um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE:
For the treatment of the following conditions:
Ophthalmic: Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctuate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical or thermal burns, or penetration of foreign bodies.
Otic: Steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and nonpurulent infective otitis externa when the hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
1 INDICATIONS AND USAGE
Benazepril hydrochloride tablets 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 mm Hg 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 thiazide diuretics.
Benazepril hydrochloride tablets are an angiotensin-converting enzyme (ACE) inhibitor 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 INDICATIONS AND USAGE
Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure.
Labetalol Hydrochloride (HCl) is a beta-adrenergic blocker. Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure. (1)
1 INDICATIONS AND USAGE
Gemcitabine Injection is a nucleoside metabolic inhibitor indicated:
in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (
1.1)
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (
1.2)
in combination with cisplatin for the treatment of non-small cell lung cancer. (
1.3)
as a single agent for the treatment of pancreatic cancer. (
1.4)
1.1 Ovarian Cancer
Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
1.2 Breast Cancer
Gemcitabine Injection in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
1.3 Non-Small Cell Lung Cancer
Gemcitabine Injection in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
1.4 Pancreatic Cancer
Gemcitabine Injection is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine Injection is indicated for patients previously treated with fluorouracil.
1 INDICATIONS AND USAGE
Gabapentintablets are indicated for:
Management of postherpetic neuralgia in adults.
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.
Gabapentintablets are indicated for:
Postherpetic neuralgia in adults (1)
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
INDICATIONS AND USAGE
Diphenhydramine hydrochloride injection, is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical.
Antihistaminic
For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
Motion sickness
For active treatment of motion sickness.
Antiparkinsonism
For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combinations with centrally acting anticholinergic agents.
1 INDICATIONS AND USAGE
Paliperidone is an atypical antipsychotic agent indicated for
Treatment of schizophrenia (
1.1)
Adults: Efficacy was established in three 6-week trials and one maintenance trial. (
14.1)
Adolescents (ages 1217): Efficacy was established in one 6-week trial. (
14.1)
Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. (
1.2)
Efficacy was established in two 6-week trials in adult patients. (
14.2)
1.1	Schizophrenia
Paliperidone Extended-Release Tablets are indicated for the treatment of schizophrenia
[see
Clinical Studies (14.1)]
.
The efficacy of Paliperidone Extended-Release Tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.
1.2	Schizoaffective Disorder
Paliperidone Extended-Release Tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy
[see
Clinical Studies (14.2)]
.
The efficacy of Paliperidone Extended-Release Tablets in schizoaffective disorder was established in two 6-week trials in adults.
INDICATIONS AND USAGE
Famotidine tablets USP are indicated in:
1. Short-term treatment of active duodenal ulcer
Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.
2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer
Controlled studies in adults have not extended beyond one year.
3. Short-term treatment of active benign gastric ulcer
Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
4. Short-term treatment of gastroesophageal reflux disease (GERD)
Famotidine tablets USP are indicated for short-term treatment of patients with symptoms of GERD (see
CLINICAL PHARMACOLOGY IN ADULTS,
Clinical Studies).
Famotidine tablets are also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see
CLINICAL PHARMACOLOGY IN ADULTS,
Clinical Studies).
5. Treatment of pathological hypersecretory conditions
(e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see
CLINICAL PHARMACOLOGY IN ADULTS,
Clinical Studies).
INDICATIONS AND USAGE
Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques, such as percutaneous injection, and by peripheral nerve block techniques such as brachial plexus and intercostal,when the accepted procedures for these techniques as described in standard textbooks are observed.
INDICATIONS:
Prophylactic treatment and management of nausea and vomiting, and dizziness associated with motion sickness.
1
INDICATIONS AND USAGE
Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years.
Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. (1)
1 INDICATIONS AND USAGE
VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
VILTEPSO is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (1)
1.1 Treatment of Osteoporosis
in Postmenopausal Women
BINOSTO effervescent tablet 70 mg is indicated for the treatment
of osteoporosis in postmenopausal women. For the treatment of osteoporosis,
alendronate sodium increases bone mass and reduces the incidence of
fractures, including those of the hip and spine (vertebral compression
fractures).
[See Clinical Studies (
14.1).]
INDICATIONS AND USAGE
This solution is indicated for use in adults as a source of electrolytes and water for hydration, and as an alkalinizing agent.
1 INDICATIONS AND USAGE
Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults.
Limitations of Use:
Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established.
Mesalamine delayed-release tablets are aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults.
