um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Risedronate sodiumis abisphosphonate indicated for:
Treatment and prevention of postmenopausal osteoporosis (1.1)
Treatment to increase bone mass in men with osteoporosis (1.2)
Treatment and prevention of glucocorticoid-induced osteoporosis (1.3)
Treatment of Paget's disease (1.4)
Limitations of UseOptimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.5)
1.1 Postmenopausal Osteoporosis
Risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1, 14.2)].
1.2 Osteoporosis in Men
Risedronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis.
1.3 Glucocorticoid-Induced Osteoporosis
Risedronate sodium tablets are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
1.4 Paget's Disease
Risedronate sodium tablets are indicated for treatment of Paget's disease of bone in men and women.
1.5 Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
1 INDICATIONS AND USAGE
Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [
see
Dosage and Administration (2.2)
].
Limitations of Use
Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [
see Dosage and
Administration (2.2),
Contraindications (4),
Warnings and Precautions (
5.1,
5.4,
5.5,
5.7,
5.9)
].
Bupivacaine hydrochloride injection contains bupivacaine, an amide local anesthetic. Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. (
1,
2.2)
Limitations of Use
Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use. (
1,
2.2,
4,
5.1,
5.4,
5.5,
5.7,
5.9)
1 INDICATIONS AND USAGE
Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidones greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]
Schizophrenia
Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)].
Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].
Ziprasidone hydrochloride is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidonecapsules to prolong the QT interval and may consider the use of other drugs first(1)
Ziprasidonecapsules are indicated for the:
treatment of schizophrenia in adults. (1)
acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder. (1)
maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. (1)
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of nabumetone tablets USP and other treatment options before deciding to use nabumetone tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis
1 INDICATIONS AND USAGE
Betamethasone dipropionate ointment (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.
Betamethasone dipropionate ointment (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. (1)
1 INDICATIONS AND USAGE
Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Azithromycin for injection is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
Community-acquired pneumonia in adults (1.1)
Pelvic inflammatory disease (1.2)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for injection and other antibacterial drugs, azithromycin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
1.1 Community-Acquired Pneumonia
due to Chlamydophila pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae in patients who require initial intravenous therapy.
1.2 Pelvic Inflammatory Disease
due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin for injection.
Azithromycin for injection should be followed by azithromycin by the oral route as required.
[see Dosage and Administration (2)]
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only totreat 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.
INDICATIONS AND USAGE
SYNALAR Solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
1 INDICATIONS AND USAGE
Methadone Hydrochloride Oral Solution is indicated for the:
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 (5.2)], reserve Methadone Hydrochloride Oral Solution for 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 Oral Solution is not indicated as an as-needed (prn) analgesic.
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
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 Oral Solution is an opioid agonist indicated for the:
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 Oral Solution 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 Oral Solution is not indicated as an as-needed (prn) analgesic.
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
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 INDICATIONSAND USAGE
Ciclopirox Shampoo 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.
Ciclopirox Shampoo 1% is an antifungal indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. (1)
INDICATIONS & USAGE SECTION
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, USP and other antibacterial drugs, amoxicillin for oral suspension, 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 for oral suspension, USP is indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
1.1 Infections of the Ear, Nose, and Throatdue 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 Structuredue to Streptococcus spp. (- and -hemolytic isolates only), Staphylococcus spp., or E. coli.
1.4 Infections of the Lower Respiratory Tractdue 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 for oral suspension, USP is not recommended for empiric treatment of gonorrhea. Amoxicillin for oral suspension, 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 for oral suspension, USP, in combination with clarithromycin plus lansoprazole as triple therapy, is 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
Amoxicillin for oral suspension, USP, in combination with lansoprazole delayed-release capsules as dual therapy, is 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.
1 INDICATIONS AND USAGE
Hydromorphone hydrochloride suppositories are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve hydromorphone hydrochloride suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Hydromorphone hydrochloride suppositories contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (1)
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve hydromorphone hydrochloride suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesia
1 INDICATIONS AND USAGE
Zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks.
Zolmitriptan tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache.
Zolmitriptan is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use:
Use only after a clear diagnosis of migraine has been established (1)
Not indicated for the prophylactic therapy of migraine (1)
Not indicated for the treatment of cluster headache (1)
1 INDICATIONS AND USAGE
Succinylcholine chloride is indicated in adults and pediatric patients:
as an adjunct to general anesthesia
to facilitate tracheal intubation
to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Succinylcholine chloride is a depolarizing neuromuscular blocker indicated in adults and pediatric patients:
as an adjunct to general anesthesia (1)
to facilitate tracheal intubation (1)
to provide skeletal muscle relaxation during surgery or mechanical ventilation. (1)
1 INDICATIONS AND USAGE
Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
Tamsulosin hydrochloride capsules are an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia. (1)
Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. (1)
1 INDICATIONS AND USAGE
Meloxicam tablets are a 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)
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh
60 kg [
see Dosage and Administration (2.4) and Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for:
Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (
1)
Treatment of candidemia and the following
Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. (
1)
Treatment of esophageal candidiasis. (
1)
Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (
1)
1.1	Empirical Therapy for Presumed Fungal Infections in Febrile, Neutropenic Patients
Caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pediatric patients (3 months of age and older)
[see
Clinical Studies (14.1,
14.5)].
1.2	Treatment of Candidemia and Other
Candida Infections
Caspofungin acetate for injection is indicated for the treatment of candidemia and the following candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections in adult and pediatric patients (3 months of age and older)
[see
Clinical Studies (14.2,
14.5)].
Limitations of Use:
Caspofungin acetate for injection has not been studied in endocarditis, osteomyelitis, and meningitis due to
Candida.
1.3	Treatment of Esophageal Candidiasis
Caspofungin acetate for injection is indicated for the treatment of esophageal candidiasis in adult and pediatric patients (3 months of age and older)
[see
Clinical Studies (14.3,
14.5)].
Limitations of Use:
Caspofungin acetate for injection has not been approved for the treatment of oropharyngeal candidiasis (OPC). In the study that evaluated the efficacy of caspofungin in the treatment of esophageal candidiasis, patients with concomitant OPC had higher relapse rate of the OPC
[see
Clinical Studies (14.3)].
1.4	Treatment of Invasive Aspergillosis in Patients Who Are Refractory to or Intolerant of Other Therapies
Caspofungin acetate for injection is indicated for the treatment of invasive aspergillosis in adult and pediatric patients (3 months of age and older) who are refractory to or intolerant of other therapies
[see
Clinical Studies (14.4,
14.5)].
Limitations of Use:
Caspofungin acetate for injection has not been studied as initial therapy for invasive aspergillosis.
INDICATIONS AND USAGE
Thiotepa for Injection has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors:
Adenocarcinoma of the breast.
Adenocarcinoma of the ovary.
For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
For the treatment of superficial papillary carcinoma of the urinary bladder.
While now largely superseded by other treatments, Thiotepa for Injection has been effective against other lymphomas, such as lymphosarcoma and Hodgkin's disease.
1 INDICATIONS & USAGE
Quetiapine 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 is indicated for the treatment of schizophrenia. The efficacy of quetiapine 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 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 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 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 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 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.
1 INDICATIONS AND USAGE
Desoximetasone topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older (1).
Desoximetasone topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.