um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodoltablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see Dosage and Administration (2)].
Carisoprodoltablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. (1)
Important Limitations:
Should only be used for acute treatment periods up to two or three weeks (1)
Not recommended in pediatric patients less than 16 years of age (8.4)
1	INDICATIONS AND USAGE
Docetaxel is a microtubule inhibitor indicated for:
Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1)
Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2)
Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3)
Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4)
Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5)
1.1	Breast Cancer
Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
1.2	Non-small Cell Lung Cancer
Docetaxel as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.
1.3	Prostate Cancer
Docetaxel in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
1.4	Gastric Adenocarcinoma
Docetaxel in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.
1.5	Head and Neck Cancer
Docetaxel in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
1 INDICATIONS AND USAGE
Zoledronic acid injection is a bisphosphonate indicated for the treatment of:
Hypercalcemia of malignancy. (1.1)
Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2)
Limitations of use: The safety and efficacy of zoledronic acid injection has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia.
1.1 Hypercalcemia of Malignancy
Zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12mg/dL [3.0mmol/L] using the formula: cCa in mg/dL= Ca in mg/dL + 0.8 (4.0g/dL
patient albumin [g/dL]).
1.2 Multiple Myeloma and Bone Metastases of Solid Tumors
Zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy.
Limitations of Use
The safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
INDICATIONS AND USAGE:
For mydriasis and cycloplegia for diagnostic procedures.
INDICATIONS AND USAGE
Estradiol Valerate Injection is indicated in the:
1.Treatment of moderate to severe vasomotor symptoms associated with the menopause.
2.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. Whenprescribingsolelyfor the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
3.Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
4.Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
1. INDICATIONS AND USAGE
Celecoxib is indicated
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
For the management of the signs and symptoms of OA [
see
Clinical Studies (14.1)
].
1.2 Rheumatoid Arthritis
For the management of the signs and symptoms of RA [
see
Clinical Studies (14.2)
].
1.3 Juvenile Rheumatoid Arthritis
For the management of the signs and symptoms of JRA in patients 2 years and older [
see
Clinical Studies (14.3)
].
1.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS [
see
Clinical Studies (14.4)
].
1.5 Acute Pain
For the management of acute pain in adults [
see
Clinical Studies (14.5)
].
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [
see
Clinical Studies (14.5)
].
1 INDICATIONS & USAGE
Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor.
Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.
(1)
Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
(1)
1.1 HIV-1 Infection
Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older.
The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of HIV-1 infection:
Tenofovir disoproxil fumarate tablets should not be used in combination with ATRIPLA
, BIKTARVY
, COMPLERA
, DESCOVY
, GENVOYA
, ODEFSEY
, STRIBILD
, TRUVADA
, or VEMLIDY
[See Warnings and Precautions
(5.4)].
1.2 Chronic Hepatitis B
Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of chronic hepatitis B infection:
The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-nave and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease
[See Clinical Studies
(14.2)].
Tenofovir disoproxil fumarate tablets were evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease
[See Adverse Reactions
(6.1),Clinical Studies
(14.2)].
The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy
[See Microbiology
(12.4),Clinical Studies (
14.2)].
Indications & Usage
Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
INDICATIONS AND USAGE
Calcitrene (calcipotriene) ointment, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
INDICATIONS AND USAGE
Intralipid 10% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time (usually for more than 5 days) and
as a source of essential fatty acids for prevention of EFAD.
1 INDICATIONS AND USAGE
ProAir Digihaler is a beta2-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in patients 4years 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)
1.1Bronchospasm
ProAir Digihaler is indicated for the treatment or prevention of bronchospasm in patients 4years of age and older with reversible obstructive airway disease.
1.2Exercise-Induced
Bronchospasm
ProAir Digihaler is indicated for the prevention of exercise-induced bronchospasm in patients 4years of age and older.
INDICATIONS AND USAGE
Diuretics such as chlorthalidone are indicated in the management of hypertension either alone or in combination with other antihypertensive drugs.
Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see
PRECAUTIONS, below). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and be appropriate.
