um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Irbesartan and Hydrochlorothiazide Tablet USP is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension:
In patients not adequately controlled with monotherapy. (1)
As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1)
Irbesartan and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension.
Irbesartan and hydrochlorothiazide tablets USP may be used in patients whose blood pressure is not adequately controlled on monotherapy.
Irbesartan and hydrochlorothiazide tablets USP may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
The choice of irbesartan and hydrochlorothiazide tablets USP as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.
Data from Studies V and VI [see CLINICAL STUDIES (14.2)] provide estimates of the probability of reaching a blood pressure goal with irbesartan-hydrochlorothiazide compared to irbesartan or HCTZ monotherapy. The relationship between baseline blood pressure and achievement of a SeSBP <140 or <130 mmHg or SeDBP <90 or <80 mmHg in patients treated with irbesartan-hydrochlorothiazide compared to patients treated with irbesartan or HCTZ monotherapy are shown in Figures 1a through 2b.
*For all probability curves, patients without blood pressure measurements at Week 7 (Study VI) and Week 8 (Study V) were counted as not reaching goal (intent-to-treat analysis).
The above graphs provide a rough approximation of the likelihood of reaching a targeted blood pressure goal (e.g., Week 8 sitting systolic blood pressure 140 mmHg) for the treatment groups. The curve of each treatment group in each study was estimated by logistic regression modeling from all available data of that treatment group. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.
For example, a patient with a blood pressure of 180/105 mmHg has about a 25% likelihood of achieving a goal of <140 mmHg (systolic) and 50% likelihood of achieving <90 mmHg (diastolic) on irbesartan alone (and lower still likelihoods on HCTZ alone). The likelihood of achieving these goals on irbesartan-hydrochlorothiazide rises to about 40% (systolic) or 70% (diastolic).
Figure 1a and 1b
Figure 2a and 2b
1 INDICATIONS & USAGE
Tamsulosin Hydrochloride Capsules is an alpha 1 adrenoceptor antagonist indicated for treatment of
the signs and symptoms of benign prostatic hyperplasia (1)
Tamsulosin Hydrochloride Capsules
are not indicated for the treatment of hypertension (1)
1
INDICATIONS AND USAGE
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULESis indicated for use by females of reproductive ageto prevent pregnancy [
see
Clinical Studies (
14
)
].
The efficacy of NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULESin women with a body mass index (BMI) of more than35 kg/m2 has not been evaluated.
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULESis an estrogen/progestin COC indicated for use by women to prevent pregnancy (1)
The efficacy ofNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULESin women with a body mass index (BMI) of >35kg/m2 has not been evaluated (1, 8.8)
1 INDICATIONS AND USAGE
ROCTAVIAN is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity < 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test.
ROCTAVIAN is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity < 1 IU/dL) without pre-existing antibodies to adeno-associated virus serotype 5 detected by an FDA-approved test. (1)
1 INDICATIONSAND USAGE
Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years of age and older weighing at least 15 kg.
Limitations of Use:
Atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)].
Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].
Atazanavir capsules are a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years of age and older weighing at least 15 kg. (1)
1 INDICATIONS AND USAGE
CALQUENCE is a kinase inhibitor indicated for the treatment of adult patients with:
Mantle cell lymphoma (MCL) who have received at least one prior therapy. (1.1)This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1.1, 14.1)
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.2)
1.1 Mantle Cell Lymphoma
CALQUENCE is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
1.2 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
INDICATIONS AND USAGE
PredniSONE 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 mineralocorticoids where applicable; in infancy mineralocorticoid
supplementation is of particular importance)Congenital adrenal
hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with
cancer
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 sarcoidosisLoeffler's syndrome not manageable by
other meansBerylliosisAspiration pneumonitisFulminating or
disseminated pulmonary tuberculosis when used concurrently with appropriate
antituberculous chemotherapy
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 a 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
chemotherapyTrichinosis with neurologic or myocardial involvement
Indications and Usage
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Acute Pain in Adult Patients
Ketorolac tromethamine is indicated for the short-term (5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine injection, and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS,
PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days (see DOSAGE AND ADMINISTRATION, PHARMACEUTICAL INFORMATIONFOR KETOROLAC TROMETHAMINE INJECTION).
