um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS & USAGE
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults (1)
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
1
INDICATIONS AND USAGE
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha2-adrenergic receptor agonist indicated for:
Sedation of initially intubated and mechanically ventilated 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 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 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 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 patients prior to and/or during surgical and other procedures.
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
USAGE
Vitafol
Ultra provides vitamin, mineral, and DHA supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*
Vitafol
Ultra does not contain fish, fish oils, fish proteins or fish byproducts.
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
*Efficacy for this organism was studied in fewer than 10 infections
CONJUNCTIVITIS:
Gram-positive bacteria:
Gram-negative bacteria:
Staphylococcus aureus
Enterobacter cloacae
Staphylococcus epidermidis
Haemophilus influenzae
Streptococcus pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
CORNEAL ULCERS:
Gram-positive bacteria:
Gram-negative bacteria:
Staphylococcus aureus
Pseudomonas aeruginosa
Staphylococcus epidermidis
Serratia marcescens*
Streptococcus pneumoniae
Anaerobic species:
Propionibacterium acnes
1 INDICATIONS & USAGE
Celecoxib capsules are indicated
Celecoxib capsules are nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (
1.1)
Rheumatoid Arthritis (RA) (
1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (
1.3)
Ankylosing Spondylitis (AS) (
1.4)
Acute Pain (AP) (
1.5)
Primary Dysmenorrhea (PD) (
1.6)
1.1 Osteoarthritis
For the management of the signs and symptoms of OA [
see Clinical Studies (
14.1)
].
1.2 Rheumatoid Arthritis
For the management of the signs and symptoms of RA [
see Clinical Studies (
14.2)
].
1.3 Juvenile Rheumatoid Arthritis
For the management of the signs and symptoms of JRA in patients 2 years and older [
see Clinical Studies (
14.3)
].
1.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS [
see Clinical Studies (
14.4)
].
1.5	Acute Pain
For the management of acute pain in adults [
see Clinical Studies (
14.5)
].
1.6	Primary Dysmenorrhea
For the management of primary dysmenorrhea [
see Clinical Studies (
14.5)
].
1 INDICATIONS AND USAGE
Aripiprazole oral tablets are indicated for the treatment of:
Schizophrenia
Treatment of Tourettes Disorder
Aripiprazole tablets are an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (
14.1)
Treatment of Tourettes disorder (
14.5)
1 INDICATIONS AND USAGE
Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonistindicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1).
For treatment of adult patients with severe hypertriglyceridemia (1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate at a dose equivalent to 160 mg of fenofibrate tablet was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
Mycobacterial Infections (1.2)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3)
1.2 Mycobacterial Infections
Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease
Azithromycin tablets taken alone or in combination with rifabutin at its approved dose, are indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection [see Dosage and Administration (2)].
Treatment of Disseminated MAC Disease
Azithromycin tablets taken in combination with ethambutol, are indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection [see Use in Specific Populations (8.4) and Clinical Studies (14.1)].
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat 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.
INDICATIONS AND USAGE
Acarbose Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
Difluprednate ophthalmic emulsion (0.05%) is a topical corticosteroid that is indicated for:
Thetreatmentofinflammationandpainassociatedwithocular surgery (1.1)
The treatment of endogenous anterior uveitis (1.2)
1.1 Ocular Surgery
Difluprednate ophthalmic emulsion (0.05%)is a topical corticosteroid, indicated for the treatment of inflammation and pain associated with ocular surgery.
1.2 Endogenous AnteriorUveitis
Difluprednate ophthalmic emulsion (0.05%) is also indicated for the treatment of endogenous anterior uveitis.
INDICATIONS AND USAGE
Adult Patients:Flumazenil injection is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
Pediatric Patients (aged 1 to 17):Flumazenil injection is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: PEDIATRIC USE).
INDICATIONS AND USAGE:
Dextroamphetamine sulfate is indicated:
1. In Narcolepsy.
2. In Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) 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.
Hydrocodone bitartrate and acetaminophen tablets 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 [seeWARNINGS], reserve Hydrocodone Bitartrate 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
NovoLog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus (1.1).
1.1 Treatment of Diabetes Mellitus
NovoLog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
INDICATIONS AND USAGE
Citalopram tablets, USP are indicated for the treatment of depression.