1	INDICATIONS AND USAGE
Pediatric use information for patients 7 to 17 years of age is approved for AstraZenecas CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZenecas marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Rosuvastatin calcium tablets are an HMG CoA reductase inhibitor indicated for:
adult patients with hypertriglyceridemia as an adjunct to diet
(1.3)
adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet
(1.4)
adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDLC, total-C, and ApoB
(1.5)
Limitations of use
(1.8)
: Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1.3 Hypertriglyceridemia
Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
1.4	Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).
1.5 Adult Patients with Homozygous Familial Hypercholesterolemia
Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
1.8 Limitations of Use
Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.
1INDICATIONS AND USAGE
KISQALI is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
an aromatase inhibitor as initial endocrine-based therapy; or
fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men.
KISQALI is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
an aromatase inhibitor as initial endocrine-based therapy; or
fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men. (1)
1 INDICATIONS AND USAGE
Acetaminophen injection is indicated for the
Management of mild to moderate pain in adult and pediatric patients 2 years and older (
1)
Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older (
1)
Reduction of fever in adult and pediatric patients (
1)
Acetaminophen injection is indicated for
the management of mild to moderate pain in adult and pediatric patients 2 years and older
the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older
the reduction of fever in adult and pediatric patients
INDICATIONS AND USAGE
Glyburide Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
1 INDICATIONS AND USAGE
Gonal-f RFF Redi-ject
is a prefilled gonadotropin-containing auto-injection device indicated for:
Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure (1.1)
Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (1.2)
1.1	Induction of Ovulation and Pregnancy in Oligo-Anovulatory Women in whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure.
Prior to initiation of treatment with Gonal-f RFF Redi-ject:
Perform a complete gynecologic and endocrinologic evaluation
Exclude primary ovarian failure
Exclude the possibility of pregnancy
Demonstrate tubal patency
Evaluate the fertility status of the male partner
1.2	Development of Multiple Follicles in Ovulatory Women as Part of an Assisted Reproductive Technology (ART) Cycle.
Prior to initiation of treatment with Gonal-f RFF Redi-ject
:
Perform a complete gynecologic and endocrinologic evaluation, and diagnose the cause of infertility
Exclude the possibility of pregnancy
Evaluate the fertility status of the male partner
INDICATIONS AND USAGE
Hydrocortisone 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
Non suppurative 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:
Psoriatic arthritis
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Ankylosing spondylitis
Acute and subacute bursitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Post-traumatic osteoarthritis
Synovitis of osteoarthritis
Epicondylitis
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
Pemphigus
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Exfoliative dermatitis
Mycosis fungoides
Severe psoriasis
Severe seborrheic dermatitis
5. Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitis
Serum sickness
Bronchial asthma
Contact dermatitis
Atopic dermatitis
Drug hypersensitivity reactions
6. Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic conjunctivitis
Keratitis
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Iritis and iridocyclitis
Chorioretinitis
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Optic neuritis
Sympathetic ophthalmia
7. Respiratory Diseases
Symptomatic sarcoidosis
Loeffler's syndrome not manageable by other means
Berylliosis
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
INDICATIONS AND USAGE
Sincalide may be used: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; to stimulate pancreatic secretion (especially in conjunction with secretin) prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract
1 INDICATIONS AND USAGE
SPRIX is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.
Limitations of Use
Sprix is not for use in pediatric patients less than 2 years of age.
SPRIX is a nonsteroidal anti-inflammatory drug indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. (1)
1 INDICATIONS AND USAGE
Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (
1.1)
Levetiracetam tablets are 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 in patients 1month 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
OPDUALAG is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. (1)
1 INDICATIONS AND USAGE
Lamotrigine, USP is indicated for:
Epilepsyadjunctive therapy in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome. (
1.1)
Epilepsymonotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED. (
1.1)
Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (
1.2)
Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
1.1 Epilepsy
Adjunctive Therapy
Lamotrigine tablets, USP are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic (PGTC) seizures.
generalized seizures of Lennox-Gastaut syndrome.
Monotherapy
Lamotrigine tablets, USP are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine tablets, USP have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2 Bipolar Disorder
Lamotrigine tablets, USP are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy
[see Clinical Studies (
14.2)]
.
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.