um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
KABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. KABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.
Limitations of Use:
KABIVEN is not recommended for use in pediatric patients under the age of 2 years, including preterm infants because the fixed content of the formulation does not meet the nutritional requirements of this age group
[see
Warnings and Precautions (5.1)
and
Use in Specific Populations (8.4)
].
KABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. KABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients. (1)
Limitations of Use:
Not recommended for use in pediatric patients < 2 years including preterm infants because the fixed content of the formulation does not meet nutritional requirements in this age group. (1,
5.1,
8.4)
INDICATIONS AND USAGE
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
1 INDICATIONS AND USAGE
Indomethacin capsules are a nonsteroidal anti-inflammatory drug indicated for:
Moderate to severe rheumatoid
arthritis including acute flares of chronic disease
Moderate to severe ankylosing
spondylitis
Moderate to severe
osteoarthritis
Acute painful shoulder
(bursitis and/or tendinitis)
Acute gouty arthritis (1)
Indomethacin capsules are indicated for:
Moderate to severe rheumatoid arthritis including acute
flares of chronic disease
Moderate to severe ankylosing spondylitis
Moderate to severe osteoarthritis
Acute painful shoulder (bursitis and/or tendinitis)
Acute gouty arthritis
1 INDICATIONS AND USAGE
Medroxyprogesterone acetate is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Medroxyprogesterone acetate long-term
[see
Warnings and Precautions (5.1)]
.
Medroxyprogesterone acetate is a progestin indicated only for the prevention of pregnancy. (
1)
INDICATIONS AND USAGE
Lindane Shampoo is indicated for the treatment of head lice (infestations of Pediculus humanus capitis), crab lice (infestations of Pthirus pubis), and their ova only in patients who
cannot tolerate other approved therapies, or
have failed treatment with other approved therapies.
Lindane Shampoo should be used in the context of an overall lice management program that includes:
Visual inspection to ensure that the patient is currently
infested with live lice (empty egg casings or "nits" can remain on
hair shaft long after true infestation).
Manual removal of nits using a comb designed for this
purpose and/or individual removal with tweezers followed by close
examination of the hair and scalp.
Evaluation and treatment of sexual contacts
simultaneously. Sexual contacts should be prescribed Lindane Shampoo only
if they either have failed to respond to adequate doses of other approved
therapies or are intolerant of other approved therapies.
All recently worn clothing, underwear, pajamas, used
sheets, pillowcases, and towels should be washed in very hot water or
dry-cleaned.
Caregivers applying this product to patients should wear gloves less permeable to Lindane such as nitrile, latex with neoprene or sheer vinyl, and thoroughly clean hands after application. Natural latex gloves should be avoided because they are more permeable to Lindane.
Lindane Shampoo does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.
1 INDICATIONSAND USAGE
Digoxin is a cardiac glycoside indicated for:
Treatment of mild to moderate heart failure in adults. (1.1)
Increasing myocardial contractility in pediatric patients with heart failure. (1.2)
Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3)
1.1 Heart Failure in Adults
Digoxin tablets are indicated for the treatment of mild to moderate heart failure in adults. Digoxin tablets increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin tablets should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor.
1.2 Heart Failure in Pediatric Patients
Digoxin tablets increases myocardial contractility in pediatric patients with heart failure.
1.3 Atrial Fibrillation in Adults
Digoxin tablets are indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.
1 INDICATIONS AND USAGE
Valproic Acid Oral Solution is indicated for:
Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1)
1.1 Epilepsy
Valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
See
Warnings and Precaution (5.1) for statement regarding fatal hepatic dysfunction.
1.2 Important Limitations
Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. [see Warnings and Precautions (5.2, 5.3, 5.4), Use in Specific Populations (8.1), and Patient Counseling Information (17)].
For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [
see Contraindications (4
)].
INDICATIONS AND USAGE
Tobramycin and Dexamethasone Ophthalmic Suspension is indicated for steroid- responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:
Staphylococci, including
S. aureus and
S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some
Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most
Proteus vulgaris strains
, Haemophilus influenzae and
H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some
Neisseria species.
1 INDICATIONS AND USAGE
Linezolid tablets are an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.1); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.2); Uncomplicated skin and skin structure infections (1.2); Vancomycin-resistant Enterococcus faecium infections(1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.4)
Linezolid tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid tablets are not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [see Warnings and Precautions (5.4)].
1.1 Pneumonia
Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14)].
Community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14)].
1.2 Skin and Skin Structure Infections
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 tablets have not been studied in the treatment of decubitus ulcers [see Clinical Studies (14)].
