um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets 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 empiric selection of therapy.
Urinary Tract Infections:
For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiellaspecies, Enterobacterspecies, Morganella morganii, Proteus mirabilisand Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media:
For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniaeor Haemophilus influenzaewhen in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults:
For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniaeor Haemophilus influenzaewhen in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent.
Shigellosis:
For the treatment of enteritis caused by susceptible strains of Shigella flexneriand Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis Carinii Pneumonia:
For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis cariniipneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis cariniipneumonia.
Traveler's Diarrhea in Adults:
For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.
1 INDICATIONSAND USAGE
Sildenafil tablets are 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 tablets were 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 II to III 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 tablets are 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 II to III 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
Meloxicam Tablets are non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) ( 1.1)
Rheumatoid Arthritis (RA) ( 1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients who weigh
60 kg ( 1.3)
1 INDICATIONS AND USAGE
ATNAA is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity in adults.
ATNAA, a combination of atropine, a cholinergic muscarinic antagonist, and pralidoxime chloride, a cholinesterase reactivator, is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity in adults. (1)
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 & USAGE SECTION
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.
INDICATIONS & USAGE
Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Indomethacin extended-release capsules have been found effective in active stages of the following:
1.Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2.Moderate to severe ankylosing spondylitis. 3.Moderate to severe osteoarthritis. 4.Acute painful shoulder (bursitis and/or tendinitis). Indomethacin extended-release capsules, USP are not recommended for the treatment of acute gouty arthritis.Indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.The use of indomethacin in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of indomethacin and aspirin does not produce any greater therapeutic effect than the use of indomethacin alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy. (See
PRECAUTIONS,Drug Interactions
).
1 INDICATIONS AND USAGE
PRANDIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitation of Use:
PRANDIN should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
PRANDIN is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Limitation of Use:
Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis (1)
INDICATIONS AND USAGE
Enalapril maleate and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension.
These fixed dose combinations are not indicated for initial treatment (see
DOSAGE AND ADMINISTRATION
).
In using enalapril maleate and hydrochlorothiazide tablets, USP, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril does not have a similar risk (see
WARNINGS
).
In considering use of enalapril maleate and hydrochlorothiazide tablets, USP, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see
WARNINGS
,
Head and Neck Angioedema
).
1 INDICATIONS AND USAGE
KYZATREX is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (folliclestimulating hormone (FSH), luteinizing hormone (LH)) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations but have gonadotropins in the normal or low range.
KYZATREX is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (
1).
Limitations of Use:
Safety and efficacy of KYZATREX in males less than 18 years old have not been established (
1,
8.4).
Limitations of Use
Safety and efficacy of KYZATREX in males less than 18 years old have not been established
[see
Use in Specific Populations (8.4)]
.
1 INDICATIONS AND USAGE
Leflunomide tablets are indicated for the treatment of adults with active rheumatoid arthritis (RA).
Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis.
INDICATIONS AND USAGE
Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension.
These fixed-dose combinations are not indicated for initial therapy (see
DOSAGE AND ADMINISTRATION
).
In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See
WARNINGS
.)
In considering use of lisinopril and hydrochlorothiazide tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See
WARNINGS,
Head and Neck Angioedema
.)
1 INDICATIONS AND USAGE
Glimepiride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see
Clinical Studies (14.1)
].
Limitations of Use
Glimepiride tablets USP should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1).
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis (1).
1 INDICATIONS AND USAGE
1 INDICATIONS AND USAGECarisoprodol Tablets 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 moreprolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration. [see Dosage and Administration (2)].
1 INDICATIONS AND USAGE
OZOBAX is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
OZOBAX may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Limitations of Use
OZOBAX is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
OZOBAX is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. (
1)
OZOBAX may also be of some value in patients with spinal cord injuries and other spinal cord diseases. (
1)
Limitations of Use
OZOBAX is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders (
1)
1 INDICATIONS AND USAGE
Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate -amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimers Disease (AD) and other causes of cognitive decline.
A negative Neuraceq scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patients cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.
Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. Safety and effectiveness of Neuraceq have not been established for:o Predicting development of dementia or other neurologic conditions;o Monitoring responses to therapies.
Neuraceq is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate -amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimers Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patients cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.
Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder.
Safety and effectiveness of Neuraceq have not been established for:
Predicting development of dementia or other neurologic conditions
Monitoring responses to therapies
INDICATIONS AND USAGE
RESTASIS
ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
INDICATIONS AND USAGE
Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:
Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci.
Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.
Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis.
Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis.
Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy.
Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing.
It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin 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.
Indicated surgical procedures should be performed
1 INDICATIONS AND USAGE
LOVAZA (omega-3-acid ethyl esters) is
indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult
patients with severe (500 mg/dL) hypertriglyceridemia.
Usage Considerations: Patients should be placed on an
appropriate lipid-lowering diet before receiving LOVAZA and should continue this
diet during treatment with LOVAZA.
Laboratory studies should be done to ascertain that the lipid levels are
consistently abnormal before instituting LOVAZA therapy. Every attempt should be
made to control serum lipids with appropriate diet, exercise, weight loss in
obese patients, and control of any medical problems such as diabetes mellitus
and hypothyroidism that are contributing to the lipid abnormalities. Medications
known to exacerbate hypertriglyceridemia (such as betablockers, thiazides,
estrogens) should be discontinued or changed if possible prior to consideration
of triglyceride-lowering drug therapy.
Limitations of Use: The effect of LOVAZA on
cardiovascular mortality and morbidity in patients with elevated triglycerides
has not been determined.
LOVAZA is a combination of ethyl esters of omega 3 fatty acids,
principally EPA and DHA, indicated as an adjunct to diet to reduce triglyceride
(TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia.
(1)
Limitations of Use: The effect of LOVAZA on cardiovascular mortality and
morbidity in patients with elevated triglycerides has not been determined.
(1)
1 INDICATIONS AND USAGE
Acetaminophen injectionis indicated for
the management of mild to moderate pain in adult and pediatric patients 2 years and older
the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older
the reduction of fever in adult and pediatric patients.
ACETAMINOPHEN injection for intravenous useis indicated for the
Management of mild to moderate pain in adult and pediatric patients 2 years and older (1)
Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older (1)
Reduction of fever in adult and pediatric patients (1)
INDICATIONS AND USAGE
Lidocaine Hydrochloride Oral Topical Solution, USP 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.
1 INDICATIONS AND USAGE
Quetiapine tablet is an atypical antipsychotic indicated for the treatment of:
Schizophrenia (
1.1)
Bipolar I disorder manic episodes
(
1.2	)
Bipolar disorder, depressive episodes
(
1.2	)
1.1 Schizophrenia
Quetiapine tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials
[see
Clinical Studies (14.1)].
1.2 Bipolar Disorder
Quetiapine tablet is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex.
Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [
see
Clinical Studies
(14.2)]
.
Quetiapine tablet is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [
see
Clinical Studies (14.2)]
.
Quetiapine tablet is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [
see
Clinical Studies
(14.2)]
.
1.3	Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.