um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS.)Experience with non-obstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75% concentration in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block). (See WARNINGS.)The routes of administration and indicated Sensorcaine concentrations are:local infiltration	0.25%peripheral nerve block	0.25%, 0.5%retrobulbar block	0.75%sympathetic block	0.25%lumbar epidural	0.25%, 0.5% and 0.75%	(non-obstetrical)caudal	0.25%, 0.5%epidural test dose	(see PRECAUTIONS)(See DOSAGE AND ADMINISTRATION for additional information.) Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.Use only the single dose ampules and single dose vials for caudal or epidural anesthesia; the multiple dose vials contain a preservative and, therefore, should not be used for these procedures.
INDICATIONS AND USAGE
10% Calcium Chloride Injection, USP is indicated (1) for the treatment of hypocalcemia in those conditions requiring a prompt increase in blood plasma calcium levels, (2) in the treatment of magnesium intoxication due to overdosage of magnesium sulfate and (3) to combat the deleterious effects of hyperkalemia as measured by electrocardiographic (ECG), pending correction of the increased potassium level in the extracellular fluid.
10% Calcium Chloride Injection, USP also may be used in cardiac resuscitation when weak or inadequate contractions return following defibrillation or when epinephrine injection has failed to strengthen myocardial contractions.
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 treatmentof acute deep vein thrombosis with
or without pulmonary embolism, when administered in conjunction with
warfarin sodium
the outpatient treatmentof 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
Montelukast sodium is a leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (
1.1).
Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older (
1.2).
Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies (
1.3).
Limitations of Use:
Not indicated to treat an acute asthma attack (
5.2).
1.1 Asthma
Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
1.2 Exercise-Induced Bronchoconstriction (EIB)
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
1.3 Allergic Rhinitis
Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. Because the benefits of montelukast sodium may not outweigh the risk
of neuropsychiatric symptoms in patients with allergic rhinitis
[see
Warnings and Precautions (5.1)]
, reserve use for patients who have an inadequate response or intolerance to alternative therapies.
1.4 Limitations of Use
Montelukast sodium is not indicated for the
treatment of an acute asthma attack.
INDICATIONS & USAGE
Sensorcaine (bupivacaine HCl) is indicated for the production of local or regional anesthesia or analgesia for surgery, oral surgeryprocedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations areindicated for obstetrical anesthesia (see WARNINGS).Experience with non-obstetrical surgical procedures in pregnant patients is not sufficient to recommend use of the 0.75%concentration of bupivacaine HCl in these patients. Sensorcaine is not recommended for intravenous regional anesthesia (Bier Block)(see WARNINGS).The routes of administration and indicated Sensorcaine concentrations are:local infiltration 0.25%peripheral nerve block 0.25%, 0.5%retrobulbar block 0.75%sympathetic block 0.25%lumbar epidural 0.25%, 0.5% and 0.75% (non-obstetrical)caudal 0.25%, 0.5%
epidural test dose (see PRECAUTIONS)(see DOSAGE AND ADMINISTRATION for additional information).Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Sensorcaine.Use only the single dose ampules and single dose vials for caudal or epidural anesthesia; the multiple dose vials contain a preservativeand, therefore, should not be used for these procedures.
INDICATIONS AND USAGE
Desonide Cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
It should not be used for longer than two weeks unless directed by a physician.
INDICATIONS AND USAGE
Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine,
butorphanol and cyclazocine. Naloxone hydrochloride is also indicated for
diagnosis of suspected or known acute opioid overdosage.
Naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see CLINICAL PHARMACOLOGY; Adjunctive Use in Septic Shock).
INDICATIONS
AND USAGE
Folic acid, USP is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid, USP (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.
1.2 Prevention
of CMV Disease in Transplant Recipients
Ganciclovir for Injection, USP is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
(1.1)
1.1 Hypertension
Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure
[see
Clinical Studies (14.1)].
Nebivolol tablets may be used alone or in combination with other antihypertensive agents
[see
Drug Interactions (7)].
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nebivolol 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 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.
Carefully consider the potential benefits and risks of nabumetone tablets, USP and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Nabumetone tablets, USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
INDICATIONS AND USAGE
Butalbital, acetaminophen and caffeine tablets are indicated for
the relief of the symptom complex of tension (or muscle contraction)
headache.
