um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Enoxaparin sodium injection is a low molecular weight heparin [LMWH] indicated for:
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (
1.1)
Inpatient treatment of acute DVT with or without pulmonary embolism (
1.2)
Outpatient treatment of acute DVT without pulmonary embolism (
1.2)
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction [MI] (
1.3)
Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI] (
1.4)
1.1 Prophylaxis of Deep Vein Thrombosis
Enoxaparin sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
in patients undergoing abdominal surgery who are at risk for thromboembolic complications [
see Clinical Studies (
14.1)
]
in patients undergoing hip replacement surgery, during and following hospitalization
in patients undergoing knee replacement surgery
in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness
1.2 Treatment of Acute Deep Vein Thrombosis
Enoxaparin sodium injection is indicated for:
the
inpatient treatment of acute deep vein thrombosis
with or without pulmonary embolism
, when administered in conjunction with warfarin sodium
the
outpatient treatment of acute deep vein thrombosis
without pulmonary embolism when administered in conjunction with warfarin sodium
1.3 Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction
Enoxaparin sodium injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
1.4 Treatment of Acute ST-Segment Elevation Myocardial Infarction
Enoxaparin sodium injection, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).
1 INDICATIONS AND USAGE
Aripiprazole Oral Tablets are indicated for the treatment of:
Schizophrenia
[see
Clinical Studies (14.1)]
Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.s ABILIFY
(aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.s marketing exclusivity rights, this drug product is not labeled with that information.
Aripiprazole tablets are an atypical antipsychotic. The oral formulations are indicated for:
Schizophrenia (
14.1)
INDICATIONS AND USAGE
Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
1 INDICATIONS AND USAGE
Potassium Chloride Extended-release Tablets, USP is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
Potassium Chloride Extended-release Tablets, USP is a potassium salt, indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. (1)
INDICATIONS AND USAGE
Clotrimazole lozenges are indicated for the local treatment of
oropharyngeal candidiasis. The diagnoses should be confirmed by a KOH smear
and/or culture prior to treatment.
Clotrimazole lozenges are also indicated prophylactically to reduce the
incidence of oropharyngeal candidiasis in patients immunocompromised by
conditions that include chemotherapy, radiotherapy, or steroid therapy utilized
in the treatment of leukemia, solid tumors, or renal transplantation. There are
no data from adequate and well-controlled trials to establish the safety and
efficacy of this product for prophylactic use in patients immunocompromised by
etiologies other than those listed in the previous sentence. (See DOSAGE AND ADMINISTRATION.)
INDICATIONS AND USAGE
HEMABATE Sterile Solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion:
Failure of expulsion of the
fetus during the course of treatment by another method;
Premature rupture of membranes
in intrauterine methods with loss of drug and insufficient or absent
uterine activity;
Requirement of a repeat
intrauterine instillation of drug for expulsion of the fetus;
Inadvertent or spontaneous
rupture of membranes in the presence of a previable fetus and absence of
adequate activity for expulsion.
HEMABATE is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. Studies have shown that in such cases, the use of HEMABATE has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, HEMABATE used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.
1.1 Hypertension
Amlodipine besylate 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 amlodipine besylate tablets.
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.
Amlodipine besylate tablets may be used alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
Verapamil hydrochloride extended-release tablets are indicated for the management of essential hypertension.
1
INDICATIONS AND USAGE
ORENCIA is a selective T cell costimulation modulator indicated for:
the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1)
the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2)
the treatment of adult patients with active psoriatic arthritis (PsA). (1.3)
the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4)
Limitations of Use:
Concomitant use of ORENCIA with other immunosuppressives [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended (1.5, 5.1).
1.1
Adult Rheumatoid Arthritis
ORENCIA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
1.2
Polyarticular Juvenile Idiopathic Arthritis
ORENCIA is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis.
1.3
Adult Psoriatic Arthritis
ORENCIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).
1.4
Prophylaxis for Acute Graft versus Host Disease
ORENCIA is indicated for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor.
1.5
Limitations of Use
The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.
1INDICATIONS AND USAGE
FANAPTtablets are indicated for the treatment of adults with schizophrenia. Efficacy was established in two short-term (4- and 6-week) placebo and active-controlled studies of adult patients with schizophrenia [see Clinical Studies (14)].
When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that FANAPTis associated with prolongation of the QTc interval [see Warnings and Precaution
s
(5.2)].Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death.In many cases this would lead to the conclusion that other drugs should be tried first.Whether FANAPTwill cause torsade de pointes or increase the rate of sudden death is not yet known.
