um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
For Dermatologic Use
Salicylic Acid 6% is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles).
For Podiatric Use
Salicylic Acid 6% is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of salicylic acid have been reported to be useful adjunctive therapy for verrucae plantares.
1 INDICATIONS AND USAGE
Risedronate sodium tablets are a bisphosphonate indicated for:
Treatment and prevention of postmenopausal osteoporosis (1.1)
Treatment to increase bone mass in men with osteoporosis (1.2)
Treatment and prevention of glucocorticoid-induced osteoporosis (1.3)
Treatment of Pagets disease (1.4)
Limitations of Use
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.5)
1.1 Postmenopausal Osteoporosis
Risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1, 14.2)].
1.2 Osteoporosis in Men
Risedronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis.
1.3 Glucocorticoid-Induced Osteoporosis
Risedronate sodium tablets are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
1.4 Pagets Disease
Risedronate sodium tablets are indicated for treatment of Pagets disease of bone in men and women.
1.5 Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
INDICATIONS AND USAGE
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
1.For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
2.For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, eg, digitalized patients or patients with significant cardiac arrhythmias.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.
1 INDICATIONS AND USAGE
Argatroban is a direct thrombin inhibitor indicated:
For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). (1.1)
As an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). (1.2)
1.1 Heparin-Induced Thrombocytopenia
Argatroban injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT).
1.2
Percutaneous Coronary Intervention
Argatroban injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).
1 INDICATIONS AND USAGE
ABSTRAL (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-theclock medicine consisting of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid medication daily for a week or longer. Patients must remain on around-the-clock opioids when taking ABSTRAL.
ABSTRAL is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could result at any dose in patients not on a chronic regimen of opioids. For this reason, ABSTRAL is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room.
ABSTRAL is intended to be prescribed only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.
Limitations of Use:
As a part of the TIRF REMS Access program, ABSTRAL may be dispensed only to outpatients enrolled in the program [see Warnings and Precautions (5.10)]. For inpatient administration of ABSTRAL (e.g., hospitals, hospices, and long-term care facilities that prescribe for inpatient use), patient and prescriber enrollment is not required.
ABSTRAL is an opioid agonist indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. (1) Limitations of Use:
ABSTRAL may be dispensed only to patients enrolled in the TIRF REMS Access program.
1 INDICATIONS AND USAGE
TIVICAY and TIVICAY PD are indicated in combination with: other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in adults (treatment-nave or -experienced) and in pediatric patients (treatment-nave or -experienced but integrase strand transfer inhibitor [INSTI]-nave)aged at least 4 weeks and weighing at least 3 kg [
see Microbiology (
12.4)].
TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.
1 INDICATIONSAND USAGE
Abiraterone acetate tabletsare indicated in combination with prednisone for the treatment of patients with
Metastatic castration-resistant prostate cancer (CRPC)
Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with
metastatic castration-resistant prostate cancer (CRPC).
1 INDICATIONS & USAGE
Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. (1)
1 INDICATIONS AND USAGE
Doxazosin tablets are an alpha1 adrenergic antagonist indicated for: (1)
Signs and symptoms of Benign Prostatic Hyperplasia (BPH)
Treatment of Hypertension
1.1	Benign Prostatic Hyperplasia (BPH)
Doxazosin tablets are indicated for the treatment of the signs and symptoms of BPH.
1.2	Hypertension
Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Doxazosin tablets may be used alone or in combination with other antihypertensives.
INDICATIONS AND USAGE
Depression - For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
Childhood Enuresis - May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.
1INDICATIONS AND USAGE
MICARDIS is an angiotensin II receptor blocker (ARB) indicated for:
Treatment of hypertension (1.1)
Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors (1.2)
1.1Hypertension
MICARDIS is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents
[see
Clinical Studies (14.1)]
.
1.2Cardiovascular Risk Reduction
MICARDIS is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors.
High risk for cardiovascular events can be evidenced by a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent or non-insulin dependent) with evidence of end-organ damage
[see Clinical Studies (14.2)]
. MICARDIS can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy)
[see Clinical Studies (14.2)]
.
Studies of telmisartan in this setting do not exclude that it may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves.
Use of telmisartan with an ACE inhibitor is not recommended
[see Warnings and Precautions (5.6)]
.
1 INDICATIONS & USAGE
Oseltamivir phosphate capsules USP, is an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (
1.1)
Prophylaxis of influenza A and B in patients 1 year and older. (
1.2)
Limitations of Use:
Not a substitute for annual influenza vaccination. (
1.3)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (
1.3)
Not recommended for patients with end-stage renal disease not undergoing dialysis. (
1.3)
1.1 Treatment of Influenza
Oseltamivir phosphate capsule is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2 Prophylaxis of Influenza
Oseltamivir phosphate capsule is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3 Limitations of Use
Oseltamivir phosphate capsule is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Oseltamivir phosphate capsules [
see Microbiology (
12.4)
].
