um-ids/dailymed-annotations huggingface dataset:
1
INDICATIONS AND USAGE
Fludeoxyglucose F-18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings:
Fludeoxyglucose F18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings:
Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures (1).
1.1 Oncology
For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.
1.2 Cardiology
For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3 Neurology
For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
INDICATIONS
Oxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Anxiety associated with depression is also responsive to oxazepam therapy.
This product has been found particularly useful in the management of anxiety, tension, agitation and irritability in older patients.
Alcoholics with acute tremulousness, inebriation, or with anxiety associated with alcohol withdrawal are responsive to therapy.
The effectiveness of oxazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Phentermine hydrochloride Tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches
0.0254 = meters.
The limited usefulness of agents of this class, including phentermine, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine Hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index
30 kg/m2, or
27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). (
1)
The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (
1)
Phentermine01
1 INDICATIONS AND USAGE
Paroxetine tablets areindicatedinadultsforthetreatmentof:
Majordepressivedisorder(MDD)
Obsessivecompulsivedisorder(OCD)
Panicdisorder(PD)
Socialanxietydisorder(SAD)
Generalizedanxietydisorder(GAD)
Posttraumaticstressdisorder(PTSD)
Paroxetine tablets is a selective serotonin reuptake inhibitor (SSRI) indicated in adults forthetreatment of (
1):
MajorDepressiveDisorder(MDD)
ObsessiveCompulsiveDisorder(OCD)
PanicDisorder(PD)
SocialAnxietyDisorder(SAD)
GeneralizedAnxietyDisorder(GAD)
PosttraumaticStressDisorder(PTSD)
1 INDICATIONS AND USAGE
AZEDRA is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.
AZEDRA is a radioactive therapeutic agent indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy. (1)
1 INDICATIONS AND USAGE
Topotecan hydrochloride for injection is indicated for the treatment of:
Small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy [see Clinical Studies (14)].
Topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of:stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
Topotecan hydrochloride for injection is a topoisomerase inhibitor indicated for:
Small cell lung cancer sensitive disease after failure of first-line chemotherapy. (1)
Combination therapy with cisplatin for stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. (1)
INDICATIONS AND USAGE
Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Hydrochlorothiazidehas also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Hydrochlorothiazideis indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
Use in Pregnancy
Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see
PRECAUTIONS, Pregnancy
). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
1 INDICATIONS AND USAGE
Oseltamivir phosphate for oral suspension is an influenza neuraminidase inhibitor (NAI) indicated for:
Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. (1.1)
Prophylaxis of influenza A and B in patients 1 year and older. (1.2)
Limitations of Use:
Not a substitute for annual influenza vaccination. (1.3)
Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use. (1.3)
Not recommended for patients with end-stage renal disease not undergoing dialysis. (1.3)
1.1 Treatment of Influenza
Oseltamivir phosphate for oral suspension is indicated for the treatment of acute, uncomplicated illness due to influenza A and B infection in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours.
1.2 Prophylaxis of Influenza
Oseltamivir phosphate for oral suspension is indicated for the prophylaxis of influenza A and B in patients 1 year and older.
1.3 Limitations of Use
Oseltamivir phosphate for oral suspension is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices.
Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use oseltamivir phosphate for oral suspension [see Microbiology (12.4)].
Oseltamivir phosphate for oral suspension is not recommended for patients with end-stage renal disease not undergoing dialysis [see Dosage and Administration (2.4) and Use in Specific Populations (8.6)].
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
WARNINGS
Diclofenac sodium extended-release tablets are indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
1 INDICATIONS AND USAGE
Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder.
Diclofenac sodium topical gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
Diclofenac sodium topical gel was not evaluated for use on joints of the spine, hip, or shoulder.
(14.1)
1 INDICATIONS & USAGE
Olanzapine for injection is an atypical antipsychotic indicated for the:
Treatment of acute agitation associated with schizophrenia and bipolar I mania. ( )
1.4
Efficacy was established in three 1-day trials in adults. ( )
14.3
1.4 Agitation Associated with Schizophrenia and BipolarI Mania
Olanzapine for injection is indicated for the treatment of acute agitation associated with schizophrenia and bipolarI mania.
Efficacy was demonstrated in 3 short-term (24 hours of IM treatment) placebo-controlled trials in agitated adult inpatients with: schizophrenia or bipolarI disorder (manic or mixed episodes) [see ].
Clinical Studies (
14.3
)
Psychomotor agitation is defined in DSM-IV as excessive motor activity associated with a feeling of inner tension. Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation.
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are indicated for:
Pantoprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (
1.1)
Maintenance of Healing of Erosive Esophagitis (
1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (
1.3)
1.1	Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2	Maintenance of Healing of Erosive Esophagitis
Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3	Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
INDICATIONS AND USAGE:
For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.
