um-ids/dailymed-annotations huggingface dataset:
INDICATIONS & USAGE
Carefully consider the potential benefits and risks ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Acute Pain in Adult Patients
Ketorolac tromethamine is indicated for the short-term (5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
Ketorolac tromethamine injection has been used concomitantly with morphine and meperidine and has shown an opioid-sparing effect. For breakthrough pain, it is recommended to supplement the lower end of the ketorolac tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Ketorolac tromethamine injection and narcotics should not be administered in the same syringe (see DOSAGE AND ADMINISTRATION -Pharmaceutical Information for Ketorolac Tromethamine
Injection).
1 INDICATIONS AND USAGE
Meloxicam Tablets are non-steroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA)
(1.1)
Rheumatoid Arthritis (RA)
(1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients who weigh
60 kg
(1.3)
1.1 Osteoarthritis (OA)
Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis
[see
Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis
[see
Clinical Studies (14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course
Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh 60 kg
[see
Dosage and Administration (2.4) and
Clinical Studies (14.2)].
1 INDICATIONS AND USAGE
Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for:
The treatment of inflammation following cataract surgery.
The temporary relief of ocular itching due to seasonal allergic conjunctivitis (1).
1 INDICATIONS AND USAGE
Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for:
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
Telmisartan tablets 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 the class to which this drug principally belongs.
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.
Telmisartan tablets may be used alone or in combination with other antihypertensive agents
[see Clinical Studies (
14.1)]
.
Use of telmisartan and ACE inhibitor is not recommended [
see Warnings and Precautions (
5.6)
].
INDICATIONS AND USAGE
Nitrofurantoin (monohydrate/macrocrystals) is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of
Escherichia coli or
Staphylococcus saprophyticus.
Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin (monohydrate/macrocrystals) 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.
Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin (monohydrate/macrocrystals) are predisposed to persistence or reappearance of bacteriuria (see
CLINICAL STUDIES). Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin (monohydrate/macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin (monohydrate/macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
1. INDICATIONS AND USAGE
Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:
Atropine is an anti-muscarinic agent indicated for:
Cycloplegia (1.1)
Mydriasis (1.2)
Penalization of the healthy eye in the treatment of amblyopia (1.3)
1.1 Cycloplegia
1.2 Mydriasis
1.3 Penalization of the healthy eye in the treatment of amblyopia.
1 INDICATIONSAND USAGE
Teriflunomide tabletsare indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Teriflunomide tablet is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis (1)
1 INDICATIONS AND USAGE
Methadone Hydrochloride contains methadone, an opioid agonist indicated for the:
detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8 [see Dosage and Administration (2.1)].
Methadone Hydrochloride is an opioid agonist indicated for the:
Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). (1)
Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. (1)
Limitations of Use
Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec. 8. (2.1)
1 INDICATIONS AND USAGE
STRATTERA is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1)
1.1 Attention-Deficit/Hyperactivity Disorder (ADHD)
STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
The efficacy of STRATTERA Capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) [see Clinical Studies (14)].
1.2 Diagnostic Considerations
A diagnosis of ADHD(DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age7years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g.,in social, academic, or occupational functioning, and must be present in 2or more settings, e.g.,school (or work) and at home. The symptoms must not be better accounted for by another mental disorder.
The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, on the go, excessive talking, blurting answers, can't wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met.
1.3 Need for Comprehensive Treatment Program
STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.
Indications and Usage
DIPRIVAN Injectable Emulsion is an IV sedative-hypnotic agent
that can be used as described in the table below.
Table 3. Indications for DIPRIVAN
Injectable Emulsion
Indication
Approved Patient Population
Initiation and maintenance of Monitored Anesthesia Care (MAC) sedation
Adults only
Combined sedation and reginoal anesthesia
Adults only (see PRECAUTIONS)
Induction of General Anesthesia
Patients more than or equal to 3 years of age
Maintenance of General Anesthesia
Patients more than or equal to 2 years of age
Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients
Adults only
Safety, effectiveness and dosing guidelines for DIPRIVAN Injectable Emulsion
have not been established for MAC Sedation in the pediatric population;
therefore, it is not recommended for this use (see PRECAUTIONS, Pediatric Use)
.
DIPRIVAN Injectable Emulsion is not recommended for induction of anesthesia
below the age of 3 years or for maintenance of anesthesia below the age of 2
months because its safety and effectiveness have not been established in those
populations.
In the Intensive Care Unit (ICU), DIPRIVAN Injectable Emulsion can be
administered to intubated, mechanically ventilated adult patients to provide
continuous sedation and control of stress responses only by persons skilled in
the medical management of critically ill patients and trained in cardiovascular
resuscitation and airway management.
