um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, 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. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets.
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.
It may be used alone or in combination with other antihypertensive agents.
Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adult and pediatric patients six years of age and older, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1).
1 INDICATIONS AND USAGE
Pilocarpine hydrochloride ophthalmic solution is indicated for the:
Pilocarpine hydrochloride ophthalmic solution is a muscarinic cholinergic agonist indicated for:
The reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. (1.1)
The management of acute angle-closure glaucoma. (1.2)
The prevention of postoperative elevated IOP associated with laser surgery. (1.3)
The induction of miosis. (1.4)
1.1 Reduction of Elevated Intraocular Pressure
(IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension
1.2
Management of Acute Angle-Closure
Glaucoma
1.3
Prevention of Postoperative Elevated IOP
Associated with Laser Surgery
1.4
Induction of Miosis
1 INDICATIONS AND USAGE
Lacosamide oral solution is indicated for:
Treatment of partial-onset seizures in patients 4 years of age and older (1.1)
1.1 Partial-Onset Seizures
Lacosamide oral solution isindicated for the treatment of partial-onset seizuresin patients 4 years of age and older.
Additional pediatric use information is approved for UCB, Inc.s VIMPAT (lacosamide) oral solution. However, due to UCB, Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see CLINICAL STUDIES (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
1 INDICATIONS AND USAGE
LATUDA is indicated for:
Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia
[see Clinical Studies (
14.1)]
.
Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression)
[see Clinical Studies (
14.2)]
.
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression)
[see Clinical Studies (
14.2)]
.
LATUDA is an atypical antipsychotic indicated for the treatment of:
Schizophrenia in adults and adolescents (13 to 17 years) (
1,
14.1)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and
pediatric patients (10 to 17 years) as monotherapy (
1,
14.2)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate (
1,
14.2)
1 INDICATIONS AND USAGE
Voriconazole for Injection is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue Candida infections (1.2)
Esophageal candidiasis (1.3)
Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4)
1.1 Invasive Aspergillosis
Voriconazole for Injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus
[see Clinical Studies (14.1
, 14.5) and Microbiology (12.4)].
1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections
Voriconazole for Injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2
, 14.5) and Microbiology (12.4)].
1.3 Esophageal Candidiasis
Voriconazole for Injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients 2 years of age and older [see Clinical Studies (14.3
, 14.5) and Microbiology (12.4)].
1.4 Scedosporiosis and Fusariosis
Voriconazole for Injection is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see Clinical Studies (14.4) and Microbiology (12.4)].
1.5 Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules USP is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1)
Generalized Anxiety Disorder (GAD) (1)
Diabetic Peripheral Neuropathic Pain (DPNP) (1)
Chronic Musculoskeletal Pain (1)
Duloxetine is indicated for the treatment of:
Major Depressive Disorder [see Clinical Studies (14.1)]
Generalized Anxiety Disorder [see Clinical Studies (14.2)]
Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]
Chronic Musculoskeletal Pain [see
Clinical Studies (14.5)]
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diclofenac is indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
1 INDICATIONS AND USAGE
Risperidone is an atypical antipsychotic indicated for:
Treatment of schizophrenia (
1.1)
As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar
Disorder (
1.2)
Treatment of irritability associated with autistic disorder (
1.3)
1.1 Schizophrenia
Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults
[see Clinical Studies (
14.1)]
.
1.2 Bipolar Mania
Monotherapy
Risperidone tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years)
[see Clinical Studies (
14.2)]
.
Adjunctive Therapy
Risperidone tablets adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults
[see Clinical Studies (
14.3)].
1.3 Irritability Associated with Autistic Disorder
Risperidone tablets are indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years)
[see Clinical Studies (
14.4)].
INDICATIONS AND USAGE
CIPRO HC OTIC is indicated for the
treatment of acute otitis externa in adult and pediatric patients, one year and
older, due to susceptible strains of Pseudomonas aeruginosa, Staphylococcus
aureus, and Proteus mirabilis.
