um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant.
(1.1)
Use in combination with cyclosporine and corticosteroids.
(1.1)
Limitations of Use:
Mycophenolic acid delayed release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably.
(1.2)
1.1 Prophylaxis of Organ Rejection in Kidney Transplant
Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Mycophenolic acid is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.
Mycophenolic acid is to be used in combination with cyclosporine and corticosteroids.
1.2 Limitations of Use
Mycophenolic acid delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
Acute Otitis Media:
For the treatment of acute otitis media in pediatric patients due to susceptible strains of
Streptococcus pneumoniae
or
Haemophilus influenzae
when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.
1 INDICATIONS AND USAGE
Entecavir tablet is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (1)
Entecavir tablet is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
1 INDICATIONS AND USAGE
Carisoprodol is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].
Hypertension
Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Angina Pectoris
Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.
Myocardial Infarction
Metoprolol tartrate tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous metoprolol tartrate. Oral metoprolol tartrate therapy can be initiated after intravenous metoprolol tartrate therapy, or alternatively, oral treatment can begin within 3 to 10 days of acute event(see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS).
1 INDICATIONS AND USAGE
CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.
CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. (1)
Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. (1)
1 INDICATIONSAND USAGE
Pantoprazole Sodium Delayed-Release Tablets are indicated for:
Pantoprazole sodium delayed-release tablet is a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated withGastroesophageal Reflux Disease (GERD)
(1.1)
Maintenance of Healing of Erosive Esophagitis (
1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome
(1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole Sodium Delayed-Release Tablet is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
Pantoprazole Sodium Delayed-Release Tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Pantoprazole Sodium Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
1 INDICATIONS AND USAGE
EstroGel 0.06% is an estrogen indicated for:
Treatment of moderate to severe vasomotor symptoms due to menopause (
1.1)
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause (
1.2)
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
1	INDICATIONS AND USAGE
LANTUS is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. (1)
Limitations of Use
Not recommended for the treatment of diabetic ketoacidosis. (1)
Limitations of Use
LANTUS is not recommended for the treatment of diabetic ketoacidosis.
1 INDICATIONS AND USAGE
Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) (
1).
1.1 Obsessive-Compulsive Disorder
Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.
The efficacy of Fluvoxamine Maleate Tablets was established in four trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8-17), and one maintenance trial in adults
[see Clinical Studies (
14)]
.
1 INDICATIONS AND USAGE
Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following:
Short-term treatment (7 to 10 days) of gastroesophageal reflux disease(GERD) associated with a history of Erosive Esophagitis (EE). (1.1)
Pathological hypersecretion conditions including Zollinger-Ellison (ZE)Syndrome. (1.2)
1.1	Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis
Pantoprazole sodium for injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE).
Safety and efficacy of pantoprazole sodium for injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.
1.2	Pathological Hypersecretion Including Zollinger-Ellison Syndrome
Pantoprazole sodium for injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.
INDICATIONS AND USAGE
Caffeine citrate injection is indicated for the treatment of apnea of prematurity.
1 INDICATIONS AND USAGE
Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)
INDICATIONS AND USAGE
Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
Skin and Skin Structure Infections caused by beta-lactamase producing strains of
Staphylococcus aureus,
Escherichia coli,*
Klebsiella spp.* (including
K. pneumoniae*),
Proteus mirabilis,*
Bacteroides fragilis,*
Enterobacter spp.,* and
Acinetobacter calcoaceticus.*
NOTE: For information on use in pediatric patients (see
PRECAUTIONS-Pediatric Use
and
CLINICAL STUDIES
sections).
Intra-Abdominal Infections caused by beta-lactamase producing strains of
Escherichia coli,
Klebsiella spp. (including
K. pneumoniae*),
Bacteroides spp. (including
B. fragilis), and
Enterobacter spp.*
Gynecological Infections caused by beta-lactamase producing strains of
Escherichia coli,* and
Bacteroides spp.* (including
B. fragilis*).
* Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While ampicillin and sulbactam for injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection, USP should not require the addition of another antibacterial.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection, USP.
Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.
To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection, USP and other antibacterial drugs, ampicillin and sulbactam for injection, USP 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.
1 INDICATIONS AND USAGE
Ondansetron Injection is a 5-HT3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (1.1)
postoperative nausea and/or vomiting. (1.2)
1.1 Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy
Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.
Ondansetron Injection is approved for patients aged 6 months and older.
1.2 Prevention of Postoperative Nausea and/or Vomiting
Ondansetron Injection is indicated for the 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 in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Injection and experience nausea and/or vomiting postoperatively, Ondansetron Injection may be given to prevent further episodes. Ondansetron Injection is approved for patients aged 1 month and older.
