um-ids/dailymed-annotations huggingface dataset:
INDICATIONSANDUSAGE
Aminocaproic acid tablets, USP is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usualIy a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.)
1 INDICATIONS AND USAGE
Voriconazole for injection is an azole antifungal indicated for use in the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with:
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue Candida infections (1.2)
Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.3)
1.1 Invasive Aspergillosis
Voriconazole for injection is indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) 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) and Microbiology (12.4)].
1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections
Voriconazole for injection is indicated in adult and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) 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) and Microbiology (12.4)].
1.3 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 adult and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) intolerant of, or refractory to, other therapy [see Clinical Studies (14.3) and Microbiology (12.4)].
1.4 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.
Additional pediatric use information is approved for PF PRISM C.V.'s VFEND (voriconazole) for injection. However, due to PF PRISM C.V.'s marketing exclusivity rights, this drug product is not labeled with that information.
INDICATIONS AND USAGE
Phentermine hydrochloride is indicated as a short-term (a few
weeks) adjunct in a regimen of weight reduction based on exercise, behavioral
modification and caloric restriction in the management of exogenous obesity for
patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g.,
hypertension, diabetes, hyperlipidemia).
Below is a chart of Body Mass Index (BMI) based on various heights and
weights.
BMI is calculated by taking the patient's weight, in kilograms (kg), divided
by the patient's height, in meters (m), squared. Metric conversions are as
follows: pounds
2.2 = kg; inches
0.0254 = meters.
The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible
risk factors inherent in their use such as those described below.
image of table
1. INDICATIONS AND USAGE
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). (
1)
Indications and Usage:
A stable thixotropic fluoride treatment gel used to help prevent dental decay.
For Professional Use Only. This product is not intended for home or unsupervised use.
1 INDICATIONS AND USAGE
Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Limitation of Use
Carisoprodol Tablets 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 Tablet is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (1)
Limitation of Use
Should only be used for acute treatment periods up to two or three weeks (1)
1 INDICATIONS AND USAGE
Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:
Fludeoxyglucose F18 Injection
is indicated for
positron emission tomography (PET) imaging in the following settings:
Oncology: For assessment of abnormal glucose
metabolism to assist in the evaluation of malignancy in patients with known or
suspected abnormalities found by other testing modalities, or in patients with
an existing diagnosis of cancer.
Cardiology: For the identification of left ventricular
myocardium with residual glucose metabolism and reversible loss of systolic
function in patients with coronary artery disease and left ventricular
dysfunction, when used together with myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal glucose metabolism associated with
foci of epileptic seizures (
1).
1.1 Oncology
For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1.2 Cardiology
For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3 Neurology
For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Acute Pain in Adult Patients
Ketorolac tromethamine is indicated for the short-term (5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine injection, and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see
WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION
, and
ADVERSE REACTIONS
). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
1. INDICATIONS AND USAGE
Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablet are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
1.3 Limitations of Use
Pravastatin sodium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (
Fredrickson Types I and V).
INDICATIONS AND USAGE
Diazoxide Oral Suspension, USP is useful in the management of hypoglycemia due to hyperinsulinism associated with the following conditions:
Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy.
Infants and Children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis. Diazoxide Oral Suspension, USP may be used preoperatively as a temporary measure, and postoperatively, if hypoglycemia persists.
Diazoxide should be used only after a diagnosis of hypoglycemia due to one of the above conditions has been definitely established. When other specific medical therapy or surgical management either has been unsuccessful or is not feasible, treatment with diazoxide should be considered.
INDICATIONS AND USAGE
Leucovorin Calcium, USPrescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin Calcium, USPis also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.
Leucovorin Calcium, USPis indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible.
Leucovorin Calcium, USP is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.
1 INDICATIONS AND USAGE
Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Limitation of Use
Carisoprodol 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 is 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)
Carisoprodol Tablets are indicated for the relief of discomfort associatedwith acute, painful musculoskeletal conditions. (1)
Important Limitations: Should only be used for acute treatment periods up to two or threeweeks (1)
Not recommended in pediatric patients less than 16 years of age (8.4)
1 INDICATIONS AND USAGE
Adults
Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)].
Additional information is approved for Viatris Specialty LLC's REVATIO (sildenafil) product. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.