INDICATIONS AND USAGE
Hypertension
Metoprolol tartrate tablets, USPare indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets, USPare indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate tablets, USPare indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol can be initiated as soon as the patient's clinical condition allows (see
DOSAGE AND ADMINISTRATION,
CONTRAINDICATIONS,
and
WARNINGS
). Alternatively, treatment can begin within 3 to 10 days of the acute event (see
DOSAGE AND ADMINISTRATION
).
INDICATIONS & USAGE
Orphenadrine Citrate, Aspirin and Caffeine 25 mg/ 385 mg/ 30 mg Tablets are indicated in:
Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders.
The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine Citrate, Aspirin and Caffeine Tablets do not directly relax tense muscles in man.
INDICATIONS & USAGE
Glimepiride Tablet USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (See DOSAGE AND ADMINISTRATION section).
1	INDICATIONS AND USAGE
Posaconazole delayed-release tablets are an azole antifungal agent indicated as follows:
Posaconazole delayed-release tablets is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such ashematopoietic stem cell transplant (HSCT) recipients with graftversus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2)
o Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older
1.2 Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. [see Clinical Studies (14.2)] as follows:
Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older
Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.s NOXAFIL (posaconazole) delayed-release tablets. However, due to Merck Sharp & Dohme Corp.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
INDICATIONS AND USAGE
Disulfiram is an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage.
Disulfiram is not a cure for alcoholism. When used alone, without proper motivation and supportive therapy, it is unlikely that it will have any substantive effect on the drinking pattern of the chronic alcoholic.
1 INDICATIONS AND USAGE
Limitation of Use
Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodoltablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [
see
Dosage and Administration (2)
].
Carisoprodol tablets are a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults (
1)
Limitations of Use:
Should only be used for acute treatment periods up to two or three weeks (
1)
1 INDICATIONS AND USAGE
Epinastine HCl Ophthalmic Solution is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.
Epinastine HCl ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.
1 INDICATIONS AND USAGE
Fenofibrate tablet USP is a peroxisome proliferator receptor alpha (PPAR) activator indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and
Apo B, and to increase HDL-C in adult patients with primary
hypercholesterolemia or mixed dyslipidemia (1.1).
For treatment of adult patients with
severe hypertriglyceridemia (1.2).
Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablet USP is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablet USP is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablet USP was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see WARNINGS AND PRECAUTIONS (5.1)].
INDICATIONS AND USAGE
This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.
1 INDICATIONS AND USAGE
LASTACAFT
is anH1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.
LASTACAFTis an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. (1)
1 INDICATIONS AND USAGE
ASCOMP with Codeine is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate.
ASCOMP with Codeine is a combination of butalbital, a barbiturate, aspirin, a nonsteroidal anti-inflammatory drug, caffeine, a methylxanthine, and codeine phosphate, an opioid agonist, and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesics and alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve ASCOMP with Codeine for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) (5.1):
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve ASCOMP with Codeine for use in patients for whom alternative treatment options (e.g., non-opioid, non-barbiturate 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
Metolazone tablets are indicated for the treatment of salt and water retention including:
edema accompanying congestive heart failure;
edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.
Metolazone tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if MYKROX Tablets are to be substituted for ZAROXOLYN and other formulations of metolazone in the treatment of hypertension.
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 evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS). 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 be appropriate.
INDICATIONS & USAGE SECTION
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, Amoxicillin Powder for Oral Suspension, 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 Powder for Oral Suspension, USP is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
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 urethralinfections in males and females)
- due to Neisseria gonorrhoeae.
Because of high rates of amoxicillin resistance, Amoxicillin Powder for Oral Suspension, USP is not recommended for empiric treatment of gonorrhea. Amoxicillin Powder for Oral Suspension, 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 Powder for Oral Suspension, USP, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.7 Dual therapy for H. pyloriwith lansoprazole:
Amoxicillin Powder for Oral Suspension, USP, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) 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.