um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Butorphanol Tartrate Injection is indicated
as a preoperative or pre-anesthetic medication
as a supplement to balanced anesthesia
for the relief of pain during labor, and
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
], reserve butorphanol tartrate for use in patients for whom alternative treatment options [e.g. non-opioid analgesics]
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
Amlodipine and benazepril hydrochloride capsule, USP is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, USP is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent (1).
1.1 Hypertension
Amlodipine and benazepril hydrochloride capsules, USP are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
1 INDICATIONS AND USAGE
Pregabalin capsules are indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Pediatric use information is approved for Pfizers LYRICA (pregabalin) Capsules. However, due to Pfizers marketing exclusivity rights, this drug product is not labeled with that pediatric
information.
Pregabalin capsules are indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN).
(1)
Postherpetic neuralgia (PHN)
(1)
Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older.
(1)
Fibromyalgia
(1)
Neuropathic pain associated with spinal cord injury.
(1)
1	INDICATIONS AND USAGE
ZOCOR is indicated:
To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):
In adults with primary hyperlipidemia.
In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
ZOCOR is an HMG-CoA reductase inhibitor indicated: (1)
To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):
In adults with primary hyperlipidemia.
In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
1 INDICATIONS AND USAGE
Flurbiprofen tablets are indicated:
For relief of the signs and symptoms of rheumatoid arthritis.
For relief of the signs and symptoms of osteoarthritis.
Flurbiprofen tablets are a nonsteroidal anti-inflammatory drug indicated for
Relief of the signs and symptoms of rheumatoid arthritis
Relief of the signs and symptoms of osteoarthritis
1 INDICATIONS AND USAGE
ESTRADIOL TRANSDERMAL SYSTEM is an estrogen indicated for:
Treatment of moderate to severe vasomotor symptoms due to menopause (1.1)
Prevention of postmenopausal osteoporosis (1.2)
Limitation of Use
When prescribing solely for the treatment of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
1.2 Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate tablets is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1
INDICATIONS AND USAGE
Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to:
Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis (1.1).
The effects of concomitant myelosuppressive chemotherapy,and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.2).
Limitations of Use
Aranesp has not been shown to improve quality of life, fatigue, or patient well-being (1.3).
Aranesp is not indicated for use:
In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy (1.3).
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure(1.3).
In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion (1.3).
As a substitute for RBC transfusions inpatients who require immediate correction of anemia (1.3).
1.1
Anemia Due to Chronic Kidney Disease
Aranesp is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
1.2
Anemia Due to Chemotherapy in Patientswith Cancer
Aranesp is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressivechemotherapy, andupon initiation, there is a minimum of two additional months of planned chemotherapy.
1.3
Limitations of Use
Aranesp has not been shown to improve quality of life, fatigue, or patient well-being.
Aranesp is not indicated for use:
In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion.
As a substitute for RBC transfusions in patients who require immediate correction of anemia.
INDICATIONS & USAGE
Metastatic Prostate Cancer
Nilutamide tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2). For maximum benefit, Nilutamide treatment must begin on the same day as or on the day after surgical castration.
INDICATIONS AND USAGE
THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).
Allopurinol is indicated in: 1.The management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
2.The management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present.
3.The management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
1 INDICATIONS & USAGE
Eszopiclone tabletsare indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance.
The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
Eszopiclone tablets areindicated for the treatment of insomnia. Eszopiclone tablets has been shown to decrease sleep latency and improve sleep maintenance (1)
1 INDICATIONS AND USAGE
Pregabalin capsules are indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
Pregabalin capsules are indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN). (1)
Postherpetic neuralgia (PHN) (1)
Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. (1)
Fibromyalgia (1)
Neuropathic pain associated with spinal cord injury. (1)
1 INDICATIONS AND USAGE
Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for:
treatment of major depressive disorder (MDD)(1.1)
prevention of seasonal affective disorder (SAD) (1.2)
1.1 Major Depressive Disorder (MDD)
Bupropion hydrochloride extended-release tablets (XL)are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see
Clinical Studies (14.1)
].
1.2 Seasonal Affective Disorder (SDD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).
The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see
Clinical Studies (14.2)
].
1 INDICATIONS AND USAGE
Morphine Sulfate Extended-release Capsules, USP is an 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.
Morphine Sulfate Extended-release Capsules, USP 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. ( )
1
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 extended-release opioid formulations, reserve Morphine Sulfate Extended-release Capsules 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.
Morphine Sulfate Extended-release Capsules are not indicated as an as-needed (prn) analgesic.
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 extended-release opioid formulations, reserve Morphine Sulfate Extended-release Capsules 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.
Morphine Sulfate Extended-release Capsules are not indicated as an as-needed (prn) analgesic.
1. Indications and Usage
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
1 INDICATIONS AND USAGE
Click here to enter Indications
Ondansetron injection is a 5-HT
3 receptor antagonist indicated for the prevention of:
nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. (
1.1)
postoperative nausea and/or vomiting. (
1.2)
1.1 Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy
Ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin.
Ondansetron injection is approved for patients aged 6 months and older.
1.2 Prevention of Postoperative Nausea and/or Vomiting
Ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes.
Ondansetron injection is approved for patients aged 1 month and older.
INDICATIONS AND USAGE
Tolazamide tablets are indicated as an adjunct to diet to lower the blood glucose in patients with noninsulin-dependent diabetes mellitus (Type II) whose hyperglycemia cannot be satisfactorily controlled by diet alone.In initiating treatment for noninsulin-dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed and cardiovascular risk factors should be identified and corrective measures taken where possible.If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of tolazamide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient thus requiring only short-term administration of tolazamide.During maintenance programs, tolazamide should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgments should be based on regular clinical and laboratory evaluations.In considering the use of tolazamide in asymptomatic patients, it should be recognized that controlling the blood glucose in noninsulin-dependent diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes.
1 INDICATIONS AND USAGE
Venlafaxine Extended Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
Major Depressive Disorder (MDD) (1.1)
Social Anxiety Disorder (SAD) (1.2)
1.1 Major Depressive Disorder
Venlafaxine Extended Release Tablets (venlafaxine hydrochloride) are indicated for the treatment of major depressive disorder (MDD).
Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [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 mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure 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 Social Anxiety Disorder
Venlafaxine Extended Release Tablets are indicated for the treatment of Social Anxiety Disorder (SAD), also known as Social Phobia, as defined in DSM-IV.
Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.
Efficacy of venlafaxine extended release in the treatment of SAD was established in short-term SAD trials [see Clinical Studies (14.2)
].
1 INDICATIONS AND USAGE
IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test (1.1).
1.1 Acute Myeloid Leukemia
IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
1 INDICATIONS AND USAGE
Estradiol transdermal system is indicated for:
Estradiol transdermal system is an estrogen indicated for:
Treatment of moderate to severe vasomotor symptoms due to menopause (1.1)
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause (1.2)
Limitations of Use
When prescribing solely for the treatment of moderate to severe vaginal atrophy, first consider the use of topical vaginal products.
Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure (1.3)
Prevention of postmenopausal osteoporosis (1.4)
Limitations of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Due to Menopause
Limitations of Use:When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.
1.3 Treatment of Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure
1.4 Prevention of Postmenopausal Osteoporosis
Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
INDICATIONSAND USAGE
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result ofdiuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.
1 INDICATIONS AND USAGE
Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Solifenacin succinate tablets are a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)
INDICATIONS AND USAGE
PROVERA tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.