um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Enter section text here
Fenoglide is a peroxisome proliferator receptor alpha (PPAR)
activator indicated:
as an adjunct to diet to reduce elevated LDL-C, Total-C, TG, and Apo B, and
to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia
when response to diet and non-pharmacological interventions alone has been
inadequate. (1.1)
as an adjunct to diet to treat patients with hypertriglyceridemia. Improving
glycemic control in diabetic patients showing fasting chylomicronemia will
usually obviate the need for pharmacologic intervention. (1.2).
Fenofibrate was not shown to reduce coronary heart disease morbidity and
mortality in a large, randomized controlled trial of patients with type 2
diabetes mellitus. (1.3).
1.1 Hyperlipidemia and Mixed Dyslipidemia
Fenoglide is indicated as adjunctive therapy to diet to reduce elevated LDL-C,
Total-C, Triglycerides, and Apo B, and to increase HDL-C in adult patients with
primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be
used in addition to a diet restricted in saturated fat and cholesterol when
response to diet and non-pharmacological interventions alone has been
inadequate.
1.2 Hypertriglyceridemia
Fenoglide is also indicated as adjunctive therapy to diet for treatment of adult
patients with hypertriglyceridemia. Improving glycemic control in diabetic
patients showing fasting chylomicronemia will usually reduce fasting
triglycerides and eliminate chylomicronemia thereby obviating the need for
pharmacologic intervention.
1.3 General Guidelines
Fenofibrate was not shown to reduce coronary heart disease
morbidity and mortality in a large, randomized controlled trial of patients with
type 2 diabetes mellitus. [see Warnings and
Precautions(5.6)
.]
Markedly elevated levels of serum triglycerides (e.g. >2,000 mg/dL) may
increase the risk of developing pancreatitis. The effect of Fenoglide therapy on
reducing this risk has not been adequately studied.
Drug therapy is not indicated for patients who have elevations of
chylomicrons and plasma triglycerides, but who have normal levels of very low
density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is
helpful in distinguishing these patients from those with elevated VLDL.2
1 INDICATIONS AND USAGE
Quetiapine tablets are an atypical antipsychotic indicated for the treatment of:
Schizophrenia (
1.1)
Bipolar I disorder manic episodes (
1.2)
Bipolar disorder, depressive episodes (
1.2)
1.1
Schizophrenia
Quetiapine tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [
see Clinical Studies (
14.1)
].
1.2
Bipolar Disorder
Quetiapine tablets are indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [
see Clinical Studies (
14.2)
].
Quetiapine tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [
see Clinical Studies (
14.2)
].
Quetiapine tablets are indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [
see Clinical Studies (
14.2)
].
1.3
Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
1 INDICATIONS & USAGE
Solifenacin succinate tablets is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Solifenacin succinate tablets is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency (1).
1 INDICATIONS AND USAGE
Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. (
1)
INDICATIONS AND USAGE
Aminocaproic Acid Tablets USP are useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required.
Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.
Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See
WARNINGS
.)
INDICATION
Cystografin Dilute is indicated
for retrograde cystourethrography.
1 INDICATIONS AND USAGE
GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.
GoLYTELY is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults (
1)
INDICATIONS AND USAGE
Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY - Susceptibility Test Methods).
Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin resistant Staphylococcus sp., therapy with Nafcillin for Injection should be discontinued and alternative therapy provided.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs. Nafcillin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 INDICATIONS AND USAGE
Sodium phenylacetate and sodium benzoate injection is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [
see
Warnings and Precautions (5)
].
Sodium phenylacetate and sodium benzoate injection is a nitrogen binding agent indicated as adjunctive therapy for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. (
1)
1 INDICATIONS AND USAGE
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
Famotidine tablets are indicated in adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of duodenal ulcer recurrence.
Famotidine is a histamine-2 (H
2) receptor antagonist indicated (
1):
In adult and pediatric patients 40 kg and greater for the treatment of:
active duodenal ulcer (DU).
active gastric ulcer.
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
In adults for the:
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of DU recurrence.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of Ibuprofen Oral Suspension and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
In Pediatric Patients, Ibuprofen Oral Suspension is indicated:
For reduction of fever in patients aged 6 months up to 2 years of age.
For relief of mild to moderate pain in patients aged 6 months up to 2 years of age.
For relief of signs and symptoms of juvenile arthritis.
In Adults, Ibuprofen Oral Suspension is indicated:
For treatment of primary dysmenorrhea.
For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended (see
PRECAUTIONS-Drug Interactions
).
