um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
CardioGen-82
is a closed system used to produce rubidium Rb 82 chloride injection
for intravenous administration. Rubidium Rb 82 chloride injection
is indicated for Positron Emission Tomography (PET) imaging of the
myocardium under rest or pharmacologic stress conditions to evaluate
regional myocardial perfusion in adult patients with suspected or
existing coronary artery disease.
CardioGen-82 is a closed system used to produce
rubidium Rb 82 chloride injection for intravenous use. Rubidium Rb
82 chloride injection is a radioactive diagnostic agent indicated
for Positron Emission Tomography (PET) imaging of the myocardium under
rest or pharmacologic stress conditions to evaluate regional myocardial
perfusion in adult patients with suspected or existing coronary artery
disease. (1)
1	INDICATIONS AND USAGE
PROTONIX is a proton pump inhibitor (PPI) indicated in adults for the following:
Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1)
Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2)
1.1	Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis
PROTONIX I.V. is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE).
Safety and efficacy of PROTONIX I.V. as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.
1.2
Pathological Hypersecretion Including Zollinger-Ellison Syndrome
PROTONIX I.V. is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac
sodium extended-release and other treatment options before deciding to use
diclofenac sodium extended-release. Use the lowest effective dose for the
shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diclofenac sodium extended-release tablets are indicated:
For relief of signs and symptoms of osteoarthritis
For relief of signs and symptoms of rheumatoid arthritis
INDICATIONS AND USAGE
Dacarbazine for Injection is indicated in the treatment of metastatic malignant melanoma. In addition, Dacarbazine for Injection is also indicated for Hodgkins disease as a second-line therapy when used in combination with other effective agents.
1 INDICATIONS AND USAGE
PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.
PEG-3350 and Electrolytes for Oral Solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults (
1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS).
IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
IBU tablets are indicated for relief of mild to moderate pain.
IBU tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.
1 INDICATIONS AND USAGE
Ganciclovir Injection
Ganciclovir Injection
is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the:
treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). (
1.1)
prevention of CMV disease in adult transplant recipients at risk for CMV disease. (
1.2)
1.1	Treatment of CMV Retinitis
Ganciclovir Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS)
[see
Clinical Studies (14.1)].
1.2	Prevention of CMV Disease in Transplant Recipients
Ganciclovir Injectionis indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease
[see
Clinical Studies (14.2)].
1INDICATIONS AND USAGE
ENTRESTO is indicated:
to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1)
for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (1.2)
1.1Adult Heart Failure
ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
LVEF is a variable measure, so use clinical judgment in deciding whom to treat [see Clinical Studies (14.1)].
1.2Pediatric Heart Failure
ENTRESTO is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes.
1 INDICATIONS AND USAGE
Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of:
Parkinsons disease (PD) (1.1)
1.1 Parkinson's Disease
Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinsons disease.
INDICATIONS & USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets and other antibacterial drugs, trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
For the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organisms:
Escherichia coli,
Proteus mirabilis,
Klebsiella pneumoniae,
Enterobacter species, and coagulase-negative
Staphylococcus species, including
S. saprophyticus.
Cultures and susceptibility tests should be performed to determine the susceptibility of the bacteria to trimethoprim. Therapy may be initiated prior to obtaining the results of these tests.
INDICATIONS AND USAGE
Sulfasalazine delayed release tablets are indicated:
a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis;
b)for the prolongation of the remission period between acute attacks of ulcerative colitis;
c)in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); and
d)in the treatment of pediatric patients with polyarticular-course1 juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.
Sulfasalazine delayed release tablets are particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance, and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites, e.g., patients experiencing nausea and vomiting with the first few doses of the drug, or patients in whom a reduction in dosage does not alleviate the adverse gastrointestinal effects.
In patients with rheumatoid arthritis or juvenile rheumatoid arthritis, rest and physiotherapy as indicated should be continued. Unlike anti-inflammatory drugs, sulfasalazine delayed release tablets do not produce an immediate response. Concurrent treatment with analgesics and/or nonsteroidal anti-inflammatory drugs is recommended at least until the effect of sulfasalazine delayed release tablets is apparent.
1 INDICATIONS AND USAGE
Levoleucovorin injection is a folate analog.
Levoleucovorin injection rescue is indicated after high-dose methotrexate therapy in osteosarcoma.
Levoleucovorin injection is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
Levoleucovorin injection is indicated for use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
Levoleucovorin
injection is a folate analog indicated for:
Rescue after high-dose methotrexate therapy in osteosarcoma.
Diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
Use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.(1)
Limitations of Use
Levoleucovorin injection is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress. (1.1)
1.1 Limitations of Use
Levoleucovorin injection is not approved for pernicious anemia and megaloblastic anemias secondary to the lack of vitamin B
12.Improper use may cause a hematologic remission while neurologic manifestations continue to progress.
INDICATIONS & USAGE SECTION
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Clindamycin HCl and other antibacterial drugs, Clindamycin HCl Capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1	INDICATIONS AND USAGE
Bortezomib for injection is a proteasome inhibitor indicated for:
treatment of adult patients with multiple myeloma (
1.1)
treatment of adult patients with mantle cell lymphoma (
1.2)
1.1	Multiple Myeloma
Bortezomib for injection
, 3.5 mg/vial is indicated for the treatment of adult patients with multiple myeloma.