The efficacy ofcitalopram
in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see
CLINICAL PHARMACOLOGY
).
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. The antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied.
The efficacy ofcitalopram
in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see
CLINICAL PHARMACOLOGY
). Nevertheless, the physician who elects to usecitalopram
for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
TRACLEER is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
in adults to improve exercise ability and to decrease clinical worsening.
Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%)
[see
Clinical Studies (14.1)]
.
in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.
TRACLEER is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
in adults to improve exercise ability and to decrease clinical worsening.
Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) (
1).
in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability (
1).
1 INDICATIONS & USAGE
Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USPisindicatedforthereductionofelevatedintraocularpressure(IOP)inpatientswith open-angleglaucomaorocularhypertensionwhoareinsufficientlyresponsivetobeta-blockers(failedto achievetargetIOPdeterminedaftermultiplemeasurementsovertime).TheIOP-loweringofdorzolamide hydrochloride-timolol maleate ophthalmic solution, USP administeredtwiceadaywasslightlylessthanthatseenwiththeconcomitantadministrationof0.5% timololadministeredtwiceadayand2%dorzolamideadministeredthreetimesaday [seeClinical Studies(14)].
Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor blocking agent, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. (1)
1 INDICATIONS AND USAGE
Meperidine hydrochloride tablets are indicated for the management of acute 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 meperidine 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.
Meperidine hydrochloride tablets should not be used for treatment of chronic pain. Prolonged meperidine hydrochloride tablets use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine.
Meperidine 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 meperidine 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.
INDICATIONS AND USAGE
Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as:
Chronic bronchopulmonary disease(chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung)
Acute bronchopulmonary disease(pneumonia, bronchitis, tracheobronchitis)
Pulmonary complications of cystic fibrosis
Tracheostomy care
Pulmonary complications associated with surgery
Use during anesthesia
Post-traumatic chest conditions
Atelectasis due to mucous obstruction
Diagnostic bronchial studies (bronchograms, bronchospirometry, and bronchial wedge catheterization)
1 INDICATIONS AND USAGE
Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.
Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. (1, 14)
INDICATIONS AND USAGE
Enalapril maleate and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
These fixed dose combinations are not indicated for initial treatment (see
DOSAGE AND ADMINISTRATION
).
In using enalapril maleate and hydrochlorothiazide tablets, 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 does not have a similar risk (see
WARNINGS
).
In considering use of Enalapril maleate and hydrochlorothiazide tablets, 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, Head and Neck Angioedema
).
1 INDICATIONS AND USAGE
Triferic is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
TRIFERIC is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD). (
1)
Limitation of Use
Triferic is not intended for use in patients receiving peritoneal dialysis. (
1)
Triferic has not been studied in patients receiving home hemodialysis. (
1)
1.1 Limitation of Use
Triferic is not intended for use in patients receiving peritoneal dialysis.
Triferic has not been studied in patients receiving home hemodialysis.
INDICATIONS AND USAGE
FORTAMET is indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
Ifosfamide for Injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.
Ifosfamide for Injection is an alkylating drug indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.
1 INDICATIONS AND USAGE
Hydrocodone bitartrate and homatropine methylbromide is indicated for thesymptomatic relief of cough in patients 18 years of age and older.
Important Limitations of Use:
Not indicated for pediatric patients under 18 years of age [
see Use in Specific Populations (8.4)].
Contraindicated in pediatric patients less than 6 years of age [
see Contraindications (4)].
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [
see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
Hydrocodone bitartrate and homatropine methylbromide is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in patients 18 years of age and older. (1)
Important Limitations of Use (1)
Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
1 INDICATIONS AND USAGE
Toremifene citrate tabletsare an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
Toremifene citrate tabletsarean estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.(1)
1 INDICATIONS AND USAGE
Paroxetine extended-release tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of (1):
Major Depressive Disorder (MDD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Premenstrual Dysphoric Disorder (PMDD)
Paroxetine extended-release tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)
1.3
Complicated Skin and Skin Structure Infections
Linezolid is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae. Linezolid has not been studied in the treatment of decubitus ulcers [see Clinical Studies (14)].
1 INDICATIONS AND USAGE
Methylin is indicated for the treatment of:
Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older
Narcolepsy
Methylin 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)