um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
To reduce the development of drugresistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets 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 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*:
Amoxicillin and clavulanate potassium
tablets are a combination penicillin-class antibacterial and betalactamase inhibitor indicated for treatment of the following:
Lower respiratory tract infections
(1.1)
Acute bacterial otitis media
(1.2)
Sinusitis (1.3)
Skin and skin structure infections (1.4)
Urinary tract infections (1.5)
1.1Lower Respiratory Tract Infections
caused by betalactamaseproducing isolates of Haemophilusinfluenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
caused by betalactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by betalactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
caused by betalactamaseproducing isolates of E. coli, Klebsiellaspecies, 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 should not be used.
1 INDICATIONS AND USAGE
Hypothyroidism: Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression:Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Limitations of Use:
Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)].
Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
Levothyroxine sodium tablets are levothyroxine sodium (T4) indicated for:
Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. (1)
Limitations of Use:
-Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
-Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.
1 INDICATIONSAND USAGE
Posaconazole is an azole antifungal indicated as follows:
Posaconazole is
indicated for the prophylaxis of invasive
Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (
1.2)
o
Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older
1.2 Prophylaxis of Invasive Aspergillus and Candida Infections
Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive
Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy
[see Clinical Studies (
14.2)]
as follows:
Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older
Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.s NOXAFIL (posaconazole) delayed-release tablets. However, due to Merck Sharp & Dohme Corp.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
INDICATIONS AND USAGE
Cephalexin capsules, USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by and (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.
Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to , , , and
Skin and skin structure infections caused by and/or
Bone infections caused by and/or
Genitourinary tract infections, including acute prostatitis, caused by , , and
Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, USP and other antibacterial drugs, cephalexin capsules, 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.
Streptococcuspneumoniae
Streptococcuspyogenes
Streptococcuspneumoniae
Haemophilusinfluenzae
Staphylococcus aureus, Streptococcus pyogenes
Moraxellacatarrhalis
Staphylococcus aureus
Streptococcus pyogenes
Staphylococcus aureus
Proteusmirabilis
Escherichiacoli
Proteusmirabilis
Klebsiellapneumoniae
Note
1 INDICATIONS AND USAGE
Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following:
Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1)
Acute Maxillary Sinusitis (1.2)
Community-Acquired Pneumonia (1.3)
Limitations of Use
Clarithromycin extended-release tablets are indicated only for acute bacterial exacerbation of chronic bronchitis, acute maxillary sinusitis, and community-acquired pneumonia in adults. (1.9)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9)
1.1 Acute Bacterial Exacerbation
of Chronic Bronchitis
Clarithromycin extended-release tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)].
1.2 Acute Maxillary Sinusitis
Clarithromycin extended-release tablets (in adults) are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)].
1.3 Community-Acquired
Pneumonia
Clarithromycin extended-release tablets are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to:
Haemophilus influenzae (in adults)
Haemophilus parainfluenzae (in adults)
Moraxella catarrhalis (in adults)
Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila
pneumoniae (in adults)
1.9 Limitations of Use
Clarithromycin extended-release tablets 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 in treating other infections for which clarithromycin immediate-release tablets and clarithromycin granules are approved have not been established.
There is resistance to macrolides in certain bacterial infections caused by Streptococcus pneumoniae and Staphylococcus aureus. Susceptibility testing should be performed when clinically indicated.
1.10 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin 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
Lubiprostone capsules are a chloride channel activator indicated for the treatment of:
chronic idiopathic constipation (CIC) in adults.
(1.1)
opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
(1.2)
Limitations of Use:
Effectiveness of lubiprostone capsules in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established.
(1.2,
7.1)
irritable bowel syndrome with constipation (IBS-C) in women
18 years old.
(1.3)
1.1 Chronic Idiopathic Constipation in Adults
Lubiprostone capsules are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
1.2 Opioid-Induced Constipation
in Adult Patients with Chronic Non-Cancer Pain
Lubiprostone capsules are indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.
Limitations of Use:
Effectiveness of lubiprostone capsules in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established
[see
Clinical Studies (14.2)]
.
1.3 Irritable Bowel Syndrome with Constipation
Lubiprostone capsules are indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.
INDICATION AND USAGE
Diclona Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.
1 INDICATIONS AND USAGE
Quetiapine fumarate tablet USP 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 tablets USP are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets USP 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 USP 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 tablets USP are 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 tablets USP are 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 tablets USP are 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 USP 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.
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, Klebsiella species, Enterobacter
species, Morganella morganii, Proteus mirabilis and 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 pneumoniae or Haemophilus influenzae when
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 pneumoniae or
Haemophilus influenzae when 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 flexneri and Shigella
sonnei when antibacterial therapy is indicated.
Pneumocystis Carinii Pneumonia
For the treatment of documented Pneumocystis
carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are
immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.
Travelers Diarrhea In Adults
For the treatment of travelers diarrhea due to susceptible strains of
enterotoxigenic E. coli.
INDICATIONS AND USAGE
Perennial Allergic Rhinitis :
Cetirizine Hydrochloride Oral Solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.
Chronic Urticaria:
Cetirizine Hydrochloride Oral Solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.
1 INDICATIONS AND USAGE
PROPECIA is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY.
Efficacy in bitemporal recession has not been established.
PROPECIA is not indicated for use in women.
PROPECIA is a 5-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY (1).
PROPECIA is not indicated for use in women (1, 4, 5.1).
Sumatriptan succinate 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 succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks.
Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.
Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The effectiveness of Lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS & USAGE
Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
INDICATIONS
Se-Natal 19 tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Se-Natal 19 tablets are also useful in improving the nutritional status of women prior to conception.
1. INDICATIONS AND USAGE
Rabeprazole sodium delayed-release tablets are a proton-pump inhibitor (PPI) indicated in adults for:
Healing of
Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance
of Healing of Erosive or Ulcerative GERD (1.2)
Treatment
of Symptomatic GERD (1.3)
Healing of
Duodenal Ulcers (1.4)
Helicobacter
pylori
Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
(1.5)
Treatment
of Pathological Hypersecretory Conditions, Including Zollinger-Ellison
Syndrome (1.6)
In adolescent patients 12 years of age and older for:
Short-term
treatment of Symptomatic GERD (1.7)
1.1 Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults.
1.4 Healing of Duodenal Ulcers in Adults
Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
Rabeprazole sodium delayed-release tablets in combination with amoxicillin and clarithromycin as a three drug regimen, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.5) and Dosage and Administration (2.5)].
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.2) and the clarithromycin package insert, Clinical Pharmacology (12.2)].
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7 Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
Myocardial Infarction
Propranolol hydrochloride tablets, USP are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable.
1.2 Endogenous AnteriorUveitis
Difluprednate ophthalmic emulsion (0.05%) is also indicated for the treatment of endogenous anterior uveitis.