um-ids/dailymed-annotations huggingface dataset:
INDICATIONS
DELTASONE Tablets are indicated in the following conditions:1.Endocrine DisordersPrimary 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 hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis2.Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis3.Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis4.Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis5.Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions6.Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis7.Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis8.Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia9.Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood10.Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus11.Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis12.Nervous SystemAcute exacerbations of multiple sclerosis13.MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement
INDICATIONS: For the topical treatmentof active keratosis.
1 Indications and Usage
Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of:
active duodenal ulcer.
active gastric ulcer.
symptomatic non-erosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
Famotidine tablets are indicated in adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-
Ellison Syndrome, multiple endocrine neoplasias).
reduction of the risk of duodenal ulcer recurrence.
1 INDICATIONS AND USAGE
Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:
Atropine is an anti-muscarinic agent indicated for:
Mydriasis (1.1)
Cycloplegia (1.2)
Penalization of the healthy eye in the treatment of amblyopia (1.3)
1.1 Mydriasis
1.2 Cycloplegia
1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia
INDICATIONS AND USAGE
Hypertension
Lisinopril Tablets are indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.
Heart Failure
Lisinopril Tablets are indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis.
Acute Myocardial Infarction
Lisinopril Tablets are indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers.
In using Lisinopril Tablets, consideration should be given to the fact that another 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 Tablets do not have a similar risk.(See
WARNINGS
.)
In considering the use of Lisinopril Tablets, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients. (See
WARNINGS, Anaphylactoid and Possibly Related Reactions
.)
INDICATIONS AND
USAGE
Sotalol AF are indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Because Sotalol AF can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given Sotalol AF (see
WARNINGS
).
In general, antiarrhythmic therapy for AFIB/AFL aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see
Clinical Studies
).
Sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name
Betapace (sotalol hydrochloride). Sotalol hydrochloride tablets, however, must not be substituted for sotalol hydrochloride tablets (AF) because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information).
1 INDICATIONS AND USAGE
MEKTOVI is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test [see Dosage and Administration (2.1)].
MEKTOVI is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. (1, 2.1)
1 INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following:
Treatment of gastroesophageal reflux disease (GERD) (
1.1)
Risk reduction of NSAID-associated gastric ulcer (
1.2)
H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
(1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (
1.4)
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered.
In infants 1 month to less than 1 year, esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin):
Esomeprazole magnesium delayed-release capsules, in combination with amoxicillin and clarithromycin, are indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see
Dosage and Administration
(2)
and
Clinical Studies
(14)
].
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 prescribing information for clarithromycin].
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Esomeprazole magnesium delayed-release capsule USP is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
1 INDICATIONS AND USAGE
Pioglitazone tablets, USP are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. (1, 14)
Important Limitation of Use:
Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1)
Monotherapy and Combination Therapy
Pioglitazone tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].
Important Limitation of Use
Pioglitazone tablets, USP exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets, USP should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease [see Warnings and Precautions (5.3)].
1 INDICATIONS AND USAGE
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older
(1.1)
Levetiracetam is indicated for adjunctive therapy for the treatment of:
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy
(1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy
(1.3)
1.1 Partial-Onset Seizures
Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
1 INDICATIONS AND USAGE
SYNJARDY XR
SYNJARDY XR is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Empagliflozin
Empagliflozin when used as a component of SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of:
Cardiovascular death in adults with established cardiovascular disease. (1)
Cardiovascular death and hospitalization for heart failure in adults with heart failure. (1)
Limitations of Use:
Not recommended for use in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. (1)
Because of the metformin component, SYNJARDY XR is not recommended for use in patients with heart failure without type 2 diabetes mellitus. (1)
SYNJARDY XR
SYNJARDY XR is a combination of empagliflozin and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Empagliflozin
Empagliflozin, when used as a component of SYNJARDY XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of:
Cardiovascular death in adults with established cardiovascular disease.
Cardiovascular death and hospitalization for heart failure in adults with heart failure.
Limitations of Use
SYNJARDY XR is not recommended for use in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.2)].
Because of the metformin component, SYNJARDY XR is not recommended for use in patients with heart failure without type 2 diabetes mellitus.
