um-ids/dailymed-annotations huggingface dataset:
1.1 Heart Failure
Carvedilol tablets are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4), Clinical Studies (14.1)].
1.2 Left Ventricular Dysfunction following Myocardial Infarction
Carvedilol tablets are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)].
1.3 Hypertension
Carvedilol tablets are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].
1
INDICATIONS AND USAGE
Ondansetron
tablets are indicated for the prevention of nausea and vomiting associated with:
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 .
initial and repeat courses of moderately emetogenic cancer chemotherapy.
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.
INDICATIONS:
This product is a gluten-free prescription regimen of prenatal multi-vitamin, multi-mineral and omega fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. This product is also useful in improving the nutritional status prior to conception.
1 INDICATIONS AND USAGE
JALYN is a combination of dutasteride, a 5 alpha-reductase inhibitor, and tamsulosin, an alpha adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. (1.1)
Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. (1.2)
1.1 Benign Prostatic Hyperplasia (BPH) Treatment
JALYN (dutasteride and tamsulosin hydrochloride) Capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
1.2 Limitations of Use
Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer.
INDICATIONSAND USAGE
Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin.
Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors
(see
CLINICAL STUDIES: Breast Carcinoma).
Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Paclitaxel Injection, USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi's sarcoma.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Naproxen tablets are indicated:
For the relief of the signs and symptoms of rheumatoid arthritis
For the relief of the signs and symptoms of osteoarthritis
For the relief of the signs and symptoms of ankylosing spondylitis
For the relief of the signs and symptoms of juvenile arthritits
Naproxen tablets are also indicated:
For relief of the signs and symptoms of tendonitis
For relief of the signs and symptoms of bursitis
For relief of the signs and symptoms of acute gout
For the management of pain
For the management of primary dymenorrhea
INDICATIONS AND USAGE
Tablets of Mixed Salts of a Single Entity Amphetamine product are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Attention Deficit Hyperactivity Disorder (ADHD)
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV)
implies the presence of hyperactive-impulsive or inattentive symptoms
that caused impairment and were present before age 7 years. The
symptoms must cause clinically significant impairment, e.g., in social,
academic, or occupational functioning, and be present in two or more
settings, e.g., school (or work) and at home. The symptoms must not be
better accounted for by another mental disorder. For the Inattentive
Type, at least six of the following symptoms must have persisted for at
least 6 months: lack of attention to details/careless mistakes; lack of
sustained attention; poor listener; failure to follow through on tasks;
poor organization; avoids tasks requiring sustained mental effort;
loses things; easily distracted; forgetful. For the
Hyperactive-Impulsive Type, at least six of the following symptoms must
have persisted for at least 6 months: fidgeting/squirming; leaving
seat; inappropriate running/climbing; difficulty with quiet activities;
on the go; excessive talking; blurting answers; can't wait turn;
intrusive. The Combined Type requires both inattentive and
hyperactive-impulsive criteria to be met.
Special Diagnostic Considerations- Specific etiology of this syndrome is unknown, and there is no single
diagnostic test. Adequate diagnosis requires the use not only of
medical but of special psychological, educational, and social
resources. Learning may or may not be impaired. The diagnosis must be
based upon a complete history and evaluation of the child and not
solely on the presence of the required number of DSM-IV characterostocs/
Need for Comprehensive Treatment Program- Tablets of Mixed Salts of a Single Entity Amphetamine Product are
indicated as an integral part of a total treatment program for ADHD
that may include other measures (psychological, educational, social)
for patients with this syndrome. Drug treatment may not be indicated
for all children with this syndrome. Stimulants are not intended for
use in the child who exhibits symptoms secondary to environmental
factors and/or other primary psychiatric disorders, including
psychosis. Appropriate educational placement is essential and
psychosocial intervention is often helpful. When remedial measures
alone are insufficient, the decision to prescribe stimulant medication
will depend upon the physician's assessment of the chronicity and
severity of the child's symptoms.
Long-Term Use- The effectiveness of
Tablets of Mixed Salts of a Single Entity Amphetamine Product for long-term use
has not been systematically evaluated in controlled trials. Therefore, the
physician who elects to use Tablets of Mixed Salts of a Single Entity
Amphetamine Product for extended periods should periodically re-evaluate the
long-term usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Carmustine for injectionis a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:
Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors (
1)
Multiple myeloma-in combination with prednisone (
1)
Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs (
1)
Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs (
1)
Carmustine for injectionis indicated as palliative therapy as a single agent or in established combination therapy in the following:
Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
Multiple myeloma in combination with prednisone.
Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs.
Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.
1 INDICATIONS AND USAGE
Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].
Desvenlafaxine is aserotonin and norepinephrine reuptake inhibitor (SNRI)indicated for the treatment of adults with major depressive disorder (MDD) (1).
1. INDICATIONS AND USAGE
BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( )
1.1
1.1 Hypertension
BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure . BYSTOLIC may be used alone or in combination with other antihypertensive agents .
[see Clinical Studies ( )]
14.1
[see Drug Interactions ( )]
7
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with BYSTOLIC.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so
the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
INDICATIONS AND USAGE
Hypertension
Lisinopril tablets are indicated for the treatment of
hypertension. They may be used alone as initial therapy or concomitantly with
other classes of antihypertensive agents.
Heart Failure
Lisinopril tablets are indicated as adjunctive therapy in
the management of heart failure in patients who are not responding adequately to
diuretics and digitalis.
Acute Myocardial Infarction
Lisinopril tablets are indicated for the treatment of
hemodynamically stable patients within 24 hours of acute myocardial infarction,
to improve survival. Patients should receive, as appropriate, the standard
recommended treatments such as thrombolytics, aspirin and beta-blockers.
In using lisinopril tablets, consideration should be given to the fact that
another angiotensin-converting enzyme inhibitor, captopril, has caused
agranulocytosis, particularly in patients with renal impairment or collagen
vascular disease, and that available data are insufficient to show that
lisinopril tablets does not have a similar risk. (See
WARNINGS).
In considering the use of lisinopril tablets, it should be noted that in
controlled clinical trials ACE inhibitors have an effect on blood pressure that
is less in Black patients than in non-Blacks. In addition, ACE inhibitors have
been associated with a higher rate of angioedema in Black than in non-Black
patients (see
WARNINGS, Anaphylactoid and Possibly Related
Reactions ).
1 INDICATIONS AND USAGE
Brinzolamide ophthalmic suspension 1% is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma.
Brinzolamide ophthalmic suspension is a carbonic anhydrase inhibitor indicated for in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma (1)
1 INDICATIONS AND USAGE
Valproic acid is indicated for:
Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures
1.1 Epilepsy
Valproic acid capsules are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid capsules are indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. See Warnings and Precaution (5.1) for statement regarding fatal hepatic dysfunction.
1.2 Important Limitations
Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable [see Warnings Precautions (5.2, 5.3, 5.4), Use in Specific populations (8.1). and Patient Counseling Information (17)].
For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception [see Contraindications (4)].
INDICATIONS AND USAGE
Nitrofurantoin capsules USP, (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules USP, (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules USP, (macrocrystals) 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules USP, (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules USP, (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules USP, (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
1 INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate is a proton pump inhibitor (PPI) indicated for:
Short-term treatment of active duodenal ulcer (1.1)
Short-term treatment of active benign gastric ulcer (1.2)
Treatment of gastroesophageal reflux disease (GERD) (1.3)
Maintenance of healing of erosive esophagitis (1.4)
The safety and effectiveness of omeprazole and sodium bicarbonate capsules in pediatric patients (<18 years of age) have not been established. (8.4)
1.1 Duodenal Ulcer
Omeprazole and sodium bicarbonate is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. [See Clinical Studies (14.1).]
1.2 Gastric Ulcer
Omeprazole and sodium bicarbonate is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies (14.2).]
1.3 Treatment of Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD
Omeprazole and sodium bicarbonate is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. [See Clinical Studies (14.3).]
Erosive Esophagitis
Omeprazole and sodium bicarbonate is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.
The efficacy of omeprazole and sodium bicarbonate used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), an additional 4-8 week courses of omeprazole and sodium bicarbonate may be considered. [See Clinical Studies (14.3).]
1.4 Maintenance of Healing of Erosive Esophagitis
Omeprazole and sodium bicarbonate is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months. [See Clinical Studies (14.4).]
1 INDICATIONS & USAGE
Telmisartan is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events,
primarily strokes and myocardial infarctions.(1.1)
1.1 Hypertension
Telmisartan tablets,USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents [see Clinical Studies (14.1)].
Use of telmisartan and ACE inhibitor is not recommended [see Warnings and Precautions (5.6)].
1 INDICATIONS AND USAGE
VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia who are 5 years of age and older with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
VOXZOGO is a C type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients with achondroplasia who are 5 years of age and older with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1)