1
INDICATIONS AND USAGE
Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Entecavir is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
1 INDICATIONS AND USAGE
HERCEPTIN HYLECTA is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, indicated in adults for:
The treatment of HER2-overexpressing breast cancer. (1.1, 1.2)
Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab. (1, 2.1)
1.1	Adjuvant Breast Cancer
HERCEPTIN HYLECTA is indicated for adjuvant treatment of adults with HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1)]) breast cancer:
as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
as part of a treatment regimen with docetaxel and carboplatin
as a single agent following multi-modality anthracycline based therapy.
Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab [see Dosage and Administration (2.1)].
1.2	Metastatic Breast Cancer
HERCEPTIN HYLECTA is indicated in adults:
In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab [see Dosage and Administration (2.1)].
1 INDICATIONS AND USAGE
Naproxen Suspension is indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
Naproxen Suspension is a non-steroidal anti-inflammatory drug indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
1 INDICATIONS AND USAGE
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for the treatment of:
Left ventricular dysfunction following myocardial infarction in clinically stable patients ( )
1.2
Hypertension
(1.3)
1.2 Left Ventricular Dysfunction Following Myocardial Infarction
Carvedilol tablets, USP areindicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of 40% (with or without symptomatic heart failure) .
[see ]
Clinical Studies (14.2)
1.3 Hypertension
Carvedilol tablets, USP are indicated for the management of essential hypertension . It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics
[see , ]
Clinical Studies (14.3
14.4)
[see ].
Drug Interactions (7.2)
INDICATIONS & USAGE
Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (see
WARNINGS and
Boxed Warning.)
INDICATIONS AND USAGE
PREMARIN therapy is indicated in the:
Treatment of moderate to severe vasomotor symptoms due to menopause.
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500mg per day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU per day may also be required to ensure adequate daily intake in postmenopausal women.
1 INDICATIONS AND USAGE
Colchicine tablets are an alkaloid indicated for:
Prophylaxis and treatment of gout flares in adults (1.1).
Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).
1.1 Gout Flares
Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares.
Prophylaxis of Gout Flares:
Colchicine tablets are indicated for prophylaxis of gout flares.
Treatment of Gout Flares:
Colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare.
1.2 Familial Mediterranean Fever (FMF)
Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
1.2 Epilepsy
Depakote ER is indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Depakote ER is also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
1 INDICATIONS AND USAGE
Topiramate extended-release capsules are indicated for:
Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome (LGS) in patients 6 years of age and older (1.2)
Preventive treatment of migraine in patients 12 years of age and older (1.3)
1.1
Monotherapy Epilepsy
Topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older [see Clinical Studies (14.2)].
1.2
Adjunctive Therapy Epilepsy
Topiramate extended-release capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older [see Clinical Studies (14.3)].
1.3
Migraine
Topiramate extended-release capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older [see Clinical Studies (14.4)].
Anxiety Disorders
Alprazolam Tablets, USP(alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients:
Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability);
Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or lump in throat);
Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or mind going blank because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor.
Anxiety associated with depression is responsive to alprazolam.
1 INDICATIONS AND USAGE
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2)
Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3)
Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4).
1.1 Major Depressive Disorder
Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)].
The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see Dosage and Administration (2.1)].
1.2 Obsessive Compulsive Disorder
Fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
The effectiveness of fluoxetine in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)].
1.3 Bulimia Nervosa
Fluoxetine is indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
The physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.3)].
1.4 Panic Disorder
Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see Clinical Studies (14.4)].
The effectiveness of fluoxetine in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.4)].