um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Perindopril erbumine is indicated for the treatment of patients with essential hypertension. (1.1)
Perindopril erbumine is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. (1.2)
1.1 Hypertension
Perindopril erbumine is indicated for the treatment of patients with essential hypertension. Perindopril erbumine may be used alone or given with other classes of antihypertensives, especially thiazide diuretics.
1.2 Stable Coronary Artery Disease
Perindopril erbumine is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. Perindopril erbumine can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy.
INDICATIONS AND USAGE
Dialyvite is a prescription folic acid supplement with additional nutrients indicated for use in improving the nutritional status of renal dialysis patients.
1 INDICATIONSAND USAGE
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults (1)
1 INDICATIONS AND USAGE
Methadone hydrochloride tablets, USPare indicated for the:
1.Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Warnings and Precautions (5.1)], reserve methadone hydrochloride tablets, USPfor use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone hydrochloride tablets, USPare not indicated as an as-needed (prn) analgesic.
2.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
3.Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)].
Methadone hydrochloride tablets,USPis an opioid agonist indicated for the: 1.Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids, reserve methadone hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Methadone hydrochloride tablets, USP are not indicated as an as-needed (prn) analgesic.
2.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
3.Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (1)
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 (2.1).
1. INDICATIONS AND USAGE
Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of
the signs and symptoms of idiopathic Parkinson's disease (PD) (1.1)
1.1 Parkinsons Disease
Pramipexole dihydrochloride tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
1 INDICATIONS AND USAGE
Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older.
Important Limitations of Use
Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)].
Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)].
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)].
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution is a combination of codeine, an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist, indicated for the temporary relief of cough and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. (1)
Important Limitations of Use (1)
Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
INDICATIONS AND USAGE
Ciclopirox Topical Suspension USP is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.
Indications and Usage:
Nizatidine oral solution is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.
Nizatidine oral solution is indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with nizatidine for longer than 1 year are not known.
Nizatidine oral solution is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.
Nizatidine oral solution is indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.
In pediatric patients, nizatidine oral solution is indicated for ages 12 years and older. Nizatidine oral solution is indicated for up to 8 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.
1 INDICATIONS AND USAGE
Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.
Clotrimazole and betamethasone dipropionate cream contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. (1)
1 INDICATIONS AND USAGE
Vigabatrin for oral solution is indicated for the treatment of:
Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of ageand older who have responded inadequately to several alternative treatments; vigabatrin for oral solution is not indicated as a first line agent (1.1)
Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss (1.2)
1.1 Refractory Complex Partial Seizures
(CPS)
Vigabatrin for oral solution is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions (5.1)]. Vigabatrin for oral solution is not indicated as a first line agent for complex partial seizures.
1.2
Infantile Spasms (IS)
Vigabatrin for oral solution is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults
[see Clinical Studies (
14)]
.
Citalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults (
1
).
1 INDICATIONS AND USAGE
Seasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy.
Seasonique is an estrogen/progestin COC indicated for use by women to prevent pregnancy. (1)
INDICATIONS AND USAGE
Tobramycin 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 neonate, child, and adult caused by P. aeruginosa, E. coli, and Klebsiella sp.
Lower respiratory tract infections caused by P. aeruginosa, Klebsiella sp, Enterobacter sp, Serratia sp, 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 sp, and Enterobacter sp.
Skin, bone, and skin-structure infections caused by P. aeruginosa, Proteus sp, E. coli, Klebsiella sp, Enterobacter sp, and S. aureus.
Complicated and recurrent urinary tract infections caused by P. aeruginosa, Proteus sp (indole- positive and indole-negative), E. coli, Klebsiella sp, Enterobacter sp, Serratia sp, S. aureus, Providencia sp, and Citrobacter sp.
Aminoglycosides, including tobramycin sulfate, 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 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 sulfate 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.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tobramycin and other antibacterial drugs, tobramycin 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, Amoxicillin Tablets, USP should be used only to treat 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.
Amoxicillin Tablets, USP are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
Amoxicillin Tablets, USP are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1
1.5)
In combination for treatment of
H. pylori infection and duodenal ulcer disease. (1.6, 1.7)
1.1 Infections of the ear, nose, and throat
due to
Streptococcus species.
(- and -hemolytic isolates only),
Streptococcus pneumoniae,
Staphylococcus spp., or
Haemophilus influenzae.
