um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE:
Dapiprazole hydrochloride ophthalmic solution is indicated in the treatment of iatrogenically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents. Dapiprazole hydrochloride ophthalmic solution is not indicated for the reduction of intraocular pressure or in the treatment of open angle glaucoma.
INDICATIONS AND USAGE
Fluconazole tabletsare indicated for the treatment of:
Vaginal candidiasis (vaginal yeast infections due to
Candida).
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relativelysmall numbers of patients, fluconazole tabletswere also effective for the treatment of
Candidaurinary tract infections, peritonitis, and systemic
Candidainfections including candidemia, disseminated candidiasis, and pneumonia.
Cryptococcal meningitis. Before prescribing fluconazole tabletsfor AIDS patients with
cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole tabletsto amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
1. INDICATIONS AND USAGE
Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
Donepezil hydrochloride tablets are an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers Disease
1 INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:
Lower Respiratory Tract Infections -caused by betalactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
Acute Bacterial Otitis Media -caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
Sinusitis -caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
Skin and Skin Structure Infections -caused by betalactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
Urinary Tract Infections -caused by betalactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium Tablets should not be used.
Usage
To reduce the development of drugresistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets should be used only to treat or prevent 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 are a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a betalactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: (1)
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium Tablets should not be used. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)
INDICATIONS AND USAGE
Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide
and loop diuretics.
INDICATIONS AND USAGE
Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.
INDICATIONS AND USAGE:
Sodium Chloride Injection, USP, 0.9% preparations are indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered.
Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing of intravenous catheters.
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
Cyclobenzaprine hydrochloride extended-release capsules are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion.
Limitations of Use:
Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.
Cyclobenzaprine hydrochloride extended-release capsules are muscle relaxant indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. (1)
Limitations of Use:
Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to 2 or 3 weeks) (1)
Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity or cerebral palsy (1)
1 INDICATIONS AND USAGE
BYNFEZIA Pen is a somatostatin analogue indicated for:
Reduction of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) [somatomedin C] in adult patients with acromegaly who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses (1.1)
Treatment of severe diarrhea/flushing episodes associated with metastatic carcinoid tumors in adult patients (1.2)
Treatment of profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas) in adult patients (1.3)
Limitations of Use:
In patients with acromegaly, the effect of BYNFEZIA Pen on improvement in clinical signs and symptoms, reduction in tumor size and rate of growth, has not been determined. (1.4)
In patients with carcinoid syndrome and VIPomas, the effect of BYNFEZIA Pen on size, rate of growth and development of metastases, has not been determined. (1.4)
1.1 Acromegaly
BYNFEZIA Pen is indicated to reduce blood levels of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) [somatomedin C] in adult patients with acromegaly who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.
1.2 Carcinoid Tumors
BYNFEZIA Pen is indicated for the treatment of adult patients with severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.
1.3 Vasoactive Intestinal Peptide Tumors (VIPomas)
BYNFEZIA Pen is indicated for the treatment of adult patients with the profuse watery diarrhea associated with VIP-secreting tumors.
1.4 Limitations of Use
In patients with acromegaly, the effect of BYNFEZIA Pen on improvement in clinical signs and symptoms, reduction in tumor size, and rate of growth has not been determined.
In patients with carcinoid syndrome and VIPomas, the effect of BYNFEZIA Pen on the tumor size, rate of growth and development of metastases has not been determined.
Indications and Usage
Benzonatate is indicated for the symptomatic relief of cough.
1 INDICATIONS AND USAGE
Sumatriptan tablets, USP are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, USP, reconsider the diagnosis of migraine before sumatriptan tablets, USP are administered to treat any subsequent attacks.
Sumatriptan tablets, USP are not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan tablets, USP have not been established for cluster headache.
Sumatriptan tablets, USPare a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. (1)
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)
INDICATIONS AND USAGE
Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see
WARNINGS
), reserve acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics)
Have not provided adequate analgesia, or are not expected to provide adequate analgesia,
Have not been tolerated, or are not expected to be tolerated.
1.	INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib.
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)
]
Celecoxib is 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 (OA)
Celecoxib is indicated for relief of the signs and symptoms of OA [see Clinical Studies (14.1)
]
1.2 Rheumatoid Arthritis (RA)
Celecoxib is indicated for relief of the signs and symptoms of RA [see Clinical Studies (14.2)
]
1.3
Juvenile Rheumatoid Arthritis (JRA)
Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)
]
1.4 Ankylosing Spondylitis (AS)
Celecoxib is indicated for the relief of signs and symptoms of AS [see Clinical Studies (14.4)
]
1.5 Acute Pain (AP)
Celecoxib is indicated for the management of AP in adults [see Clinical Studies (14.5)
]
1.6 Primary Dysmenorrhea (PD)
Celecoxib is indicated for the treatment of PD [see Clinical Studies (14.5)
]
1 INDICATIONS AND USAGE
Gabapentin tablets USP are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin tablets USP is indicated for:
Postherpetic neuralgia in adults (
1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (
1)
Uses
Scar management
Temporarily protects minor cuts, scrapes and burns
Temporarily relief of pain associated with minor cuts, scrapes and minor skin irritations
INDICATIONS AND USAGE
Essential hypertension, alone or as an adjunct.
INDICATIONS AND USAGE
Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions:
Addisonian (pernicious) anemia
Gastrointestinal pathology, dysfunction, or surgery,
including gluten enteropathy or sprue, small bowel bacteria overgrowth,
total or partial gastrectomy
Fish tapeworm infestation
Malignancy of pancreas or bowel
Folic acid deficiency
It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see
Drug Interactions
), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin.
Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.
Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).
1 INDICATIONS AND USAGE
Benazepril hydrochloride 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 mm Hg 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 thiazide diuretics.
Benazepril hydrochloride tablets are an angiotensin-converting enzyme (ACE) inhibitor 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. (1)
INDICATIONS AND USAGE
CALAN SR is 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 this drug.
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.
1 INDICATIONS AND USAGE
Donepezil hydrochloride tablets are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's disease.
Donepezil hydrochloride tablets are an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1)
1 INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration
[see
Clinical Studies (14)].
Zolpidem tartrate extended-release tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (
1)
1 INDICATIONS AND USAGE
Glimepiride Tablet USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see
Clinical Studies (
14.1)
].
Limitations of Use
Glimepiride should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Glimepiride Tablets USP are a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (
1).
Important Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (
1).
1 INDICATIONS AND USAGE
Lacosamide tablets are indicated for:
Treatment of partial-onset seizures in patients4 years
of age and older (1.1)
1.1 Partial-Onset Seizures
Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients4 years
of age and older.
Additional pediatric use information is approved for UCB, Inc.s VIMPAT (lacosamide) tablets. However, due to UCB, Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1
INDICATIONS AND USAGE
Calcium acetate, USP is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease(ESRD).
Calcium acetate, USP is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.(1)
1 INDICATIONS AND USAGE
Sumatriptan Injection, USP is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with Sumatriptan Injection, USP,reconsider the diagnosis beforeSumatriptan Injection, USPis administered to treat any subsequent attacks.
Sumatriptan Injection, USPis not indicated for the prevention of migraine or cluster headacheattacks.
Sumatriptan succinateis a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for:
Acute treatment of migraine with or without aura in adults (1)
Acute treatment of cluster headache in adults (1)
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been established. (1)
Not indicated for the prophylactic therapy ofmigraine or cluster headache attacks. (1)