations huggingface dataset:
1. Indications and Usage Section
INDICATIONS & USAGE
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
1 INDICATIONS AND USAGE
Xulane is indicated for the prevention of pregnancy in women with a body mass index (BMI) <30 kg/m2 for whom a combined hormonal contraceptive is appropriate.
Limitations of Use:
Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs. (90kg) or more. Xulane is contraindicated for use in women with BMI
30 kg/m2[see Contraindications (4), Warnings and Precautions (5.1) and Clinical Studies (14)].
Xulane is an estrogen/progestin combination hormonal contraceptive (CHC), indicated for the prevention of pregnancy in women with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. (1)
Limitations of Use:
Xulane may be less effective in preventing pregnancy in women at or above 198 lbs. (90 kg).(1, 4, 14)
1 INDICATIONS AND USAGE
Finasteride, is a 5-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1):
Improve symptoms
Reduce the risk of acute urinary retention
Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
Finasteride tablets administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score) (1.2).
Limitations of Use: Finasteride tablets are not approved for the prevention of prostate cancer (1.3).
1.1 Monotherapy
Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
- Improve symptoms- Reduce the risk of acute urinary retention- Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1.2 Combination with Alpha-Blocker
Finasteride tablets administered in combination with the alpha-blocker doxazosinare indicated to reduce the risk of symptomatic progression of BPH (a confirmed 4 point increase in American Urological Association (AUA) symptom score).
1.3 Limitations of Use
Finasteride tablets are not approved for the prevention of prostate cancer.
INDICATIONS AND USAGE
Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.
1 INDICATIONS AND USAGE
KANUMA is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency.
KANUMA is a hydrolytic lysosomal cholesteryl ester and triacylglycerol-specific enzyme indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency. (1)
1 INDICATIONS & USAGE
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older ofallogeneic 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 adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.
(1)
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)
1
INDICATIONS AND USAGE
Tamsulosin hydrochloride capsules USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. Tamsulosin hydrochloride capsules USP are not indicated for the treatment of hypertension.
1	INDICATIONS AND USAGE
MAXALT and MAXALT-MLT are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use
MAXALT 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 MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks.
MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
MAXALT is not indicated for the prevention of migraine attacks.
Safety and effectiveness of MAXALT have not been established for cluster headache.
MAXALT 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)
1 INDICATIONS AND USAGE
Solifenacin succinate tablets, 5 mg and 10 mg are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Solifenacin succinate tablets, 5 mg and 10 mg are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency (1)
1 INDICATIONS AND USAGE
HYCAMTIN for injection is a topoisomerase inhibitor indicated for treatment of:
Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent (1.1)
Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent (1.2)
Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin (1.3)
1.1 Ovarian Cancer
HYCAMTIN for injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy.
1.2 Small Cell Lung Cancer
HYCAMTIN for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of firstline chemotherapy.
1.3 Cervical Cancer
HYCAMTIN for injection, in combination with cisplatin, is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment.
1 INDICATIONS AND USAGE
Pioglitazone and glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14)].
Important Limitations of Use
Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone and glimepiride 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 Warnings and Precautions (5.5)].
Pioglitazone and glimepiride tablets are a thiazolidinedione and a sulfonylurea combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and glimepiride is appropriate. (1)
Important Limitations of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
INDICATIONS AND USAGE: For eradication of scabies (
Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.
1	INDICATIONS AND USAGE
EOVIST is indicated for intravenous use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in patients with known or suspected focal liver disease.
EOVIST is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in patients with known or suspected focal liver disease (1)
1 INDICATIONS AND USAGE
Esomeprazole magnesium is a proton pump inhibitor indicated for the following:
Treatment of gastroesophageal reflux disease (GERD) (1.1)
Risk reduction of NSAID-associated gastric ulcer (1.2)
H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4)
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules, USP are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules, USP may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules, USP are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole magnesium delayed-release capsules, USP are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole magnesium delayed-release capsules, USP are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (esomeprazole magnesium plus amoxicillin and clarithromycin): Esomeprazole magnesium delayed-release capsules, USP in combination with amoxicillin and clarithromycin, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see
Dosage and Administration (2) and Clinical Studies (14)].
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and
the prescribing information for clarithromycin].