Evidence supporting the efficacy and safety of this combination product in
the treatment of multiple recurrent headaches is unavailable. Caution in this
regard is required because butalbital is habit-forming and potentially abusable.
1 INDICATIONS AND USAGE
Dexmedetomidine injection is a relatively selective alpha
2-adrenergic agonist indicated for:
Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer dexmedetomidine injection by continuous infusion not to exceed 24 hours. (
1.1)
Sedation of non-intubated patients prior to and/or during surgical and other procedures. (
1.2)
1.1 Intensive Care Unit Sedation
Dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours.
Dexmedetomidine injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine injection prior to extubation.
1.2 Procedural Sedation
Dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
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 sublingual tablets are a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. (1)
1 INDICATIONS AND USAGE
Duloxetine delayed-release capsules are indicated for the treatment of:
Major depressive disorder in adults
Generalized anxiety disorder in adults and pediatric patients 7 years of age and older
Diabetic peripheral neuropathic pain in adults
Fibromyalgia in adults and pediatric patients 13 years of age and older
Chronic musculoskeletal pain in adults
Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions:
Major Depressive Disorder (MDD) in adults (1)
Generalized Anxiety Disorder (GAD) in adults and pediatric patients 7 years of age and older (1)
Diabetic Peripheral Neuropathic Pain (DPNP) in adults (1)
Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older (1)
Chronic Musculoskeletal Pain in adults (1)
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)
INDICATIONS AND USAGE
Cephalexin capsules, USP areindicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.)
Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphyloccus aureus, Streptococcus pyogenes, and Moraxella catarrhalis
Skin and skin structure infections caused by Staphylococcus aureusand/or Streptococcus pyogenes
Bone infections caused by Staphylococcus aureusand/or Proteus mirabilis
Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae
NoteCulture 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 cephalexin and other antibacterial drugs, cephalexin 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 epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Emtricitabine, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
Phentermine Hydrochloride, USP 15 mg and 30 mg is 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, or27 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 patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds
2.2 = kg; inches x 0.0254 = meters.
91cf84db-figure-01
The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
INDICATIONS AND USAGE
Fexmid is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Fexmidshould be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Fexmid has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
INDICATIONS AND USAGE
Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or 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.
The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Associations Diagnostic and Statistical Manual, III
1 as follows:
Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:
Motor tension:
shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.
Autonomic hyperactivity:
sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
Apprehensive expectation:
anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
Vigilance and scanning:
hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling on edge, irritability, impatience.
The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.
The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Enter section text here
Tindamax is a nitroimidazole antimicrobial indicated for:
Trichomoniasis ( 1.1)
Giardiasis: in patients age 3 and older (
1.2)
Amebiasis: in patients age 3 and older (
1.3)
Bacterial Vaginosis: in non-pregnant, adult women (
1.4,
8.1)
1.1 Trichomoniasis
Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by
appropriate diagnostic procedures. Because trichomoniasis is a sexually
transmitted disease with potentially serious sequelae, partners of infected
patients should be treated simultaneously in order to prevent re-infection[see Clinical Studies ( 14.1)].
1.2 Giardiasis
Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G.
lamblia) in both adults and pediatric patients older than three years of
age [see Clinical Studies (
14.2)].
1.3 Amebiasis
Tinidazole is indicated for the treatment of intestinal amebiasis and amebic
liver abscess caused by Entamoeba histolytica in both
adults and pediatric patients older than three years of age. It is not indicated
in the treatment of asymptomatic cyst passage [see Clinical
Studies ( 14.3,
14.4)].
1.4 Bacterial Vaginosis
Tinidazole is indicated for the treatment of bacterial vaginosis
(formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic
vaginosis) in non-pregnant women [see Use in Specific
Populations ( 8.1) and Clinical Studies ( 14.5)].
Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria
gonorrhoeae, Candida albicans and Herpes
simplex virus should be ruled out.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Tindamax and other antibacterial drugs, Tindamax 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 epidemiology and susceptibility
patterns may contribute to the empiric selection of therapy.