INDICATIONS AND USAGE
Predialysis PatientsCalcitriol 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 PatientsCalcitriol 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 PatientsCalcitriol 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
OSPHENA is indicated for:
OSPHENA is an estrogen agonist/antagonist indicated for:
The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1.1)
The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause. (1.2)
1.1	The Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause.
1.2	The Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, Due to Menopause.
INDICATIONS AND USAGE
Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics)
Have not provided adequate analgesia, or are not expected to provide adequate analgesia,
Have not been tolerated, or are not expected to be tolerated.
INDICATIONS AND USAGE
Parenteral
Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure. Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract. Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients. However, thyrotoxic individuals occasionally react poorly to barbiturates.
Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see
CLINICAL PHARMACOLOGY
).
Preanesthetic.
Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics. Phenobarbital sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use. When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain. Therefore, injecting phenobarbital sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression.
Phenobarbital is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.
1 INDICATIONS AND USAGE
Piroxicam Capsule is a nonsteroidal anti-inflammatory drug indicated for
Relief of the signs and symptoms of osteoarthritis (OA) (1)
Relief of the signs and symptoms of rheumatoid arthritis (RA) (1)
Piroxicam Capsules is indicated:
For relief of the signs and symptoms of osteoarthritis.
For relief of the signs and symptoms of rheumatoid arthritis.
1 INDICATIONS AND USAGE
Cinacalcet hydrochloride is a calcium-sensing receptor agonist indicated for:
Secondary Hyperparathyroidism (HPT) in adult
patients with chronic kidney disease (CKD) on dialysis. (1.1)
Limitations of Use: Cinacalcet hydrochloride tablets are not indicated for use in patients with CKD who are not on dialysis.
Hypercalcemia in adult patients with Parathyroid Carcinoma
(PC). (1.2)
Severe hypercalcemia in adult patients with primary HPT
who are unable to undergo parathyroidectomy. (1.3)
1.1 Secondary Hyperparathyroidism
Cinacalcet hydrochloride tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (14.1)].
Limitations of Use:
Cinacalcet hydrochloride tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions (5.1)].
1.2 Parathyroid Carcinoma
Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies (14.2)].
1.3 Primary Hyperparathyroidism
Cinacalcet hydrochloride tablets are indicated for the treatment of severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy [see Clinical Studies (14.3)].
INDICATIONS AND USAGE
Fluticasone propionate ointment, 0.005% is a medium potency corticosteroid
indicated for the relief of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses in adult patients.
1. INDICATIONS AND USAGE
Doxepin HCl Tablets is 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 HCl Tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. (1, 14)
1 INDICATIONS AND USAGE
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.
Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin capsules have been found effective in active stages of the following:
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.
INDICATIONS
Klaron Lotion is indicated in the topical treatment of acne vulgaris.
1 INDICATIONS AND USAGE
STRIVERDI RESPIMAT Inhalation Spray is a long-acting beta2-adrenergic agonist (LABA) indicated for:
The long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema (1.1)
Important limitations:
STRIVERDI RESPIMAT is NOT indicated to treat acute deterioration of COPD (1.2)
STRIVERDI RESPIMAT is NOT indicated to treat asthma (1.2)
1.1	Maintenance Treatment of COPD
STRIVERDI RESPIMAT is a long-acting beta2-agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
1.2	Important Limitations of Use
STRIVERDI RESPIMAT is not indicated to treat acute deteriorations of COPD [see Warnings and Precautions (5.2)
].
STRIVERDI RESPIMAT is not indicated to treat asthma. The safety and effectiveness of STRIVERDI RESPIMAT in asthma have not been established.
INDICATIONS AND USAGE
For control of severe nausea and vomiting.
For the treatment of schizophrenia.
Prochlorperazine
is effective for the short-term treatment of generalized non-psychotic
anxiety. However, prochlorperazine is not the first drug to be used in
therapy for most patients with non-psychotic anxiety, because certain
risks associated with its use are not shared by common alternative
treatments (e.g., benzodiazepines).
When used in the treatment
of non-psychotic anxiety, prochlorperazine should not be administered
at doses of more than 20 mg per day or for longer than 12 weeks,
because the use of prochlorperazine at higher doses or for longer
intervals may cause persistent tardive dyskinesia that may prove
irreversible (see
WARNINGS
).
The
effectiveness of prochlorperazine as treatment for non-psychotic
anxiety was established in 4-week clinical studies of outpatients with
generalized anxiety disorder. This evidence does not predict that
prochlorperazine will be useful in patients with other non-psychotic
conditions in which anxiety, or signs that mimic anxiety, are found
(e.g., physical illness, organic mental conditions, agitated
depression, character pathologies, etc.).
Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.
1 INDICATIONS AND USAGE
KEPPRA XR is indicated for the treatment of partial-onset seizures in patients 12 years of age and older.
KEPPRA XR is indicated for the treatment of partial-onset seizures in patients 12 years of age and older (1)