Adults
Sildenafil for oral suspension is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening. (1)
INDICATIONS & USAGE
Pyridostigmine Bromide Oral Solution, USPis useful in the treatment of myasthenia gravis.
INDICATIONS AND USAGE
Triamcinolone Acetonide Ointment, USP 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Mirtazapine Tablets are indicated for the treatment of major depressive disorder (MDD) in adults
[see Clinical Studies (14)].
Mirtazapine Tablets is indicated for the treatment of major depressive disorder (MDD) in adults. (1)
1. INDICATIONS AND USAGE
Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.
Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)].
Bicalutamide tablets 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. (1)
Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. (1)
1 INDICATIONS AND USAGE
Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older.
Hydrocodone bitartrate and homatropine methylbromide is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in adult patients 18 years of age and older. (1)
Limitations of Use (1)
Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
Limitations of Use:
Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)].
Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)].
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses
[see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
1 INDICATIONS AND USAGE
ZETONNA is a corticosteroid indicated for:
treatment of symptoms associated with seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. (1.1)
Treatment of symptoms associated with perennial allergic rhinitis in adult and pediatric patients 12 years of age and older. (1.1)
1.1 Treatment of Seasonal Allergic Rhinitis
ZETONNA (ciclesonide) is indicated for the treatment of symptoms associated with seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.
1.2 Treatment of Perennial Allergic Rhinitis
ZETONNA (ciclesonide) is indicated for the treatment of symptoms associated with perennial allergic rhinitis in adult and pediatric patients 12 years of age and older.
INDICATIONS AND USAGE: BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).
1	INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets are indicated for the 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, are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (
1)
1	INDICATIONS AND USAGE
Phenytoin Infatabs are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin Infatabs are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. (1)
INDICATIONS & USAGE:
Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug- susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months.* 4 )
(Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of such therapy.)
(In patients with concomitant HIV infection, the physician should be aware of current recommendation of CDC. It is possible these patients may require a longer course of treatment).
It is also indicated after treatment failure with other primary drugs in any form of active tuberculosis.
Pyrazinamide should only be used in conjunction with other effective antituberculous agents.
*See recommendations of Center for Disease Control (CDC) and American Thoracic Society for complete regimen and dosage recommendations.4
1 INDICATIONS AND USAGE
Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.
Amlodipine besylate tablets, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
Hypertension (1.1)
Coronary Artery Disease (1.2)
Chronic Stable Angina
Vasospastic Angina (Prinzmetals or Variant Angina)
1.1 Hypertension
Amlodipine besylate tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
1.2 Coronary Artery Disease (CAD)
Chronic Stable Angina
Amlodipine besylate tablets, USP are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablets, USP may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetals or Variant Angina)
Amlodipine besylate tablets, USP are indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate tablets, USP may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CAD
In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets, USP are indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.
INDICATIONS AND USAGE
Ofloxacin otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus.
Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus.
Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus,and Streptococcus pneumoniae.
INDICATIONS AND USAGEPromethazine hydrochloride tablets are useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and
angioedema.
Amelioration of allergic reactions to blood or plasma.
Dermographism.
Anaphylactic reactions, as adjunctive therapy to epinephrine and other
standard measures, after the acute manifestations have been controlled.
Preoperative, postoperative, or obstetric sedation.
Prevention and control of nausea and vomiting associated with certain types
of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of
postoperative pain.
Sedation in both children and adults, as well as relief of apprehension and
production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
1 INDICATIONS AND USAGE
Escitalopram oxalateis a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years
(1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults
(1.2)
1.1 Major Depressive Disorder
Escitalopram tabletsare indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age
[see
Clinical Studies (14.1)]
.
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram tabletsare indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults
[see
Clinical Studies (14.2)]
.
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
INDICATIONS AND USAGE
Monotherapy EpilepsyTopiramate tablets are indicated as initial monotherapy in
patients 10 years of age and older with partial onset or primary generalized
tonic-clonic seizures.
Effectiveness was demonstrated in a controlled trial in patients with
epilepsy who had no more than 2 seizures in the 3 months prior to enrollment.
Safety and effectiveness in patients who were converted to monotherapy from a
previous regimen of other anticonvulsant drugs have not been established in
controlled trials.
Adjunctive Therapy EpilepsyTopiramate tablets are indicated as adjunctive therapy for adults
and pediatric patients ages 2to16 years 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.