(1)
Limitation of Use: Safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established
(1)
INDICATIONS AND USAGE
Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration (see WARNINGS
)
, reserve acetaminophen and codeine phosphate tablets 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
Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
INDICATIONS AND USAGE
Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
Tamsulosin hydrochloride is an alpha 1 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
MONJUVI, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
MONJUVI is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). (1)
1 INDICATIONS AND USAGE
Clopidogrel tablets are a P2Y12 platelet inhibitor indicated for:
Acute coronary syndrome
- For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], clopidogrel tablets has been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia. (1.1)
- For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary PCI is unknown. (1.1)
Recent MI, recent stroke, or established peripheral arterial disease. clopidogrel tablets has been shown to reduce the combined endpoint of new ischemic stroke, new MI, and other vascular death. (1.2)
1.1 Acute Coronary Syndrome (ACS)
For patients with non-ST-segment elevation ACS [unstable angina (UA)/non-ST-elevation myocardial infarction (NSTEMI)], including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel tablets have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (MI), or stroke as well as the rate of a combined endpoint of cardiovascular death, MI, stroke, or refractory ischemia.
For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. The benefit for patients who undergo primary percutaneous coronary intervention is unknown.
The optimal duration of clopidogrel tablet therapy in ACS is unknown.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
For patients with a history of recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease, clopidogrel tablets has been shown to reduce the rate of a combined endpoint of new ischemic stroke (fatal or not), new MI (fatal or not), and other vascular death.
1 INDICATIONS AND USAGE
BRYHALI (halobetasol propionate) lotion, 0.01% is indicated for the topical treatment of plaque psoriasis in adults.
BRYHALI lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in adults. (1)
INDICATIONS & USAGE SECTION
Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS).
Etodolac Capsules and Tablets, USP are indicated:
For acute and long-term use in the management of signs and symptoms of the following:
Osteoarthritis
Rheumatoid arthritis
For the management of acute pain
INDICATION AND USAGE
Diclona Patch is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.
1 INDICATIONS AND USAGE
Levocetirizine dihydrochloride is a histamine H
1-receptor antagonist indicated for:
The relief of symptoms associated with perennial allergic rhinitis (
1.1)
The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (
1.2)
1.1 Perennial Allergic Rhinitis
Levocetirizine dihydrochloride tablets are indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 years of age and older.
1.2 Chronic Idiopathic Urticaria
Levocetirizine dihydrochloride tablets
are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
Topiramate is indicated for:
Epilepsy: initial monotherapy in patients 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1); adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and for patients 2 years of age with seizures associated with Lennox-Gastaut syndrome (1.2)
Prophylaxis of migraine in patients 12 years of age and older (1.3)
1.1 Monotherapy Epilepsy
Topiramate tablets and topiramate capsules are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures.
1.2 Adjunctive Therapy Epilepsy
Topiramate tablets and topiramate capsules are indicated as adjunctive therapy for adults and pediatric patients 2 to 16 years of ages with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.
1.3 Migraine
Topiramate tablets and topiramate capsules are indicated for patients 12 years of age and older for the prophylaxis of migraine headache.
1 INDICATIONS & USAGE
Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II
III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1)
1.1 Pulmonary Arterial Hypertension
Tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II
III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
1 INDICATIONSAND USAGE
Calcium Gluconate Injectionis indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia.
Limitations of Use
The safety of Calcium Gluconate Injectionfor long term use has not been established.
Calcium Gluconate Injection is a form of calcium indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. (1)
Limitations of Use: The safety of Calcium Gluconate Injectionfor long term use has not been established. (1)
1 INDICATIONS AND USAGE
Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with:
Multiple myeloma (MM), in combination with dexamethasone (1.1).
MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1).
Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2).
Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3).
Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4).
Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).
Limitations of Use:
Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials (1.4).
1.1
Multiple Myeloma
Lenalidomide capsules in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM).
Lenalidomide capsules are indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).
1.2 Myelodysplastic Syndromes
Lenalidomide capsules are indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
1.3
Mantle Cell Lymphoma
Lenalidomide capsules are indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
1.4 Follicular Lymphoma
Lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).
1.5 Marginal Zone Lymphoma
Lenalidomide capsules in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).
1.6 Limitations of Use:
Lenalidomide capsules are not indicated and are not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions (5.5)].
INDICATION
Propoxyphene napsylate and acetaminophen tablets, USPare indicated for the relief of mild to moderate pain.