um-ids/dailymed-annotations huggingface dataset:
1. INDICATIONS AND USAGE
Montelukastsodiumtabletsarealeukotrienereceptorantagonistindicatedfor:
Prophylaxisandchronictreatmentofasthmainpatients12monthsofageandolder(1.1).
Acutepreventionofexercise-inducedbronchoconstriction(EIB)inpatients15yearsofageandolder(1.2).
Relief'ofsymptomsofallergicrhinitis(AR):seasonalallergicrhinitis(SAR)inpatients2yearsofageandolder , andperennialallergicrhinitis(PAR)inpatients6monthsofageandolder(1.3).
1.1 Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
1.2 Exercise-Induced Bronchoconstriction
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
Pediatricuseinformationforpatientsages6to14years ofageforacutepreventionof exercise-inducedbronchoconstriction(EIB) isapprovedforMerckSharp&DohmeCorp'smontelukasttabletproducts.However, duetoMerckSharp&DohmeCorp'smarketingexclusivityrights, thisdrugproductisnotlabeledwiththatpediatricinformation.
1.3 Allergic Rhinitis
Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.
1 INDICATIONS AND USAGE
Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).
Limitations of Use
In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.
Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). (
1)
Limitations of Use
In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
INDICATIONS AND USAGE
Anxiety DisordersAlprazolam tablets are indicated for the management of anxiety
disorder (a condition corresponding most closely to the APA Diagnostic and
Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the
short-term relief of symptoms of anxiety. Anxiety or tension associated with the
stress of everyday life usually does not require treatment with an
anxiolytic.
Generalized anxiety disorder is characterized by unrealistic or excessive
anxiety and worry (apprehensive expectation) about two or more life
circumstances, for a period of six months or longer, during which the person has
been bothered more days than not by these concerns. At least 6 of the following
18 symptoms are often present in these patients: Motor
Tension (trembling, twitching, or feeling shaky; muscle tension, aches,
or soreness; restlessness; easy fatigability); Autonomic
Hyperactivity (shortness of breath or smothering sensations; palpitations
or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness
or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or
chills; frequent urination; trouble swallowing or lump in throat); Vigilance and Scanning (feeling keyed up or on edge;
exaggerated startle response; difficulty concentrating or mind going blank
because of anxiety; trouble falling or staying asleep; irritability). These
symptoms must not be secondary to another psychiatric disorder or caused by some
organic factor.
Anxiety associated with depression is responsive to alprazolam.
Panic DisorderAlprazolam is also indicated for the treatment of panic disorder,
with or without agoraphobia.
Studies supporting this claim were conducted in patients whose diagnoses
corresponded closely to the DSM-III-R/IV criteria for panic disorder (see
CLINICAL STUDIES
).
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic
attacks, ie, a discrete period of intense fear or discomfort in which four (or
more) of the following symptoms develop abruptly and reach a peak within 10
minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2)
sweating; (3) trembling or shaking; (4) sensations of shortness of breath or
smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or
abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9)
derealization (feelings of unreality) or depersonalization (being detached from
oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias
(numbness or tingling sensations); (13) chills or hot flushes.
Demonstrations of the effectiveness of alprazolam by systematic clinical
study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks
duration for panic disorder; however, patients with panic disorder have been
treated on an open basis for up to 8 months without apparent loss of benefit.
The physician should periodically reassess the usefulness of the drug for the
individual patient.
Hypertrophic Subaortic Stenosis
Propranolol hydrochloride tablets, USP improve NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
INDICATIONS AND USAGE
Sodium Chloride Injection, USP, 23.4%, is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirements of the patient with unusual fluid and electrolyte needs. After available clinical and laboratory information is considered and correlated, the appropriate number of milliequivalents of sodium chloride required can be withdrawn from Sodium Chloride Injection, USP, 23.4% and diluted for use.
Sodium Chloride Injection is indicated for the treatment of sodium, chloride and water deficiencies that commonly occur in many diseases. Isotonic Sodium Chloride Injection should be limited to cases in which the chloride loss is greater than the sodium loss, as in vomiting from pyloric obstruction, or in which the loss is about equal, as in vomiting from duodenal, jejunal or ileal obstruction and in the replacement of aspirated gastrointestinal fluids.
The toxic symptoms that follow various forms of intestinal obstruction are accompanied by a marked reduction of blood chloride and often sodium chloride has a lifesaving effect.
Symptoms of sodium chloride deficiency are very similar to those of Addisons disease and large doses of sodium chloride will produce temporary alleviation of the symptoms. Other disorders in which sodium chloride is therapeutically useful include extensive burns, failure of gastric secretion and postoperative intestinal paralysis.
1 INDICATIONS AND USAGE
FLOVENT HFA Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.
FLOVENT HFA Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.
FLOVENT HFA is an inhaled corticosteroid indicated for:
Maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. (1)
Treatment of asthma for patients requiring oral corticosteroid therapy. (1)
FLOVENT HFA is NOT indicated for the relief of acute bronchospasm. (1)
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for:
treatment of major depressive disorder (MDD) (
1.1)
prevention of seasonal affective disorder (SAD) (
1.2)
1.1 Major Depressive Disorder (MDD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment
[see
Clinical Studies (14.1)].
1.2 Seasonal Affective Disorder (SAD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM
[see
Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
Verapamil hydrochloride extended-release capsules (PM) for oral use are indicated for the management of essential hypertension.
