um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Atenolol tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol.
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 1 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.
Atenolol tablets USP may be administered with other antihypertensive agents.
Indications & Usage
Ondansetron orally disintegrating 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 orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting.
1 INDICATIONS AND USAGE
Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
Clopidogrel tablets is a P2Y
12 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 have been shown to reduce the rate of myocardial infarction (MI) and stroke.
(1.1)
For patients with ST-elevation myocardial infarction (STEMI), clopidogrel tablets have been shown to reduce the rate of MI and stroke.
(1.1)
Recent MI, recent stroke, or established peripheral arterial disease. Clopidogrel tablets have been shown to reduce the rate of MI and stroke.
(1.2)
1.1 Acute Coronary Syndrome (ACS)
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction (MI) and stroke in 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 should be administered in conjunction with aspirin.
Clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin.
1.2 Recent MI, Recent Stroke, or Established Peripheral Arterial Disease
In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke clopidogrel tablets are indicated to reduce the rate of MI and stroke.
INDICATIONS AND USAGE
Edema
Furosemide is indicated in in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.
Hypertension
Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.
INDICATIONSAND USAGE
Carboprost tromethamine injection 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:
1.Failure of expulsion of the fetus during the course of treatment by another method; 2.Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3.Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4.Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.
Carboprost tromethamine injection 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 carboprost tromethamine injection 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, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.
1. INDICATIONS AND USAGE
Celecoxib is indicated
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)
1.1	Osteoarthritis (OA)
For the management of the signs and symptoms of OA [see Clinical Studies (14.1)
]
1.2	Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [see Clinical Studies (14.2)
]
1.3	Juvenile Rheumatoid Arthritis (JRA)
For the management of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies (14.3)
]
1.4	Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [see Clinical Studies (14.4)
]
1.5	Acute Pain
For the management of acute pain in adults [see Clinical Studies (14.5)
]
1.6	Primary Dysmenorrhea
For the management of primary dysmenorrhea [see Clinical Studies (14.5)
]
INDICATIONS AND USAGE
Ketorolac tromethamine ophthalmic solution is indicated for the
temporary relief of ocular itching due to seasonal allergic conjunctivitis.
Ketorolac tromethamine ophthalmic solution is also indicated for the treatment
of postoperative inflammation in patients who have undergone cataract
extraction.
1 INDICATIONS AND USAGE
Trazodone hydrochloride tablets, USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets, USP has been established in trials with the immediate release formulation of trazodone
[see Clinical Studies (14)].
Trazodone hydrochloride tablets, USP are indicated for the treatment of major depressive disorder (
1).
Efficacy was established in trials of trazodone immediate release formulation in patients with major depressive disorder (
14).
1 INDICATIONS AND USAGE
Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.
Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. (1)
1 INDICATIONS AND USAGE
Donepezil hydrochloride tabletsare indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers disease.
Donepezil is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimers type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimers Disease(1).
1.1 Partial Onset Seizures
Levetiracetam tablet is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy.
1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam tablet is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.
1.3 Primary Generalized Tonic-Clonic Seizures
Levetiracetam tablet is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
1.3 Gastric Adenocarcinoma
1 INDICATIONS AND USAGE
DOCETAXEL INJECTION is a microtubule inhibitor indicated for:
Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1)
Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2)
Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3)
Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4)
Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5)
1.1 Breast Cancer
DOCETAXEL INJECTION is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
DOCETAXEL INJECTION in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
1.2 Non-small Cell Lung Cancer
DOCETAXEL INJECTION as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
DOCETAXEL INJECTION in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.
1.3 Prostate Cancer
DOCETAXEL INJECTION in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
1.4 Gastric Adenocarcinoma
DOCETAXEL INJECTION in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.
1.5 Head and Neck Cancer
DOCETAXEL INJECTION in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
INDICATIONS AND USAGE
1. Indications
Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
2. Efficacy
If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.
SHAROBEL
Tablets have not been studied for and are not indicated for use in emergency contraception.
INDICATIONS AND USAGE
Cefadroxil is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:
Urinary tract infections caused by
E. coli, P. mirabilis, and
Klebsiella species.
Skin and skin structure infections caused by staphylococci and/or streptococci.
Pharyngitis and/or tonsillitis caused by
Streptococcus pyogenes (Group A beta-hemolytic streptococci).
Note:
Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of cefadroxil for the prophylaxis of subsequent rheumatic fever are not available.
Note:
Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil and other antibacterial drugs, cefadroxil 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 epidemology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
Femynor Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)
].
Femynor are estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1)
1 INDICATIONS AND USAGE
Lamotrigine is indicated for:
Epilepsyadjunctive therapy in patients aged 2 years and older:
Partial-onset seizures.
primary generalized tonic-clonic
seizures.
generalized seizures of Lennox-Gastaut
syndrome. (1.1)
Epilepsymonotherapy in patients aged 16 years and older:
Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. (1.1)
Bipolar disorder:
Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2)
Limitations of Use:
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
1.1 Epilepsy
Adjunctive Therapy
Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic seizures
(PGTC) seizures.
generalized seizures of Lennox-Gastaut
syndrome.
Monotherapy
Lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.2 Bipolar Disorder
Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see Clinical Studies (14.2)].
Limitations of Use
Treatment of acute manic or mixed episodes is not recommended. Effectiveness of lamotrigine in the acute treatment of mood episodes has not been established.
1 INDICATIONS AND USAGE
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.
Fluvastatin sodium extended-release tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:
Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia (1.1)
Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy (1.1)
Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD (1.2)
Slow the progression of atherosclerosis in patients with CHD (1.2)
Limitations of Use:
Fluvastatin sodium extended-release tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V). (1.3)
1.1 Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia
Fluvastatin sodium extended-release tablets are indicated
as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb).
as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10 to 16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present:
LDL-C remains 190 mg/dL or
LDL-C remains 160 mg/dL and:
there is a positive family history of premature cardiovascular disease or
two or more other cardiovascular disease risk factors are present
The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below.
Category
Total-C (mg/dL)
LDL-C (mg/dL)
Acceptable
<170
<110
Borderline
170 to 199
110 to 129
High
200
130
Children treated with fluvastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals.
1.2 Secondary Prevention of Cardiovascular Disease
In patients with clinically evident CHD, fluvastatin sodium extended-release tablets are indicated to:
reduce the risk of undergoing coronary revascularization procedures
slow the progression of coronary atherosclerosis
1.3 Limitations of Use
Fluvastatin sodium extended-release tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V).
1 INDICATIONS AND USAGE
Efavirenz tabletsin combination with other antiretroviral agents are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.
Efavirenztabletsare a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg. (1)
1 INDICATIONS AND USAGE
OSMOLEX ER is indicated for the treatment of Parkinsons disease and for the treatment of drug-induced extrapyramidal reactions in adult patients.
OSMOLEX ER is indicated for the treatment of:
Parkinsons disease (1)
Drug-induced extrapyramidal reactions in adult patients (1)
1 INDICATIONS AND USAGE
Tramadol hydrochloride tablets are indicated in adults 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 and Precautions (5.1)], reserve tramadol hydrochloride 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.
Tramadol hydrochloride tabletsare an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate (1).
Limitations of Use (1)
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (5.1), reserve tramadol hydrochloride 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.
1 INDICATIONS AND USAGE
EPZICOM, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV1) infection.
EPZICOM, a combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
INDICATIONS AND USAGE
Metformin hydrochloride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.