um-ids/dailymed-annotations huggingface dataset:
INDICATIONS
Prednisone 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
Hypercalcemia associated with cancer
Nonsuppurative thyroiditis
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
Bronchial asthma
Contact dermatitis
Atopic dermatitis
Serum sickness
Drug hypersensitivity reactions
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
Allergic conjunctivitis
Keratitis
Chorioretinitis
Optic neuritis
Iritis and iridocyclitis
7. Respiratory Diseases
Symptomatic sarcoidosis
Loefflers 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
INDICATION AND USAGE
Fluocinolone acetonide oil, 0.01% (ear drops) is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.
1 INDICATIONS AND USAGE
Topotecan Hydrochloride for Injection is a topoisomerase inhibitor indicated for treatment of:
Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent (1.1)
Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent (1.2)
Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin (1.3)
1.1 Ovarian Cancer
Topotecan Hydrochloride for Injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy.
1.2 Small Cell Lung Cancer
Topotecan Hydrochloride for Injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy.
1.3 Cervical Cancer
Topotecan Hydrochloride for Injection, in combination with cisplatin, is indicated for the treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer not amenable to curative treatment.
INDICATIONS AND USAGE
Venlafaxine tablets are indicated for the treatment of major depressive disorder.
The efficacy of venlafaxine tablets in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see
CLINICAL TRIALS
).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see
CLINICAL TRIALS
). Nevertheless, the physician who elects to use venlafaxine tablets/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Etodolac extended-release tablets are indicated:
*For relief of signs and symptoms of juvenile arthritis
*For relief of the signs and symptoms of rheumatoid arthritis
*For relief of the signs and symptoms of osteoarthritis
1
INDICATIONS AND USAGE
BOTOX Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
moderate to severe lateral canthal lines associated with orbicularis oculi activity
moderate to severe forehead lines associated with frontalis muscle activity
BOTOX Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvement in the appearance of (1):
Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
Moderate to severe lateral canthal lines associated with orbicularis oculi activity
Moderate to severe forehead lines associated with frontalis muscle activity
1
INDICATIONS AND USAGE
DELZICOLis an aminosalicylate indicated for:
Treatment of mildly to moderately active ulcerative colitis in patients5 years of age and older. (1.1)
Maintenance of remission of ulcerative colitis in adults. (1.2)
1.1
Treatment of Mildly to Moderately Active Ulcerative Colitis
DELZICOL is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.
1.2
Maintenance of Remission of Ulcerative Colitis
DELZICOL is indicated for the maintenance of remission of ulcerative colitis in adults.
1 INDICATIONS AND USAGE
Celecoxib is a non-steroidal 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)
Celecoxib capsules are indicated
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 AND USAGE
PIRNUO cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).
PIRNUO cream is an RNA synthetase inhibitor antibacterial indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. (1)
INDICATIONS & USAGE
Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized.Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery.Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure.
INDICATIONS AND USAGE
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
*Efficacy for this organism was studied in fewer than 10 infections
CONJUNCTIVITIS:
Gram-positive bacteria:
Gram-negative bacteria:
Staphylococcus aureus
Enterobacter cloacae
Staphylococcus epidermidis
Haemophilus influenzae
Streptococcus pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
CORNEAL ULCERS:
Gram-positive bacteria:
Gram-negative bacteria:
Staphylococcus aureus
Pseudomonas aeruginosa
Staphylococcus epidermidis
Serratia marcescens*
Streptococcus pneumoniae
Anaerobic species:
Propionibacterium acnes
Glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
Pramipexole dihydrochloride extended-release tablets is indicated for the treatment of Parkinson's disease.
Pramipexole dihydrochloride extended-release tablets are a non-ergot dopamine agonist indicated for the treatment of Parkinson's disease (PD) (1)
INDICATIONS AND USAGE
Heparin Sodium Injection, USP is indicated for:
Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension;
Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery who are at risk of developing thromboembolic disease (see
DOSAGE AND ADMINISTRATION
);
Prophylaxis and treatment of pulmonary embolism;
Atrial fibrillation with embolization;
Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation);
Prevention of clotting in arterial and cardiac surgery;
Prophylaxis and treatment of peripheral arterial embolism;
Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures.
Indications and Usage
Lidocaine Hydrochloride Jelly USP, 2% is indicated for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).