DIPRIVAN Injectable Emulsion is not indicated for use in Pediatric ICU
sedation since the safety of this regimen has not been established (see PRECAUTIONS, Pediatric Use).
DIPRIVAN Injectable Emulsion is not recommended for obstetrics, including
Cesarean section deliveries. DIPRIVAN Injectable Emulsion crosses the placenta,
and as with other general anesthetic agents, the administration of DIPRIVAN
Injectable Emulsion may be associated with neonatal depression (see PRECAUTIONS
).
DIPRIVAN Injectable Emulsion is not recommended for use in nursing mothers
because DIPRIVAN Injectable Emulsion has been reported to be excreted in human
milk, and the effects of oral absorption of small amounts of propofol are not
known(see PRECAUTIONS
).
INDICATIONS & USAGE
Selegiline hydrochloride capsules,
USP are
indicated as an adjunct
in the
management
of Parkinsonian patients being
treated
with
levodopa/carbidopa
who
exhibit
deterioration
in the quality
of
their
response
to this
therapy.
There
is
no
evidence
from
controlled
studies that
selegiline has
any
beneficial
effect
in the
absence
of
concurrent
levodopa
therapy.
Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa.
Selegiline
was
significantly
superior
to
placebo
on
all
three principal
outcome
measures employed:
change
from
baseline
in
daily
levodopa/carbidopa
dose, the
amount
of 'off' time,
and patient
self-rating
of treatment
success.
Beneficial
effects were
also
observed on
other
measures
of treatment
success
(e.g.,
measures
of
reduced end
of
dose akinesia,
decreased
tremor
and
sialorrhea,
improved
speech
and
dressing
ability
and
improved
overall
disability as
assessed by walking
and
comparison
to
previous state).
INDICATIONS AND USAGE
Tobramycin ophthalmic solution 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of tobramycin ophthalmic solution 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.
1	INDICATIONS AND USAGE
Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. (1.1)
Levetiracetam injection is indicated for adjunctive therapy for the treatment of:
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. (1.3)
Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. (1.4)
1.1	Partial-Onset Seizures
Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
1.2	Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy
Levetiracetam injection is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
1.3	Primary Generalized Tonic-Clonic Seizures
Levetiracetam injection is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
1.4	Limitations of Use
Levetiracetam Injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
INDICATIONS AND USAGE
Prochlorperazine 25 mg suppositories are indicated in the control of severe
nausea and vomiting in adults.
INDICATIONS AND USAGE
Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions:
Addisonian (pernicious) anemia
Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy
Fish tapeworm infestation
Malignancy of pancreas or bowel
Folic acid deficiency
It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see
Drug Interactions ), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue.Such measures remove the need for long-term administration of cyanocobalamin.
Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.
Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).
INDICATIONS & USAGE
1.1 Duodenal Ulcer (adults)
Omeprazole delayed-release capsules, USP are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
Omeprazole delayed-release capsules, USP, in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.
Omeprazole delayed-release capsules, USP, in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2)].
Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Microbiology section (12.4)], and the clarithromycin package insert, Microbiology section.
1.2 Gastric Ulcer (adults)
Omeprazole delayed-release capsules, USP are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults [see Clinical Studies (14.2)].
1.3 Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients)
Symptomatic GERDOmeprazole delayed-release capsules, USP are indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults for up to 4 weeks.
Erosive EsophagitisOmeprazole delayed-release capsules, USP are indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults [see Clinical Studies (14.4)].
The efficacy of omeprazole delayed-release capsules, USP used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4 to 8 week courses of omeprazole may be considered.
1.4 Maintenance of Healing of Erosive Esophagitis (adults and pediatric patients)
Omeprazole delayed-release capsules, USP are indicated to maintain healing of erosive esophagitis in pediatric patients and adults.
Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].
1.5 Pathological Hypersecretory Conditions (adults)
Omeprazole delayed-release capsules, USP are indicated for the long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
1 INDICATIONS AND USAGE
Albendazole tablet is an anthelmintic drug indicated for:
Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. (1.1)
Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus. (1.2)
1.1 Neurocysticercosis
Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.
1.2 Hydatid Disease
Albendazole tablets are indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.
1 INDICATIONS AND USAGE
Amiodarone Hydrochloride Injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.Amiodarone Hydrochloride Injection also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with Amiodarone Hydrochloride Injection, patients may be transferred to oral amiodarone therapy
[see Dosage and Administration (
2)]
.
UseAmiodarone Hydrochloride Injection for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, butAmiodarone Hydrochloride Injection may be safely administered for longer periods if necessary.
Amiodarone Hydrochlroide Injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. (
1)