um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Prazosin hydrochloride capsules USP are 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug.
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 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.
Prazosin hydrochloride capsules USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets, USP and other antibacterial drugs, neomycin sulfate tablets, USP 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.
Suppression of intestinal bacteria
Neomycin sulfate tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, eg, preoperative preparation of the bowel.
It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION).
Hepatic coma (portal-systemic encephalopathy)
Neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.
1 INDICATIONS & USAGE
Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.
Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1)
1.1 Travelers Diarrhea
XIFAXAN
200 mg is indicated for the treatment of patients (
12 years of age) with travelers diarrhea caused by
noninvasive strains of Escherichia coli
[
see
Warnings
and
Precautions (5), Clinical
Pharmacology (12.4) and
Clinical
Studies
(14.1)].
Limitations of Use
XIFAXAN
should not be used in patients with diarrhea complicated by
fever or blood in the stool or diarrhea due to pathogens other
than Escherichia coli.
INDICATIONS AND USAGE
Epilepsy
Carbamazepinetablets USP and carbamazepine tablets USP (chewable)are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepinetablets USP and carbamazepine tablets USP (chewable) as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:
1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types.
2. Generalized tonic-clonic seizures (grand mal).
3. Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled bycarbamazepinetablets USP and carbamazepine tablets USP (chewable) (see PRECAUTIONS, General).
Trigeminal Neuralgia
Carbamazepinetablets USP and carbamazepine tablets USP (chewable)are indicated in the treatment of the pain associated with true trigeminal neuralgia.
Beneficial results have also been reported in glossopharyngeal neuralgia.
This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.
1 INDICATIONS AND USAGE
Lamotrigine extended-release tablets areindicated for:
adjunctive therapy for primary generalized tonic-clonicseizures and partial-onset seizures with or without secondary generalization in patients aged 13 yearsand older.(1.1)
conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug.(1.2)
Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established.(1.3)
1.1 Adjunctive Therapy
Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older.
1.2 Monotherapy
Lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED).
Safety and effectiveness of lamotrigine extended-release tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.
1.3 Limitation of Use
Safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established.
By Intralesional Injection
Keloids
Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare and lichen simplex chronicus (neurodermatitis)
Discoid lupus erythematosus
Necrobiosis lipoidica diabeticorum
Alopecia areata
May also be useful in cystic tumors of an aponeurosis or tendon (ganglia)
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by 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 Capsules are indicated in the treatment of infections due to susceptible (ONLY -lactamasenegative) isolates of the designated bacteria in the conditions listed below:
1.1
Infectio
ns of the ear, nose, and throat
due to
Streptococcus species,
(- and -hemolytic isolates only),
Streptococcus pneumoniae,
Staphylococcus spp., or
Haemophilus influenzae.
1.2
Infections of the genitourinar
y tract
due to
Escherichia coli, Proteus mirabilis, or
Enterococcus faecalis.
1.3
Infections
of the skin and skin structure
due to
Streptococcus spp.
(- and -hemolytic isolates only),
Staphylococcus spp., or
E. coli.
1.4
Infections of the lower respir
atory tract
due to
Streptococcus spp.
(- and -hemolytic isolates only),
S. pneumoniae, Staphylococcus spp., or
H. influenzae.
1.5
Gonorrhea, acute uncomplicated (ano-genital and urethral i
nfections)
due to
Neisseria gonorrhoeae.
Because of high rates of amoxicillin resistance, Amoxicillin Capsules are not recommended for empiric treatment of gonorrhea. Amoxicillin Capsules use should be limited to situations where
N. gonorrhoeae isolates are known to be susceptible to amoxicillin.
1.6 Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole
Amoxicillin Capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
1.7
Dual therapy for
H. pylori with lansoprazole
Dual therapy for
H. pylori with lansoprazole:
Amoxicillin Capsules in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer)
who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
INDICATIONS AND USAGE
Parkinsons Disease:
Ropinirole tablets USP are indicated for the treatment of the signs and symptoms of idiopathic Parkinsons disease.
The effectiveness of ropinirole hydrochloride was demonstrated in randomized, controlled trials in patients with early Parkinsons disease who were not receiving concomitant L-dopa therapy as well as in patients with advanced disease on concomitant L-dopa (see CLINICAL PHARMACOLOGY: Clinical Trials).
