um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use.
COLESTID Granules and FLAVORED COLESTID Granules are indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [LDL] cholesterol) who do not respond adequately to diet. Generally, COLESTID and FLAVORED COLESTID have no clinically significant effect on serum triglycerides, but with its use triglyceride levels may be raised in some patients.
Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy (see NCEP guidelines). A minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. Shorter periods may be considered in patients with severe elevations of LDL-C or with definite CHD.
According to the NCEP guidelines, the goal of treatment is to lower LDL-C, and LDL-C is to be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy. The NCEP treatment guidelines are shown below.
LDL-Cholesterol
mg/dL (mmol/L)
Definite Atherosclerotic Disease
Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease).
Two or More Other Risk Factors
Other risk factors for coronary heart disease (CHD) include: age (males: 45 years; females: 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is 60 mg/dL (1.6 mmol/L).
Initiation Level
Goal
No
No
190(4.9)
<160(<4.1)
No
Yes
160(4.1)
<130(<3.4)
Yes
Yes or No
130(3.4)
100(2.6)
1 INDICATIONS & USAGE
Entecavir tablet is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Entecavir tablets are a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (1)
INDICATIONS AND USAGE
Cycloserine is indicated in the treatment
of active pulmonary and extrapulmonary
tuberculosis (including renal disease) when
the causative organisms are susceptible to
this drug and when treatment with the primary
medications (streptomycin, isoniazid, rifampin,
and ethambutol) has proved inadequate. Like
all antituberculosis drugs, cycloserine should be
administered in conjunction with other effective
chemotherapy and not as the sole therapeutic
agent.
Cycloserine may be effective in the treatment
of acute urinary tract infections caused by
susceptible strains of gram-positive and gram-
negative bacteria. Use of cycloserine in these
infections should be considered only when
more conventional therapy has failed and when
the organism has been demonstrated to be
susceptible to the drug
1 INDICATIONS AND USAGE
Alendronate sodium is a bisphosphonate indicated for:
Treatment and prevention of osteoporosis in postmenopausal women. (
1.1,
1.2)
Treatment to increase bone mass in men with osteoporosis. (
1.3)
Treatment of glucocorticoid-induced osteoporosis. (
1.4)
Treatment of Paget's disease of bone. (
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
Alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
[See
Clinical Studies (14.1).]
1.2 Prevention of Osteoporosis in Postmenopausal Women
Alendronate sodium tablets are indicated for the prevention of postmenopausal osteoporosis
[see
Clinical Studies (14.2)]
.
1.3 Treatment to Increase Bone Mass in Men with Osteoporosis
Alendronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis
[see
Clinical Studies (14.3)]
.
1.4 Treatment of Glucocorticoid-Induced Osteoporosis
Alendronate sodium tablets are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to7.5 mg or greater of prednisone and who have low bone mineral density
[see
Clinical Studies (14.4)]
.
1.5 Treatment of Paget's Disease of Bone
Alendronate sodium tablets are indicated for the treatment of Pagets disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
[See
Clinical Studies (14.5).]
1.6 Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness of alendronate sodium tablets for the treatment of osteoporosis are based on clinical data of four years duration. 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
NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for:
Add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. (1.1)
Add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP). (1.2)
The treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). (1.3)
The treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for 6 months without an identifiable non-hematologic secondary cause. (1.4)
Limitations of use: Not for relief of acute bronchospasm or status asthmaticus. (1.1)
1.1 Maintenance Treatment of Severe Asthma
NUCALA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype [see Use in Specific Populations (8.4), Clinical Studies (14.1)].
Limitations of Use
NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.
1.2 Maintenance Treatment of Chronic Rhinosinusitis with Nasal Polyps
NUCALA is indicated for the add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.
1.3 Eosinophilic Granulomatosis with Polyangiitis
NUCALA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
1.4 Hypereosinophilic Syndrome
NUCALA is indicated for the treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for 6 months without an identifiable non-hematologic secondary cause.
1 INDICATIONS AND USAGE
Cisatracurium Besylate Injection is indicated:
as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age
to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU
to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older
Limitations of Use
Cisatracurium Besylate Injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.
Cisatracurium besylate injection is a nondepolarizing neuromuscular blocker indicated:
as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age (1)
to provide skeletal muscle relaxation during surgery in adults and in pediatric patients 2 to 12 years of age as a bolus or infusion maintenance (1)
for mechanical ventilation in the ICU in adults (1)
Limitations of Use
Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action (1)
INDICATIONS AND USAGE
Hypertension
Losartan potassium and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics
and Clinical Effects, and DOSAGE AND ADMINISTRATION).
Hypertensive Patients With Left Ventricular Hypertrophy
Losartan potassium and hydrochlorothiazide tablets USP are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients (see PRECAUTIONS, Race; CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke,
Race
; and DOSAGE AND ADMINISTRATION).
INDICATIONS AND USAGE
Blisovi Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Oral contraceptives are highly effective. Table I 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 I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD Adapted from RA Hatcher et al, Reference 7. *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 other reason.
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 other reason. N/A--Data not available
% of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use
Method
Lowest Expected1
Typical2
(No contraception)
(85)
(85)
Oral contraceptive
3
breCombined
0.1
N/A3
Progestin only
0.5
N/A3
Diaphragm with spermicidal cream or jelly
6
20
Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film)
6
26
Vaginal Sponge
Nulliparous
9
20
Parous
20
40
Implant
0.05
0.05
Injection:depot medroxyprogesterone acetate
0.3
0.3
IUD
Progesterone T
1.5
2.0
Copper T 380A
0.6
0.8
LNg 20
0.1
0.1
Condom without spermicides
Female
5
21
Male
3
14
Cervical Cap with spermicidal Cream of jelly
Nulliparous
9
20
Parous
26
40
Periodic abstinence (all methods)
1-9
25
Withdrawal
4
19
Female sterilization
0.5
0.5
Male sterilization
0.10
0.15
INDICATIONS AND USAGE
Hydrocortisone valerate ointment USP, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
INDICATIONS AND USAGE
1.5% Glycine Irrigation, USP is indicated for use as irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.
