um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
Limitations of Use
LUMOXITI is not recommended in patients with severe renal impairment (CrCl
29 mL/min) [see Dosage and Administration (2.3), Warnings and Precautions (5.3), and Use in Specific Populations (8.5)].
LUMOXITI is a CD22-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). (1)
Limitations of Use
Not recommended in patients with severe renal impairment (CrCl
29 mL/min). (1)
1 INDICATIONS & USAGE
Lacosamide tablets are indicated for:
Treatment of partial-onset seizures in patients 4 years of age and older (1.1)
1.1	Partial-Onset Seizures
Lacosamidetablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Additional pediatric use information is approved for UCB, Inc.'s VIMPAT (lacosamide) tablets. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (
1.1)
Levetiracetam 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)
1.1 Partial-Onset Seizures
Levetiracetam tablets are 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 tablets are 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 tablets are 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 INDICATIONS AND USAGE
RELEXXII
is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see
Clinical Studies (14)].
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: 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 six 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. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
RELEXXII
is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65. (1)
1.1 Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and 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.
1.2 Need for Comprehensive Treatment Program
RELEXXII
is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.
1 INDICATIONS AND USAGE
DIFFERIN Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
DIFFERIN Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. (1)
1 INDICATIONS AND USAGE
SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.
SUBOXONE
sublingual film contains buprenorphine, a partialopioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. (1)
SUBOXONE sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. (1)
INDICATIONS AND USAGE
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE 1: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
% of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use
Method
Lowest
Expected*
Typical**
Reproduced with permission of the Population Council from J. Trussell, et al: Contraceptive failure in the United States: An update. Studies in Family Planning, 21(1), January-February 1990.
*The authors best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any reason other than pregnancy.
**This term represents typical couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any reason other than pregnancy.
***Combined typical rate for both combined and progestin only.
#Combined typical rate for both medicated and nonmedicated IUD.
(No contraception)
(85)
(85)
Oral contraceptives
combined
0.1
3***
progestin only
0.5
3***
Diaphragm with spermicidal
cream or jelly
6
18
Spermicides alone (foam, creams,
jellies and vaginal suppositories)
3
21
Vaginal sponge
nulliparous
6
18
multiparous
9
28
IUD
0.8-2.0
3#
Condom without spermicides
2
12
Periodic abstinence (all methods)
1-9
20
Injectable progestogen
0.3-0.4
0.3-0.4
Implants
6 capsules
0.04
0.04
2 rods
0.03
0.03
Female sterilization
0.2
0.4
Male sterilization
0.1
0.15
INDICATIONS AND USAGE
Ketamine hydrochloride injection is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine hydrochloride injection is best suited for short procedures but it can be used, with additional doses, for longer procedures.
Ketamine hydrochloride injection is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents.
Ketamine hydrochloride injection is indicated to supplement low-potency agents, such as nitrous oxide.
Specific areas of application are described in the CLINICAL PHARMACOLOGY Section.
Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG)
levels in adult patients with severe (500 mg/dL) hypertriglyceridemia (HTG).
Usage Considerations : Patients should be placed on an appropriate lipid-lowering diet before
receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with
omega-3-acid ethyl esters capsules, USP.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before
instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids
with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such
as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications
known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be
discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use:
Sections or subsections omitted from the full prescribing information are not listed.
The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been
determined. The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has
not been determined.
Olopatadine hydrochloride ophthalmic solution USP 0.1 % is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
1 INDICATIONS AND USAGE
Pemetrexed for injection is a folate analog metabolic inhibitor indicated:
in combination with pembrolizumab and platinum chemotherapy,for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. (
1.1
)
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
(1.1)
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
(1.1)
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.
(1.1)
Limitations of Use:Pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.
(1.1)
initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
(1.2)
1.1 Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Pemetrexed for injection is indicated:
in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC)
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.
Limitations of Use: Pemetrexed for injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer [see Clinical Studies (14.1)].
