um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Clopidogrel tablets are a P2Y
12 platelet inhibitor indicated for:
Acute coronary syndrome
For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], clopidogrel tablets have been shown to reduce the rate of myocardial infarction (MI) and stroke. (
1.1)
For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke. (
1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke. (
1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel tablets should be administered in conjunction with aspirin. Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel tablets should be administered in conjunction with aspirin.
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin.Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
.
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets are indicated to reduce the rate of MI and stroke.
1 INDICATIONS AND USAGE
Pregabalin capsules are indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients1 Month of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Pregabalin is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1)
Postherpetic neuralgia (PHN) (1)
Adjunctive therapy for the treatment of partial-onset seizures in patients1 month of age and older (1)
Fibromyalgia (1)
Neuropathic pain associated with spinal cord injury (1)
1 INDICATIONS AND USAGE
Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults for 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 has not been studied for treatment of established nausea and vomiting.
1 INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsules area 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 areindicated 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 may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules 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 areindicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole magnesium delayed-release capsules areindicated 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 delayed-release capsules plus amoxicillin and clarithromycin): esomeprazole magnesium delayed-release capsules, 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 areindicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
INDICATIONS AND USAGE
Hypertension:
Captopril tablets, USP are indicated for the treatment of hypertension.
In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see
WARNINGS
).
Captopril tablets may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations.
Captopril tablets are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.
Heart Failure: Captopril tablets are indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment.
Left Ventricular Dysfunction After Myocardial Infarction
: Captopril tablets are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction
40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients.
Diabetic Nephropathy
: Captopril tablets are indicated for the treatment of diabetic nephropathy (proteinuria > 500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril tablets decrease the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis).
In considering use of captopril tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see
WARNINGS: Head and Neck Angioedema and Intestinal Angioedema
).
INDICATIONS AND USAGE
Severe Recalcitrant Nodular Acne
Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. Severe, by definition,2 means many as opposed to few or several nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, isotretinoin capsulesare indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see
Boxed CONTRAINDICATIONS AND WARNINGS
).
A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see
WARNINGS, Skeletal, Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure
).
1 INDICATIONS AND USAGE
Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
Nitroglycerin sublingual tablets are a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
1.1 Infections of the Ear, Nose, and Throat
Amoxicillin tablets are indicated in the treatment of infections due to susceptible (ONLY -lactamase-negative) isolates of Streptococcus species. (- and -hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
1.2 Infections of the Genitourinary Tract
Amoxicillin tablets 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 tablets are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of Streptococcus spp. (- and -hemolytic isolates only), Staphylococcus spp., or E. coli.
1.4 Infections of the Lower Respiratory Tract
Amoxicillin tablets 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 tablets, 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.
Dual therapy for H. pylori with lansoprazole:
Amoxicillin tablets, 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.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets and other antibacterial drugs, amoxicillin tablets 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 AND USAGE
Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics).
Fluphenazine Decanoate Injection has not been shown effective in the management of behavioral complications in patients with mental retardation.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Etodolac extended-release tablets are indicated:
* For relief of signs and symptoms of juvenile arthritis
* For relief of the signs and symptoms of rheumatoid arthritis
* For relief of the signs and symptoms of osteoarthritis
INDICATIONS AND USAGE
FOSAMAX is indicated for:
Treatment and prevention of osteoporosis in postmenopausal women
For the treatment of osteoporosis, FOSAMAX increases bone mass and reduces
the incidence of fractures, including those of the hip and spine (vertebral
compression fractures). Osteoporosis may be confirmed by the finding of low bone
mass (for example, at least 2standard deviations below the premenopausal mean)
or by the presence or history of osteoporotic fracture. (See CLINICAL PHARMACOLOGY, Pharmacodynamics.)
For the prevention of osteoporosis, FOSAMAX may be considered in
postmenopausal women who are at risk of developing osteoporosis and for whom the
desired clinical outcome is to maintain bone mass and to reduce the risk of
future fracture.
Bone loss is particularly rapid in postmenopausal women
younger than age 60. Risk factors often associated with the development of
postmenopausal osteoporosis include early menopause; moderately low bone mass
(for example, at least 1 standard deviation below the mean for healthy young
adult women); thin body build; Caucasian or Asian race; and family history of
osteoporosis. The presence of such risk factors may be important when
considering the use of FOSAMAX for prevention of osteoporosis.
Treatment to increase bone mass in men with osteoporosis
Treatment of glucocorticoid-induced osteoporosis in men and women receiving
glucocorticoids in a daily dosage equivalent to 7.5mg or greater of prednisone
and who have low bone mineral density (see PRECAUTIONS,
Glucocorticoid-induced osteoporosis). Patients treated with glucocorticoids
should receive adequate amounts of calcium and vitamin D.
Treatment of Paget's disease of bone in men and women
Treatment is indicated in patients with Paget's disease of bone having
alkaline phosphatase at least two times the upper limit of normal, or those who
are symptomatic, or those at risk for future complications from their disease.
INDICATIONS AND USAGE
Flucytosine Capsules are indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.
Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.
Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.
Flucytosine Capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine Capsules (see
MICROBIOLOGY
).
1. INDICATIONS AND USAGE
Oxycodone Hydrochloride Oral Solution, USP is an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate.
INDICATIONS AND USAGE
Felbamate oral suspension, USP is not indicated as a first line antiepileptic treatment (see
Warnings
). Felbamate oral suspension is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.
If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
INDICATIONS AND USAGE
Ganite is indicated for the treatment of clearly symptomatic cancer-related hypercalcemia that has not responded to adequate hydration. In general, patients with a serum calcium (corrected for albumin) < 12 mg/dL would not be expected to be symptomatic. Mild or asymptomatic hypercalcemia may be treated with conservative measures (i.e., saline hydration, with or without diuretics). In the treatment of cancer-related hypercalcemia, it is important first to establish adequate hydration, preferably with intravenous saline, in order to increase the renal excretion of calcium and correct dehydration caused by hypercalcemia.
1 INDICATIONS AND USAGE
Phentermine hydrochloride, USP 37.5 mg is indicated as short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of Body Mass Index (BMI) based on various heights and weights.
BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine Hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (1)
The limited usefulness of agents of this class, including Phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1)
BMI Index
INDICATIONS AND USAGE
25% Dextrose Injection is indicated in the treatment of acute symptomatic episodes of hypoglycemia in the neonate or older infant to restore depressed blood glucose levels and control symptoms. Other drugs, such as epinephrine and glucagon, should be considered in patients unresponsive or intolerant to dextrose (glucose). Oral feeding of dextrose may be necessary in infants with frequently recurring hypoglycemic episodes or to prevent recurrences due to hyperinsulinemia.
25% Dextrose Injection also provides a minimal source of carbohydrate calories.
INDICATIONS AND USAGE
This product may be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps.
Along with appropriate analgesics, this product is indicated in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis.
This product is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome, acute enterocolitis and other functional gastrointestinal disorders.
INDICATIONS AND USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled.
The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days (see
DOSAGE AND ADMINISTRATION
section).
1 INDICATIONS AND USAGE
EPCLUSA is indicated for the treatment of adults and pediatric patients 6 years of age and older or weighing at least 17 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection
[see
Dosage and Administration (2.2,
2.3,
2.4) and
Clinical Studies (14)]
:
without cirrhosis or with compensated cirrhosis
with decompensated cirrhosis for use in combination with ribavirin.
EPCLUSA is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult and pediatric patients 6 years of age and older or weighing at least 17 kg with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection (
1):
without cirrhosis or with compensated cirrhosis
with decompensated cirrhosis for use in combination with ribavirin