um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS & USAGE
Risedronate sodium tablet,USPis a bisphosphonate indicated for:
Treatment and prevention of postmenopausal osteoporosis (1.1)
Treatment to increase bone mass in men with osteoporosis (1.2)
Treatment and prevention of glucocorticoid-induced osteoporosis (1.3)
Treatment of Paget's disease (1.4)
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. (1.5)
1.1 Postmenopausal Osteoporosis
Risedronate sodium tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets, USP reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1, 14.2)].
1.2 Osteoporosis in Men
Risedronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis.
1.3 Glucocorticoid-Induced Osteoporosis
Risedronate sodium tablets, USP are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
1.4 Paget's Disease
Risedronate sodium tablets, USP are indicated for treatment of Paget's disease of bone in men and women.
1.5 Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets, USP for the treatment of osteoporosis are based on clinical data of three 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
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 IV or IM ketorolac tromethamine, and the oral dosage form is to be used only as continuation treatment, if necessary. Combined use of IV/IM and the oral dosage form 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.
Pediatric Patients:
The safety and effectiveness of single doses of ketorolac tromethamine injection have been established in pediatric patients between the ages of 2 and 16 years. Ketorolac tromethamine as a single injectable dose, has been shown to be effective in the management of moderately severe acute pain that requires analgesia at the opioid level, usually in the postoperative setting. There is limited data available to support the use of multiple doses of ketorolac tromethamine injection in pediatric patients. Safety and effectiveness have not been established in pediatric patients below the age of 2 years. Use of ketorolac tromethamine injection in pediatric patients is supported by evidence from adequate and well-controlled studies of ketorolac tromethamine injection in adults with additional pharmacokinetic, efficacy and safety data on its use in pediatric patients available in the published literature (see CLINICAL PHARMACOLOGY: Clinical Studies, WARNINGS, and PRECAUTIONS).
Ketorolac tromethamine injection has been used concomitantly with morphine and meperidine and has shown an opioid-sparing effect. For breakthrough pain, it is recommended to supplement the lower end of the ketorolac tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Ketorolac tromethamine and narcotics should not be administered in the same syringe (see DOSAGE AND ADMINISTRATION Pharmaceutical Information for Ketorolac Tromethamine Injection).
1 INDICATIONS AND USAGE
Finasteride tablets, USP 1 mg are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY.
Efficacy in bitemporal recession has not been established.
Finasteride tablets, USP 1 mg are not indicated for use in women.
Finasteride tablets, USP 1 mg are 5-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY (1).
Finasteride tablets, USP 1 mg are not indicated for use in women (1, 4, 5.1).
1 INDICATIONS AND USAGE
XATMEP is a folate analog metabolic inhibitor indicated for the:
Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen (1.1).
Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy (1.2).
1.1 Acute Lymphoblastic Leukemia
XATMEP is indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen.
1.2 Polyarticular Juvenile Idiopathic Arthritis
XATMEP is indicated in the management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
INDICATIONS AND USAGE
Desipraminehydrochloride tablets are indicated for the treatment of depression.
1. INDICATIONS AND USAGE
Montelukast sodium tablets are a leukotriene receptor antagonist indicated for:
Prophylaxis
and chronic treatment of asthma in patients 2 years of age and older
(1.1).
Acute
prevention of exercise-induced bronchoconstriction (EIB) in patients 6
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 2 years of age and older (1.3).
1.1 Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium 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 2 years of age and older.
INDICATIONS AND USAGE
Sulfacetamide Sodium Ophthalmic Solution, USP 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma:
Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group),
Haemophilus influenzae, Klebsiella species, and
Enterobacter species.
Topically applied sulfonamides do not provide adequate coverage against
Neisseria species,
Serratia marcescens and
Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
1 INDICATIONS AND USAGE
Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin) indicated (1):
To reduce the risk of
myocardial infarction, myocardial revascularization procedures, and
cardiovascular mortality in adults with elevated lowdensity lipoprotein
cholesterol (LDL-C) without clinically evident coronary heart disease
(CHD).
To reduce the risk of coronary
death, myocardial infarction, myocardial revascularization procedures,
stroke or transient ischemic attack, and slow the progression of coronary
atherosclerosis in adults with clinically evident CHD.
As an adjunct to diet to
reduce LDL-C in adults with primary hyperlipidemia.
As an adjunct to diet to
reduce LDL-C in pediatric patients ages 8 years and older with
heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to diet for the
treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
Pravastatin sodium tablets are indicated:
To reduce the risk of myocardial infarction, myocardial
revascularization procedures, and cardiovascular mortality in adults with
elevated low-density lipoprotein cholesterol (LDLC) without clinically
evident coronary heart disease (CHD).
To reduce the risk of coronary death, myocardial
infarction, myocardial revascularization procedures, stroke or transient
ischemic attack, and slow the progression of coronary atherosclerosis in
adults with clinically evident CHD.
As an adjunct to diet to reduce LDL-C in adults with
primary hyperlipidemia.
As an adjunct to diet to
reduce LDL-C in pediatric patients ages 8 years and older with
heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to diet for the
treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
1 INDICATIONSAND USAGE
Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.
Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.
For the safe and effective use of allopurinol, see allopurinol prescribing information.
Limitations of Use:
Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.
Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. (
1)
For the safe and effective use of allopurinol, see allopurinol prescribing information.