Oseltamivir phosphate capsule is not recommended for patients with end-stage renal disease not undergoing dialysis [
see Dosage and Administration (
2.4) and Use in Specific Populations (
8.6)
].
INDICATIONS AND USAGE
Medroxyprogesterone Acetate Injectable Suspension, USP is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Medroxyprogesterone Acetate Injectable Suspension, USP long-term (see WARNINGS.)
It is a long-term injectable contraceptive in women when administered at 3-month (13-week) intervals. Dosage does not need to be adjusted for body weight.
In five clinical studies using Medroxyprogesterone Acetate Injectable Suspension, USP, the 12-month failure rate for the group of women treated with Medroxyprogesterone Acetate Injectable Suspension, USP was zero (no pregnancies reported) to 0.7 by Life-Table method. Pregnancy rates with contraceptive measures are typically reported for only the first year of use as shown in Table 1. Except for intrauterine devices (IUD), implants, sterilization, and Medroxyprogesterone Acetate Injectable Suspension, USP, the efficacy of these contraceptive measures depends in part on the reliability of use. The effectiveness of Medroxyprogesterone Acetate Injectable Suspension, USP is dependent on the patient returning every 3 months (13 weeks) for reinjection.
Table 1 Lowest Expected and Typical Failure RatesLowest expected - when used exactly as directed. Typical - includes those not following directions exactly.
Expressed as Percent of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use
Method
Lowest Expected
Typical
Source: Trussell et al1
Injectable progestogen
Medroxyprogesterone
0.3
0.3
Acetate
Implants
Norplant (6 capsules)
0.2from Norplant package insert.
0.2
Female sterilization
0.2
0.4
Male sterilization
0.1
0.15
Pill
3
Combined
0.1
Progestogen only
0.5
IUD
3
Progestasert
2
Copper T 380A
0.8
Condom
2
12
Diaphragm
6
18
Cap
6
18
Spermicides
3
21
Sponge
Parous women
9
28
Nulliparous women
6
18
Periodic abstinence
19
20
Withdrawal
4
18
No method
85
85
Monotherapy and Combination Therapy
Pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see CLINICAL STUDIES (14)].
Important Limitations of Use
Pioglitazone tablets exert its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings.
Use caution in patients with liver disease [see WARNINGS AND PRECAUTIONS (5.3)].
INDICATION AND USAGE: IROSPAN 24/6 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, post-surgical convalescence, and dietary needs.
1 INDICATIONS AND USAGE
Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (1)
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.
INDICATIONS AND USAGE
DIFLUCAN (fluconazole) is indicated for the treatment of:
1.Vaginal candidiasis (vaginal yeast infections due to Candida).
2.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, DIFLUCAN was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
3.Cryptococcal meningitis. Before prescribing DIFLUCAN (fluconazole) for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing DIFLUCAN to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis
DIFLUCAN is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ketoprofen capsules USP and other treatment options before deciding to use ketoprofen capsules USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS).
Ketoprofen capsules USP are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ketoprofen capsules USP are indicated for the management of pain. Ketoprofen capsules USP are also indicated for treatment of primary dysmenorrhea.
1 INDICATIONS AND USAGE
Indocyanine Green for Injection USP is indicated:
Indocyanine Green for Injection USP a tricarbocyanine dye, is indicated:
For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system (1.1)
For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system (1.2)
For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system (1.3)
1.1 Visual assessment of blood vessels, blood flow and related tissue perfusion
For visual assessment of blood vessels, blood flow and related tissue perfusion with OLYMPUS infrared compatible endoscopic imaging system
1.2 Visual assessment of the major extrahepatic bile duct
For visual assessment of the major extrahepatic bile ducts with OLYMPUS infrared imaging endoscopic imaging system.
1.3 Viewing intra-operative blood flow in the cerebral area
For viewing intra-operative blood flow in the cerebral area with OLYMPUS infrared compatible video microscopic imaging system
1 INDICATIONS AND USAGE
Tadalafil Tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of:
erectile dysfunction (ED) (
1.1)
the signs and symptoms of benign prostatic hyperplasia (BPH) (
1.2)
ED and the signs and symptoms of BPH (ED/BPH) (
1.3)
If Tadalafil Tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks (
1.4).
1.1 Erectile Dysfunction
Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED).
1.2 Benign Prostatic Hyperplasia
Tadalafil Tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia
Tadalafil Tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).
1.4 Limitation of Use
If Tadalafil Tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of Tadalafil Tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of Tadalafil Tablets beyond 26 weeks is unknown
[see Clinical Studies (
14.3)]
.
INDICATIONS AND USAGE
Paregoric is useful for the treatment of diarrhea.
1 INDICATIONS AND USAGE
STAXYN is indicated for the treatment of erectile dysfunction.
STAXYN is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (
1
)
INDICATIONS SECTION
INDICATIONS NEUTRAMAXXtm 5000 PLUS TURBO IS A SELF-APPLIED DENTIFRICE FOR PREVENTION OF TOOTH DECAY, ORTHODONTIC DECALCIFICATION AND HYPERSENSITIVITY