um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Fenofibrate Tablets, USP are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet:
To reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (
1.1).
For treatment of adult patients with severe hypertriglyceridemia (
1.2).
Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (
5.1).
1.1 Primary Hypercholesterolemia or Mixed Dyslipidemia
Fenofibrate Tablets, USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides, and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
1.2 Severe Hypertriglyceridemia
Fenofibrate Tablets, USP are also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
1.3 Important Limitations of Use
Fenofibrate, at a dose equivalent to 160 mg of Fenofibrate Tablets, USP, 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 (5.1)]
.
INDICATIONS AND USAGE
Hypertension
Losartan potassium and hydrochlorothiazide tablets, USPare 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, USPare 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
Vitafol
-OB is indicated to provide vitamin, mineral, supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.*
INDICATIONS AND USAGE
Cyclobenzaprine HCl Tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.
Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Cyclobenzaprine should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.
Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
INDICATIONS & USAGE SECTION
Venlafaxine tablets, USP is indicated for the treatment of major depressive disorder.
The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.
The efficacy of venlafaxine hydrochloride extended-release capsules in maintaining an antidepressant response for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of venlafaxine tablets, USP in maintaining an antidepressant response in patients with recurrent depression who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). Nevertheless, the physician who elects to use venlafaxine tablets, USP/venlafaxine hydrochloride extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin 50 mg/m2.
Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron hydrochloride tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.
INDICATIONS AND USAGE
Citalopram hydrobromide is indicated for the treatment of depression.
The efficacy of Citalopram hydrobromide in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see
CLINICAL PHARMACOLOGY
).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
The antidepressant action of Citalopram hydrobromide in hospitalized depressed patients has not been adequately studied.
The efficacy of Citalopram hydrobromide in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see
CLINICAL PHARMACOLOGY
). Nevertheless, the physician who elects to use Citalopram hydrobromide for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Nateglinide is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use: Not for treating type 1 diabetes mellitus or diabetes ketoacidosis (1)
Limitations of Use:
Nateglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
INDICATIONS AND USAGE
Primidone tablets, used alone or concomitantly with other anticonvulsants, are indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.
INDICATIONS AND USAGE
Prevention of nausea and vomiting associated with highly emetogenic cancer
chemotherapy, including cisplatin 50 mg/m2.
Prevention of nausea and vomiting associated with initial and repeat courses
of moderately emetogenic cancer chemotherapy.
Prevention of nausea and vomiting associated with radiotherapy in patients
receiving either total body irradiation, single high-dose fraction to the
abdomen, or daily fractions to the abdomen.
Prevention of postoperative nausea and/or vomiting. As with other
antiemetics, routine prophylaxis is not recommended for patients in whom there
is little expectation that nausea and/or vomiting will occur postoperatively. In
patients where nausea and/or vomiting must be avoided postoperatively,
ondansetron hydrochloride tablets and ondansetron orally disintegrating tablets
are recommended even where the incidence of postoperative nausea and/or vomiting
is low.
INDICATIONS AND USAGE
Glipizide Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
INDICATIONS AND USAGE
Citalopram oral solution, USP is indicated for the treatment of depression.
The efficacy of citalopram oral solution, USPin the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see
CLINICAL PHARMACOLOGY
).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram oral solution, USPin hospitalized depressed patients has not been adequately studied.
The efficacy of citalopram oral solution, USPin maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see
CLINICAL PHARMACOLOGY
). Nevertheless, the physician who elects to use citalopram oral solution, USPfor extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
INDICATIONSAND USAGE
Triamcinolone Acetonide Topical Aerosol, USP is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
1 INDICATIONS AND USAGE
Simvastatinis indicated:
To reduce the risk of total mortality by reducing risk of
coronary heart disease death, non-fatal myocardial infarction and stroke,
and the need for coronary and non-coronary revascularization procedures in
adults with established coronary heart disease, cerebrovascular disease,
peripheral vascular disease, and/or diabetes, who are at high risk of
coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein
cholesterol (LDL-C):
In adults with primary hyperlipidemia.
In adults and pediatric patients aged 10 years and older with
heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C
in adults with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
Simvastatin tablets are an HMG-CoA reductase inhibitor indicated: (1)
To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):
In adults with primary hyperlipidemia.
In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
As an adjunct to diet for the treatment of adults with:
Primary dysbetalipoproteinemia.
