um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60mg morphine per day, 25 mcg transdermal fentanyl per hour, 30mg oral oxycodone per day, 8mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
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/long-acting opioid formulations [see Warnings and Precautions (5.1)], reserve fentanyl transdermal system 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.
Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.
Fentanyl transdermal system contains fentanyl, an opioid agonist, and is indicated for the management of pain in opioid-tolerant patients, severe enough torequire daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1)
Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. (2.1)
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 fentanyl transdermal system 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)
Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic
INDICATIONS AN
D USAGE
Pilocarpine hydrochloride tablets, USP are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogrens syndrome.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (
see
WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation
).
Naproxen delayed-release tablets are indicated:
For the relief of the signs and symptoms
of rheumatoid arthritis
For the relief of the signs and symptoms
of osteoarthritis
For the relief of the signs and symptoms
of ankylosing spondylitis
For the relief of the signs and symptoms
of juvenile arthritis
Naproxen delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products
(see
CLINICAL PHARMACOLOGY,
DOSAGE AND ADMINISTRATION).
1 INDICATIONS AND USAGE
VENTOLIN HFA is a beta2-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1)
Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2)
1.1 Bronchospasm
VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
INDICATIONS AND USAGE
Hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani.
INDICATIONS AND USAGE
1.1 Bronchospasm
Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
Albuterol sulfate inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
USE
Antiseptic skin preparation
1
INDICATIONS AND USAGE
Gatifloxacin ophthalmic solution 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Aerobic gram-positive bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mitis group*
Streptococcus oralis*
Streptococcus pneumoniae
Aerobic gram-negative bacteria:
Haemophilus influenzae
*Efficacy for these organisms were studied in fewer than 10 infections.
Gatifloxacinophthalmic solution is a quinolone antimicrobial
indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae (1)
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns ; or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.
This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.
1 INDICATIONS AND USAGE
Phentermine Hydrochloride Capsules USP, 37.5 mg are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index 30 kg/m2, or 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).
Below is a chart of body mass index (BMI) based on various heights and weights.
BMI is calculated by taking the 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.
BODY MASS INDEX (BMI), kg/m2
Height (feet, inches)
Weight (pounds)
5'0"
5'3"
5'6"
5'9"
6'0"
6'3"
140
27
25
23
21
19
18
150
29
27
24
22
20
19
160
31
28
26
24
22
20
170
33
30
28
25
23
21
180
35
32
29
27
25
23
190
37
34
31
28
26
24
200
39
36
32
30
27
25
210
41
37
34
31
29
26
220
43
39
36
33
30
28
230
45
41
37
34
31
29
240
47
43
39
36
33
30
250
49
44
40
37
34
31
The limited usefulness of agents of this class, including phentermine [see
Clinical Pharmacology
(12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index 30 kg/m2, or 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia. (1)
The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. (1)
1 INDICATIONS AND USAGE
1 INDICATIONS AND USAGE
Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Ritonavir tablets are HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection (
1)
1 INDICATIONS AND USAGE
GEMTESA is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. (1)
1 INDICATIONS AND USAGE
INVOKAMET and INVOKAMET XR are a combination of canagliflozin and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Canagliflozin is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD).
Canagliflozin is indicated to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day.
INVOKAMET and INVOKAMET XR are a combination of canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated:
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
Canagliflozin is indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease (1)
Canagliflozin is indicated to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria (1).
Limitations of Use:
Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients (1)
Limitations of Use
INVOKAMET/INVOKAMET XR is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.3)].
1 INDICATIONS AND USAGE
Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3
)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]
Schizophrenia
Ziprasidone is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
Ziprasidone is indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)] .
Ziprasidone is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)] .
Ziprasidone is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone to prolong the QT interval and may consider the use of other drugs first (1)
Ziprasidone capsules are indicated for the:
treatment of schizophrenia in adults. (1)
acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder. (1)
maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. (1)
1 INDICATIONS AND USAGE
Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [
see
Clinical Studies (14)]
.
The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
1
INDICATIONS AND USAGE
Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
[see
Clinical Studies (
14.1)].
Limitations of Use
Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (
1)
Limitations of Use:
Not for treating type 1 diabetes mellitus or diabetic ketoacidosis
(
1)
INDICATIONS AND USAGE
Hypertension
Enalapril maleate tablets USP are indicated for the treatment of hypertension.
Enalapril maleate tablets USP are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate tablets USP and thiazides are approximately additive.