INDICATIONS AND USAGE
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE 1: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
% of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use
Method
Lowest Expected*
Typical**
(No contraception)
(85)
(85)
Oral contraceptives
combined
0.1
3***
progestin only
0.5
3***
Diaphragm with spermicidal cream or jelly
6
18
Spermicides alone (foam, creams, jellies and vaginal suppositories)
3
21
Vaginal sponge
nulliparous
6
18
multiparous
9
28
IUD
0.8-2.0
3#
Condom without spermicides
2
12
Periodic abstinence (all methods)
1-9
20
Injectable progestogen
0.3-0.4
0.3-0.4
Implants
6 capsules
0.04
0.04
2 rods
0.03
0.03
Female sterilization
0.2
0.4
Male sterilization
0.1
0.15
Reproduced with permission of the Population Counsil from J. Trusell, et. al: Contraceptive failure in the United States: An update. Studies in Family Planning, 21(1), January-February 1990.
* The authors best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any reason other than pregnancy.
** This term represents typical couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any reason other than pregnancy.
*** Combined typical rate for both combined and progestin only.
# Combined typical rate for both medicated and nonmedicated IUD.
INDICATIONS AND USAGE
Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicansand other susceptible Candida species.
Nystatin Topical Powderis not indicated for systemic, oral, intravaginal or ophthalmic use.
1 INDICATIONS & USAGE
Rivastigmine tartrate capsules, are an acetylcholinesterase inhibitor indicated for treatment of:
Mild to moderate dementia of the Alzheimers type (1.1)
Mild to moderate dementia associated with Parkinsons disease (1.2)
1.1 Alzheimers Disease
Rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.
1.2 Parkinsons Disease Dementia
Rivastigmine tartrate capsules are indicated for the treatment of mild to moderate dementia associated with Parkinsons disease.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 empiric selection of therapy.
Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms:
Escherichia coli,
Klebsiella species,
Enterobacter species,
Morganella morganii,
Proteus mirabilis and
Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of
Streptococcus pneumoniae or
Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim oral suspension in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim oral suspension is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of
Streptococcus pneumoniae or
Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim oral suspension offer some advantage over the use of a single antimicrobial agent.
Shigellosis: For the treatment of enteritis caused by susceptible strains of
Shigella flexneri and
Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis
Jiroveci Pneumonia:
For the treatment of documented
Pneumocystis jiroveci pneumonia and for prophylaxis against
Pneumocystis jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing
Pneumocystis jiroveci pneumonia.
Travelers Diarrhea In Adults: For the treatment of travelers diarrhea due to susceptible strains of enterotoxigenic
E. coli.
INDICATIONS AND USAGE
Testosterone Cypionate Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
1.
Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy.
2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.
Safety and efficacy of testosterone cypionate in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin extended-release capsules have been found effective in active stages of the following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease.
2. Moderate to severe ankylosing spondylitis.
3. Moderate to severe osteoarthritis.
4. Acute painful shoulder (bursitis and/or tendinitis).
Indomethacin extended-release capsules is not recommended for the treatment of acute gouty arthritis.
Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.
The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (See PRECAUTIONS, Drug Interactions
).
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.
1 INDICATIONS AND USAGE
Levoleucovorin for Injection is indicated for:
rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma.
diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients.
the treatment of adults with metastatic colorectal cancer in combination with fluorouracil.
Limitations of Use
Levoleucovorin for Injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B12, because of the risk of progression of neurologic manifestations despite hematologic remission.
Levoleucovorin for Injection is a folate analog indicated for:
Rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. (1)
Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. (1)
Treatment of adults with metastatic colorectal cancer in combination with fluorouracil. (1)
Limitations of Use:
Levoleucovorin for Injection is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12, because of the risk of progression of neurologic manifestations despite hematologic remission. (1)
1 INDICATIONS AND USAGE
ACZONE (dapsone) Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
ACZONE Gel, 7.5%, is a sulfone indicated for the topical treatment of acne vulgaris in patients 9 years of age and older (1).
1 INDICATIONS AND USAGE
Norepinephrine Bitartrate Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension.
Norepinephrine Bitartrate Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. (1)
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are indicated for:
Pantoprazole sodium delayed-release tablets are a proton pump inhibitor (PPI)indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD).
(1.1)
Maintenance of Healing of Erosive Esophagitis.
(1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE)Syndrome.
(1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE)Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE)Syndrome.