um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
INNOHEP is indicated for the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium.
The safety and effectiveness of INNOHEP were established in hospitalized patients.
1 INDICATIONS AND USAGE
Methadone hydrochloride tablets, USP are 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 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 tablets 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.
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, USP are an opioid agonist indicated for the:
4.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 tablets, USP 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
Methadone hydrochloride tablets, USP are not indicated as an as-needed (prn) analgesic.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
5.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
6.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).
INDICATIONS AND USAGE
MYSOLINE, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.
1 INDICATIONS AND USAGE
Savella is indicated for the management of fibromyalgia.
Savella is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia (1)
Savella is not approved for use in pediatric patients (5.1)
1 INDICATIONS AND USAGE
Ammonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
Ammonia N 13 Injection is a radioactive
diagnostic agent for Positron Emission Tomography (PET) indicated for
diagnostic PET imaging of the myocardium under rest or pharmacologic stress
conditions to evaluate myocardial perfusion in patients with suspected or
existing coronary artery disease (1).
INDICATIONS AND USAGE
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)
Refissa [Tretinoin Cream, USP (Emollient) 0.05%] is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs (see bullet 3 for populations in which effectiveness has not been established). REFISSA DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Many patients achieve desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sun avoidance programs including sunscreens, protective clothing, and emollient creams NOT containing tretinoin.
Tretinoin Cream, USP (Emollient) 0.05% has demonstrated NO MITIGATING EFFECT on significant signs of chronic sun exposure such as
coarse
or
deep
wrinkling, skin yellowing, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
Refissa should be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing when desired results on fine wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sun avoidance program alone.
The effectiveness of Refissa [Tretinoin Cream, USP (Emollient) 0.05%] in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin has not been established in people greater than 50 years of age OR in people with moderately to heavily pigmented skin. In addition, patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of Tretinoin Cream, USP (Emollient) 0.05%. Thus the effectiveness and safety of Refissa in these populations are not known at this time.
Neither the safety nor the effectiveness of Tretinoin Cream, USP (Emollient) for the prevention or treatment of actinic keratoses or skin neoplasms has been established.
Neither the safety nor the efficacy of using Tretinoin Cream, USP (Emollient) 0.05% daily for greater than 48 weeks has been established, and daily use beyond 48 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. (See WARNINGS section.)
INDICATIONS AND USAGE
Dantrium Intravenous is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages.
Dantrium Intravenous should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever).Dantrium Intravenous is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.
1 INDICATIONS AND USAGE
Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with:
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue Candida infections (1.2)
Esophageal candidiasis (1.3)
Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4)
1.1	Invasive Aspergillosis
Voriconazole tablets are indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus [see Clinical Studies (14.1, 14.5) and Microbiology (12.4)].
1.2	Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections
Voriconazole tablets are indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2, 14.5) and Microbiology (12.4)].
1.3	Esophageal Candidiasis
Voriconazole tablets are indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight [see Clinical Studies (14.3, 14.5) and Microbiology (12.4)].
1.4	Scedosporiosis and Fusariosis
Voriconazole tablets are indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) intolerant of, or refractory to, other therapy [see Clinical Studies (14.4) and Microbiology (12.4)].
1.5
Usage
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
Additional pediatric use information is approved for PF PRISM C.V.'s VFEND (voriconazole). However, due to PF PRISM C.V.'s marketing exclusivity rights, this drug product is not labeled with that information.
1 INDICATIONS AND USAGE
WinRho SDF is a Rho(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rho(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rho(D)-negative patients.
WinRho SDF is a Rho(D) Immune Globulin Intravenous (Human) indicated for: Immune Thrombocytopenic Purpura (ITP) (1.1)
Raising platelet counts in Rho(D) positive, non-splenectomized:
children with chronic or acute ITP
adults with chronic ITP
children and adults with ITP secondary to HIV infection Suppression of Rhesus (Rh) Isoimmunization (1.2)
Pregnancy and other obstetric conditions in non-sensitized, Rho(D)-negative women with a Rh-incompatible pregnancy including:
Routine antepartum and postpartum Rh prophylaxis
Rh prophylaxis in obstetric complications or invasive procedures
Incompatible transfusions in Rho(D)-negative individuals transfused with blood components containing Rho(D)-positive red blood cells (RBCs).
1.1 Treatment of ITP
WinRho SDF is indicated for use in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of non-splenectomized, Rho(D)-positive
children with chronic or acute ITP
adults with chronic ITP
children and adults with ITP secondary to HIV infection
The safety and efficacy of WinRho SDF have not been evaluated in clinical trials for patients with non-ITP causes of thrombocytopenia or in previously splenectomized patients or in patients who are Rho(D)-negative.
1.2 Suppression of Rh Isoimmunization
Pregnancy and Other Obstetric Conditions
WinRho SDF is indicated for the suppression of Rh isoimmunization in non-sensitized, Rho(D)-negative (D-negative) women with a Rh-incompatible pregnancy, including:
Routine antepartum and postpartum Rh prophylaxis
Rh prophylaxis in cases of:
Obstetric complication (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage)
Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma)
A Rh-incompatible pregnancy is assumed if the fetus/baby is either Rho(D)-positive or Rho(D)-unknown or if the father is either Rho(D)-positive or Rho(D)-unknown.