Patients must be titrated to an effective dose of FANAPT.Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration.Prescribers should be mindful of this delay when selecting an antipsychotic drug for the treatment of schizophrenia [
s
ee Dosage and Administration (2.1) and Clinical Studies (14)].
The effectiveness of FANAPTin long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials.Therefore, the physician who elects to use FANAPTfor extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [s
ee Dosage and Administration (2.3)].
FANAPT is anatypical antipsychotic agent indicated for the treatment of schizophreniain adults. (1) Efficacy was established in two short-term (4- and 6-week) placebo- and active-controlled studies of adult patients with schizophrenia. (14) In choosing among treatments, prescribers should consider the ability of FANAPT to prolong the QT interval and theuse of other drugs first.Prescribers should also consider the need to titrate FANAPT slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration.
1 INDICATIONSAND USAGE
Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
BIMATOPROST ophthalmic solution, 0.03% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. (1)
1 INDICATIONSAND USAGE
Temozolomide capsules, USP is an alkylating drug indicated for the treatment of adult patients with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1)
Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (1.2)
1.1 Newly Diagnosed Glioblastoma
Temozolomide capsules, USP is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment.
1.2 Refractory Anaplastic Astrocytoma
Temozolomide capsules, USP is indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
INDICATIONS AND USAGE
Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by
Candida albicans and other susceptible
Candida species.
Nystatin Cream USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
1 INDICATIONS AND USAGE
Bivalirudin for Injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
Bivalirudin for Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS). (1)
1 INDICATIONS AND USAGE
Nevirapine tablets, USP are an NNRTI indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older. (1)
Limitations of Use:
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Nevirapine tablets, USP is not recommended to be initiated, unless the benefit outweighs the risk, in:
adult females with CD4+cell counts greater than 250 cells/mm3
adult males with CD4+cell counts greater than 400 cells/mm3 (1, 5.1)
Nevirapine tablets, USP is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)].
Limitations of Use:
Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, Nevirapine tablets, USP is not recommended to be initiated, unless the benefit outweighs the risk, in:
adult females with CD4+cell counts greater than 250 cells/mm3or
adult males with CD4+cell counts greater than 400 cells/mm3
[see Warnings and Precautions (5.1)] .
1 INDICATIONS AND USAGE
Diarrhea caused by
Giardia lamblia or
Cryptosporidium parvum:
ALINIA for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by
Giardia lamblia or
Cryptosporidium parvum.
Limitations of Use
ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the treatment of diarrhea caused by
Cryptosporidium parvum in HIV-infected or immunodeficient patients
[
see Clinical Studies (14.2)]
ALINIA is an antiprotozoal indicated for the treatment of diarrhea caused by
Giardia lamblia or
Cryptosporidium parvum
(1).
Limitations of Use:
ALINIA has not been shown to be effective for the treatment of diarrhea caused by
C. parvum in HIV-infected or immunodeficient patients
(1).
INDICATIONS AND USAGE
Erythromycin Topical Solution, USP 2% is indicated for the topical treatment of acne vulgaris.
1 INDICATIONS AND USAGE
Bepotastine Besilate Ophthalmic Solution, 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.
Bepotastine Besilate Ophthalmic Solution
is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. (1)
1 INDICATIONS AND USAGE
Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
Ephedrine sulfate injection is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
(1)
1 INDICATIONS AND USAGE
Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
Azithromycin is a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria:
Sexually Transmitted Diseases (1.1)
Mycobacterial Infections (1.2)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria (1.3).
1.1 Sexually Transmitted Diseases
Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis
1.2 Mycobacterial Infections
Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease
Azithromycin tablets, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection [see Dosage and Administration (2)].
Treatment of Disseminated MAC Disease
Azithromycin tablets, taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection [see Use in Specific Populations (8.4)
and Clinical Studies (14.1)].
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat 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.
1
INDICATIONS AND USAGE
Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of
Adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). (
1.1)
1.1
Myelodysplastic Syndromes (MDS)
Azacitidine for injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes:
refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
INDICATIONS AND USAGE
Fluconazole in Sodium Chloride Injection, USP is indicated for the treatment of:
1.Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
2.Cryptococcal meningitis. Before prescribing Fluconazole in Sodium Chloride Injection, USP for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis: Fluconazole in Sodium Chloride Injection, USP is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
1 INDICATIONS AND USAGE
Fluoxetine is 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 monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
Fluoxetine is 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)