um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE:
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 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 conjunctivitis 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.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus,
Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, Pseudomonas aeruginosa.
This product does not provide adequate coverage against Serratia marcescens, and Streptococci, including Streptococcus pneumoniae.
1 INDICATIONS AND USAGE
Besivance (besifloxacin ophthalmic suspension) 0.6%, is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:
CDC coryneform group G
Corynebacterium pseudodiphtheriticum*
Corynebacterium striatum*
Haemophilus influenzae
Moraxella lacunata*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus hominis*
Staphylococcus lugdunensis*
Streptococcus mitis group
Streptococcus oralis
Streptococcus pneumoniae
Streptococcus salivarius*
*Efficacy for this organism was studied in fewer than 10 infections.
Besivance (besifloxacin ophthalmic suspension) 0.6%, is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:
CDC coryneform group G
Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella lacunata*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius*
*Efficacy for this organism was studied in fewer than 10 infections. (1)
1 INDICATIONS AND USAGE
Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan, reconsider the diagnosis of migraine before sumatriptan tablets are
administered to treat any subsequent attacks.
Sumatriptan tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.
Sumatriptan is a serotonin (5-HT
1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. (
1)
Limitations of Use:
Use only if a clear diagnosis of migraine headache has been established. (
1)
Not indicated for the prophylactic therapy of migraine attacks. (
1)
Not indicated for the treatment of cluster headache. (
1)
MOBIC is a non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older (1.3)
1 INDICATIONS AND USAGE
Piperacillin and Tazobactam for Injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of:
Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1)
Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2)
Skin and skin structure infections in adults (1.3)
Female pelvic infections in adults (1.4)
Community-acquired pneumonia in adults (1.5)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, piperacillin and tazobactam should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.6)
1.1 Intra-abdominal Infections
Piperacillin and Tazobactam for Injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis, B. ovatus, B. thetaiotaomicron, or B. vulgatus.
1.2 Nosocomial Pneumonia
Piperacillin and Tazobactam for Injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of Staphylococcus aureus and by piperacillin/tazobactam-susceptible Acinetobacter baumannii, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside) [see Dosage and Administration (2)].
1.3 Skin and Skin Structure Infections
Piperacillin and Tazobactam for Injection is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by beta-lactamase producing isolates of Staphylococcus aureus.
1.4 Female Pelvic Infections
Piperacillin and Tazobactam for Injection is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of Escherichia coli.
1.5 Community-acquired Pneumonia
Piperacillin and Tazobactam for Injection is indicated in adults for the treatment of community-acquired pneumonia (moderate severity only) caused by beta-lactamase producing isolates of Haemophilus influenzae.
1.6
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, piperacillin and tazobactam should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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.
INDICATIONS
For use as an adjunct in the therapy of all forms of parkinsonism (see DOSAGE AND ADMINISTRATION).
Useful also in the control of extrapyramidal disorders (except tardive dyskinesia
see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).
Gabapentin Capsules, USP are indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (
1)
1.1 Major Depressive Disorder
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
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 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 INDICATIONSAND USAGE
Levetiracetam Oral Solution, USP is an antiepileptic drug indicated for adjunctive therapy in the treatment of:
Partial onset seizures in patients 4 years of age and older with epilepsy (1.1)
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
1.1 Partial Onset Seizures
Levetiracetam Oral Solution, USP is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets and oral solution. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.2 Myoclonic Seizures In Patients With Juvenile Myoclonic Epilepsy
Levetiracetam Oral Solution, USP is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam Oral Solution, USP is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
1
INDICATIONS AND USAGE
KHAPZORY is indicated for:
rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma.
diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination adult and pediatric patients.
The treatment of adults with metastatic colorectal cancer in combination with fluorouracil.
Limitations of Use
KHAPZORY is not indicated for pernicious anemia and megaloblastic anemia secondary to lack the of vitamin B12 because of the risk of progression of neurologic manifestations despite hematologic remission.
KHAPZORY is a folate analog indicated for:
Rescue after high-dose methotrexate therapy in adults and pediatric patients with osteosarcoma. (1)
Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. (1)
Treatment of adults with metastatic colorectal cancer in combination with fluorouracil. (1)
Limitations of Use
KHAPZORY is not indicated for pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12 because of the risk of progression of neurologic manifestations despite hematologic remission.(1)
INDICATIONS
SSS 10-1 Cleanser (Sodium Sulfacetamide 10% & Sulfur 1%) is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
INDICATIONS
For the temporary relief of minor pain of muscles and joints associated with:
Arthritis
Simple Backache
Strains
Sprains
Bruises
DIRECTIONS
Adults and children over 18 years:
Apply generously to affected area
Massage into painful area until thoroughly absorbed into skin
Repeat as necessary, not more than 3-4 times daily.
Wash hands with soap and water immediately after use.
Children 18 years or younger: ask a doctor
Store at 20-25C (68-77 F). Avoid direct sunlight.
1 INDICATIONS AND USAGE
Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with partial seizures.
