um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Tekturna is a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, 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
Tekturna is indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age and older 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. There are no controlled trials demonstrating risk reduction with Tekturna.
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 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also 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 (e.g., 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.
1 INDICATIONSAND USAGE
Zoledronic acid injection is a bisphosphonate indicated for:
Treatment and prevention of postmenopausal osteoporosis (1.1, 1.2)
Treatment to increase bone mass in men with osteoporosis (1.3)
Treatment and prevention of glucocorticoid-induced osteoporosis (1.4)
Treatment of Pagets disease of bone in men and women (1.5)
Limitations of Use
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.6)
1.1 Treatment of Osteoporosis in Postmenopausal Women
Zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, zoledronic acid injection reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, zoledronic acid injection reduces the incidence of new clinical fractures [
see Clinical Studies (14.1)].
1.2 Prevention of Osteoporosis in Postmenopausal Women
Zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women [
see Clinical Studies (14.2)].
1.3 Osteoporosis in Men
Zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis [
see Clinical Studies (14.3)].
1.4 Glucocorticoid-Induced Osteoporosis
Zoledronic acid injection is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months [
see Clinical Studies (14.4)].
1.5 Paget's Disease of Bone
Zoledronic acid injection is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Pagets disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [
see Clinical Studies (14.5)].
1.6 Important Limitations of Use
The safety and effectiveness of zoledronic acid injection for the treatment of osteoporosis is based on clinical data of three years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
1 INDICATIONS AND USAGE
Morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate.
Morphine sulfate extended-release capsules is indicated for the management of severe and persistent pain that requires an extended period with a daily opioid analgesic and for which alternative treatment options are inadequate. (1)
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve morphine sulfate extended-release capsules 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)
Morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic. (1)
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release capsules 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.
Morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic.
1 INDICATIONS AND USAGE
Metoclopramide Orally Disintegrating Tablets are a dopamine receptor antagonist indicated for:
Relief of Symptomatic Gastroesophageal Reflux: short-term (4 to 12 weeks) therapy for adults with symptomatic, documented
gastroesophageal reflux who fail to respond to conventional therapy
(1.1)
Diabetic Gastroparesis (Diabetic Gastric Stasis): the relief of symptoms in adults associated with acute and recurrent
diabetic gastroparesis (gastric stasis) (1.2)
Important Limitations:
Therapy should not exceed 12 weeks in duration
(1.3)
Metoclopramide Hydrochloride Orally Disintegrating Tablets
are recommended only for adults. The safety and effectiveness in pediatric
patients have not been established (1.3)
1.1 Symptomatic Gastroesophageal Reflux Disease
Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy.
1.2 Diabetic Gastroparesis (Diabetic Gastric Stasis)
Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis) in adults.
1.3 Important Limitations
Metoclopramide Hydrochloride Orally Disintegrating Tablets are indicated for adults only. Therapy should not exceed 12 weeks in duration. The safety and effectiveness in pediatric patients have not been established.
Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.
INDICATIONS AND USAGE FOR ENDOMETRIOSIS
(For Central Precocious Puberty, See
Reverse Side
)
SYNAREL is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. Experience with SYNAREL for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months.
1 INDICATIONS AND USAGE
Perindopril Erbumine Tablets are indicated for the treatment of patients with essential hypertension (1.1)
Perindopril Erbumine Tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction (1.2)
1.1 Hypertension
Perindopril Erbumine Tablets are indicated for the treatment of patients with essential hypertension. Perindopril Erbumine Tablets may be used alone or given with other classes of antihypertensives, especially thiazide diuretics.
1.2 Stable Coronary Artery Disease
Perindopril Erbumine Tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. Perindopril Erbumine Tablets can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy.
1 INDICATIONS AND USAGE
Lurasidone hydrochloride tablets are indicated for:
Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)].
Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
Lurasidone hydrochloride tablets are an atypical antipsychotic indicated for the treatment of:
Schizophrenia in adults and adolescents (13 to 17 years) (1, 14.1)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy (1, 14.2)
Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate (1, 14.2)
INDICATIONS AND USAGE
For once weekly use as a dental caries preventative in pediatric patients.
INDICATIONS AND USAGE
Hydromorphone hydrochloride tablets USP are indicated for the management of pain
in patients where an opioid analgesic is appropriate.