1.	INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib.
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [
see
Warnings and Precautions (5)
]
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (
1.1)
Rheumatoid Arthritis (RA) (
1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (
1.3)
Ankylosing Spondylitis (AS) (
1.4)
Acute Pain (AP) (
1.5)
Primary Dysmenorrhea (PD) (
1.6)
1.1 Osteoarthritis (OA)
Celecoxib is indicated for relief of the signs and symptoms of OA [
see
Clinical Studies (14.1)
]
1.2 Rheumatoid Arthritis (RA)
Celecoxib is indicated for relief of the signs and symptoms of RA [
see
Clinical Studies (14.2)
]
1.3
Juvenile Rheumatoid Arthritis (JRA)
Celecoxib is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [
see
Clinical Studies (14.3)
]
1.4 Ankylosing Spondylitis (AS)
Celecoxib is indicated for the relief of signs and symptoms of AS [
see
Clinical Studies (14.4)
]
1.5 Acute Pain (AP)
Celecoxib is indicated for the management of AP in adults [
see
Clinical Studies (14.5)
]
1.6 Primary Dysmenorrhea (PD)
Celecoxib is indicated for the treatment of PD [
see
Clinical Studies (14.5)
]
1 INDICATIONS AND USAGE
Rabeprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated in adults for:
Healing of
Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (1.1).
Maintenance
of Healing of Erosive or Ulcerative GERD (1.2).
Treatment
of Symptomatic GERD (1.3).
Healing of
Duodenal Ulcers (1.4).
Helicobacter
pylori
Eradication to Reduce Risk of Duodenal Ulcer Recurrence (1.5).
Treatment
of Pathological Hypersecretory Conditions, Including Zollinger-Ellison
Syndrome (1.6).
In adolescent patients 12 years of age and older for:
Short-term Treatment of Symptomatic GERD (1.7).
1.1 Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
1.4 Healing of Duodenal Ulcers in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
Rabeprazole sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
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 (12.2) and the full prescribing information for clarithromycin].
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
1 INDICATIONS AND USAGE
Alendronate sodium 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 reduce 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 Paget's 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 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.
1 INDICATIONS & USAGE
Famciclovir tablet, a prodrug of penciclovir, is a nucleoside analog DNA polymerase inhibitor indicated for:
Immunocompetent Adult Patients (1.1)
Herpes labialis (cold sores)
o Treatment of recurrent episodes
Genital herpes
o Treatment of recurrent episodes
o Suppressive therapy of recurrent episodes
HIV-Infected Adult Patients (1.2)
Treatment of recurrent episodes of orolabial or genital herpes
Limitation of Use (1.3)
The efficacy and safety of famciclovir tablets have not been established for:
Patients <18 years of age
Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
1.1 Immunocompetent Adult Patients
Herpes labialis (cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis.
Genital herpes:
Recurrent episodes: Famciclovir tablets are indicated for the treatment of recurrent episodes of genital herpes. The efficacy of famciclovir tablets when initiated more than 6 hours after onset of symptoms or lesions has not been established.
Suppressive therapy: Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established.
1.2 HIV-Infected Adult Patients
Recurrent orolabial or genital herpes: Famciclovir tablets are indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of famciclovir tablets when initiated more than 48 hours after onset of symptoms or lesions has not been established.
1.3 Limitation of Use
The efficacy and safety of famciclovir tablets have not been established for:
Patients <18 years of age
Patients with first episode of genital herpes
Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
INDICATIONS AND USAGE
Alclometasone Dipropionate Cream USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see
PRECAUTIONS: Pediatric Use
). Since the safety and efficacy of alclometasone dipropionate cream have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.
1 INDICATIONS AND USAGE
MITIGARE
(colchicine) capsules are indicated for prophylaxis of gout flares in adults.
Limitations of use: The safety and effectiveness of MITIGARE
for acute treatment of gout flares during prophylaxis has not been studied.
MITIGARE
is not an analgesic medication and should not be used to treat pain from other causes.
MITIGARE
is indicated for prophylaxis of gout flares in adults (1).
Limitations of use:The safety and effectiveness of MITIGARE
for acute treatment of gout flares during prophylaxis has not been studied.
MITIGARE
is not an analgesic medication and should not be used to treat pain from other causes.