1 INDICATIONS AND USAGE
Letrozole Tablets, USP are aromatase inhibitor indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer (
1.1)
Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy (
1.2)
First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer (
1.3)
1.1 Adjuvant Treatment of Early Breast Cancer
Letrozole Tablets, USP are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
1.2 Extended Adjuvant Treatment of Early Breast Cancer
Letrozole Tablets, USP are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. The effectiveness of letrozole in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole for a median of 60 months [
see Clinical Studies (
14.2
,
14.3
)].
1.3 First and Second-Line Treatment of Advanced Breast Cancer
Letrozole Tablets, USP are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer.Letrozole Tablets, USP are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy
[see Clinical Studies (
14.4
,
14.5
)].
1 INDICATIONS AND USAGE
Metronidazole Gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.
Metronidazole Gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. (1)
INDICATIONS AND USAGE
Benign Prostatic Hyperplasia (BPH)
Doxazosin mesylate is indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). Doxazosin mesylate may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with doxazosin mesylate monotherapy. Doxazosin mesylate provides rapid improvement in symptoms and urinary flow rate in 66 to 71% of patients. Sustained improvements with doxazosin mesylate were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies.
Hypertension
Doxazosin mesylate is also indicated for the treatment of hypertension. Doxazosin mesylate may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers, or angiotensin-converting enzyme inhibitors.
INDICATIONS AND USAGE
Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.
THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION.
When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.
Indications and Usage:
A homecare, self-applied topical fluoride treatment. Aids in the prevention of dental caries (decay).
Divalproex sodium delayed release tablets are an anti-epileptic drug indicated for:
Treatment
of manic episodes associated with bipolar disorder (1.1)
Monotherapy
and adjunctive therapy of complex partial seizures and simple and complex
absence seizures; adjunctive therapy in patients with multiple seizure
types that include absence seizures (1.2)
Prophylaxis
of migraine headaches (1.3)
1.1 Mania
Divalproex sodium delayed release tablets are a valproate and are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.
The efficacy of divalproex sodium delayed release tablets were established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)].
The safety and effectiveness of divalproex sodium delayed release tablets for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed release tablets for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.
1.2 Epilepsy
Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.
Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.
1.3 Migraine
Divalproex sodium delayed release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium delayed release tablets are useful in the acute treatment of migraine headaches.
1.4 Important Limitations
Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see Warnings and Precautions (5.2, 5.3, 5.4), Use in Specific Populations (8.1), and Patient Counseling Information (17.3)].
Divalproex sodium delayed release tablets are contraindicated for prophylaxis of migraine headaches in women who are pregnant.
1. INDICATIONS AND USAGE
Arformoterol Tartrate Inhalation Solution is a long-acting beta
2-adrenergic agonist (beta
2-agonist) indicated for:
Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1)
Important limitations of use:
Arformoterol Tartrate Inhalation Solution is not inidcated to treat acute deteriorations of chronic obstructive pulmonary disease. (1.2, 5.2)
Arformoterol Tartrate Inhalation Solution is not indicated to treat asthma. (1.2)
1.1 Maintenance Treatment of COPD
Arformoterol Tartrate Inhalation Solution is indicated for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Arformoterol Tartrate Inhalation Solution is for use by nebulization only.
1.2 Important Limitations of Use
Arformoterol Tartrate Inhalation Solution is not indicated to treat acute deteriorations of chronic obstructive pulmonary disease
[see Warnings and Precautions (5.2)].
Arformoterol Tartrate Inhalation Solution is not indicated to treat asthma. The safety and effectiveness of Arformoterol Tartrate Inhalation Solution in asthma have not been established.
1 INDICATIONS AND USAGE
Alprazolam orally disintegrating tablets are a benzodiazepine indicated for:
The treatment of generalized anxiety disorder (1.1). The efficacy of alprazolam was demonstrated in 5 short-term, placebo-controlled trials (14).
The treatment of panic disorder, with or without agoraphobia (1.2). The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials (14).
1.1 Generalized Anxiety Disorder
Alprazolam orally disintegrating tablets, USP are indicated for the treatment of generalized anxiety disorder.
The efficacy of alprazolam in the treatment of generalized anxiety disorder was demonstrated in 5 short-term, placebo-controlled trials [see Clinical Studies (14.1)].
1.2 Panic Disorder
Alprazolam orally disintegrating tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia.
The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials [see Clinical Studies (14.2)].
Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months in duration for generalized anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Tramadol hydrochloride
ER tablets are indicated for the management of moderate to moderately severe
chronic pain in adults who require around-the-clock treatment of their pain for
an extended period of time
INDICATIONS AND USAGE
For control of severe nausea and vomiting.
For the treatment of schizophrenia.
Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).
When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).
The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).
Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.
INDICATIONS AND USAGE
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderateto moderately severe pain.
1 INDICATIONS AND USAGE
Galantamine Hydrobromide Tablets, USP are indicated for the treatment of mild tomoderate dementia of the Alzheimers type.
Galantamine hydrobromide tablets, USP is a cholinesterase inhibitor indicated for thetreatment of mild to moderate dementia of the Alzheimers type(1)
1 INDICATIONS AND USAGE
Sodium Fluoride F-18 Injection, USP, is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity.
Sodium Fluoride F-18 Injection, USP, is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity (1).