Restless Legs Syndrome:
Ropinirole tablets USP are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Key diagnostic criteria for RLS are: an urge to move the legs usually accompanied or caused by uncomfortable and unpleasant leg sensations; symptoms begin or worsen during periods of rest or inactivity such as lying or sitting; symptoms are partially or totally relieved by movement such as walking or stretching at least as long as the activity continues; and symptoms are worse or occur only in the evening or night. Difficulty falling asleep may frequently be associated with moderate-to-severe RLS.
1 INDICATIONS AND USAGE
Pramipexole Dihydrochloride Extended-Release Tablets are indicated for the treatment of Parkinson's disease.
Pramipexole dihydrochloride extended-release tablets are a non-ergot dopamine agonist indicated for the treatment of Parkinsons disease (PD) (1)
1.1 Major Depressive Disorder (MDD)
Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).
The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1)].
1 INDICATIONS AND USAGE
Pramipexole dihydrochloride extended-release tablets are a non-ergot dopamine agonist indicated for the treatment of Parkinson's disease (PD) (1)
Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease.
INDICATIONS AND USAGE
Edema
Furosemide tablets are indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide Tablets are particularly useful when an agent with greater diuretic potential is desired.
Hypertension
Oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone.
INDICATIONS AND USAGE
Carboprost tromethamine injection, USP is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion:
1. Failure of expulsion of the fetus during the course of treatment by another method;
2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity;
3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus;
4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.
Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations.
Studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. In a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium 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 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:
Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following:
Lower respiratory tract infections (1.1)
Acute bacterial otitis media (1.2)
Sinusitis (1.3)
Skin and skin structure infections (1.4)
Urinary tract infections (1.5)
1.1 Lower Respiratory Tract Infections
Caused by beta-lactamase producing isolates of Haemophilusinfluenzae and Moraxellacatarrhalis.
1.2 Acute Bacterial Otitis Media
Caused by beta-lactamase producing isolates of H.influenzaeand M.catarrhalis.
1.3 Sinusitis
Caused by beta-lactamase producing isolates of H.influenzaeand M.catarrhalis.
1.4 Skin and Skin Structure Infections
Caused by beta-lactamase producing isolates of Staphylococcusaureus, Escherichiacoli, and Klebsiellaspecies.
1.5 Urinary Tract Infections
Caused by beta-lactamase producing isolates of E.coli, Klebsiellaspecies, and Enterobacterspecies.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used.
INDICATIONS AND USAGE
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.
In OSAHS, PROVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating PROVIGIL. If PROVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.
In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.
The effectiveness of modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSAHS and SWSD clinical trials) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe PROVIGIL for an extended time in patients with Narcolepsy, OSAHS, or SWSD should periodically reevaluate long-term usefulness for the individual patient.
INDICATIONS AND USAGE
Fluconazole is indicated for the treatment of:
Vaginal candidiasis (vaginal yeast infections due to Candida).
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis. Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
INDICATIONS & USAGE
Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence)
Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic.
In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).
Conversion of Atrial Fibrillation/Flutter
Dofetilide capsules are indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.
Dofetilide capsules have not been shown to be effective in patients with paroxysmal atrial fibrillation.
1 INDICATIONS AND USAGE
Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Oxymorphone Hydrochloride Extended-Release Tablets are an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Oxymorphone Hydrochloride Extended-Release Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. (1)
Oxymorphone Hydrochloride Extended-Release Tabletsare not indicated as an as-needed (prn) analgesic. (1)
Limitations of Usage
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserveOxymorphone Hydrochloride Extended-Release Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Oxymorphone Hydrochloride Extended-Release Tabletsare not indicated as an as-needed (prn) analgesic.
1 INDICATIONS AND USAGE
Amlodipine and benazepril hydrochloride capsules are a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. (1)
1.1 Hypertension
Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
1 INDICATIONS AND USAGE
Irinotecan Hydrochloride Injection, USP is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.
Irinotecan Hydrochloride Injection, USP is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
Irinotecan Hydrochloride Injection, USP is a topoisomerase inhibitor indicated for:
First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. (1)
Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. (1)