um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Gabapentin is 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)
Gabapentin Tablets, USP 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
INDICATIONSAND USAGE:
Anesthesia
Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.
Peptic Ulcer
For use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
INDICATIONS AND USAGE
In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of
paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptomsparoxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms
Flecainide acetate tablets, USP are also indicated for the prevention of
documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening.
Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate tablets, USP are not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.
Because of the proarrhythmic effects of flecainide acetate tablets, USP, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.
Flecainide acetate tablets, USP should not be used in patients with recent myocardial infarction. (See
BOXED WARNINGS
.)
Use of flecainide acetate tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See
BOXED WARNINGS
.)
As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, USP favorably affects survival or the incidence of sudden death.
INDICATIONS AND USAGE
Hypertension
CaptoprilTablets, USPare indicated for the treatment of hypertension.
In using Captopril Tablets, USP consideration should be given to the risk of neutropenia/agranulocytosis (see
WARNINGS
).
Captopril Tablets, USPmay be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations.
Captopril Tablets, USP are effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.
Heart Failure
Captopril Tablets, USPare indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of captopril in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with captopril has been in patients receiving digitalis, as well as diuretic treatment.
Left Ventricular Dysfunction After Myocardial Infarction
Captopril Tablets, USP are indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction 40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients.
Diabetic Nephropathy
CaptoprilTablets, USP are indicated for the treatment of diabetic nephropathy (proteinuria >500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Captopril decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis).
In considering use of captopril, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (seeWARNINGS: Head and Neck Angioedemaand Intestinal Angioedema).
1 INDICATIONS AND USAGE
VARIZIG [Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include:
immunocompromised children and adults,
newborns of mothers with varicella shortly before or after delivery,
premature infants,
neonates and infants less than one year of age,
adults without evidence of immunity,
pregnant women.
VARIZIG administration is intended to reduce the severity of varicella. Administer VARIZIG as soon as possible following varicella zoster virus (VZV) exposure, ideally within 96 hours for greatest effectiveness.
There is no convincing evidence that VARIZIG reduces the incidence of chickenpox infection after exposure to VZV.
There is no convincing evidence that established infections with VZV can be modified by VARIZIG administration.
There is no indication for the prophylactic use of VARIZIG in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone marrow transplantation.
VARIZIG is a Varicella Zoster Immune Globulin (Human) indicated for post-exposure prophylaxis in high risk individuals (1). High risk groups include:
immunocompromised children and adults,
newborns of mothers with varicella shortly before or after delivery,
premature infants,
infants less than one year of age,
adults without evidence of immunity,
pregnant women.
VARIZIG administration is intended to reduce the severity of varicella.
1. INDICATIONS AND USAGE
ELYXYB is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
ELYXYB is not indicated for the preventive treatment of migraine.
ELYXYB is a nonsteroidal anti-inflammatory drug indicated for the acute treatment of migraine with or without aura in adults (1)
Limitations of Use
ELYXYB is not indicated for the preventive treatment of migraine. (1)
INDICATIONS AND USAGE
Estradiol Tablets, USP are indicated in the:
Treatment of moderate to severe vasomotor symptoms associated with the
menopause.
Treatment of moderate to severe symptoms of vulvar and vaginal atrophy
associated with the menopause. When prescribing solely for the treatment of
symptoms of vulvar and vaginal atrophy, topical vaginal products should be
considered.
Treatment of hypoestrogenism due to hypogonadism, castration or primary
ovarian failure.
Treatment of breast cancer (for palliation only) in appropriately selected
women and men with metastatic disease.
Treatment of advanced androgen-dependent carcinoma of the prostate (for
palliation only).
Prevention of osteoporosis. When prescribing solely for the prevention of
postmenopausal osteoporosis, therapy should only be considered for women at
significant risk of osteoporosis and for whom non-estrogen medications are not
considered to be appropriate. (See CLINICAL
PHARMACOLOGY, Clinical Studies.)The mainstays
for decreasing the risk of postmenopausal osteoporosis are weight bearing
exercise, adequate calcium and vitamin D intake, and when indicated,
pharmacologic therapy. Postmenopausal women require an average of 500mg/day of
elemental calcium. Therefore, when not contraindicated, calcium supplementation
may be helpful for women with suboptimal dietary intake. Vitamin D
supplementation of 400-800 IU/day may also be required to ensure adequate daily
intake in postmenopausal women.
1 INDICATIONS AND USAGE
Enoxaparin sodium injection, USP 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, USP 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, USP is indicated for:
the
inpatient treatment of acute deep vein thrombosis
with or without pulmonary embolism, when administered in conjunction with warfarin sodium.
the
outpatient treatment of acute deep vein thrombosis
without pulmonary embolism when administered in conjunction with warfarin sodium.
1.3 Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction
Enoxaparin sodium injection, USP 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, USP, 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).
1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia
Esmolol hydrochloride injection 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 injection 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.
INDICATIONS AND USAGE
Moexipril hydrochloride tablets are indicated for treatment of patients with hypertension. They may be used alone or in combination with thiazide diuretics.
In using moexipril hydrochloride tablets, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that moexipril hydrochloride tablets do not have a similar risk (see
WARNINGS
).
In considering use of moexipril hydrochloride tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see
WARNINGS, Angioedema
).
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
Divalproex Sodium Delayed-Release Tablets are an anti-epileptic drug indicated for:
Treatment of manic episodes associated with bipolar disorder (1.1)
Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures (1.2)
Prophylaxis of migraine headaches (1.3)
1.1	Mania
Divalproex sodium is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.
The efficacy of divalproex sodium delayed-release tablets was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)].
The safety and effectiveness of divalproex sodium delayed-release tablets for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed-release tablets for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.
1.2	Epilepsy
Divalproex sodium delayed-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
1.3	Migraine
Divalproex sodium delayed-release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium delayed-release tablets are useful in the acute treatment of migraine headaches.
1.4 Important Limitations
Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see Warnings and Precautions (5.2, 5.3, 5.4), Use in Specific Populations (8.1), and Patient Counseling Information (17)].
Divalproex sodium delayed-release tablets are contraindicated for prophylaxis of migraine headaches in women who are pregnant.
INDICATIONS AND USAGE
Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide.
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.
This fixed dose combination is not indicated for initial therapy (see
DOSAGE AND ADMINISTRATION).
INDICATIONS & USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets 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.
Urinary Tract Infections
For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media
For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in Adults
For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of a single antimicrobial agent.
Shigellosis
For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis Carinii Pneumonia
For the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.
Travelers Diarrhea in Adults
For the treatment of travelers diarrhea due to susceptible strains of enterotoxigenic E. coli.
1 INDICATIONS AND USAGE
Oxycodone hydrochloride tablets are indicated 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 oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):
Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
Oxycodone hydrochloride is an opioid agonist indicated 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, reserve oxycodone hydrochloride for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products):
Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.
INDICATIONS AND USAGE
Diazepam is 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.
In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patients recall of the procedures. (See WARNINGS.)
Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus.
Diazepam is a useful adjunct in status epilepticus and severe recurrent convulsive seizures.
Diazepam is a useful premedication (the I.M. route is preferred) for relief of anxiety and tension in patients who are to undergo surgical procedures. Intravenously, prior to cardioversion for the relief of anxiety and tension and to diminish the patients recall of the procedure.