1 INDICATIONS AND USAGE
Esmolol Hydrochloride is a beta-adrenergic blocker indicated for the short-term treatment of:
Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia (1.1)
Control of perioperative tachycardia and hypertension (1.2)
1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia
Esmolol hydrochloride is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable.
Esmolol hydrochloride is also indicated in noncompensatory sinus tachycardia where, in the physicians judgment, the rapid heart rate requires specific intervention. Esmolol hydrochloride is intended for short-term use.
1.2 Intraoperative and Postoperative Tachycardia and Hypertension
Esmolol hydrochloride is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physicians judgment such specific intervention is considered indicated.
Use of esmolol hydrochloride to prevent such events is not recommended.
INDICATIONS AND USAGE
For symptomatic relief of anxiety and tension associated with
psychoneurosis and as an adjunct in organic disease states in which anxiety is
manifested.
Useful in the management of pruritus due to allergic conditions such as
chronic urticaria and atopic and contact dermatoses, and in histamine-mediated
pruritus.
As a sedative when used as premedication and following general anesthesia,
hydroxyzine may potentiate meperidine and barbiturates,
so their use in pre-anesthetic adjunctive therapy should be modified on an
individual basis. Atropine and other belladonna alkaloids are not affected by
the drug. Hydroxyzine is not known to interfere with the action of digitalis in
any way and it may be used concurrently with this agent.
The effectiveness of hydroxyzine as an antianxiety agent for long term use,
that is more than 4 months, has not been assessed by systematic clinical
studies. The physician should reassess periodically the usefulness of the drug
for the individual patient.
1 INDICATIONS AND USAGE
Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. 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)
]
Schizophrenia
Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [see
Clinical Studies (
14.1)
].
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see
Clinical Studies (
14.2)].
Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see
Clinical Studies (
14.2)
].
Ziprasidone capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone capsule to prolong the QT interval and may consider the use of other drugs first
(5.3)
Ziprasidone capsule is indicated as an oral formulation for the:
Treatment of schizophrenia. (
1)
Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder. (
1)
Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate. (
1)
INDICATIONS AND USAGE
Clindamycin Phosphate Topical Solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS.)
1 INDICATIONS AND USAGE
Sodium Fluoride F 18 Injection, USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.
Sodium Fluoride F 18 Injection, USP is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity(1).
1 INDICATIONS AND USAGE
Gabapentin capsules 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.
Gabapentin capsules 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)
1 INDICATIONS AND USAGE
NEXOBRID is indicated for eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.
Limitations of Use
The safety and effectiveness of NEXOBRID have not been established for treatment of:
Chemical or electrical burns
Burns on the face, perineum, or genitalia
Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease
Circumferential burns
Burns in
patients with significant cardiopulmonary disease, including inhalation injury
NEXOBRID is not recommended for wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance.
NEXOBRID contains proteolytic enzymes and is indicated for eschar removal in adults with deep partial thickness and/or full thickness thermal burns (1).
Limitations of Use
The safety and effectiveness of NEXOBRID have not been established for treatment of:
Chemical or electrical burns (1).
Burns on the face, perineum, or genitalia (1).
Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease (1).
Circumferential burns (1).
Burns in
patients with significant cardiopulmonary disease, including inhalation injury (1).
NEXOBRID is not recommended for wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance (1).
INDICATIONS AND USAGE
DEMADEX is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials.DEMADEX intravenous injection is indicated when a rapid onset of diuresis is desired or when oral administration is impractical.DEMADEX is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.
INDICATIONS AND USAGE
Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is indicated in the treatment of surfaceocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, causedby susceptible strains of the following microorganisms:
Staphylococcus aureus, Staphylococcus
epidermidis, Streptococcus pneumoniae, Streptococcus virida
ns, Haemophilus influenzae and
Pseudomonas aeruginosa.*
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
INDICATIONS AND USAGE
Benign Prostatic Hyperplasia (BPH)
Doxazosin tablets are indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin monotherapy. Doxazosin provides rapid improvement in symptoms and urinary flow rate in 66 to 71% of patients. Sustained improvements with doxazosin were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies.
Hypertension
Doxazosin tablets are also indicated for the treatment of hypertension. Doxazosin may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers or angiotensin-converting enzyme inhibitors.
1 INDICATIONS AND USAGE
Clobazam Tablets are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Clobazam Tablets are a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older (1)
1 INDICATIONS AND USAGE
FLOVENT HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older.
Limitations of Use
Flovent HFA is not indicated for the relief of acute bronchospasm.
FLOVENT HFA is an inhaled corticosteroid indicated for:
Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. (1)
Limitations of use: Not indicated for relief of acute bronchospasm. (1)