Heart Failure
Enalapril maleate tablets USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets USP improves symptoms, increases survival, and decreases the frequency of hospitalization (see
CLINICAL PHARMACOLOGY
,
Heart Failure, Mortality Trials
for details and limitations of survival trials).
Asymptomatic Left Ventricular Dysfunction
In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction
35 percent), enalapril maleate tablets USP decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see
CLINICAL PHARMACOLOGY
,
Heart Failure, Mortality Trials
for details and limitations of survival trials).
In using enalapril maleate tablets USP, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate tablets USP does not have a similar risk (see
WARNINGS
).
In considering use of enalapril maleate tablets USP, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks (see
WARNINGS
,
Anaphylactoid and Possibly Related Reactions
,
Head and Neck Angioedema
).
1 INDICATIONS AND USAGE
Rivastigmine tartrate capsules are an acetylcholinesterase inhibitor indicated for treatment of:
Mild-to-moderate dementia of the Alzheimers type (AD) (1.1)
Mild-to-moderate dementia associated with Parkinsons disease (PD) (1.2)
1.1 Alzheimers Disease
Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia of the Alzheimer's type (AD).
1.2 Parkinsons Disease Dementia
Rivastigmine tartrate capsules are indicated for the treatment of mild-to-moderate dementia associated with Parkinsons disease (PD).
INDICATIONS AND USAGE:
DIPRIVAN is an IV general anesthetic and sedation drug that can be used as described in the table below.
Table 3. Indications for DIPRIVAN
Indication
Approved Patient Population
Initiation and maintenance of Monitored Anesthesia Care (MAC) sedation
Adults only
Combined sedation and regional anesthesia
Adults only (see PRECAUTIONS)
Induction of General Anesthesia
Patients greater than or equal to 3 years of age
Maintenance of General Anesthesia
Patients greater than or equal to 2 months of age
Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients
Adults only
Safety, effectiveness and dosing guidelines for DIPRIVAN have not been established for MAC Sedation in the pediatric population; therefore, it is not recommended for this use (see
PRECAUTIONS,
Pediatric Use
).
DIPRIVAN 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 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 is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established (see
PRECAUTIONS
,
Pediatric Use
).
DIPRIVAN is not recommended for obstetrics, including Cesarean section deliveries. DIPRIVAN crosses the placenta, and as with other general anesthetic agents, the administration of DIPRIVAN may be associated with neonatal depression (see
PRECAUTIONS
).
DIPRIVAN is not recommended for use in nursing mothers because propofol 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
).
1 INDICATIONS AND USAGE
Rufinamide tablet is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.
Rufinamide tablet is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults (
1)
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 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 for use in patients younger than 13 years have not been established.
1INDICATIONS AND USAGE
Deferasirox oral granules is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1)
Deferasirox oral granules is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion- dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L. (1.2)
Limitations of Use:
The safety and efficacy of deferasirox oral granules when administered with other iron chelation therapy have not been established. (1.3)
1.1Treatment of Chronic Iron Overload Due to Blood Transfusions (Transfusional Iron Overload)
Deferasirox oral granules is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
1.2Treatment of Chronic Iron Overload in Non-Transfusion-Dependent Thalassemia Syndromes
Deferasirox oral granules is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L.
1.3Limitations of Use
The safety and efficacy of deferasirox oral granules when administered with other iron chelation therapy have not been established.
INDICATIONS AND USAGE
Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP are indicated for the symptomatic relief of cough in adults and children 6 years of age and older.
INDICATIONS AND USAGE
Mupirocin ointment, 2% is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes.
INDICATIONS & USAGE
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
INDICATIONS AND USAGE
Estradiol Transdermal System Continuous Delivery (Once-Weekly),
USP is 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.
Prevention of postmenopausal osteoporosis. When prescribing solely for the
prevention of postmenopausal osteoporosis, therapy should only be considered for
women at significant risk of osteoporosis and non-estrogen medications should be
carefully considered.
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 1500 mg/day of elemental calcium. Therefore, when
not contraindicated, calcium supplementation may be helpful for women with
suboptimal dietary intake. Vitamin D supplementation of 400 IU/day to 800 IU/day
may also be required to ensure adequate daily intake in postmenopausal women.
Hypertension
Lisinopril tablets, USP is indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.
INDICATIONS AND USAGE
GABITRIL (tiagabine hydrochloride) is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
1 INDICATIONS AND USAGE
TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.
TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults (
1,
14).