um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
SINGULAIR is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 12months of age and older (1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older (1.3).
1.1 Asthma
SINGULAIR
Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Copyright
1998-2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved
is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12months of age and older.
1.2 Exercise-Induced Bronchoconstriction
SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
1.3 Allergic Rhinitis
SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
Indications and usage
Carefully consider the potential benefits and risks of Ibuprofen Tablets, USP and other treatment options before deciding to use Ibuprofen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Ibuprofen Tablets, USP are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain.
Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP in children have not been conducted.
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).
INDICATIONS AND USAGE:
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
1 INDICATIONS AND USAGE
1.1 Treatment of Active Duodenal Ulcer
Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Triple Therapy
Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.
Dual Therapy
Omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Among patients who fail therapy, omeprazole delayed-release capsules are with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4) and the clarithromycin prescribing information, Microbiology section].
1.3 Treatment of Active Benign Gastric Ulcer
Omeprazole delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.
1.4 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
Omeprazole delayed-release capsules are indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 2 years of age and older.
1.5 Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD
Pediatric Patients 2 Years of Age to Adults
Omeprazole delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD that has been diagnosed by endoscopy in patients 2 years of age and older.
The efficacy of omeprazole delayed-release capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered.
1.6 Maintenance of Healing of EE Due to Acid-Mediated GERD
Omeprazole delayed-release capsules are indicated for the maintenance healing of EE due to acid-mediated GERD in patients 2 years of age and older.
Controlled studies do not extend beyond 12 months.
1.7 Pathological Hypersecretory Conditions
Omeprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
1 INDICATIONS AND USAGE
Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures.
Oxcarbazepine tablets are indicated for:
Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures
Pediatrics:
Monotherapy in the treatment of partial-onset seizures in children 416 years
Adjunctive therapy in the treatment of partial-onset seizures in children 216 years (1)
1 INDICATIONS AND USAGE
GlucaGen is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated:
for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes (1.1)
as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2)
1.1 Severe Hypoglycemia
GlucaGen is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes.
1.2 Diagnostic Aid
GlucaGen is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.
1 INDICATIONS AND USAGE
RECTIV (nitroglycerin) Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.
RECTIV is a nitrate vasodilator indicated for the treatment of moderate to severe pain associated with chronic anal fissure (1).
INDICATIONS
BAL in Oil (Dimercaprol Injection USP) is indicated in the treatment of arsenic, gold and mercury poisoning. It is indicated in acute lead poisoning when used concomitantly with Edetate Calcium Disodium Injection USP.Dimercaprol Injection USP is effective for use in acute poisoning by mercury salts if therapy is begun within one or two hours following ingestion. It is not very effective for chronic mercury poisoning.Dimercaprol Injection USP is of questionable value in poisoning caused by other heavy metals such as antimony and bismuth. It should not be used in iron, cadmium, or selenium poisoning because the resulting dimercaprol-metal complexes are more toxic than the metal alone, especially to the kidneys.
INDICATIONS AND USAGE: Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
INDICATIONS AND USAGE
Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
1 INDICATIONS AND USAGE
Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinsons disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (
1.1,
1.2)
1.1 Parkinsons Disease
Ropinirole tablets are indicated for the treatment of Parkinson's disease.
1.2 Restless Legs Syndrome
Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium for oral suspension, and
amoxicillin and clavulanate potassium tablets (chewable) is indicated in the
treatment of infections caused by susceptible strains of the designated
organisms in the conditions listed below:
Lower Respiratory Tract Infections- caused by
-lactamase-producing strains of H. influenzae and
M. catarrhalis.
Otitis Media- caused by -lactamase-producing strains
of H. influenzae and M.
catarrhalis.
Sinusitis- caused by -lactamase-producing strains of
H. influenzae and M.
catarrhalis.
Skin and Skin Structure Infections- caused by
-lactamase-producing strains of S. aureus, E. coli, and Klebsiella spp.
Urinary Tract Infections- caused by
-lactamase-producing strains of E. coli, Klebsiella spp. and Enterobacter
spp.
While amoxicillin and clavulanate potassium is indicated only for the
conditions listed above, infections caused by ampicillin-susceptible organisms
are also amenable to treatment with amoxicillin and clavulanate potassium due to
its amoxicillin content. Therefore, mixed infections caused by
ampicillin-susceptible organisms and -lactamase-producing organisms susceptible
to amoxicillin and clavulanate potassium should not require the addition of
another antibiotic. Because amoxicillin has greater in
vitro activity against S. pneumoniae than does
ampicillin or penicillin, the majority of S.
pneumoniae strains with intermediate susceptibility to ampicillin or
penicillin are fully susceptible to amoxicillin and amoxicillin and clavulanate
potassium. (See Microbiology.)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and clavulanate potassium for oral suspension, and
amoxicillin and clavulanate potassium tablets (chewable) and other antibacterial
drugs, amoxicillin and clavulanate potassium for oral suspension, and
amoxicillin and clavulanate potassium tablets (chewable) 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.
Bacteriological studies, to determine the causative organisms and their
susceptibility to amoxicillin and clavulanate potassium for oral suspension, and
amoxicillin and clavulanate potassium tablets (chewable) should be performed
together with any indicated surgical procedures.
