um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Budesonide capsules (enteric coated) are a glucocorticosteroid indicated for:
Treatment of mild to moderate active Crohns disease involving the ileum and/or the ascending colon. ( )
1.1
Maintenance of clinical remission of mild to moderate Crohns disease involving the ileum and/or the ascending colon for up to 3 months. ( )
1.2
1.1	Mild to Moderate Active Crohns Disease
Budesonide capsules (enteric coated) are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.
1.2	Maintenance of Clinical Remission of Mild to Moderate Crohns Disease
Budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate Crohns disease involving the ileum and/or the ascending colon for up to 3 months.
1 INDICATIONS AND USAGE
Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinsons disease. (1)
Ropinirole extended-release tablets are indicated for the treatment of Parkinsons disease.
INDICATIONS AND USAGE
Medroxyprogesterone acetate tablets contain a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone acetate is also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.
INDICATIONS AND USAGE
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.
For prophylaxis of ophthalmia neonatorum due to
N. gonorrhoeae or C. trachomatis.
The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing
N. gonorrhoeae is not established.
For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.
1
INDICATIONS AND USAGE
E-Z-HD is indicated for use in double-contrast
radiographic examinations of the esophagus, stomach and duodenum to
help visualize the gastrointestinal (GI) tract in patients 12 years
and older.
E-Z-HD, a radiographic contrast agent, is indicated for use in double-contrast radiographic examinations of the esophagus, stomach and duodenum to visualize the gastrointestinal (GI) tract in patients 12 years and older (1)
1 INDICATIONS AND USAGE
Tramadol Hydrochloride Extended-Release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
Tramadol Hydrochloride Extended-Release is an opioid agonist indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. (
1)
1 INDICATIONS AND USAGE
Telmisartan is an angiotensin II receptor blocker (ARB) indicated for:
Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1)
1.1 Hypertension
Telmisartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Telmisartan tablets may be used alone or in combination with other antihypertensive agents [see Clinical Studies (14.1)].
Use of telmisartan and ACE inhibitor is not recommended [see Warnings and precautions (5.6)]
1 INDICATIONS AND USAGE
LEVEMIR is indicated to improve glycemic control in adults and children with diabetes mellitus.
Important Limitations of Use:
LEVEMIR is not recommended for the treatment of diabetic ketoacidosis. Intravenous rapid-acting or short-acting insulin is the preferred treatment for this condition.
LEVEMIR is a long-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. (1)
Important Limitations of Use:
Not recommended for treating diabetic ketoacidosis. Use intravenous, rapid-acting or short-acting insulin instead.
INDICATION AND USAGE
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Lidocaine patch 5% safely and effectively. See full prescribing information for Lidocaine patch 5%.
Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
1 INDICATIONS AND USAGE
Calcitonin salmon injection, synthetic, is a calcitonin, indicated for the following conditions:
Treatment of symptomatic Pagets disease of bone when alternative treatments are not suitable (1.1)
Treatment of hypercalcemia (1.2)
Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated (1.3)
Limitations of Use:
Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis (1.4, 5.3)
1.1	Treatment of Pagets Disease of Bone
Calcitonin salmon injection is indicated for the treatment of symptomatic Pagets disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients. Calcitonin salmon injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
1.2	Treatment of Hypercalcemia
Calcitonin salmon injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents.
1.3	Treatment of Postmenopausal Osteoporosis
Calcitonin salmon injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Calcitonin salmon injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
1.4	Important Limitations of Use
Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see Warnings and Precautions (5.3)].
1 INDICATIONS AND USAGE
ELCYS is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants
requiring total parenteral nutrition (TPN) and of adult and pediatric patients with severe liver disease who may have
impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete
profile of amino acids for protein synthesis.
ELCYS is a sulfur-containing amino acid indicated to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis. (1)
Indications and Usage
Bromfenac ophthalmic solution is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term (generally less than 10 days) management of acute pain. Hydrocodone bitartrate and ibuprofen tablets are not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis.
Indications and Usage
Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
NOTE: THE MANUFACTURER'S COMPLETE DRUG INFORMATION CAN BE FOUND AT THE FOLLOWING FDA SITE:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=ad2a0633-50fe-4180-b743-c1e49fc110c6
INDICATIONS AND USAGE
Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.
INDICATIONS AND USAGE
Renal, Cardiac, and Hepatic Transplant
Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids.
Mycophenolate mofetil intravenous is an alternative dosage form to mycophenolate mofetil capsules, tablets and oral suspension. Mycophenolate mofetil intravenous should be administered within 24 hours following transplantation. Mycophenolate mofetil intravenous can be administered for up to 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication.
1 INDICATIONS & USAGE
Aripiprazole oral tablets are indicated for the treatment of:
Schizophrenia [seeClinical Studies (14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (14.1)
1 INDICATIONS AND USAGE
Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset
seizures in adults and as monotherapy in the treatment of partial-onset
seizures in pediatric patients aged 4 years and above and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset
seizures.
Oxcarbazepine tablets are indicated for:
Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures
Pediatrics:
oMonotherapy in the treatment of partial-onset
seizures in children 4 to 16 years
oAdjunctive therapy in the treatment of partial-onset
seizures in children 2 to 16 years (1)
1
INDICATIONS AND USAGE
PYLERAis a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline,- a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole,for the treatment of patients with Helicobacter pylori infection andduodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. (1.1)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA and other antibacterial drugs, PYLERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.2)
1.1
Eradication of
Helicobacter pylori
in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease
PYLERA in combination with omeprazole are indicated for the treatment of patients with
Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
The eradication of Helicobacter pylori
has been shown to reduce the risk of duodenal ulcer recurrence.
1.2
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA and other antibacterial drugs, PYLERA should be used to treat only indicated 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.
1 INDICATIONS AND USAGE
ORFADIN
is indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
ORFADIN is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. (
1)
INDICATIONS AND USAGE
Naftifine Hydrochloride Gel USP, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans1 and Epidermophyton floccosum.1
1Efficacy for this organism in this organ system was studied in fewer than 10 infections.
1. Indications and Usage
1.1 Respiratory Tract Infections
Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.
1.2 Otitis Media
Cephalexin capsules are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis.
1.3 Skin and Skin Structure Infections
Cephalexin capsules are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.
1.4 Bone Infections
Cephalexin capsules are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.
1.5 Genitourinary Tract Infections
Cephalexin capsules are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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.
10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.
10% Calcium Chloride Injection, USP is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels.
1 INDICATIONS AND USAGE
Tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)].
Tizanidine tablets are a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important. (1)
1 INDICATIONS AND USAGE
Atomoxetine hydrochloride 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 hydrochloride capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
The efficacy of atomoxetine hydrochloride capsules was established in six clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18) and two 10-week trials in adults [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 2or 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 6months: 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 least 6 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 hydrochloride 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.