um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated:
in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 22 kg. (
1.1)
for the treatment of chronic hepatitis B in adults and pediatric patients 12 years and older. (
1.2)
1.1	HIV-1 Infection
Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 22 kg.
1.2	Chronic Hepatitis B
Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 12 years of age and older.
Pediatric use information is approved for Gilead Sciences, Inc.s VIREAD
(tenofovir disoproxil fumarate) tablets. However, due to Gilead Sciences, Inc.s marketing exclusivity rights,this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Ritonavir tablets are an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
1 INDICATIONS AND USAGE
Clotrimazole and Betamethasone Dipropionate Cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to
Epidermophyton floccosum,
Trichophyton mentagrophytes, and
Trichophyton rubrumin patients 17 years and older.
INDICATIONS & USAGE
Enalaprilat injection, USP is indicated for the treatment of hypertension when oral therapy is not practical.
Enalaprilat injection, USP has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension.
In using enalaprilat injection, USP, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalaprilat injection, USP does not have a similar risk. (See
WARNINGS.)
In considering use of enalaprilat injection, USP, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks. (See
WARNINGS, Angioedema).
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (
see WARNINGS).
Mefenamic acid is 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.
1 INDICATIONS AND USAGE
Tadalafil Tablets are 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)]
.
1 INDICATIONS & USAGE
Oxycodone Hydrochloride Tablets is indicated 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
[see
Warnings and Precautions (5.1)],
reserve Oxycodone Hydrochloride Tablets 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.
Oxycodone Hydrochloride Tablets is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (
1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-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.
1 INDICATIONS AND USAGE
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
Trazodone hydrochloride tablets are
a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (1).
12. Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement
1 INDICATIONS AND USAGE
ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ.
Limitations of Use:
Not for use in opioid non-tolerant patients.
Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)].
As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see
Warnings and Precautions
(5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.
ACTIQ is an opioid agonist indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids while taking ACTIQ.
Limitations of Use
Not for use in opioid non-tolerant patients.
Not for use in the management of acute or postoperative pain, including headache/migraine or dental pain. (4)
As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program. (5.7) For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.
1 INDICATIONS AND USAGE
Zidovudine capsules are a nucleoside analogue reverse transcriptase inhibitor indicated for:
Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents.(1.1)
Prevention of maternal-fetal HIV-1 transmission.(1.2)
1.1 Treatment of HIV-1
Zidovudine capsules,
a nucleoside reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
1.2 Prevention of Maternal-Fetal HIV-1 Transmission
Zidovudine capsules are
indicated for the prevention of maternal-fetal HIV-1 transmission [see Dosage and Administration (2.3)]. The indication is based on a dosing regimen that included 3 components:
antepartum therapy of HIV-1-infected mothers
intrapartum therapy of HIV-1-infected mothers
post-partum therapy of HIV-1-exposed neonate
Points to consider prior to initiating zidovudine capsules
in pregnant women for the prevention of maternal-fetal HIV-1 transmission include:
In most cases, zidovudine capsules
for prevention of maternal-fetal HIV-1 transmission should be given in combination with other antiretroviral drugs.
Prevention of HIV-1 transmission in women who have received zidovudine capsules
for a prolonged period before pregnancy has not been evaluated.
Because the fetus is most susceptible to the potential teratogenic effects of drugs during the first 10 weeks of gestation and the risks of therapy with zidovudine capsules
during that period are not fully known, women in the first trimester of pregnancy who do not require immediate initiation of antiretroviral therapy for their own health may consider delaying use; this indication is based on use after 14 weeks' gestation.
1INDICATIONS AND USAGE
Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].
Focalin XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). (1)
1 INDICATIONS AND USAGE
Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).
Limitations of Use
In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness.
Modafinil tablets areindicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). (
1)
Limitations of Use
In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
Indications and Usage:
In the wasting syndrome in chronic renal failure; uremia; impaired metabolic functions of the kidney and to maintain levels when dietary intake of vitamins is inadequate or excretion or loss in excessive.
Also, highly effective as a stress vitamin.
1 INDICATIONS AND USAGE
Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.
Buprenorphine and naloxone sublingual tablet contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. (
1)
Buprenorphine and naloxone sublingual tablet should be used as part of a complete treatment plan that includes counseling and psychosocial support. (
1)
1 INDICATIONS AND USAGE
MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
MYCAPSSA is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide (1).
1 INDICATIONS AND USAGE
Diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (AK).
Diclofenac sodium gel is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the topical treatment of actinic keratoses (AK). (
1)
INDICATIONS & USAGE
Hypertension
Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol can be initiated as soon as the patient's clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS ). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).
1 INDICATIONS AND USAGE
Atomoxetine capsules are selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1)
1.1 Attention-Deficit/Hyperactivity Disorder (ADHD)
Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
The efficacy of atomoxetine capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies (14)].
1.2 Diagnostic Considerations
A diagnosis of ADHD(DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age7years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g.,in social, academic, or occupational functioning, and must be present in 2or more settings, e.g.,school (or work) and at home. The symptoms must not be better accounted for by another mental disorder.
The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, on the go, excessive talking, blurting answers, can't wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met.
1.3 Need for Comprehensive Treatment Program
Atomoxetine capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.
INDICATIONS AND USAGE
Granisetron hydrochloride tablets are indicated for the prevention of:
Nausea and vomiting associated with initial and repeat courses of emetogeniccancer therapy, including high-dose cisplatin.
Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
1 INDICATIONS AND USAGE
Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
Bexarotene capsules are a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.(1)
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:
CONJUNCTIVITIS:
Gram-positive bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Gram-negative bacteria:
Enterobacter cloacae
Haemophilus influenzae
Proteus mirabilis
Pseudomonas aeruginosa
CORNEAL ULCERS:
Gram-positive bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Gram-negative bacteria:
Pseudomonas aeruginosa
Serratia marcescens*
Anaerobic species:
Propionibacterium acnes
*Efficacy for this organism was studied in fewer than 10 infections
INDICATIONS AND USAGE:
Proparacaine hydrochloride ophthalmic solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.
INDICATIONS AND USAGE
Triamcinolone acetonide cream 0.025% and 0.1% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
INDICATIONS AND USAGE:
Isosorbide Mononitrate Tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease.
The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
INDICATIONS AND USAGE
TENORETIC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol and chlorthalidone.
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 1 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 Programs 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.
This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.