1.2 Infections of the genitourinary tract
due to
Escherichia coli,
Proteus mirabilis, or
Enterococcus faecalis.
1.3 Infections of the skin and skin structure
due to
Streptococcus spp.
(- and -hemolytic isolates only),
Staphylococcus spp., or
E. coli.
1.4 Infections of the lower respiratory tract
due to
Streptococcus spp.
(- and -hemolytic isolates only),
S. pneumoniae,
Staphylococcus spp., or
H. influenzae.
1.5 Gonorrhea, acute uncomplicated (ano-genital and urethral infections)
due to
Neisseria gonorrhoeae.
Because of high rates of amoxicillin resistance, Amoxicillin Tablets, USP are not recommended for empiric treatment of gonorrhea. Amoxicillin Tablets, USP use should be limited to situations where
N. gonorrhoeae isolates are known to be susceptible to amoxicillin.
1.6 Triple therapy for
Helicobacter pylori with clarithromycin and lansoprazole
Amoxicillin Tablets, USP, in combination with clarithromycin plus lansoprazole as triple therapy, are indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.7 Dual therapy for
H. Pylori with lansoprazole
Dual therapy for
H. pylori with lansoprazole:
Amoxicillin Tablets, USP, in combination with lansoprazole delayed-release capsules as dual therapy, are indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer)
who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
INDICATIONS AND USAGE
Sumatriptan tablets, USP are indicated for the acute treatment of migraine attacks with or without aura in adults.
Sumatriptan tablets, USP are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of sumatriptan tablets, USP have not been established for cluster headache, which is present in an older, predominantly male population.
1 INDICATIONS AND USAGE
Colchicine Tablets, USP are an alkaloid indicated for:
Prophylaxis and treatment of gout flares in adults (1.1).
Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).
1.1	Gout Flares
Colchicine Tablets, USP are indicated for prophylaxis and the treatment of acute gout flares.
Prophylaxis of Gout Flares
:
Colchicine Tablets, USP are indicated for prophylaxis of gout flares.
Treatment of Gout Flares
:
Colchicine Tablets, USP are indicated for treatment of acute gout flares when taken at the first sign of a flare.
1.2	Familial Mediterranean Fever (FMF)
Colchicine Tablets, USP are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
INDICATIONS AND USAGE
Labetalol Hydrochloride Tablets are indicated in the management of hypertension.
Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
1 INDICATIONS AND USAGE
Quetiapine
fumarate
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 fumarate tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate 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 fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials.
[see (14.1)]
Clinical Studies
1.2 Bipolar Disorder
Quetiapine fumarate 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 (14.2)]
Clinical Studies
Quetiapine fumarate 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 (14.2)]
Clinical Studies
Quetiapine fumarate 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 fumarate tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials. [ .
see (14.2)]
Clinical Studies
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.
1 INDICATIONS & USAGE
Zidovudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated for:
Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. (
1.1)
Prevention of maternal-fetal HIV-1 transmission. (
1.2)
1.1 Treatment of HIV-1
Zidovudine tablets, a nucleoside reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
1.2 Prevention of Maternal-Fetal HIV-1 Transmission
Zidovudine tablets are indicated for the prevention of maternal-fetal HIV-1 transmission
[see Dosage and Administration (
2.3)].
The indication is based on a dosing regimen that included 3 components:
1. antepartum therapy of HIV-1-infected mothers
2.intrapartum therapy of HIV-1-infected mothers
3.post-partum therapy of HIV-1-exposed neonate
Points to consider prior to initiating zidovudine in pregnant women for the prevention of maternal-fetal HIV-1 transmission include:
In most cases, zidovudine for prevention of maternal-fetal HIV-1 transmission should be given in combination with other antiretroviral drugs.
Prevention of HIV-1 transmission in women who have received zidovudine for a prolonged period before pregnancy has not been evaluated.
Because the fetus is most susceptible to the potential teratogenic effects of drugs during the first 10 weeks of gestation and the risks of therapy with zidovudine during that period are not fully known, women in the first trimester of pregnancy who do not require immediate initiation of antiretroviral therapy for their own health may consider delaying use; this indication is based on use after 14 weeks' gestation.
1 INDICATIONS AND USAGE
Clonidine hydrochloride 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)].
Clonidine hydrochloride extended-release tablets are centrally acting alpha2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. (1)
1 INDICATIONS AND USAGE
ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
ESBRIET is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). (1)
INDICATIONS AND USAGE
Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.