Incompatible Transfusions
WinRho SDF is indicated for the suppression of Rh isoimmunization in Rho(D)-negative individuals transfused with Rho(D)-positive red blood cells (RBCs) or blood components containing Rho(D)-positive RBCs.
WinRho SDF is not indicated for use as immunoglobulin replacement therapy for immune globulin deficiency syndromes.
INDICATIONS AND USAGE
Milrinone Lactate Injection, USP is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours.
INDICATIONS AND USAGE
NORCO is indicated for the relief of moderate to moderately severe pain.
INDICATIONS AND USAGE
Oxybutynin chloride is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).
INDICATIONS AND USAGE
Neomycin and Polymyxin B Sulfates Solution for Irrigation is indicated for short-term use (up to 10 days) as a continuous irrigant or rinse in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters.
Since organisms gain entrance to the bladder by way of, through, and around the catheter, significant bacteriuria is induced by bacterial multiplication in the bladder urine, in the mucoid film often present between catheter and urethra, and in other sites. Urinary tract infection may result from the repeated presence in the urine of large numbers of pathogenic bacteria. The use of closed systems with indwelling catheters has been shown to reduce the risk of infection. A three-way closed catheter system with constant neomycin-polymyxin B bladder rinse is indicated to prevent the development of infection while using indwelling catheters.
If uropathogens are isolated, they should be identified and tested for susceptibility so that appropriate antimicrobial therapy for systemic use can be initiated.
INDICATIONS AND USAGE
Viadur is indicated in the palliative treatment of advanced prostate cancer.
1 INDICATIONS AND USAGE
Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated
influenza A and B in patients 2 weeks of age and
older who have been symptomatic for no more than 48 hours. (
1.1)
Prophylaxis of influenza A and B in patients 1 year and older. (
1.2)
Limitations of Use:
Not a substitute for annual influenza
vaccination. (
1.3)
Consider available information on
influenza drug susceptibility patterns and treatment effects when deciding
whether to use. (
1.3)
Not recommended for patients with end-stage renal disease
not undergoing dialysis. (
1.3)
1.1 Treatment of Influenza
Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2 Prophylaxis of Influenza
Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3 Limitations of Use
Oseltamivir phosphate for oral suspension
is not a substitute for early influenza vaccination on an annual basis as
recommended by the Centers for Disease Control and Prevention Advisory
Committee on Immunization Practices.
Influenza viruses change over time.
Emergence of resistance substitutions could decrease drug effectiveness.
Other factors (for example, changes in viral virulence) might also
diminish clinical benefit of antiviral drugs. Prescribers should consider
available information on influenza drug susceptibility patterns and
treatment effects when deciding whether to use oseltamivir phosphate for oral suspension
[see
Microbiology (
12.4)]
.
Oseltamivir phosphate for oral suspension is not
recommended for patients with end-stage renal disease not undergoing
dialysis
[see DOSAGE AND ADMINISTRATION (
2.4)
and USE IN SPECIFIC POPULATIONS (
8.6)]
.
1 INDICATIONS AND USAGE
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for:
Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (
1.1)
Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (
1.2)
1.1 Major Depressive Disorder
Escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age
[see Clinical Studies (
14.1)].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
1.2 Generalized Anxiety Disorder
Escitalopram tablets are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [
see
Clinical
Studies
(
14.2)
].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
1 INDICATIONS AND USAGE
Fluoxetine
capsules are indicated for the treatment of:
Acute and maintenance treatment of Major Depressive Disorder
[see
Clinical Studies (14.1)]
.
Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)
[see
Clinical Studies (14.2)]
.
Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa
[see
Clinical Studies (14.3)]
.
Acute treatment of Panic Disorder, with or without agoraphobia
[see
Clinical Studies (14.4)]
.
Fluoxetine capsules and Olanzapine in Combinationare indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.
Fluoxetine
capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax
.
Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (
1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (
1)
Acute and maintenance treatment of Bulimia Nervosa (
1)
Acute treatment of Panic Disorder, with or without agoraphobia (
1)
Fluoxetine capsules and olanzapine in combination
for treatment of:
Acute Depressive Episodes Associated with Bipolar I Disorder (
1)
1 INDICATIONS AND USAGE
Oxaliplatin for Injection, in combination with infusional fluorouracil and leucovorin, is indicated for:
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
treatment of advanced colorectal cancer.
Oxaliplatin for Injection is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for:
adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. (1)
treatment of advanced colorectal cancer. (1)
INDICATIONS AND USAGE:
Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified.
Atrial Fibrillation: Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation.
INDICATIONS AND USAGE
Levonorgestrel tablets are a prescription-only emergency contraceptive, for women age 17 and younger, that can be used to prevent pregnancy following unprotected intercourse or a known or suspected contraceptive failure. This product is not approved for nonprescription use.
To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet must be taken 12 hours later.
INDICATIONS & USAGE
INDICATIONS:
For cauterization of skin or mucous membrane and for removing warts and granulated tissue.
UNCOMPLICATED GONORRHEA
UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae.
1 INDICATIONS & USAGE
Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis
Doxercalciferol is a synthetic vitamin D2 analog:Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. (1)