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies (14)].
1.3 Vancomycin-resistant Enterococcus faecium Infections
Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14)].
1.4 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid tablets and other antibacterial drugs, linezolid tablets 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 safety and efficacy of linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
INDICATIONS AND USAGE
Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Associations Diagnostic and Statistical Manual, III
1 as follows:
Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling on edge, irritability, impatience.
The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.
The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin 50 mg/m
2.
Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets, USPare recommended even where the incidence of postoperative nausea and/or vomiting is low.
INDICATIONS AND USAGE
Seasonal Allergic RhinitisOMNARIS Nasal Spray is indicated for the treatment of nasal
symptoms associated with seasonal allergic rhinitis in adults and children 6
years of age and older.
Perennial Allergic RhinitisOMNARIS Nasal Spray is indicated for the treatment of nasal
symptoms associated with perennial allergic rhinitis in adults and adolescents
12 years of age and older.
1 INDICATIONS AND USAGE
Hydromorphone hydrochloride 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
[see
Warnings and Precautions (5.2)],
reserve hydromorphone 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
Hydromorphone hydrochloride tablets contain hydromorphone, an opioid agonist, and are 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 hydromorphone 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
1 INDICATIONS & USAGE
1.1
Monotherapy
Dutasteride Capsules
are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
improve symptoms,
reduce the risk of acute urinary retention (AUR), and
reduce the risk of the need for BPH-related surgery.
1.2
Combination With Alpha Adrenergic Antagonist
Dutasteride Capsules in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
1.3
Limitations of Use
Dutasteride Capsules are not approved for the prevention of prostate cancer.
Dutasteride Capsulesare a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1.1)
improve symptoms,
reduce the risk of acute urinary retention, and
reduce the risk of the need for BPH-related surgery.
Dutasteride Capsules in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (1.2)
Limitations of Use: Dutasteride Capsules are not approved for the prevention of prostate cancer. (1.3)
1 INDICATIONS AND USAGE
Gabapentin tablets USP are indicated for:
Management of postherpetic neuralgia in adults
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 tablets are indicated for:
Postherpetic neuralgia in adults (1)
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 AND USAGE
Peridex is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Peridex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see
PRECAUTIONS.
1 INDICATIONS AND USAGE
ZELAPAR is indicated as an adjunct in the management of patients with Parkinsons disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that ZELAPAR has any beneficial effect in the absence of concurrent levodopa therapy [see
Clinical Studies (14
)
].
ZELAPAR, a monoamine oxidase type B (MAO-B) inhibitor, is indicated as an adjunct in the management of patients with Parkinsons disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy (1)
INDICATIONS AND USAGE
Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by
Candidaalbicans and other susceptibleCandidaspecies.
Nystatin Ointment, USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
1 INDICATIONS AND USAGE
TWYNEO is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.
TWYNEO is a combination tretinoin, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. (1)
1 INDICATIONS AND USAGE
Indications and Usage:
1.1 Respiratory Tract Infections
Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of
Streptococcus pneumoniae and
Streptococcus pyogenes.
1.2 Otitis Media
Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of
Streptococcus pneumoniae,
Haemophilus influenzae,
Staphylococcus aureus,
Streptococcus pyogenes, and
Moraxella catarrhalis.
1.3 Skin and Skin Structure Infections
Cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria:
Staphylococcus aureus and
Streptococcus pyogenes.
1.4 Bone Infections
Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of
Staphylococcus aureus and
Proteus mirabilis.
1.5 Genitourinary Tract Infections
Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of
Escherichia coli,
Proteus mirabilis, and
Klebsiella pneumoniae.
1.6 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets and other antibacterial drugs, cephalexin capsules, cephalexin for oral suspension, and cephalexin 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 is available, this information 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
Hypertension
Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol succinate extended-release tablets are indicated in the long-term treatment of angina pectoris.
Heart Failure
Metoprolol succinate extended-release tablets are indicated for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, metoprolol succinate extended-release tablets decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure.
1 INDICATIONS AND USAGE
Cisatracurium besylate injection, USPis indicated:
as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age
to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU
to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older
Limitations of Use
Cisatracurium besylate injection, USP is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.
Cisatracurium besylate injection, USPis a nondepolarizing neuromuscular blocker indicated:
as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age (1)
to provide skeletal muscle relaxation during surgery in adults and in pediatric patients 2 to 12 years of age as a bolus or infusion maintenance (1)
for mechanical ventilation in the ICU in adults (1)
Limitations of Use:
Cisatracurium besylate injection, USP is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action (1)