Oxcarbazepine tablets are an antiepileptic drug indicated for:
Adults:
Monotherapy or adjunctive therapy in the treatment of partial seizures
Children:
Monotherapy in the treatment of partial seizures in children 4-16 years
Adjunctive therapy in the treatment of partial seizures in children 2-16 years ( )
1
1 INDICATIONS AND USAGE
Guanfacine Extended-Release Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications
[see
Clinical Studies (14)].
Guanfacine Extended-Release Tablets are a central alpha
2A-adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications(
1,
14).
1 INDICATIONS AND USAGE
Lacosamide tablets are indicated for:
Treatment of partial-onset seizures in patients 4 years of age and older.(1.1)
1.1 Partial-Onset Seizures
Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Additional pediatric use information is approved for UCB, Inc.s VIMPAT (lacosamide) tablets. However, due to UCB, Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1.9 Limitations of Use
Clarithromycin Extended-release Tablets, USP are indicated only for acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia in adults. The efficacy and safety of Clarithromycin Extended-release Tablets, USP in treating other infections for which other formulations of clarithromycin are approved have not been established.
There is resistance to macrolides in certain bacterial infections caused by
Streptococcus pneumoniaeand
Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.
1 INDICATIONS AND USAGE
COTELLIC
is a kinase inhibitor indicated:
For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. (1.1, 14.1)
As a single agent for the treatment of adult patients with histiocytic neoplasms. (1.2, 14.2)
1.1
Unresectable or Metastatic Melanoma
COTELLIC
is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.
1.2
Histiocytic Neoplasms
COTELLIC, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.
1 INDICATIONS AND USAGE
Celecoxib is a non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (
1.1)
Rheumatoid Arthritis (RA) (
1.2)
Juvenile Rheumatoid Arthritis (JRA) in
patients 2 years and older (
1.3)
Ankylosing Spondylitis (AS) (
1.4)
Acute Pain (AP) (
1.5)
Primary Dysmenorrhea (PD) (
1.6)
Celecoxib capsules are indicated
1.1 Osteoarthritis
For the management of the signs and symptoms of OA [
see Clinical Studies (
14.1)
].
1.2 Rheumatoid Arthritis
For the management of the signs and symptoms of RA [
see Clinical Studies (
14.2)
].
1.3 Juvenile Rheumatoid Arthritis
For the management of the signs and symptoms of JRA in patients 2 years and older [
see Clinical Studies (
14.3)
].
1.4 Ankylosing Spondylitis
For the management of the signs and symptoms of AS [
see Clinical Studies (
14.4)
].
1.5 Acute Pain
For the management of acute pain in adults [
see Clinical Studies (
14.5)
].
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea
[see Clinical Studies (
14.5)
].
1 INDICATIONS AND USAGE
Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.
Terbinafine tablets are an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). (1)
INDICATIONS AND USAGE
Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. (See
CLINICAL PHARMACOLOGY: Susceptibility Test Methods
).
Oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant Staphylococcus, therapy should not be continued with oxacillin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Oxacillin for Injection, USP and other antibacterial drugs, Oxacillin for Injection, USP 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.
1
INDICATIONS AND USAGE
Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
Icatibant injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. (1)
1.	INDICATIONS AND USAGE
Duloxetine Delayed-release Capsules is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (
1.1)
Generalized Anxiety Disorder (GAD) (
1.2)
Diabetic Peripheral Neuropathic Pain (DPNP) (
1.3)
Chronic Musculoskeletal Pain (
1.5)
1.1	Major Depressive Disorder
Duloxetine Delayed-release Capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of Duloxetine Delayed-release Capsules was established in four short-term and one maintenance trial in adults
[see
Clinical Studies (14.1)]
.
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
1.2	Generalized Anxiety Disorder
Duloxetine Delayed-release Capsules are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of Duloxetine Delayed-release Capsules was established in three short-term trials and one maintenance trial in adults
[see
Clinical Studies (14.2)]
.
Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance.
1.3	Diabetic Peripheral Neuropathic Pain
Duloxetine Delayed-release Capsules are indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy
[see
Clinical Studies (14.3)]
.
1.5	Chronic Musculoskeletal Pain
Duloxetine Delayed-release Capsules are indicated for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis
[see
Clinical Studies (14.5)]
.
INDICATIONS AND USAGE
HypertensionMetoprolol tartrate tablets are
indicated for the treatment of hypertension. They may be used alone or in
combination with other antihypertensive agents.
Angina PectorisMetoprolol tartrate tablets
are indicated in the long-term treatment of angina pectoris.
Myocardial InfarctionMetoprolol tartrate
tablets are indicated in the treatment of hemodynamically stable patients with
definite or suspected acute myocardial infarction to reduce cardiovascular
mortality. Treatment with intravenous metoprolol can be initiated as soon as the
patient's clinical condition allows (see DOSAGE AND
ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to
10 days of the acute event (see DOSAGE AND
ADMINISTRATION).
1 INDICATIONS AND USAGE
Methylphenidate HCl Extended-Release Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65
[see
Clinical Studies (14)]
.
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Methylphenidate HCl Extended-Release Tablets are a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65. (
1)
1.1	Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
1.2	Need for Comprehensive Treatment Program
Methylphenidate HCl Extended-Release Tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.