um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Methylprednisolone Tablets are indicated in the following conditions:
1. Endocrine Disorders
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
2. Rheumatic Disorders
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Synovitis of osteoarthritis
Acute nonspecific tenosynovitis
Post-traumatic osteoarthritis
Psoriatic arthritis
Epicondylitis
Acute gouty arthritis
3. Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
4. Dermatologic Diseases
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Severe seborrheic dermatitis
Exfoliative dermatitis
Mycosis fungoides
Pemphigus
Severe psoriasis
5. Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Drug hypersensitivity reactions
Serum sickness
Contact dermatitis
Bronchial asthma
Atopic dermatitis
6.
Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Sympathetic ophthalmia
Keratitis
Optic neuritis
Allergic conjunctivitis
Chorioretinitis
Iritis and iridocyclitis
7.
Respiratory Diseases
Symptomatic sarcoidosis
Berylliosis
Loeffler's syndrome not manageable by other means
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Aspiration pneumonitis
8. Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9. Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10. Edematous States
To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
11.
Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis
Regional enteritis
12. Nervous System
Acute exacerbations of multiple sclerosis
13. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.
Trichinosis with neurologic or myocardial involvement.
1INDICATIONS AND USAGE
1
INDICATIONS AND USAGE
1.1
Renal Tubular Acidosis (RTA) with Calcium Stones
Potassium Citrate is indicated for the management of renal tubular acidosis
[see Clinical Studies (14.1)].
1.2
Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology
Potassium Citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis
[see Clinical Studies (14.2)].
1.3
Uric Acid Lithiasis with or without Calcium Stones
Potassium Citrate is indicated for the management of Uric acid lithiasis with or without calcium stones
[see Clinical Studies (14.3)].
Potassium Citrate is a citrate salt of potassium indicated for the management of:
Renal tubular acidosis (RTA) with calcium stones
(1.1)
Hypocitraturic calcium oxalate nephrolithiasis of any etiology
(1.2)
Uric acid lithiasis with or without calcium stones
(1.3)
1.1Renal tubular acidosis (RTA) with calcium stones
Potassium Citrate is indicated
for the management of renal tubular acidosis
[see Clinical
Studies
(14.1)].
1.2Hypocitraturic calcium oxalate nephrolithiasis of any etiology
Potassium Citrate is indicated
for the management of Hypocitraturic calcium oxalate nephrolithiasis
[see Clinical Studies
(14.2)]
.
1.3Uric acid lithiasis with or without calcium stones
Potassium Citrate is indicated
for the management of Uric acid lithiasis with or without calcium
stones
[see Clinical Studies
(14.3)].
1 INDICATIONS AND USAGE
Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesic
Belladonna and opium suppositories are an opioid agonist indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
INDICATIONS AND USAGE
Major Depressive Disorder: Bupropion
hydrochloride extended-release tablets (XL) are indicated for the treatment of
major depressive disorder.
The efficacy of bupropion in the treatment of a major depressive episode was
established in two 4-week controlled trials of inpatients and in one 6-week
controlled trial of outpatients whose diagnoses corresponded most closely to the
Major Depression category of the APA Diagnostic and Statistical Manual (DSM)
(see CLINICAL TRIALS).
A major depressive episode (DSM-IV) implies the presence of 1) depressed mood
or 2) loss of interest or pleasure; in addition, at least 5 of the following
symptoms have been present during the same 2-week period and represent a change
from previous functioning: depressed mood, markedly diminished interest or
pleasure 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 efficacy of bupropion in maintaining an antidepressant response for up to
44 weeks following 8 weeks of acute treatment was demonstrated in a
placebo-controlled trial with the sustained-release formulation of bupropion
(see CLINICAL TRIALS). Nevertheless, the physician who elects to use bupropion
hydrochloride extended-release tablets (XL) for extended periods should
periodically reevaluate the long-term usefulness of the drug for the individual
patient.
INDICATIONS AND USAGE
Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Ursodiol beyond 24 months is not established.
Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
1. INDICATIONS AND USAGE
Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied.