Verapamil hydrochloride is a calcium channel blocker indicated for the management of essential hypertension. (1)
1 INDICATIONS AND USAGE
Pantoprazole sodium for delayed-release oral suspension is indicated for:
Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal 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 for delayed-release oral suspension 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 for delayed-release oral suspension 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 for delayed-release oral suspension is 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 for delayed-release oral suspension is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
1 INDICATIONS AND USAGE
Clobetasol propionate cream, 0.05% (emollient) is a corticosteroid indicated for:
The relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. (1.1)
The treatment of moderate to severe plaque-type psoriasis in patients 16 years of age and older. (1.2)
Limitations of Use
Clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. (1.3)
The total dosage should not exceed 50 grams per week.(1.3)
Avoid use if skin atrophy is present at the treatment site.(1.3)
Clobetasol propionate cream, 0.05% (emollient) is a super-high potency corticosteroid indicated for:
1.1 Corticosteroid-Responsive Dermatoses
Clobetasol propionate cream, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age and older. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week.
1.2 Moderate to Severe Plaque-Type Psoriasis
Clobetasol propionate cream, 0.05% (emollient) is indicated for the topical treatment of moderate to severe plaque-type psoriasis. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age is not recommended.
1.3 Limitations of Use
Clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
The total dosage should not exceed 50 grams per week.
Avoid use if skin atrophy is present at the treatment site.
INDICATIONS AND USAGE
This formulation is indicated for use as a supplement to intravenous solutions given for TPN. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese, selenium and chromium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms.
INDICATIONS AND USAGE
Adult Patients
Flumazenil Injection, USPis indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
Pediatric Patients (aged 1 to 17)
Flumazenil Injection,USPis indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: Pediatric Use).
1 INDICATIONS & 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)
INDICATIONS AND USAGE
Flurbiprofen sodium ophthalmic solution 0.03% is indicated for the inhibition of intraoperative miosis.
1 INDICATIONS AND USAGE
ORTHO-CYCLEN and ORTHO TRI-CYCLEN are combinations of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (
1.1)
ORTHO TRI-CYCLEN is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche.
ORTHO TRI-CYCLEN should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (
1.2)
1.1 Oral Contraceptive
ORTHO-CYCLEN and ORTHO TRI-CYCLEN Tablets are indicated for use by females of reproductive potential to prevent pregnancy
[see
Clinical Studies (14)]
.
1.2 Acne
ORTHO TRI-CYCLEN is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. ORTHO TRI-CYCLEN should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control
[see
Clinical Studies (14)]
.
1 INDICATIONS AND USAGE
XOFLUZA is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for:
Treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are:
otherwise healthy, or
at high risk of developing influenza-related complications. (1.1)
Post-exposure prophylaxis of influenza in patients 12 years of age and older following contact with an individual who has influenza. (1.2)
Limitations of Use
Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA. (1.3)
1.1 Treatment of Influenza
XOFLUZA is indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are:
otherwise healthy, or
at high risk of developing influenza-related complications1[see Clinical Studies (14.2)].
1.2 Post-Exposure Prophylaxis of Influenza
XOFLUZA is indicated for post-exposure prophylaxis of influenza in persons 12 years of age and older following contact with an individual who has influenza [see Clinical Studies (14.3)].
1.3 Limitations of Use
Influenza viruses change over time, and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use XOFLUZA [see Microbiology (12.4)
and
Clinical Studies (14)].
INDICATIONS & USAGE SECTION
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, 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.
Amoxicillin and clavulanate potassium tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
1.1 Lower Respiratory Tract Infections
caused by beta-lactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by beta-lactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
caused by beta-lactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets, USP should not be used.
INDICATIONS AND USAGE
Clomipramine hydrochloride capsules 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 hydrochloride capsules 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 hydrochloride capsules 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 hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE:
Tobramycin for Injection, USP is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below:
Septicemia in the pediatric patient and adult caused by
P. aeruginosa
,
E. coli
, and
Klebsiella
spp.
Lower respiratory tract infections caused by
P. aeruginos
a,
Klebsiella
spp,
Enterobacter
spp,
Serratia
spp,
E. coli
, and
S. aureus
(penicillinase- and non-penicillinase-producing strains).
Serious central-nervous-system infections (meningitis) caused by susceptible organisms.
Intra-abdominal infections, including peritonitis, caused by
E. coli
,
Klebsiella
spp, and
Enterobacter
spp.
Skin, bone, and skin structure infections caused by
P. aeruginosa
,
Proteus
spp,
E. coli
,
Klebsiella
spp,
Enterobacter
spp, and
S. aureus.
Complicated and recurrent urinary tract infections caused by
P. aeruginosa
,
Proteus
spp, (indole-positive and indole-negative),
E. coli
,
Klebsiella
spp,
Enterobacter
spp,
Serratia
spp,
S. aureus
,
Providencia
spp, and
Citrobacter
spp.
Aminoglycosides, including tobramycin sulfate injection, USP are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity. Tobramycin for Injection, USP may be considered in serious staphylococcal infections when penicillin or other potentially less toxic drugs are contraindicated and when bacterial susceptibility testing and clinical judgment indicate its use.
Bacterial cultures should be obtained prior to and during treatment to isolate and identify etiologic organisms and to test their susceptibility to tobramycin. If susceptibility tests show that the causative organisms are resistant to tobramycin, other appropriate therapy should be instituted. In patients in whom a serious life-threatening gram-negative infection is suspected, including those in whom concurrent therapy with a penicillin or cephalosporin and an aminoglycoside may be indicated, treatment with tobramycin may be initiated before the results of susceptibility studies are obtained. The decision to continue therapy with tobramycin should be based on the results of susceptibility studies, the severity of the infection, and the important additional concepts discussed in the
WARNINGS
box above.