um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGENeomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic
Suspension is indicated for steroid-responsive inflammatory ocular conditions
for which a corticosteroid is indicated and where bacterial infection or a risk
of bacterial ocular infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the
palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where
the inherent risk of corticosteroid 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 infection is high or where there is an expectation that
potentially dangerous numbers of bacteria will be present in the eye (See
CLINICAL
PHARMACOLOGY: Microbiology
).
The particular anti-infective drugs in this product are active against the
following common bacterial eye pathogens: Staphylococcus
aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas
aeruginosa.
The product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae.
1 INDICATIONS AND USAGE
Renagel
is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of Renagel in CKD patients who are not on dialysis have not been studied.
Renagel
is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. (
1)
INDICATIONS AND USAGE
Proparacaine hydrochloride ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.
1.5 Uncomplicated Skin and Skin Structure Infections
Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to
Staphylococcus aureus, or
Streptococcus pyogenes.
1 INDICATIONS AND USAGE
Gabapentin is 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 is 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
REGIOCIT (sodium chloride and sodium citrate) solution is indicated for use asreplacement solution for regional citrate anticoagulation (RCA) of the extracorporeal circuit in patients treated with continuous renal replacement therapy (CRRT), particularly when systemic anticoagulation with heparin is contraindicated, e.g., in patients with increased bleeding risks.
REGIOCIT should be administered only under the supervision of a physicianexperienced in the use of CRRT.
Pediatrics
Pediatrics (<18 years of age): No data are available to Health Canada; therefore,Health Canada has not authorized an indication for pediatric use.
Geriatrics
Geriatrics (> 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness.
INDICATIONS AND USAGE
Hydrocodone bitartrate and acetaminophen tablets are indicated for the management ofpain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see
WARNINGS
], reserve 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
Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm
2 in area) due to susceptible isolates of
Staphylococcus aureus (S. aureus) and
Streptococcus pyogenes (S. pyogenes).
Mupirocin cream is an RNA synthetase inhibitor antibacterial indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm
2 in area) due to susceptible isolates of
Staphylococcus aureus and
Streptococcus pyogenes. (
1)
1 INDICATIONS AND USAGE
MYDAYIS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older [see Clinical Studies (14)].
MYDAYIS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. (1)
Limitations of Use:
Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite. (8.4)
Limitations of Use
Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see Use in Specific Populations (8.4)].
INDICATIONS AND USAGE
Amiloride HCl tablets are indicated as adjunctive treatment with
thiazide diuretics or other kaliureticdiuretic agents in congestive heart
failure or hypertension to:
a. help restore normal serum potassium levels in patients who develop
hypokalemia on the kaliuretic diuretic
b. prevent development of hypokalemia in patients who would be exposed to
particular risk if hypokalemia were to develop, e.g., digitalized patients or
patients with significant cardiac arrhythmias.
The use of potassium-conserving agents is often unnecessary in patients
receiving diuretics for uncomplicated essential hypertension when such patients
have a normal diet. Amiloride HCl tablets have little additive diuretic or
antihypertensive effect when added to a thiazide diuretic.
Amiloride HCl tablets should rarely be used alone. It has weak (compared with
thiazides) diuretic and antihypertensive effects. Used as single agents,
potassium sparing diuretics, including amiloride HCl tablets, result in an
increased risk of hyperkalemia (approximately 10% with amiloride). Amiloride HCl
tablets should be used alone only when persistent hypokalemia has been
documented and only with careful titration of the dose and close monitoring of
serum electrolytes.
INDICATIONS AND USAGE:PRTM Benzoyl Peroxide Wash is indicated for the topical treatment of acne vulgaris.
1.1 Oncology
For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1 INDICATIONS AND USAGE
Pregabalin Capsules are indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 4 years of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Additional pediatric use information is approved for Pfizers LYRICA (pregabalin) Capsules. However, due to Pfizers marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Pregabalin Capsules are indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (
1)
Postherpetic neuralgia (PHN) (
1)
Adjunctive therapy for the treatment of partial-onset seizures in patients 4years of age and older (
1)
Fibromyalgia (
1)
Neuropathic pain associated with spinal cord injury (
1)
1 INDICATIONS AND USAGE
FORTAMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FORTAMET is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
INDICATIONS & USAGE
Attention Deficit Disorders, Narcolepsy
Attention Deficit Disorders (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 is 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.Special
Diagnostic Considerations
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 physicians assessment of the chronicity and severity of the childs
symptoms.
1 INDICATIONS AND USAGE
VANCOCIN is indicated for the treatment of Clostridioides difficile-associated diarrhea.
VANCOCIN is also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.
Limitations of Use
Parenteral administration of vancomycin is not effective for the above infections; therefore, VANCOCIN must be given orally for these infections.
Orally administered VANCOCIN is not effective for other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VANCOCIN and other antibacterial drugs, VANCOCIN 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.
VANCOCIN is a glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of:
(1)
Clostridioides difficile-associated diarrhea
Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains)
Limitations of Use:
(1) (5.1)
Parenteral administration of vancomycin is not effective for the above infections; therefore, vancocin must be given orally for these infections.
