um-ids/dailymed-annotations huggingface dataset:
INDICATIONS & USAGE SECTION
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 hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis.
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.
Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.
Dermatologic diseases: pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis.
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.
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.
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.
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.
1 INDICATIONS AND USAGE
VARUBI is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
VARUBI is a substance P/neurokinin 1 (NK1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. (1)
1 INDICATIONS AND USAGE
Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets has been shown to decrease sleep latency and improve sleep maintenance (1)
INDICATIONS AND USAGE
PhosLo is indicated for the control of hyperphosphatemia in end stage renal
failure and does not promote aluminum absorption.
INDICATIONS AND USAGE
Dialyvite Supreme D is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.
INDICATIONS
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Limitations of Use:
The dosage of this product is for HIV-1 and not for HBV.
Lamivudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Limitations of Use: The dosage of this product is for HIV-1 and not for HBV.
(1)
1 INDICATIONS AND USAGE
CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
CIBINQO is a Janus kinase (JAK) inhibitor indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. (1)
Limitation of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
Limitations of Use
CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
1 INDICATIONS AND USAGE
Sapropterin dihydrochloride tablets are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride is to be used in conjunction with a Phe-restricted diet.
Sapropterin dihydrochloride is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4) responsive Phenylketonuria (PKU). Sapropterin dihydrochloride is to be used in conjunction with a Pherestricted diet. (1)
INDICATIONS AND USAGE
Fludrocortisone acetate tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.
INDICATIONS AND USAGE:
Tobramycin ophthalmic solution 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution. Clinical studies have shown tobramycin to be safe and effective for use in children.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of mefenamic acid capsules and other treatment options before deciding to use mefenamic acid capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation).
Mefenamic acid capsules are indicated:
For relief of mild to moderate pain in patients 14
years of age, when therapy will not exceed one week (7 days).
For treatment of primary dysmenorrhea.
INDICATIONS AND USAGE
Oxycodone and acetaminophen tablets, USP is indicated for the relief of moderate to moderately severe pain.
INDICATIONS AND USAGE
A. Benign Prostatic Hyperplasia (BPH)
Doxazosin mesylate is indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin mesylate may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin mesylate monotherapy. Doxazosin mesylate provides rapid improvement in symptoms and urinary flow rate in 66 to 71% of patients. Sustained improvements with doxazosin mesylate were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies.
B. Hypertension
Doxazosin mesylate is also indicated for the treatment of hypertension. Doxazosin mesylate may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers, or angiotensin-converting enzyme inhibitors.
INDICATIONS AND USAGE
Midazolam injection is indicated:
intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;
intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;
intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);
continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
Midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours (see
CLINICAL PHARMACOLOGY
).
INDICATIONS AND USAGE
TOLINASE Tablets are indicated as an adjunct to diet to lower the blood glucose in patients with noninsulin dependent diabetes mellitus (Type II) whose hyperglycemia cannot be satisfactorily controlled by diet alone.
In initiating treatment for noninsulin-dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed and cardiovascular risk factors should be identified and corrective measures taken where possible.
If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of TOLINASE must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient thus requiring only short-term administration of TOLINASE.
During maintenance programs, TOLINASE should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgments should be based on regular clinical and laboratory evaluations.
In considering the use of TOLINASE in asymptomatic patients, it should be recognized that controlling the blood glucose in noninsulin-dependent diabetes has not been definitely established to be
effective in preventing the long-term cardiovascular or neural complications of diabetes.
1 INDICATIONS AND USAGE
Meperidine Hydrochloride Injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia.
Meperidine Hydrochloride Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Meperidine Hydrochloride Injection is indicated for preoperative medication, support of anesthesia, for obstetrical analgesia, and for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Meperidine Hydrochloride Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)
], reserve Meperidine Hydrochloride Injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Meperidine Hydrochloride Injection should not be used for treatment of chronic pain. Prolonged Meperidine Hydrochloride Injection use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine.
INDICATIONS AND USAGE
Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension.
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.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.
INDICATIONS AND USAGE
Lidocaine Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.
INDICATIONS AND USAGE
Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is 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 II 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 these methods can result in lower failure rates.
TABLE II: Percentage of women experiencing an unintended pregnancy during the first year of typical use and the first year of perfect use of contraception and the percentage continuing use at the end of the first year, United States.
% of Women Experiencing an Unintended Pregnancy within the First Year of Use
% of Women
Continuing Use at
One Year
1
Method
(1)
Typical Use
2
(2)
Perfect Use
3
(3)
(4)
Chance
4
85
85
Spermicides
5
26
6
40
Periodic Abstinence
25
63
Calendar
9
Ovulation Method
3
Sympto-Thermal
6
2
Post-Ovulation
1
Withdrawal
19
4
Cap
7
Parous Women
40
26
42
Nulliparous Women
20
9
56
Sponge
Parous Women
40
20
42
Nulliparous Women
20
9
56
Diaphragm
7
20
6
56
Condom
8
Female (Reality)
21
5
56
Male
14
3
61
Pill
5
71
Progestin Only
0.5
Combined
0.1
IUD
Progesterone T
2
1.5
81
Copper T 380A
0.8
0.6
78
LNg 20
0.1
0.1
81
Depo-Provera
0.3
0.3
70
Norplant and Norplant-2
0.05
0.05
88
Female Sterilization
0.5
0.5
100
Male Sterilization
0.15
0.10
100
Adapted from Hatcher et al., 1998, ref #1.
1.
Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
2.
Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3.
Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
4.
The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5.
Foams, creams, gels, vaginal suppositories, and vaginal film.
6.
Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7.
With spermicidal cream or jelly.
8.
Without spermicides.
INDICATIONS AND USAGE
Acyclovir Ointment, 5%is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.
1	INDICATIONS AND USAGE
AdreView is a radiopharmaceutical agent for gamma-scintigraphy indicated for:
use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests (
1.1)
scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF)
35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio
1.6. (
1.2)
Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for:
selecting a therapeutic intervention or for monitoring the response to therapy;
using the H/M ratio to identify a patient with a high risk for death.
1.1	Pheochromocytoma and Neuroblastoma
AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.
1.2	Congestive Heart Failure
AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF)
35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio
1.6.
Limitations of Use: In patients with congestive heart failure, AdreView utility has not been established for:
selecting a therapeutic intervention or for monitoring the response to therapy;
using the H/M ratio to identify a patient with a high risk for death.
INDICATIONS AND USAGE
Status EpilepticusLorazepam injection is indicated for the treatment of status epilepticus.PreanestheticLorazepam injection is indicated in adult patients for preanesthetic medication, producing sedation (sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related to the day of surgery. It is most useful in those patients who are anxious about their surgical procedure and who would prefer to have diminished recall of the events of the day of surgery (seePRECAUTIONS, Information for Patients).
1. INDICATIONS AND USAGE
1.1 Obsessive-Compulsive DisorderFluvoxamine Maleate Tablets are indicated for the treatment of
obsessions and compulsions in patients with obsessive compulsive disorder (OCD),
as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked
distress, are time-consuming, or significantly interfere with social or
occupational functioning.
Obsessive compulsive disorder is characterized by recurrent and persistent
ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or
repetitive, purposeful, and intentional behaviors (compulsions) that are
recognized by the person as excessive or unreasonable.
The efficacy of Fluvoxamine Maleate Tablets was established in four trials in
outpatients with OCD: two 10-week trials in adults, one 10-week trial in
pediatric patients (ages 8-17), and one maintenance trial in adults. (See
CLINICAL STUDIES
[14].)