Uses
temporarily relieves minor aches and pains due to:
headache
muscle pain
toothache
menstrual pain
colds
minor pain of arthritis
temporarily reduces fever
1 INDICATIONS AND USAGE
RHOPRESSA (netarsudil ophthalmic solution) 0.02% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
RHOPRESSA
(netarsudil ophthalmic solution) 0.02% is a Rho kinase inhibitor indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (1)
1 INDICATIONS AND USAGE
IMPEKLO lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older (1).
Limitations of Use:
Do not in the treatment of rosacea or perioral dermatitis.
1.1	Indication
IMPEKLO lotion is a super-high potent topical corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.
1.2	Limitations of Use
IMPEKLO lotion should not be used in the treatment of rosacea or perioral dermatitis.
Use in patients under 18 years of age is not recommended due to numerically high rates of HPA axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
1
INDICATIONS AND USAGE
Carisoprodol Tablets USP are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol Tablets USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (
2
)].
Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. (1)
Limitations of Use:
Should only be used for acute treatment periods up to two or three weeks (1)
INDICATIONS AND USAGE
Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome.
Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
1 INDICATIONS AND 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
Lacosamide tablets 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.
INDICATIONS AND USAGE
Flucytosine Capsules are indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.
Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine
Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.
Flucytosine Capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine Capsules (see
MICROBIOLOGY
).
1 INDICATIONS AND USAGE
Gonal-F RFF is indicated for:
GONAL-F RFF is a gonadotropin indicated for:
Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure. (1.1)
Development of multiple follicles in ovulatory infertile women as part of Assisted Reproductive Technology (ART) cycles. (1.2)
1.1	Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure
1.2	Development of multiple follicles in ovulatory infertile women as part of an assisted reproductive technology (ART) cycle
1 INDICATIONS AND USAGE
Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).
Limitations of Use
In OSA, modafinil is indicated to treat excessive sleepiness and not as treatment 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 and during treatment with modafinil for excessive sleepiness.
Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). (1)
Limitations of Use
In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
1 INDICATIONS AND USAGE
ADAPALENE Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
ADAPALENE Gel, 0.3% is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
INDICATIONS AND USAGE
Hypertension
Enalapril maleate tablets are indicated for the treatment of hypertension.
Enalapril maleate tablets are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate tablets and thiazides are approximately additive.
Heart Failure
Enalapril maleate tablets are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets improve symptoms, increase survival, and decrease 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 decrease the rate of development of overt heart failure and decrease 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, 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 do not have a similar risk (see
WARNINGS
).
In considering use of enalapril maleate tablets, 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
).
INDICATIONS AND USAGE
Lidocaine HCl Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.
INDICATIONS & USAGE
Intravenous adenosine injection is indicated for the following:
Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine administration.
It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see
DOSAGE AND ADMINISTRATION).
Adenosine injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine administration.
1 INDICATIONS AND USAGE
LYRICA is indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury
LYRICA is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1)
Postherpetic neuralgia (PHN) (1)
Adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older (1)
Fibromyalgia (1)
Neuropathic pain associated with spinal cord injury (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 II 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 and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
Table II: Percentage of Women Experiencing an Unintended Pregnancy during the First Year of Use of a Contraceptive Method
Method
Perfect
Use
Typical
Use
NA - not available
Levonorgestrelimplants
0.05
0.05
Malesterilization
0.1
0.15
Femalesterilization
0.5
0.5
Depo-Provera
(injectableprogestogen)
0.3
0.3
Oralcontraceptives
5
Combined
0.1
NA
Progestinonly
0.5
NA
IUD
Progesterone
1.5
2.0
CopperT380A
0.6
0.8
Condom(male)withoutspermicide
3
14
(Female)withoutspermicide
5
21
Cervicalcap
Nulliparouswomen
9
20
Parouswomen
26
40
Vaginalsponge
Nulliparouswomen
9
20
Parouswomen
20
40
Diaphragmwithspermicidalcreamorjelly
6
20
Spermicidesalone(foam,creams,jellies,andvaginalsuppositories)
6
26
Periodicabstinence(allmethods)
1to9Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998
25
Withdrawal
4
19
Nocontraception(plannedpregnancy)
85
85
INDICATIONS & USAGE SECTION
Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.