1 INDICATIONS & USAGE
Finasteride tablets USP, is a 5-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1): Improve symptoms
Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.Limitations of Use: Finasteride tablets USP is not approved for the prevention of prostate cancer (1.3).
1.1 Monotherapy
Finasteride tablets USP, are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:-Improve symptoms -Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
1.3 Limitations of Use
Finasteride tablets USP are not approved for the prevention of prostate cancer.
1 INDICATIONS AND USAGE
COMBIVIR, a combination of twonucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection.
COMBIVIR, a combination of twonucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.
1 INDICATIONS AND USAGE
ATACAND is an angiotensin II receptor blocker (ARB) indicated for:
Treatment of hypertension in adults and children 1 to < 17 years of age (1.1).
Treatment of heart failure (NYHA class II-IV); ATACAND reduces cardiovascular death and heart failure hospitalization (1.2).
1.1 Hypertension
ATACAND is indicated for the treatment of hypertension in adults and children 1 to < 17 years of age.
It may be used alone or in combination with other antihypertensive agents.
1.2 Heart Failure
ATACAND is indicated for the treatment of heart failure (NYHA class II-IV) in adults with left ventricular systolic dysfunction (ejection fraction
40%) to
reduce cardiovascular death and to reduce heart failure hospitalizations [see CLINICAL STUDIES (14.2)]. ATACAND also has an added effect on these outcomes when used with an ACE inhibitor.
INDICATIONS AND USAGE
Amoxicillin is indicated in the treatment of infections due to
susceptible (ONLY -lactamase-negative) strains of the designated microorganisms
in the conditions listed below:
Infections of the ear, nose, and throat - due to
Streptococcus spp. (- and -hemolytic strains only),
S. pneumoniae, Staphylococcus spp., or H.
influenzae.
Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E.
faecalis.
Infections of the skin and skin structure - due to
Streptococcus spp. (- and -hemolytic strains only),
Staphylococcus spp., or E.
coli.
Infections of the lower respiratory tract -due to
Streptococcus spp. (- and -hemolytic strains only),
S. pneumoniae,
Staphylococcus spp., or H. influenzae.
Gonorrhea, acute uncomplicated (ano-genital and urethral
infections) - due to N. gonorrhoeae (males and
females).
H. pylori eradication to reduce the risk of
duodenal ulcer recurrence
Triple Therapy:
Amoxicillin/clarithromycin/lansoprazole
Amoxicillin, in combination with clarithromycin plus lansoprazole as triple
therapy, is indicated for the treatment of patients with H.
pylori infection and duodenal ulcer disease (active or 1-year history of
a duodenal ulcer) to eradicate H. pylori. Eradication
of H. pylori has been shown to reduce the risk of
duodenal ulcer recurrence. (See CLINICAL STUDIES and
DOSAGE AND ADMINISTRATION.)
Dual Therapy: Amoxicillin/lansoprazole
Amoxicillin, in combination with lansoprazole delayed-release capsules as
dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or
1-year history of a duodenal ulcer) who are either allergic or
intolerant to clarithromycin or in whom resistance to clarithromycin is known or
suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H.
pylori has been shown to reduce the risk of duodenal ulcer recurrence.
(See CLINICAL STUDIES and DOSAGE AND
ADMINISTRATION.)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin capsules, amoxicillin tablets, amoxicillin tablets
(chewable) and amoxicillin for oral suspension and other antibacterial drugs,
amoxicillin capsules, amoxicillin tablets, amoxicillin tablets (chewable) and
amoxicillin for oral suspension 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.
Indicated surgical procedures should be performed.
1 INDICATIONS AND USAGE
Fludeoxyglucose F 18 Injection, USPis indicated for positron emission tomography (PET) imaging in the following settings:
Fludeoxyglucose F 18 Injection, USPis 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 diagnoses 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 ventriclar 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.
1 INDICATIONS AND USAGE
Brimonidine tartrate ophthalmic solution, 0.15% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
1 INDICATIONS AND USAGE
Alendronate sodium tablets, USP,is a bisphosphonate indicated for:
Treatment and prevention of osteoporosis in postmenopausal women (
1.1,
1.2)
Treatment to increase bone mass in men with osteoporosis (
1.3)
Treatment of glucocorticoid-induced osteoporosis (
1.4)
Treatment of Paget's disease of bone (
1.5)
Limitations of use:
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.(
1.6)
1.1 Treatment of Osteoporosis in Postmenopausal Women
Alendronate sodium tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets, USP increase bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
[See
Clinical Studies (14.1)
.]
1.2 Prevention of Osteoporosis in Postmenopausal Women
Alendronate sodium tablets, USP are indicated for the prevention of postmenopausal osteoporosis
[see
Clinical Studies (14.2)
].
1.3 Treatment to Increase Bone Mass in Men with Osteoporosis
Alendronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis
[see
Clinical Studies (14.3)
].
1.4 Treatment of Glucocorticoid-Induced Osteoporosis
Alendronate sodium tablets, USP are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density
[see
Clinical Studies (14.4)
].
1.5 Treatment of Paget's Disease of Bone
Alendronate sodium tablets, USP are indicated for the treatment of Pagets disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
[See
Clinical Studies (14.5)
.]
1.6 Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness of alendronate sodium tablets, USP for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
INDICATIONS AND USAGE
Azelastine hydrochloride is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.