1.2 Mesothelioma
Pemetrexed for injection is indicated, in combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
INDICATIONS AND USAGE
Dronabinol capsules are indicated for the treatment of:
anorexia associated with weight loss in patients with AIDS; and
nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
1 INDICATIONS AND USAGE
Esomeprazole Magnesium Delayed-Release Capsules is a proton pump inhibitor indicated for the following:
Treatment of
gastroesophageal reflux disease (GERD). (
1.1 )
Risk reduction of
NSAID-associated gastric ulcer. (
1.2 )
H. pylori
eradication
to reduce the risk of duodenal ulcer recurrence. (
1.3 )
Pathological
hypersecretory conditions, including Zollinger-Ellison syndrome. (
1.4 )
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-Release Capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Esomeprazole Magnesium Delayed-Release Capsules may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-Release Capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole Magnesium Delayed-Release Capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole Magnesium Delayed-Release Capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (Esomeprazole Magnesium Delayed-Release Capsules plus amoxicillin and clarithromycin): Esomeprazole Magnesium Delayed-Release Capsules in combination with amoxicillin and clarithromycin, are indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate
H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence
[see
Dosage and Administration (2) and
Clinical Studies (14)
].
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
Clinical Pharmacology (12.4) and
the prescribing information for clarithromycin
].
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Esomeprazole Magnesium Delayed-Release Capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
INDICATIONS AND USAGE
Hypertension
Enalapril maleate is indicated for the treatment of hypertension.
Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate and thiazides are approximately additive.
Heart Failure
Enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate 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 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, 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 does not have a similar risk. (See WARNINGS.)
In considering use of enalapril maleate, 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,
Head and Neck Angioedema
.)
Uses
A moisture barrier that prevents and helps heal skin irritation from: urine, diarrhea, perspiration, fistula damage, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching
INDICATION AND USAGE
Fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated:
In adult patients for the treatment of psoriasis of the scalp (scalp oil).
INDICATIONS:
Selenium Sulfide 2.3% Shampoo is a liquid antiseborrheic, antifungal preparation useful for the treatment of seborrheic dermatitis of the scalp, dandruff and tinea versicolor. Urea hydrates and is useful for conditions such as dry scalp.
INDICATIONS AND USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled.
The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section.)
INDICATIONS AND USAGE:
For treatment of tinea versicolor, seborrheic dermatitis of scalp and treatment of dandruff.
INDICATIONS AND USAGE
Sumatriptan
tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.
Sumatriptan
tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see
CONTRAINDICATIONS
). Safety and effectiveness of sumatriptan
tablets have not been established for cluster headache, which is present in an older, predominantly male population.
1 INDICATIONS AND USAGE
Anastrozole tablets are an aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer (
1.1)
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer (
1.2)
Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets. (
1.3)
1.1 Adjuvant Treatment
Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
1.2 First-Line Treatment
Anastrozole tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.
1.3 Second-Line Treatment
Anastrozole tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets.
1 INDICATIONS AND USAGE
ZIOPTAN
(tafluprost ophthalmic solution) 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
ZIOPTAN
(tafluprost ophthalmic solution) 0.0015% is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (
1)
1 INDICATIONSAND USAGE
Tramadol 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.
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 [see Warnings and Precautions (5.1)], reserve tramadol 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.
Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.
Tramadol hydrochloride is 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 tramadol 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)
Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. (1)
1
INDICATIONS AND USAGE
Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
INDICATIONS AND USAGE
Status Epilepticus
Lorazepam Injection is indicated for the treatment of status epilepticus.
Preanesthetic
Lorazepam Injection is indicated in adult patients for preanesthetic medication, producing sedation (sleepiness or drowsiness), relief of anxiety, and a decreased ability to recall events related to the day of surgery. It is most useful in those patients who are anxious about their surgical procedure and who would prefer to have diminished recall of the events of the day of surgery (see
PRECAUTIONS
,
Information for Patients
).