Sevelamer hydrochloride tablets are a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. (
1)
Indications and Usage
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
1	INDICATIONS AND USAGE
Gabapentin tablets are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin tablets are indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
INDICATIONS AND USAGE
Methylprednisolone tablets are indicated in the following
conditions:
Endocrine Disorders
:
Primary or secondary adrenocortical insufficiency (hydrocortisone or
cortisone is the first choice; synthetic analogs may be used in conjunction with
mineralocorticoid where applicable; in infancy, mineralocorticoid
supplementation is of particular importance).Congenital adrenal
hyperplasiaHypercalcemia associated with cancerNonsuppurative
thyroiditis
Rheumatic Disorders
:
As
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
osteoarthritisEpicondylitis
Collagen Diseases
:
During an exacerbation or as maintenance therapy in selected cases
of:Systemic lupus erythematosusSystemic dermatomyositis
(polymyositis)Acute rheumatic carditis
Dermatologic Diseases
:
PemphigusBullous dermatitis herpetiformisSevere erythema multiforme
(Stevens-Johnson syndrome)Exfoliative dermatitisMycosis
fungoidesSevere psoriasisSevere seborrheic dermatitis
Allergic States:
Control of severe or
incapacitating allergic conditions intractable to adequate trials of
conventional treatment:Seasonal or perennial allergic rhinitisBronchial
asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug
hypersensitivity reactions
Ophthalmic Diseases
:
Severe 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
iridocyclitis
Respiratory Diseases
:
Symptomatic sarcoidosisLoefflers syndrome not manageable by other
meansBerylliosisFulminating or disseminated pulmonary tuberculosis when
used concurrently with appropriate antituberculous chemotherapyAspiration
pneumonitis
Hematologic Disorders
:Idiopathic thrombocytopenic purpura in
adultsSecondary thrombocytopenia in adultsAcquired (autoimmune)
hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid)
hypoplastic anemia
Neoplastic Diseases
:
For
palliative management of:Leukemias and lymphomas in adultsAcute leukemia
of childhood
Edematous States
:
To
induce diuresis or remission of proteinuria in the nephrotic syndrome, without
uremia, of the idiopathic type or that due to lupus erythematosus
Gastrointestinal Diseases
:
To tide the patient over a critical period of the disease in:Ulcerative
colitisRegional enteritis
Nervous System:
Acute exacerbations of multiple
sclerosis
Miscellaneous
:
Tuberculous meningitis with subarachnoid block or impending block when used
concurrently with appropriate antituberculous chemotherapy Trichinosis with
neurologic or myocardial involvement
1 INDICATIONSAND USAGE
Fenofibrate tablet is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).
For treatment of adult patients with severe hypertriglyceridemia (1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tabletsare indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablets was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus[see Warnings and Precautions (
5.1
)].
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablet USP is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablet USP is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablet USP was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see WARNINGS AND PRECAUTIONS (5.1)].
1 INDICATIONS AND USAGE
Monotherapy
Fulvestrant Injection is indicated for the treatment of:
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
Combination Therapy
Fulvestrant Injection is indicated for the treatment of:
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of:
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. (1)
HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. (1)
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. (1)
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy. (1)
1 INDICATIONS AND USAGE
Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.
Fentanyl buccal tablet is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. (
1)
Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.
Limitations of Use:
Not for use in opioid non-tolerant patients.
Not for use in the management of acute or postoperative pain, including headache/migraine, or dental pain.
As a part of the TIRF REMS, fentanyl buccal tablet may be dispensed by outpatient pharmacies only to patients enrolled in the program (
5.7). For inpatient administration of fentanyl buccal tablet, patient and prescriber enrollment are not required.
Limitations of Use:
Not for use in opioid non-tolerant patients.
Not for use in the management of acute or postoperative pain, including headache/migraine, and dental pain
[see
Contraindications (4)]
.
As a part of the TIRF REMS, fentanyl buccal tablet may be dispensed by outpatient pharmacies only to outpatients enrolled in the program
[see
Warnings and Precautions (5.7)]
. For inpatient administration of fentanyl buccal tablet, patient and prescriber enrollment are not required.
1
INDICATIONS AND USAGE
Dicyclomine hydrochloride is indicated forthetreatment of patients with functionalbowel/irritablebowelsyndrome.
Dicyclomine Hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen tablets are indicated for relief of mild to moderate pain.
Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.
INDICATIONS AND USAGE
Glyburide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
Gallium Ga 68 Gozetotide Injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Gallium Ga 68 Gozetotide Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
(1)
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 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
I. Vasospastic Angina
Nifedipine is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers.
II. Chronic Stable Angina (Classical Effort-Associated Angina)
Nifedipine is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents.
In chronic stable angina (effort-associated angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients are incomplete.
Controlled studies in small numbers of patients suggest concomitant use of nifedipine and betablocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS).