um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50
109/L.
This indication is approved under accelerated approval based on spleen volume reduction [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
VONJO is a kinase inhibitor indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50
109/L (1).
This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
INDICATIONS AND USAGE
BETADINE 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).
1 INDICATIONS AND USAGE
DURLAZA is indicated to:
Reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a history of MI or unstable angina pectoris or with chronic stable angina
Reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack
Limitation of Use: Use immediate-release aspirin, not DURLAZA in situations where a rapid onset of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention).
DURLAZA is a nonsteroidal anti-inflammatory drug indicated to reduce the risk of death and myocardial infarction (MI) in patients with chronic coronary artery disease, such as patients with a history of MI or unstable angina pectoris or with chronic stable angina and to reduce the risk of death and recurrent stroke in patients who have had an ischemic stroke or transient ischemic attack(1)
Limitation of Use
: Use immediate-release aspirin, not DURLAZA in situations where a rapid onset of action is required (such as acute treatment of myocardial infarction or before percutaneous coronary intervention). (1,
4)
INDICATIONS & USAGE SECTION
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, USP 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.
Amoxicillin and clavulanate potassium tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
1 INDICATIONS AND USAGE
Amitiza is a chloride channel activator indicated for:
Treatment of chronic idiopathic constipation in adults (1.1)
Treatment of irritable bowel syndrome with constipation in women
18 years old (1.2)
1.1 Chronic Idiopathic Constipation
Amitiza is indicated for the treatment of chronic idiopathic constipation in adults.
1.2 Irritable Bowel Syndrome with Constipation
Amitiza is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women
18 years old.
INDICATIONS AND USAGE:
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses.
1	INDICATIONS AND USAGE
PROCRIT is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to
-
Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).
-
Zidovudine in HIV-infected patients (1.2).
-
The effects of concomitant myelosuppressive chemotherapy and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3).
Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).
Limitations of Use
PROCRIT has not been shown to improve quality of life, fatigue, or patient well-being (1.5).
PROCRIT is not indicated for use:
In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy (1.5).
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.5).
In patients scheduled for surgery who are willing to donate autologous blood (1.5).
In patients undergoing cardiac or vascular surgery (1.5).
As a substitute for RBC transfusions in patients who require immediate correction of anemia (1.5).
1.1 Anemia Due to Chronic Kidney Disease
PROCRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.
1.2	Anemia Due to Zidovudine in HIV-infected Patients
PROCRIT is indicated for the treatment of anemia due to zidovudine administered at
4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of
500 mUnits/mL.
1.3
Anemia Due to Chemotherapy in Patients With Cancer
PROCRIT is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
1.4
Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery
PROCRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to
13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. PROCRIT is not indicated for patients who are willing to donate autologous blood pre-operatively.
1.5	Limitations of Use
PROCRIT has not been shown to improve quality of life, fatigue, or patient well-being.
PROCRIT is not indicated for use:
In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
In patients scheduled for surgery who are willing to donate autologous blood.
In patients undergoing cardiac or vascular surgery.
As a substitute for RBC transfusions in patients who require immediate correction of anemia [see Clinical Pharmacology (12.2)].
1 INDICATIONS AND USAGE
Aripiprazole tablets are indicated for the treatment of:
Schizophrenia
Irritability Associated with Autistic Disorder
Treatment of Tourettes Disorder
Aripiprazole is an atypical antipsychotic. The oral formulationis indicated for:
Schizophrenia(14.1)
Irritability Associated with Autistic Disorder (14.4)
Treatment of Tourettes disorder (14.5)
INDICATIONS AND USAGE
Guanfacine tablets USP are indicated in the management of hypertension. Guanfacine tablets USP may be given alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.
Discontinue use of signs of irritation occur
Caution: For External Use only. Avoid contact with eyes.
no such information
Water/Aqua, Cyclomethicone, C12-15 Alkyl Benzoate, Alumina, Aluminum Stearate, Polyhydroxystearic Acid, Stearic Acid, Disteardimonium Hectorite, Propylene Carbonate, Isododecane, Diisostearyl Polyglyceryl-3 Diisostearate, Trimethylsiloxysilicate, Cyclopentasiloxane, Glyceryl stearate, PEG-10 Dimethicone, Talc, Dimethicone, Triethanolamine, Synthetic Wax, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Propylene Glycol, Diazolidinyl Urea, Iodopropynyl
Butylcarbamate, Silica Silylate, Stearoyl inulin, panthenol, Sodium Chloride, Tocopheryl Acetate, Trisodium EDTA, Triethoxycaprylysilane, [May contain /+/- =: Titanium DIoxide/CI77891, Iron Oxides/CI77491/77492/77499].
1 INDICATIONS AND USAGE
Acetaminophen injection is indicated for
the management of mild to moderate pain in adult and pediatric patients 2 years and older
the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older
the reduction of fever in adult and pediatric patients.
Acetaminophen injection is indicated for the
Management of mild to moderate pain in adult and pediatric patients 2 years and older (
1)
Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older (
1)
Reduction of fever in adult and pediatric patients (
1)
INDICATIONS & USAGE SECTION
Lisinopril tablets, USP are indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older 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.
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 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.
Lisinopril tablets, USP may be administered alone or with other antihypertensive agents [see
Clinical Studies (14.1)].
1.2 Heart Failure
Lisinopril tablets, USP are indicated to reduce signs and symptoms of systolic heart failure [see
Clinical Studies (14.2)].
1.3 Reduction of Mortality in Acute Myocardial Infarction
Lisinopril tablets, USP are indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see
Clinical Studies (14.3)].
1 INDICATIONS AND USAGE
Dutasteride is a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (
1.1)
improve symptoms,
reduce the risk of acute urinary retention, and
reduce the risk of the need for BPH-related surgery.
Dutasteride in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. (
1.2)
Limitations of Use: Dutasteride is not approved for the prevention of prostate cancer. (
1.3)
1.1 Monotherapy
Dutasteride capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
improve symptoms,
reduce the risk of acute urinary retention (AUR), and
reduce the risk of the need for BPH-related surgery.
1.2 Combination With Alpha Adrenergic Antagonist
Dutasteride in combination with the alpha adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate.
1.3 Limitations of Use
Dutasteride is not approved for the prevention of prostate cancer.
1 INDICATIONS AND USAGE
Lamivudine tablets are a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Limitations of Use: The dosage of this product is for HIV-1 and not for HBV. (1)
Lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1(HIV-1) infection.
Limitations of Use
The dosage of this product is for HIV-1 and not for HBV.
1.3
Migraine
Topiramate extended-release capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older [see Clinical Studies (14.4)].
INDICATIONS AND USAGE
Etomidate Injection, USP is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties (see
CLINICAL PHARMACOLOGY
) should be weighed against the high frequency of transient skeletal muscle movements (see
ADVERSE REACTIONS
).
Intravenous etomidate is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.
1 INDICATIONS AND USAGE
Klor-Con 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.
KLOR-CON 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)
1 INDICATIONS AND USAGE
Bupivacaine hydrochloride injection is
indicated in
adults for the
production of
local or
regional anesthesia or analgesia for surgery, oral surgery procedures, diagnostic and
therapeutic procedures, and for obstetrical procedures. Specific concentrations and
presentations of bupivacaine hydrochloride injection are
recommended for each type of block
indicated to
produce local or regional anesthesia or
analgesia [see
Dosage and Administration (2.2)
].
Limitations of Use
Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use [see
Dosage and Administration (2.2)
,
Contraindications (4)
,
Warnings and Precautions (5.1
,
5.4
,
5.5
,
5.7
,
5.9
)].
Bupivacaine hydrochloride injection contains bupivacaine hydrochloride, an amide local anesthetic indicated in adults for the production of local or regional anesthesia or analgesia for surgery, oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended. (1, 2.2)
Limitations of Use
Not all blocks are indicated for use with bupivacaine hydrochloride injection given clinically significant risks associated with use. (1, 2.2, 4, 5.1, 5.4, 5.5, 5.7, 5.9)
1 INDICATIONS AND USAGE
Testosterone gel is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired)
testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelters syndrome, chemotherapy, or toxic damage from alcohol, heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone [FSH] and luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired)
gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations but have gonadotropins in the normal or low range.
Limitations of Use
Safety and efficacy of testosterone gel in men with age-related hypogonadism (also referred to as late-onset hypogonadism) have not been established.
Safety and efficacy of testosterone gel in males <18 years old have not been established [see Use in Specific Populations (8.4)].
Testosterone gel is an androgen indicated for replacementtherapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired). (1)
Hypogonadotropic hypogonadism (congenital or acquired). (1)
Limitations of Use
Safety and efficacy of testosterone gel in men with age-related hypogonadism have not been established (1).
Safety and efficacy of testosterone gel in males less than 18 years old have not been established. (8.4)
1 INDICATIONS AND USAGE
Zolpidem Tartrate Extended-Release Tablets are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14)].
Zolpidem Tartrate Extended-Release Tablets are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (1)
1 INDICATIONS AND USAGE
Gabapentin is 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
Gabapentin is indicated for:
Postherpetic neuralgia in adults (
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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
(
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1 INDICATIONS & USAGE
Ziprasidone mesylate for injection, intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidones greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see WARNINGS AND PRECAUTIONS
(5.3)]. 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, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see WARNINGS AND PRECAUTIONS (
5.3)]
Acute Treatment of Agitation in Schizophrenia
Ziprasidone mesylate for injection intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation. [see Clinical Trials (14.1)].
Since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone, the practice of co-administration is not recommended.
1	INDICATIONS AND USAGE
Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
Nitroglycerin is a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. (
1)
1 INDICATIONS AND USAGE
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension extended-release suspension is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.
Important Limitations of Use:
Not indicated for pediatric patients under 18 years of age [
see
Use in Specific Populations (8.4)
].
Contraindicated in pediatric patients less than 6 years of age [
see
Contraindications (4)
].
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [
see
Warnings and Precautions (5.1)
]
, reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension is a combination of hydrocodone, an opioid agonist; and chlorpheniramine, a histamine-1 (H1) receptor antagonist, indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. (
1)
Important Limitations of Use (
1)
Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Oral Suspension for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.