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Esomeprazole magnesium delayed-release capsules, USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
1 INDICATIONS AND USAGE
Fluorouracil Injection is indicated for the treatment of patients with:
Fluorouracil Injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with
Adenocarcinoma of the Colon and Rectum (1.1)
Adenocarcinoma of the Breast (1.2)
Gastric Adenocarcinoma (1.3)
Pancreatic Adenocarcinoma (1.4)
1.1 Adenocarcinoma of the Colon and Rectum
1.2 Adenocarcinoma of the Breast
1.3 Gastric Adenocarcinoma
1.4 Pancreatic Adenocarcinoma
INDICATIONS AND USAGE
Parkinson's Disease
Pramipexole dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
The effectiveness of pramipexole dihydrochloride tablets was demonstrated in randomized, controlled trials in patients with early Parkinson's disease who were not receiving concomitant levodopa therapy as well as in patients with advanced disease on concomitant levodopa (see CLINICAL STUDIES).
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, USPand other antibacterial drugs, amoxicillin capsules, USP 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.
Amoxicillin capsules, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
Amoxicillin Capsules, USPare a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract.
(1.1-
1.5)
In combination for treatment of
H. pyloriinfection and duodenal ulcer disease.
(1.6,
1.7)
1.1 Infections of the Ear, Nose, and Throat
Due to
Streptococcus species (- and -hemolytic isolates only),
Streptococcus pneumoniae,
Staphylococcus spp., or
Haemophilus influenzae.
1.2 Infections of the Genitourinary Tract
Due to
Escherichia coli, Proteus mirabilis, or
Enterococcus faecalis.
1.3 Infections of the Skin and Skin Structure
Due to
Streptococcus spp. (- and -hemolytic isolates only),
Staphylococcus spp., or
E. coli.
1.4 Infections of the Lower Respiratory Tract
Due to
Streptococcus spp. (- and -hemolytic isolates only),
S. pneumoniae, Staphylococcus spp., or
H. influenzae.
1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections)
Due to
Neisseria gonorrhoeae.
Because of high rates of amoxicillin resistance, amoxicillin capsules, USPare not recommended for empiric treatment of gonorrhea. Amoxicillin capsules, USP use should be limited to situations where
N. gonorrhoeae isolates are known to be susceptible to amoxicillin.
1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole
Amoxicillin capsules, USP, in combination with clarithromycin plus lansoprazole as triple therapy,are 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.
1.7 Dual Therapy for H. pylori with Lansoprazole
Amoxicillin capsules, USP, in combination with lansoprazole delayed-release capsules as dual therapy,are indicated for the treatment of patients with
H. pylori infection 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.
Oxycodone and Acetaminophen Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
Have not been tolerated, or are not expected to be tolerated
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
INDICATIONS AND USAGE
Cytotec (misoprostol) is indicated for reducing the risk of NSAID (nonsteroidal
anti-inflammatory drugs, including aspirin)induced gastric ulcers in patients
at high risk of complications from gastric ulcer, e.g., the elderly and patients
with concomitant debilitating disease, as well as patients at high risk of
developing gastric ulceration, such as patients with a history of ulcer. Cytotec
has not been shown to reduce the risk of duodenal ulcers in patients taking
NSAIDs. Cytotec should be taken for the duration of NSAID therapy. Cytotec has
been shown to reduce the risk of gastric ulcers in controlled studies of 3
months' duration. It had no effect, compared to placebo, on gastrointestinal
pain or discomfort associated with NSAID use.
1 INDICATIONS AND USAGE
Fenofibric acid is 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
MethylPREDNISolone Tablets are indicated in the following conditions:
Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
Congenital adrenal hyperplasia
Hypercalcemia associated with cancer
Nonsuppurative thyroiditis
Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Synovitis of osteoarthritis
Acute nonspecific tenosynovitis
Psoriatic arthritis
Epicondylitis
Acute gouty arthritis
Post-traumatic osteoarthritis
Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Acute rheumatic carditis
Systemic dermatomyositis (polymyositis)
Dermatologic Diseases
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Severe seborrheic dermatitis
Exfoliative dermatitis
Mycosis fungoides
Pemphigus
Severe psoriasis
Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Serum sickness
Contact dermatitis
Drug hypersensitivity reactions
Bronchial asthma
Atopic dermatitis
Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcers
Anterior segment inflammation
Sympathetic ophthalmia
Keratitis
Optic neuritis
Iritis and iridocyclitis
Herpes zoster ophthalmicus
Diffuse posterior uveitis and choroiditis
Allergic conjunctivitis
Chorioretinitis
Respiratory Diseases
Symptomatic sarcoidosis
Loeffler's syndrome not manageable by other means
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis
Berylliosis
Hematologic Disorders
Idiopathic thrombocytopenia purpura in adults
Acquired (autoimmune) hemolytic anemia
Congenital (erythroid) hypoplastic anemia
Secondary thrombocytopenia in adults
Erythroblastopenia (RBC anemia)
Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
Nervous System
Acute exacerbations of multiple sclerosis
Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Trichinosis with neurologic or myocardial involvement.