Limitations of Use:
Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. (
1)
INDICATIONS AND USAGE
Dermatitis herpetiformis: (D.H.)
Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin Injection USP and other antibacterial drugs, Tobramycin Injection USP 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.Tobramycin is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:Septicemia in the pediatric patient and adult caused by P. aeruginosa, E. coli., and Klebsiella sppLower respiratory tract infections caused by P. aeruginosa, Klebsiella spp, Enterobacter spp, Serratia spp, E.
coli, and S. aureus (penicillinase
and non-penicillinase-producing strains)Serious central nervous system infections (meningitis) caused by susceptible organisms. Intra-abdominal infections, including peritonitis, caused by E. coli, Klebsiella spp, and Enterobacter sppSkin, bone, and skin-structure infections caused by P. aeruginosa, Proteus spp, E. coli, Klebsiella spp, Enterobacter spp, and S. aureusComplicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus spp (indole-positive and indole-negative), E. coli, Klebsiella spp, Enterobacter spp, Serratia spp, S. aureus, Providencia, and Citrobacter sppAminoglycosides, including tobramycin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the WARNINGS box above.
INDICATIONS
BACMIN is indicated for prophylactic or therapeutic nutritional supplementation in physiologically stressful conditions. These include:
Conditions causing depletion, reduced absorption or bioavailability of essential vitamins and minerals-
Inadequate intake due to highly restricted or unbalanced diets such as those frequently associated with anorexic conditions and other states of severe malnutrition.
Gastrointestinal disorders, chronic alcoholism, chronic or acute infections (especially those involving febrile illness), prolonged or wasting disease, congestive heart failure, hyperthyroidism, poorly controlled diabetes or other physiologic stress.
Also, patients on estrogenic oral contraceptives or other estrogen therapy, anti-bacterials which affect intestinal microflora, or other interfering drugs.
Certain conditions resulting from severe B-Vitamin or ascorbic acid deficiency-
Recovery from surgery or trauma involving severe burns, fractures or other extensive tissue damage.
Also, pregnant women and those with heavy menstrual bleeding.
INDICATIONS AND USAGE
Sumatriptan succinate tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.
Sumatriptan succinate tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see
CONTRAINDICATIONS
). Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache, which is present in an older, predominantly male population.
INDICATIONS AND USAGE
Citalopram Oral Solution, USP is indicated for the treatment of depression.
The efficacy of Citalopram Oral Solution, USP in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see
CLINICAL PHARMACOLOGY
).
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. The antidepressant action of Citalopram Oral Solution, USP in hospitalized depressed patients has not been adequately studied.
The efficacy of Citalopram Oral Solution, USP in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see
CLINICAL PHARMACOLOGY
). Nevertheless, the physician who elects to use citalopram oral solution for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.
As a sedative when used as a premedication and following general anesthesia,
hydrOXYzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. HydrOXYzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.
The effectiveness of hydrOXYzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
PROAIR HFA Inhalation Aerosol is a beta2-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (
1.1
)
Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (
1.2
)
1.1 Bronchospasm
PROAIR HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
PROAIR HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
Indications and Usage:Pre-Tabs DHA is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal for both lactating and nonlactating mothers. Pre-Tabs DHA is also beneficial in improving the nutritional status of women prior to conception.
INDICATIONS AND USAGE
Carbinoxamine maleate is effective for the symptomatic treatment of:
Seasonal and perennial allergic rhinitis.
Vasomotor rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Dermatographism.
As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
Amelioration of the severity of allergic reactions to blood or plasma.
1
INDICATIONS AND USAGE
IMBRUVICA is a kinase inhibitor indicated for the treatment of:
Adult patients withchronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.1).
Adult patients with chroniclymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.2).
Adult patients with Waldenstrms macroglobulinemia (WM) (1.3).
Adult and pediatric patients age 1 year and older with chronicgraft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.4).
1.1
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
1.
2
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma with 17p deletion
IMBRUVICA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with 17p deletion.
1.
3
Waldenstrms Macroglobulinemia
IMBRUVICA is indicated for the treatment of adult patients with Waldenstrms macroglobulinemia (WM).
1.
4
Chronic Graft versus Host Disease
IMBRUVICA is indicated for the treatment of adult and pediatric patients age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.
1 INDICATIONS AND USAGE
Posaconazole is an azole antifungal indicated as follows:
Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft- versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2)
Posaconazole
injection: adults
1.2Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy[see Clinical Studies (14.1)] as follows:
Posaconazole injection: adults
Pediatric use information is approved for Merck Sharp & Dohme Corp.s NOXAFIL (posaconazole) injection. However, due to Merck Sharp & Dohme Corp.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS & USAGE
Calcium acetate capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
Calcium acetate capsules are a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (
1)
1 INDICATIONS AND USAGE
SAVAYSA is a factor Xa inhibitor indicated:
To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) (1.1)
Limitation of Use for NVAF
SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) (1.1)
SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant (1.2)
1.1	Reduction in the Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation
SAVAYSA is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF).
Limitation of Use for NVAF
SAVAYSA should not be used in patients with CrCL > 95 mL/min because of an increased risk of ischemic stroke compared to warfarin [see Dosage and Administration (2.1), Warnings and Precautions (5.1) and Clinical Studies (14.1)].
1.2	Treatment of Deep Vein Thrombosis and Pulmonary Embolism
SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.