um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Hypertension
Enalapril maleate tablets are indicated for the treatment of hypertension.
Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.
Heart Failure
Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL
PHARMACOLOGY,
Heart Failure, Mortality Trials
for details and limitations of survival trials).
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction
35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY,
Heart Failure, Mortality Trials
for details and limitations of survival trials).
In using enalapril maleate 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 enalapril maleate does not have a similar risk (see WARNINGS).
In considering use of enalapril maleate, 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, Anaphylactoid and Possibly Related Reactions,
Hea
d
and
Neck
Angioedema
).
1 INDICATIONS AND USAGE
Morphine Sulfate Extended-Release Capsules are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve Morphine Sulfate Extended-Release Capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Morphine Sulfate Extended-Release Capsules are not indicated as an as-needed (prn) analgesic.
Morphine Sulfate Extended-Release Capsules are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Morphine Sulfate Extended-Release Capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.(1)
Morphine Sulfate Extended-Release Capsules are not indicated as an as-needed (prn) analgesic. (1)
INDICATIONS AND USAGE
Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Vancomycin Hydrochloride for Injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside.
Vancomycin Hydrochloride for Injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin Hydrochloride for Injection, USP has been used successfully in combination with either rifampin, an aminoglycoside or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.
INDICATIONS AND USAGE
Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
Otitis Externa in adults and pediatric patients, 6 months and older, due to
Escherichia coli,
Pseudomonas aeruginosa and
Staphylococcus aureus.
Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to
Proteus mirabilis,
Pseudomonas aeruginosa and
Staphylococcus aureus.
Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to
Haemophilus influenzae,
Moraxella catarrhalis,
Pseudomonas aeruginosa,
Staphylococcus aureus and
Streptococcus pneumoniae.
INDICATIONSAND USAGE
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 in 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
Risedronate sodiumis a bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis (1.1)
Limitations of UseOptimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.2)
1.1
Postmenopausal Osteoporosis
Risedronate sodiumdelayed-release is indicated for the treatment of osteoporosis inpostmenopausal women. In postmenopausal women, risedronate sodium has been shown toreduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see
Clinical Studies (14.1)
].
1.2
Important Limitations of Use
The optimal duration of use has not been determined.The safety and effectiveness of Risedronate sodium delayed-release for the treatment of osteoporosis are based on clinical data of one year 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
Jeanotope I-125 is indicated for use in the determination of total blood and plasma volume.
1 INDICATIONS AND USAGE
HECTOROL capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.
HECTOROL injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.
HECTOROL is a synthetic vitamin D2 analog:
HECTOROL capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis. (1)
HECTOROL injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. (1)
INDICATIONS AND USAGE
Clomipramine hydrochloride capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
The effectiveness of clomipramine hydrochloride capsules for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.
The effectiveness of clomipramine hydrochloride capsules for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see
DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE
Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by
Candida albicansand other susceptible
Candidaspecies.
Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets, USP and other antibacterial drugs, amoxicillin tablets, USP should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Amoxicillin tablets, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
1.1 Infections of the Ear, Nose, and Throat
Due to Streptococcus species (- and -hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
1.2 Infections of the Genitourinary Tract
Due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
1.3 Infections of the Skin and Skin Structure
Due to Streptococcus spp. (- and -hemolytic isolates only), Staphylococcus spp., or E. coli.
1.4 Infections of the Lower Respiratory Tract
Due to Streptococcus spp. (- and -hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections)
due to Neisseria gonorrhoeae.
Because of high rates of amoxicillin resistance, amoxicillin tablets, USP are not recommended for empiric treatment of gonorrhea. Amoxicillin tablets, USP use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.
1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole
Amoxicillin tablets, USP, in combination with clarithromycin plus lansoprazole as triple therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.7 Dual Therapy for H. pylori with Lansoprazole
Amoxicillin tablets, USP, in combination with lansoprazole delayed-release capsules as dual therapy, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1 INDICATIONS AND USAGE
Naproxen oral suspension is indicated for:
The relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
The management of:
pain
primary dysmenorrhea
Naproxen oral suspension is a non-steroidal anti-inflammatory drug indicated for:
The relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
The management of:
pain
primary dysmenorrhea
1 INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
Ezetimibe tablet is an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to:
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin) (
1.1)
Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate (
1.1)
Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin (
1.2)
Reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia) (
1.3)
Limitations of Use (
1.4)
The effect of ezetimibe on cardiovascular morbidity and mortality has not been determined.
Ezetimibe has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
1.1
Primary Hyperlipidemia
Monotherapy
Ezetimibe tablets, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density
lipoproteincholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary
(heterozygous familial and non-familial) hyperlipidemia.
Combination
Therapy with HMG-CoA Reductase Inhibitors (Statins)
Ezetimibe tablets, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as
adjunctivetherapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-
familial) hyperlipidemia.
Combination Therapy with Fenofibrate
Ezetimibe tablets, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia.
1.2
Homozygous Familial Hypercholesterolemia (HoFH)
The combination of ezetimibe and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3
Homozygous Sitosterolemia
Ezetimibe tablet is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.
1.4
Limitations of Use
The effect of ezetimibe on cardiovascular morbidity and mortality has not been determined.
Ezetimibe has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
1 INDICATIONS & USAGE
Aripiprazole Oral Tablets are indicated for the treatment of:
Schizophrenia
Irritability Associated with Autistic Disorder (14.4)
Treatment of Tourettes disorder (14.5)
Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (14.1)
Irritability Associated with Autistic Disorder (14.4)
Treatment of Tourettes disorder (14.5)
1 INDICATIONS AND USAGE
Alfuzosin hydrochloride is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
Alfuzosin hydrochloride is an alpha adrenergic antagonist, indicated for treatment of signs and symptoms of benign prostatic hyperplasia. (1)Important Limitations of Use:Alfuzosin hydrochloride is not indicated for the treatment of hypertension. (1.1)Alfuzosin hydrochloride is not indicated for use in the pediatric population. (1.1, 8.4 , 12.3)
1.1 Important Limitations of Use
Alfuzosin hydrochloride is not indicated for the treatment of hypertension.
Alfuzosin hydrochloride is not indicated for use in the pediatric population.
1 INDICATIONS AND USAGE
Tovet Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.
Tovet Foam is a corticosteroid indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. (1)
1 INDICATIONS AND USAGE
Methylphenidate hydrochloride oral solution is indicated for the treatment of:
Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older
Narcolepsy
Methylphenidate hydrochloride oral solution is a central nervous system (CNS) stimulant indicated for the treatment of:
Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older (1)
Narcolepsy (1)
INDICATIONS AND USAGE
Oxycodone and Acetaminophen Tablets, USP are 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
], reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]
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
Lexapro is indicated for the treatment of:
major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older.
generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older.
Lexapro is a selective serotonin reuptake inhibitor (SSRI) indicated for the:
treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older (1)
treatment of generalized anxiety disorder (GAD) in adults and pediatric patients 7 years and older (1)
1 INDICATIONS AND USAGE
Lamivudine Tablets is 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.
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.