um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
INDICATIONS AND USAGE
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus.
As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Morphine sulfate tablets are indicated for the management of acute and chronic 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 and Precautions (5.1)]
, reserve morphine sulfate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
1 INDICATIONS AND USAGE
Celecoxib capsules are indicated
Celecoxib capsules are a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)
1.1 Osteoarthritis
For the management of the signs and symptoms of OA [see Clinical Studies (14.1)]
1.2 Rheumatoid Arthritis
For the management of the signs and symptoms of RA [see Clinical Studies (14.2)]
1.3 Juvenile Rheumatoid Arthritis
For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)]
1.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS [see Clinical Studies (14.4)]
1.5 Acute Pain
For the management of acute pain in adults [see Clinical Studies (14.5)]
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see Clinical Studies (14.5)]
INDICATIONS & USAGE
Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.
1 INDICATIONS AND USAGE
PROAIR RESPICLICK is a beta2-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1)
Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2)
1.1
Bronchospasm
PROAIR RESPICLICK is indicated for the treatment or prevention of bronchospasm in patients 4years of age and older with reversible obstructive airway disease.
1.2
Exercise-Induced Bronchospasm
PROAIR RESPICLICK is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
1 INDICATIONS AND USAGE
Hydromorphone hydrochloride tablets 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 and Precautions (
5.2
)
], reservehydromorphone hydrochloride tablets
for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
1 INDICATIONS AND USAGE
Topiramate tablets are indicated for:
Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (
1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older (
1.2)
Preventive treatment of migraine in patients 12 years of age and older (
1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.
1.3 Migraine
Topiramate tablets are indicated for the preventive treatment of migraine in patients 12 years of age and older.
1 INDICATIONS AND USAGE
Edluar (zolpidem tartrate) sublingual tablet is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. The clinical trials performed with Zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment [see Clinical Studies (14)].
Edluar (zolpidem tartrate) sublingual tablet is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. (1)
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 two 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 two days. (See
DOSAGE AND ADMINISTRATION section.)
1 INDICATIONS AND USAGE
Olmesartan Medoxomil Tablets are 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 Program's 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 Tablets are 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
Calcipotriene foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older.
Calcipotriene foam, is a vitamin D analog indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older. (1)
1	INDICATIONS AND USAGE
ISENTRESS is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated:
In combination with other antiretroviral agents for the treatment of HIV-1 infection (1).
The safety and efficacy of ISENTRESS have not been established in children less than 2 years of age (1.2).
1.1	Adults
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.
This indication is based on analyses of plasma HIV-1 RNA levels in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults through 96 weeks and one was conducted in treatment-nave adults through 156 weeks.
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies (14)].
1.2	Pediatrics
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adolescents 2 years of age and older and weighing at least 10 kg [see Use in Specific Populations (8.4)].
This indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24-weeks in a multi-center, open-label, noncomparative study in HIV-1 infected children and adolescents 2 to 18 years of age [see Clinical Studies (14.3)].
The safety and efficacy of ISENTRESS have not been established in children less than 2 years of age.
INDICATIONS AND USAGE
Edema
Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.
Hypertension
Furosemide tablets may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.
1 INDICATIONS AND USAGE
Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the:
Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (
1.1)
Treatment of adults with mycosis fungoides (
1.1)
Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (
1.1)
Treatment of adults with rheumatoid arthritis (
1.2)
Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (
1.3)
Treatment of adults with severe psoriasis (
1.4)
1.1	Neoplastic Diseases
Methotrexate tablets are indicated for the:
treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen.
treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen.
1.2
Rheumatoid Arthritis
Methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis.
1.3	Polyarticular Juvenile Idiopathic Arthritis
Methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA).
1.4
Psoriasis
Methotrexate tablets are indicated for the treatment of adults with severe psoriasis.
1 INDICATIONS AND USAGE
Methylphenidate hydrochloride oral solution is indicated for the treatment of:
Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older
Narcolepsy
Methylphenidate hydrochloride oral solution is a central nervous system (CNS) stimulant indicated for the treatment of:
Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older (1)
Narcolepsy
1 INDICATIONS AND USAGE
Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied.
Sevelamer hydrochloride tablets are a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. (1)
1 INDICATIONSAND USAGE
Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
Efavirenz, lamivudine and tenofovir disoproxil fumarate tablets are three-drug combination of efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and lamivudine (3TC) and tenofovir disoproxil fumarate (TDF), both nucleo(t)side reverse transcriptase inhibitors and are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg. (1)
1 INDICATIONS AND USAGE
Voriconazole tablets are 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 tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive apergillosis (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 tablets are 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 tablets are 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 tablets are 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
To reduce the development of drugresistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, and amoxicillin and clavulanate potassium for oral suspension should be used only to treat 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.
Amoxicillin and clavulanate potassium tablets, and amoxicillin and clavulanate potassium for oral suspension are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
Amoxicillin and clavulanate potassium is a combination penicillin-class antibacterial and betalactamase inhibitor indicated for treatment of the following:
Lower respiratory tract infections
(1.1)
Acute bacterial otitis media
(1.2)
Sinusitis
(1.3)
Skin and skin structure infections
(1.4)
Urinary tract infections
(1.5)
1.1Lower Respiratory Tract Infections
Caused by betalactamaseproducing isolates of Haemophilusinfluenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
Caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
Caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
Caused by betalactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
Caused by betalactamaseproducing isolates of E. coli, Klebsiellaspecies, and Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets, and amoxicillin and clavulanate potassium for oral suspension should not be used.
1 INDICATIONS AND USAGE
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of:
Left ventricular dysfunction following myocardial infarction in clinically stable patients(1.2)
Hypertension(1.3)
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol tablets, USP are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of 40% (with or without symptomatic heart failure) [see
Clinical Studies (14.2)
].
1.3 Hypertension
Carvedilol tablets, USP is indicated for the management of essential hypertension [see
Clinical Studies (14.3)
]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see
Drug Interactions (7.2)
].
1 INDICATIONS AND USAGE
JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
JYNARQUE is a selective vasopressin V2-receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) (1)
1 INDICATIONS AND USAGE
Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia.
Phenylephrine hydrochloride injection is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia. (
1)
1 INDICATIONS AND USAGE
XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of:
Chronic sialorrhea in patients 2 years of age and older (1.1)
Upper limb spasticity in adults (1.2)
Upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy (1.2)
Cervical dystonia in adults (1.3)
Blepharospasm in adults (1.4)
Temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity in adults (1.5)
1.1	Chronic Sialorrhea
XEOMIN is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older.
1.2	Upper Limb Spasticity
Upper Limb Spasticity in Adult Patients
XEOMIN is indicated for the treatment of upper limb spasticity in adult patients.
Upper Limb Spasticity in Pediatric Patients, Excluding Spasticity Caused by Cerebral Palsy
XEOMIN is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy.
1.3	Cervical Dystonia
XEOMIN is indicated for the treatment of cervical dystonia in adult patients.
1.4	Blepharospasm
XEOMIN is indicated for the treatment of blepharospasm in adult patients.
1.5	Glabellar Lines
XEOMIN is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.