1.2	Mantle Cell Lymphoma
Bortezomib for injection
is indicated for the treatment of adult patients with mantle cell lymphoma.
INDICATIONS AND USAGE
Glipizide and metformin hydrochloride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
INDICATIONS AND 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.)
1 INDICATIONS AND USAGE
Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
Alfuzosin hydrochloride extended-release tablets, an alpha adrenergic antagonist, are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.(1)
Important Limitations of Use:
Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. (1.1)
Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. (1.1, 8.4, 12.3)
1.1 Important Limitations of Use
Alfuzosin hydrochloride extended-release tablets are not indicated for the treatment of hypertension.
Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population.
1.3 Irritability Associated with Autistic Disorder
Pediatrics Risperidone tablets are indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5 to 16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [see Clinical Studies (14.4)].
INDICATIONS AND USAGE
Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in themanagement of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronicschizophrenics).
Fluphenazine Decanoate Injection has not been shown effective in the management of behavioralcomplications in patients with mental retardation.
INDICATIONS AND USAGE
Lidocaine hydrochloride and epinephrine injection, USP solutions are indicated for the production of local anesthesia for dental procedures by nerve block or infiltration techniques.
Only accepted procedures for these techniques as described in standard textbooks are recommended.
1 INDICATIONS AND USAGE
Ganciclovir for Injection, USP is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the:
Treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). (
1.1)
Prevention of CMV disease in adult transplant recipients at risk for CMV disease. (
1.2)
1.1 Treatment of CMV Retinitis
Ganciclovir for Injection, USP is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see
Clinical Studies (14.1)].
1.2 Prevention of CMV Disease in Transplant Recipients
Ganciclovir for Injection, USP is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see
Clinical Studies (14.2)].
INDICATIONS AND USAGE:
Adult Patients
Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
Pediatric Patients (aged 1 to 17)
Flumazenil Injection, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (see
PRECAUTIONS
,
Pediatric Use
).
INDICATIONS AND USAGE:
Xylocaine (lidocaine HCl) Injections are indicated for production
of local or regional anesthesia by infiltration techniques such as
percutaneous injection and intravenous regional anesthesia by peripheral
nerve block techniques such as brachial plexus and intercostal and by
central neural techniques such as lumbar and caudal epidural blocks,
when the accepted procedures for these techniques as described in
standard textbooks are observed.
INDICATIONS AND USAGE
Malaria
Hydroxychloroquine sulfate tablets are indicated for the treatment of uncomplicated malaria due to
P. falciparum,
P. malariae,
P. ovale, and
P. vivax.
Hydroxychloroquine sulfate tablets are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use in Malaria
Hydroxychloroquine
sulfate tablets are not recommended for the treatment of complicated
malaria.
Hydroxychloroquine
sulfate tablets are not effective against chloroquine or
hydroxychloroquine-resistant strains of
Plasmodium
species (see
CLINICAL
PHARMACOLOGY
Microbiology ). Hydroxychloroquine sulfate tablets
are not recommended for the treatment of malaria acquired in geographic
areas where chloroquine resistance occurs or when the
Plasmodium
species
has not been identified.
Hydroxychloroquine
sulfate tablets are not recommended for malaria prophylaxis in geographic
areas where chloroquine resistance occurs.
Hydroxychloroquine
sulfate tablets do not prevent relapses of
P. vivax
or
P. ovale
because
it is not active against the hypnozoite forms of these parasites. For
radical cure of
P. vivax
and
P. ovale
infections,
concomitant therapy with an 8-aminoquinoline compound is necessary (see
CLINICAL
PHARMACOLOGY
Microbiology ).
Prior to prescribing hydroxychloroquine sulfate tablets for the treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website (http://www.cdc.gov/malaria).
Lupus Erythematosus
Hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults.
Rheumatoid Arthritis
Hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1
INDICATIONS AND USAGE
Levocetirizine dihydrochloride is a histamine H 1-receptor antagonist indicated for:
The relief of symptoms associated with perennial allergic rhinitis (1.1)
The treatment of the uncomplicated skin manifestations of chronic idiopathicurticaria (1.2)
1.1
Perennial Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 years of age and older.
1.2
Chronic
Idiopathic Urticaria
Levocetirizine dihydrochloride tablet are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
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
mineralocorticoids where applicable; in infancy mineralocorticoid
supplementation is of particular importance).
Congenital adrenal hyperplasia
Nonsuppurative thyroiditis
Hypercalcemia associated with cancer
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
Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis
Dermatologic Diseases
Bullous dermatitis herpetiformis
Severe erythema multiforme (Stevens-Johnson syndrome)
Severe seborrheic dermatitis
Exfoliative dermatitis
Mycosis fungoides
Pemphigus
Severe psoriasis
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
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
Respiratory Diseases
Symptomatic sarcoidosis
Berylliosis
Loefflers syndrome not manageable by other means
Fulminating or disseminated pulmonary tuberculosis when used concurrently
with appropriate antituberculous chemotherapy
Aspiration pneumonitis
Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Acquired (autoimmune) hemolytic anemia
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute 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 colitis
Regional 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.