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 III 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 III. Percentage of women experiencing an unintended pregnancy during the first year of typical use and first year of perfect use of contraception and the percentage continuing use at the end of the first year. United States.
% of Women Experiencing
an Accidental Pregnancy
within the First Year of Use
% of Women Continuing Use at One Year
3
Method
(1)
Typical Use
1
(2)
Perfect Use
2
(3)
(4)
Chance
4
85
85
Spermicides
5
26
6
40
Periodic abstinence
25
63
Calendar
9
Ovulation method
3
Sympto-thermal
6
2
Post ovulation
1
Withdrawal
19
4
Cap
7
Parous women
40
26
42
Nulliparous women
20
9
56
Sponge
Parous women
40
20
42
Nulliparous women
20
9
56
Diaphragm
7
20
6
56
Condom
8
Female (Reality)
21
5
56
Male
14
3
61
Pill
5
71
Progestin only
0.5
Combined
0.1
IUD
Progesterone T
2
1.5
81
Copper T 380A
0.8
0.6
78
Lng 20
0.1
0.1
81
Depo Provera
0.3
0.3
70
Norplant and Norplant-2
0.05
0.05
88
Female sterilization
0.5
0.5
100
Male sterilization
0.15
0.1
100
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998, in press.
1.Amongtypicalcouples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
2.Among couples who initiate use of a method (not necessarily for the first time) and who use itperfectly(both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3.Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
4.The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5.Foams, creams, gels, vaginal suppositories, vaginal film.
6.Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the postovulatory phases.
7.With spermicidal cream or jelly.
8.Without spermicides.
INDICATIONS AND USAGE:
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid 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 (see
CLINICAL PHARMACOLOGY:
Microbiology
).
The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.
The product does not provide adequate coverage against Serratia marcescens.
INDICATIONS AND USAGE
Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Amelioration of allergic reactions to blood or plasma Cold urticaria Dermatographism
As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
1 INDICATIONS AND USAGE
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. (1.1)
Limitation of Use:
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. (1.2)
1.1 Indication
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older.
1.2 Limitations of Use
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.
INDICATIONS AND USAGE
For dermatologic Use
SALVAX is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis.
For Podiatric Use
SALVAX is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions.
INDICATIONS AND USAGE
IMITREX Injection is indicated for 1) the acute treatment of migraine attacks with or without aura and 2) the acute treatment of cluster headache episodes.
IMITREX Injection is not for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS).
1
INDICATIONS AND USAGE
HepaGam B [Hepatitis B immune globulin intravenous (Human)] is an intravenous immune globulin indicated for the following:
For Intravenous or Intramuscular Administration Only
Prevention of Hepatitis B recurrence following Liver Transplantation in HBsAg-positive liver transplant patients (1.1).
Postexposure Prophylaxis (1.2) in the following settings:
Acute Exposure to Blood Containing HBsAg
Perinatal Exposure of Infants Born to HBsAg-positive Mothers
Sexual Exposure to HBsAg-positive Persons
Household Exposure to Persons with Acute HBV Infection
1.1 Prevention of Hepatitis B recurrence following liver transplant in HBsAg-positive liver transplant patients
1.2 Post-exposure prophylaxis
including
acute exposure to HBsAg-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc),
perinatal exposure of infants born to HBsAg-positive mothers,
sexual exposure to HBsAg-positive persons, and
household exposure to persons with acute HBV infection.
INDICATION AND USAGE
Desonide
Lotion is low to medium potency corticosteroids indicated for the
relief of the Inflammatory and pruritic manifestations of
corticosteroid responsive dermatoses.
INDICATIONS AND USAGE
Myocardial Infarction
Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient's clinical condition allows (see
DOSAGE AND ADMINISTRATION
,
CONTRAINDICATIONS
, and
WARNINGS
). Alternatively, treatment can begin within 3 to 10 days of the acute event (see
DOSAGE AND ADMINISTRATION
).
INDICATIONS AND USAGE
Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
Use in Pregnancy
Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see
PRECAUTIONS,
Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
INDICATIONS AND USAGE
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the
BOXED WARNING
, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).
Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
INDICATIONS & USAGE
Etomidate Injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of Etomidate Injection, the usefulness of its hemodynamic properties (see
CLINICAL PHARMACOLOGY) should be weighed against the high frequency of transient skeletal muscle movements (see
ADVERSE REACTIONS).
Intravenous Etomidate Injection is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.
1 INDICATIONS AND USAGE
Dicyclomine hydrochloride tablets, USP are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.