um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Ketamine Hydrochloride Injection is indicated:
as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
for the induction of anesthesia prior to the administration of other general anesthetic agents.
as a supplement to other anesthetic agents.
Ketamine Hydrochloride Injection is a general anesthetic indicated:
as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation (1)
for the induction of anesthesia prior to the administration of other general anesthetic agents (1)
as a supplement to other anesthetic agents (1).
Lisinopril and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 lisinopril and hydrochlorothiazide.
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 1 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 (eg., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).
In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS).
In considering the use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See WARNINGS, Lisinopril).
1 INDICATIONS AND USAGE
Sumatriptan injection 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, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks.
Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks.
Sumatriptan is 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 of migraine or cluster headache attacks. (1)
INDICATIONS AND USAGE
Fluphenazine HCl is indicated in the management of manifestations of psychotic disorders.
Fluphenazine HCl has not been shown effective in the management of behavioral complications in patients with mental retardation.
Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.
Diltiazem hydrochloride extended-release capsules (once-a-day dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
1 INDICATIONS AND USAGE
Ribavirin is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients coinfected with HIV (1)
Ribavirin tablets in combination with peginterferon alfa-2a are indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
The following points should be considered when initiating ribavirin tablets combination therapy with peginterferon alfa-2a:
This indication is based on
clinical trials of combination therapy in patients with CHC and
compensated liver disease, some of whom had histological evidence of
cirrhosis (Child-Pugh class A), and in adult patients with clinically
stable HIV disease and CD4 count greater than 100 cells/mm3.
This indication is based on
achieving undetectable HCV RNA after treatment for 24 or 48 weeks, based
on HCV genotype, and maintaining a Sustained Virologic Response (SVR) 24
weeks after the last dose.
Safety and efficacy data are
not available for treatment longer than 48 weeks.
The safety and efficacy of
ribavirin tablets and peginterferon alfa-2a therapy have not been
established in liver or other organ transplant recipients, patients with
decompensated liver disease, or previous non-responders to interferon
therapy.
The safety and efficacy of
ribavirin tablets therapy for the treatment of adenovirus, RSV,
parainfluenza or influenza infections have not been established. Ribavirin
tablets should not be used for these indications. Ribavirin for inhalation
has a separate package insert, which should be consulted if ribavirin
inhalation therapy is being considered.
1 INDICATIONS AND USAGE
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults.
Monobasic Sodium Phosphate and Dibasic Sodium Phosphate Tablets are an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.
1 INDICATIONS AND USAGE
Eplerenone tablets are an aldosterone antagonist indicated for:
Improving survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. (1.1)
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. (1.2)
1.1	Heart Failure Post-Myocardial Infarction
Eplerenone tablets are indicated to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction ( 40%) (HFrEF) after an acute myocardial infarction (MI).
1.2 Hypertension
Eplerenone tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and MI. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Control of high blood pressure should be part of comprehensive CV 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 CV 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 CV outcome benefit has been a reduction in the risk of stroke, but reductions in MI and CV mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased CV 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.
Eplerenone tablets may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation.
1
INDICATIONS AND USAGE
Ioflupane I 123 Injection is indicated as an adjunct to other diagnostic evaluationsfor striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with:
suspected Parkinsonian syndromes (PS) or
suspected dementia with Lewy bodies (DLB).
Ioflupane I 123 Injection is a radioactive diagnostic agent indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imagingin adult patients with:
suspected Parkinsonian syndromes (PS) or
suspected dementia with Lewy bodies (DLB). (1)
USES:
ACNE AND SHAVING BUMPS.
INDICATIONS AND USAGE
Fluocinolone Acetonide Cream, USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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.
Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.
Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.)
Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.)
Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.
Psittacosis or ornithosis caused by Chlamydia Psittaci.
Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum.
Granuloma inquinale caused by Calymmatobacterium granulomatis.
Relapsing fever caused by Borrelia sp.
Bartonellosis caused by Bartonella bacilliformis.
Chancroid caused by Hemophilus ducreyi.
Tularemia caused by Francisella tularensis.
Plaque caused by Yersinia pestis.
Cholera caused by Vibrio cholerae.
Brucellosis caused by Brucella species (tetracycline may be used in conjunction with an aminoglycoside).
Infections due to Campylobacter fetus.
As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica.
Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc.
Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigella sp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp.
In severe acne, adjunctive therapy with tetracycline may be useful.
When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:
syphilis and yaws caused by Treponema pallidum and pertenue, respectively,
Vincents infection caused by Fusobacterium fusiforme,
infections caused by Neisseria gonorrhoeae,
anthrax caused by Bacillus anthracis,
infections due to Listeria monocytogenes,
actinomycosis caused by Actinomyces species,
infections due to Clostridium species.
1 INDICATIONS AND USAGE
Topiramate tablets are indicated for:
Epilepsy: initial monotherapy in patients 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients 2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2)
Prophylaxis of migraine in patients 12 years of age and older (1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
1.3 Migraine
Topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache.
1 INDICATIONS AND USAGE
Topiramate is indicated for:
Epilepsy: initial monotherapy in patients 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients 2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2)
Prophylaxis of migraine in patients 12 years of age and older (1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of age with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
1.3 Migraine
Topiramate tablets are indicated for patients 12 years of age and older for the prophylaxis of migraine headache.
INDICATIONS AND USAGE
Renal, Cardiac, and Hepatic Transplant
Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids.
INDICATIONS AND ADVANTAGES
Tricitrates oral solution is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders. This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urine pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in recommended dosage. It is highlypalatable, pleasant tasting, and tolerable, even when administered for long periods. Potassium citrate and sodium citrate do not neutralize the gastric juice or disturb digestion.
1 INDICATIONS & USAGE
Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1) Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2)
1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis
Pantoprazole sodium for injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE).
Safety and efficacy of pantoprazole sodium for injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.
1.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome
Pantoprazole sodium for injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
INDICATIONS & USAGE
Fomepizole is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis (seeDOSAGE AND ADMINISTRATION).
Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
Limitations of Use
Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.
Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].
Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.
1 INDICATIONS AND USAGE
Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
Ferrlecit is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. (1)
INDICATIONS AND USAGE
CORTEF Tablets are indicated in the following conditions.
1. Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)
Congenital adrenal hyperplasia
Non suppurative thyroiditis
Hypercalcemia associated with cancer
2. Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Psoriatic arthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Post-traumatic osteoarthritis
Synovitis of osteoarthritis
Epicondylitis
3. Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
4. Dermatologic Diseases
Pemphigus
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Exfoliative dermatitis
Mycosis fungoides
Severe psoriasis
Severe seborrheic dermatitis
5. Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Serum sickness
Bronchial asthma
Contact dermatitis
Atopic dermatitis
Drug hypersensitivity reactions
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic conjunctivitis
Keratitis
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Iritis and iridocyclitis
Chorioretinitis
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Optic neuritis
Sympathetic ophthalmia
7. Respiratory Diseases
Symptomatic sarcoidosis
Loeffler's syndrome not manageable by other means
Berylliosis
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis
8. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9. Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10. Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
11. Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
12. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
Trichinosis with neurologic or myocardial involvement