um-ids/dailymed-annotations huggingface dataset:
Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
1. INDICATIONS AND USAGE
Lamotrigine tablets is an antiepileptic drug (AED) indicated for:
Epilepsyadjunctive therapy in patients 2 years of age: ( 1.1 )
partial seizures
primary generalized tonic-clonic seizures
generalized seizures of Lennox-Gastaut syndrome
Epilepsymonotherapy in patients 16 years of age: conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single AED. ( 1.1 )
Bipolar Disorder in patients 18 years of age: maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. ( 1.2 )
1.1 Epilepsy
Adjunctive Therapy:
Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients
2 years of age:
partial seizures
primary generalized tonic-clonic seizures
generalized seizures of Lennox-Gastaut syndrome
Monotherapy:
Lamotrigine tablets are indicated for conversion to monotherapy in adults (16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2 Bipolar Disorder
Lamotrigine tablets are indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (18 years of age) treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.
The effectiveness of lamotrigine tablets as maintenance treatment was established in 2 placebo-controlled trials in patients with Bipolar I Disorder as defined by DSM-IV [see Clinical Studies (14.2)]. The physician who elects to prescribe lamotrigine tablets for periods extending beyond 16 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Lanthanum carbonate chewable tablets are phosphate binder indicated to reduce serum phosphate in patients with end- stage renal disease (ESRD).
Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.
Lanthanum carbonate chewable tablets are phosphate binder indicated to reduce serum phosphate in patients with end- stage renal disease (ESRD). (1)
INDICATIONS AND USAGE
Milrinone Lactate Injection, USP and Milrinone Lactate in 5% Dextrose Injection are indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinoneshould be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.
1 INDICATIONS & USAGE
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
INDICATIONS AND USAGE
Proparacaine Hydrochloride Ophthalmic Solution is indicated for topical anesthesia in ophthalmic practice. Representative ophthalmic procedures in which the preparation provides good local anesthesia include measurement of intraocular pressure (tonometry), removal of foreign bodies and sutures from the cornea, conjunctival scraping in diagnosis and gonioscopic examination; it is also indicated for use as a topical anesthetic prior to surgical operations such as cataract extraction.
INDICATIONS AND USAGE
Isoproterenol hydrochloride injection is indicated:
For
mild or transient episodes of heart block that do not require electric
shock or pacemaker therapy.
For
serious episodes of heart block and Adams-Stokes attacks (except when
caused by ventricular tachycardia or fibrillation). (See CONTRAINDICATIONS .)
For
use in cardiac arrest until electric shock or pacemaker therapy, the
treatments of choice, is available. (See CONTRAINDICATIONS .)
For
bronchospasm occurring during anesthesia.
As an
adjunct to fluid and electrolyte replacement therapy and the use of other
drugs and procedures in the treatment of hypovolemic and septic shock, low
cardiac output (hypoperfusion) states, congestive heart failure, and
cardiogenic shock. (See WARNINGS .)
1 INDICATIONS AND USAGE
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2)
Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3)
Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4)
1.1 Major Depressive Disorder
Fluoxetine hydrochloride is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [see CLINICAL STUDIES (14.1)].
The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be reevaluated [see DOSAGE AND ADMINISTRATION (2.1)].
1.2 Obsessive Compulsive Disorder
Fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see CLINICAL STUDIES (14.2)].
The effectiveness of fluoxetine in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION (2.2)].
1.3 Bulimia Nervosa
Fluoxetine is indicated for the acute and maintenance treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa [see CLINICAL STUDIES (14.3)].
The physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION (2.3)].
1.4 Panic Disorder
Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients [see CLINICAL STUDIES (14.4)].
The effectiveness of fluoxetine in long-term use, i.e., for more than 12 weeks, has not been established in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION (2.4)].
INDICATIONS AND USAGE
Sotalol hydrochloride tablets, USP (AF)are indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Because sotalol hydrochloride tablets, USP (AF) can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol hydrochloride tablets, USP (AF) (see
WARNINGS
).
In general, antiarrhythmic therapy for AFIB/AFL aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see
CLINICAL STUDIES
).
Sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name Betapace (sotalol hydrochloride). Sotalol hydrochloride tablets, however, must not be substituted for Betapace AF (sotalol hydrochloride tablets, USP (AF) because of significant differences in labeling (i.e. patient package insert, dosing administration and safety information).
INDICATIONS AND USAGE
MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
1 INDICATIONS AND USAGE
Hypothyroidism
Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression
Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)].
Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Levothyroxine sodium tablets are a L-thyroxine (T4) indicated in adult and pediatric patients, including neonates, for:
Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)
NaN
Limitations of Use:
1
INDICATIONS AND USAGE
ZYKADIA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1)].
ZYKADIA is a kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC)whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.(1, 2.1)
INDICATIONS AND USAGE
CARNITOR
(levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation (see
CLINICAL PHARMACOLOGY
). In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.
CARNITOR
(levocarnitine) is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.
1 INDICATIONS AND USAGE
Carisoprodol Tablets, USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol Tablets 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)].
Carisoprodol Tablets, USPare indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. (1)
Important Limitations:
Should only be used for acute treatment periods up to two or three weeks (1)
Not recommended in pediatric patients less than 16 years of age (8.4)
INDICATIONS AND USAGE
A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 SF 1.1% Brush-On Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
1 INDICATIONS AND USAGE
Fluoxetine
capsules are indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)].
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)].
Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)].
Fluoxetine capsules and Olanzapine in Combinationare indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Fluoxetine
capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.
Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (1)
Acute and maintenance treatment of Bulimia Nervosa (1)
Acute treatment of Panic Disorder, with or without agoraphobia (1)
Fluoxetine capsules and olanzapine in combination
for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder (1)
INDICATIONS AND USAGE
Mentax (butenafine HCl) Cream, 1% is indicated for the topical treatment of the dermatologic infection, tinea (pityriasis) versicolor due to M. furfur (formerly P. orbiculare). Butenafine HCl cream was not studied in immunocompromised patients. (See DOSAGE AND ADMINISTRATION.)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Acute Pain in Adult Patients
Ketorolac tromethamine is indicated for the short-term (5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see
WARNINGS
,
PRECAUTIONS
,
DOSAGE AND ADMINISTRATION
, and
ADVERSE REACTIONS
). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
1 INDICATIONS AND USAGE
Cisatracurium Besylate Injection is 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 is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.
Cisatracurium Besylate Injection is 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 is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action (1)
1.1 Bronchospasm
Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
Albuterol Sulfate HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
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 GroupA-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
PULMICORT RESPULES
is an inhaled corticosteroid
indicated for:
Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1.1)
Important Limitations of Use:
Not indicated for the relief of acute bronchospasm (1.1)
1.1 Maintenance Treatment of Asthma
PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age.
Important Limitations of Use:
PULMICORT RESPULES is NOT indicated for the relief of acute bronchospasm.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Acute Pain in Adult Patients
Ketorolac tromethamine is indicated for the short-term ( 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see
WARNINGS
,
PRECAUTIONS
,
DOSAGE AND ADMINISTRATION
, and
ADVERSE REACTIONS
). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults Chronic musculoskeletal pain in adults
Additional pediatric use information is approved for Eli Lilly and Company, Inc.s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions:
Major depressive disorder (MDD) in adults(1)
Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older(1)
Diabetic peripheral neuropathic pain (DPNP) in adults (1)
Fibromyalgia (FM) in adults (1)
Chronic musculoskeletal pain in adults (1)