um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Plenamine 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when:
Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy;
Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks;
Tube feeding methods alone cannot provide adequate nutrition.
INDICATIONS AND USAGE
AttentionDeficitDisorders, Narcolepsy
AttentionDeficitDisorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.
Methylphenidate Hydrochloride Chewable Tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
SpecialDiagnosticConsiderations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.
Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.
Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.
INDICATIONS AND USAGE
Sulfasalazine tablets are indicated:
in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
for the prolongation of the remission period between acute attacks of ulcerative colitis
INDICATIONS:
This product is a keratolytic emollient useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.
INDICATIONS AND USAGE
Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemia of nutritional origin, pregnancy, infancy, or childhood.
Use:
Helps prevent sunburn.
1 INDICATIONS AND USAGE
Enter section text here
Letrozole is an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor positive
early breast cancer. (1.1)
Extended adjuvant treatment of postmenopausal women with early breast cancer
who have received prior standard adjuvant tamoxifen therapy. (1.2)
First and second-line treatment of postmenopausal women with hormone
receptor positive or unknown advanced breast cancer. (1.3)
1.1 Adjuvant Treatment of Early Breast Cancer
Letrozole
tablets are indicated for the adjuvant treatment of postmenopausal women with
hormone receptor positive early breast cancer.
1.2 Extended Adjuvant Treatment of Early Breast Cancer
Letrozole tablets are indicated for the extended adjuvant
treatment of early breast cancer in postmenopausal women, who have received 5
years of adjuvant tamoxifen therapy. The effectiveness of letrozole in extended
adjuvant treatment of early breast cancer is based on an analysis of
disease-free survival in patients treated with letrozole tablets for a median of
60 months [see Clinical Studies
(14.2, 14.3)].
1.3 First and Second-Line Treatment of Advanced Breast Cancer
Letrozole tablets are indicated for first-line treatment of
postmenopausal women with hormone receptor positive or unknown, locally advanced
or metastatic breast cancer. Letrozole tablets are also indicated for the
treatment of advanced breast cancer in postmenopausal women with disease
progression following antiestrogen therapy [see Clinical Studies
(14.4, 14.5)].
INDICATIONS AND USAGE
Nitrofurantoin Macrocrystals is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Macrocrystals and other antibacterial drugs, Nitrofurantoin Macrocrystals 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Macrocrystals are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Macrocrystals, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Macrocrystals, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
INDICATIONS AND USAGE:
Chlordiazepoxide HCI Capsules are indicated for the management of anxiety disorders or for the short-term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The effectiveness of chlordiazepoxide in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Atorvastatin calcium is indicated:
To reduce the risk of.
Myocardial infarction (MI), stroke, revascularization
procedures, and angina in adults with multiple risk factors for coronary
heart disease (CHD) but without clinically evident CHD.
MI and stroke in adults with type 2 diabetes mellitus with
multiple risk factors for CHD but without clinically evident CHD.
Non-fatal MI, fatal and non-fatal stroke,
revascularization procedures, hospitalization for congestive heart
failure, and angina in adults with clinically evident CHD.
As an adjunct to diet to reduce low-density lipoprotein
cholesterol (LDL-C) in:
Adults with primary hyperlipidemia.
Adults and pediatric patients aged 10 years and older with
heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
Atorvastatin calcium is an HMG-CoA reductase inhibitor (statin) indicated (1):
To reduce the risk of
Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD
MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD
Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.
As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in:
Adults with primary hyperlipidemia
Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia.
As an adjunct to diet for the treatment of adults with:
Primary dysbetaliproteinemia
Hypertriglyceridemia
1 INDICATIONS AND USAGE
Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]:
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Posttraumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
INDICATIONS AND USAGE
Predialysis Patients
Calcitriol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of
100 pg/mL is strongly suggestive of secondary hyperparathyroidism.
Dialysis Patients
Calcitriol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, calcitriol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization.
Hypoparathydroidism Patients
Calcitriol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.
1 INDICATIONS AND USAGE
Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation (1, 14).
Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support (1).
Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support.
The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium delayed-release tablets treatment. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.
INDICATIONS & USEAGE
INDICATIONS AND USAGE
Benzonatate is indicated for the symptomatic relief of cough.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen tablets are indicated for relief of mild to moderate pain.
Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin 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
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.
INDICATIONSAND USAGE
Aminocaproic acid oral solution is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required.
Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.
Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See
WARNINGS
.)
1 INDICATIONS AND USAGE
STEGLUJAN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.2)].
Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN [see Warnings and Precautions (5.1)].
STEGLUJAN is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. It may increase the risk of diabetic ketoacidosis in these patients. (1)
Has not been studied in patients with a history of pancreatitis. (1, 5.1)
1 INDICATIONS & USAGE
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha2-adrenergic receptor agonist indicated for: Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. (1.1) Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2)
1.1	Intensive Care Unit Sedation
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours.
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation.
1.2	Procedural Sedation
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
1 INDICATIONS AND USAGE
ALVESCO is an inhaled corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. (1)
ALVESCO is NOT indicated for the relief of acute bronchospasm. (1)
1.1 Treatment of Asthma
ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older.
Important Limitations of Use:
ALVESCO is NOT indicated for the relief of acute bronchospasm.
ALVESCO is NOT indicated for children under 12 years of age.
1 INDICATIONS AND USAGE
Escitalopram oral solution is a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2)
1.1 Major Depressive Disorder
Escitalopram oral solution is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies (14.1)
].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram oral solution is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies (14.2)
].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
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 Tablets contain 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 Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. (
1)
1 INDICATIONS & USAGE
Valganciclovir hydrochloride is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for:
Adult Patients
(1.1)
Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.
Pediatric Patients
(1.2)
Prevention of CMV disease in kidney and heart transplant patients at high risk.
1.1 Adult Patients
Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir hydrochloride is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS)
[see Clinical Studies (14.1)]
.
Prevention of CMV Disease: Valganciclovir hydrochloride is indicated for the prevention of CMV disease in kidney, heart, and kidney- pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
[see Clinical Studies (14.1)]
.
1.2	Pediatric Patients
Prevention of CMV Disease: Valganciclovir hydrochloride is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk
[see Clinical Studies (14.2)]
.
1
INDICA
TIONS AND USAGE
LAMZEDEis indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.
LAMZEDE isrecombinant human lysosomal alpha-mannosidase indicated for the treatment of non-central nervous system manifestationsof alpha-mannosidosis in adult and pediatric patients. (1)
1
INDICATIONS AND USAGE
Gabapentin is indicated for:
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin is indicated for:
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric
patients 3 years and older with epilepsy (
1)
INDICATIONS & USAGE
Oxybutynin chloride tablets, USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).