Orally administered VANCOCIN is not effective for other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VANCOCIN and other antibacterial drugs, VANCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)
INDICATIONS AND USAGE
Amphetamine sulfate tablets, USP, are indicated for:
1. Narcolepsy
2. 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 children with 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 the 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 not be warranted.
3. Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in use of the drug, such as those described below.
INDICATIONS AND USAGE
Perennial and seasonal allergic rhinitis Vasomotorrhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma
Cold urticaria Dermatographism
As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
1 INDICATIONS AND USAGE
Olanzapine and fluoxetine capsules are indicated for the treatment of:
Acute depressive episodes in Bipolar I Disorder
[see Clinical Studies
(14.1)].
Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode)
[see Clinical Studies
(14.2)].
Olanzapine and fluoxetine capsules combine olanzapine, an atypical antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor, indicated for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder
(1)
Treatment Resistant Depression
(1)
1 INDICATIONS AND USAGE
Sildenafil for Oral Suspension is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil for oral suspension was added to background epoprostenol therapy [see Clinical Studies
(14)].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class IIIII symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
Limitation of Use
: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)].
Sildenafil for Oral Suspension is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class IIIII symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). (1)
Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. (1, 14)
1 INDICATIONS AND USAGE
Zolpidem Tartrate is a GABAA agonist indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep (1)
Limitation of Use: Not indicated for the treatment of middle-of-the night awakening when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking (1)
Zolpidem Tartrate Sublingual Tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
Limitations of Use: Zolpidem Tartrate Sublingual Tablet is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
1 INDICATIONS AND USAGE
Raloxifene hydrochloride tablet, USP is an estrogen agonist/antagonist indicated for:
Treatment of osteoporosis in postmenopausal women. (1.1)
1.1 Treatment of Osteoporosis in Postmenopausal Women
Raloxifene hydrochloride tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women [see Clinical Studies (14.1)].
INDICATIONS AND USAGE
Bupivacaine hydrochloride injection, USP is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See
WARNINGS
.)
Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of bupivacaine hydrochloride injection, USP in these patients.
Bupivacaine hydrochloride injection, USP is not recommended for intravenous regional anesthesia (Bier Block). See
WARNINGS
.
The routes of administration and indicated bupivacaine hydrochloride injection, USP concentrations are:
local infiltration
0.25%
peripheral nerve block
0.25% and 0.5%
retrobulbar block
0.75%
sympathetic block
0.25%
lumbar epidural
0.25%, 0.5%, and 0.75%
(0.75% not for obstetrical anesthesia)
caudal
0.25% and 0.5%
epidural test dose
0.5% with epinephrine 1:200,000
dental blocks
0.5% with epinephrine 1:200,000
(See
DOSAGE AND ADMINISTRATION
for additional information.)
Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of bupivacaine hydrochloride injection, USP .
INDICATIONS AND USAGE
Ipratropium bromide nasal solution, 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. Ipratropium bromide nasal solution, 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis.
INDICATIONS AND USAGE
Clomipramine hydrochloride capsules USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD.
Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable.
The effectiveness of clomipramine for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking CMI experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. CMI-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents.
The effectiveness of clomipramine for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (
see
DOSAGE AND ADMINISTRATION
).
1 INDICATIONS AND USAGE
Megace ES oral
suspension is indicated for the treatment of anorexia, cachexia, or an
unexplained significant weight loss in patients with a diagnosis of acquired
immunodeficiency syndrome (AIDS).
Megace ES oral
suspension is a progestin indicated for the treatment of anorexia, cachexia, or
an unexplained significant weight loss in patients with a diagnosis of acquired
immunodeficiency syndrome (AIDS) (1.0).
1.1 Limitations of Use
Enter section text here
1.1.1 Other Treatable Causes
Therapy with megestrol
acetate for weight loss should only be instituted after treatable causes of
weight loss are sought and addressed. These treatable causes include possible
malignancies, systemic infections, gastrointestinal disorders affecting
absorption, endocrine disease, renal disease or psychiatric diseases.
1.1.2 Prophylactic Use
Megestrol acetate is not
intended for prophylactic use to avoid weight loss.
INDICATIONS AND USAGE
Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
INDICATIONS AND USAGE
R-Gene 10 is indicated as an intravenous stimulant to the pituitary for the release of human growth hormone in patients where the measurement of pituitary reserve for HGH can be of diagnostic usefulness. It can be used as a diagnostic aid in such conditions as panhypopituitarism, pituitary dwarfism, chromophobe adenoma, postsurgical craniopharyngioma, hypophysectomy, pituitary trauma, acromegaly, gigantism and problems of growth and stature.
If the insulin hypoglycemia test has indicated a deficiency of pituitary reserve for HGH, a test with R-Gene 10 is advisable to confirm the negative response. This can be done after a waiting period of one day. As patients may not respond to R-Gene 10 (Arginine Hydrochloride Injection, USP) during the first test, the unresponsive patient should be tested again to confirm the negative result. A second test can be performed after a waiting period of one day. Some patients who respond to R-Gene 10 do not respond to insulin and vice versa. The rate of false positive responses for R-Gene 10 is approximately 32%, and the rate of false negatives is approximately 27%.
1 INDICATIONS AND USAGE
LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1.1)
1.1	Follicular Lymphoma
LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).