Hypertriglyceridemia.
1 INDICATIONS AND USAGE
Sulfamethoxazole and Trimethoprim Injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria.
Pneumocystis jirovecii Pneumonia (1.1)
Shigellosis (1.2)
Urinary Tract Infections (1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sulfamethoxazole and Trimethoprim Injection and other antibacterial drugs, Sulfamethoxazole and Trimethoprim Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.4)
1.1 Pneumocystis
jirovecii Pneumonia
Sulfamethoxazole and Trimethoprim Injection is indicated in the treatment of Pneumocystis jirovecii pneumonia in adults and pediatric patients two months of age and older.
1.2 Shigellosis
Sulfamethoxazole and Trimethoprim Injection is indicated in the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei in adults and pediatric patients two months of age and older.
1.3 Urinary
Tract Infections
Sulfamethoxazole and Trimethoprim Injection is indicated in the treatment of severe or complicated urinary tract infections in adults and pediatric patients two months of age and older due to susceptible strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris when oral administration of Sulfamethoxazole and Trimethoprim Injection is not feasible and when the organism is not susceptible to single-agent antibacterials effective in the urinary tract.
1.4 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sulfamethoxazole and Trimethoprim Injection and other antibacterial drugs, Sulfamethoxazole and Trimethoprim 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 empiric selection of therapy.
Although appropriate culture and susceptibility studies should be performed, therapy may be started while awaiting the results of these studies.
INDICATIONS AND USAGE
Sonata is indicated for the short-term treatment of insomnia.
Sonata has been shown to decrease the time to sleep onset for up to 30 days in
controlled clinical studies (see
Clinical Trials
under
CLINICAL PHARMACOLOGY
). It has not been shown to
increase total sleep time or decrease the number of awakenings.
The clinical trials performed in support of efficacy ranged from a single
night to 5 weeks in duration. The final formal assessments of sleep latency were
performed at the end of treatment.
1 INDICATIONS AND USAGE
Sunitinib malate capsules are a kinase inhibitor indicated for:
treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1)
treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2)
adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3)
treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4)
1.1 Gastrointestinal Stromal Tumor
Sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
1.2 Advanced Renal Cell Carcinoma
Sunitinib malate capsules are indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC).
1.3 Adjuvant Treatment of Renal Cell Carcinoma
Sunitinib malate capsules are indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
1.4 Advanced Pancreatic Neuroendocrine Tumors
Sunitinib malate capsules are indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.
1 INDICATIONS AND USAGE
Clobetasol propionate shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older. (1)
Limitations of Use:
Do not use on the face, axillae or groin. (1.2)
Avoid any contact with the eyes and lips. (1.2)
1.1 Indication
Clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week.
Patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see Dosage and Administration (2)].
Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
1.2 Limitations of Use
Clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo.
INDICATIONS AND USAGE
Finasteride tablets USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:
-Improve symptoms
-Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
INDICATIONS AND USAGE
TOBRADEX Ophthalmic Suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:
Staphylococci, including S. aureusand S. epidermidis(coagulase-positive and coagulase-negative), including penicillin-resistant strains.
Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.
Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii,most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticusand some Neisseria species.
1 INDICATIONS AND USAGE
VENTOLIN HFA is a beta -adrenergic agonist indicated for:
2
Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. (1.1)
Prevention of exercise-induced bronchospasm in patients 4 years of age and older. (1.2)
1.1 Bronchospasm
VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
1 INDICATIONS AND USAGE
LOCOID Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.
LOCOID Lotion is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. (1)
INDICATIONS AND USAGE
Loxapine Capsules, USP are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
Indications and Usage
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.Ibuprofen tablets are indicated for relief of mild to moderate pain.Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.
1 INDICATIONS AND USAGE
ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout.
ULORIC is not recommended for the treatment of asymptomatic hyperuricemia.
ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout. (1)
ULORIC is not recommended for the treatment of asymptomatic hyperuricemia. (1)
1 INDICATIONS AND USAGE
MARINOL is indicated in adults for the treatment of:
anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome
(AIDS).
nausea and vomiting associated with cancer chemotherapy in patients who have failed to
respond adequately to conventional antiemetic treatments.
MARINOL is a cannabinoid indicated in adults for the treatment of:
Anorexia associated with weight loss in patients with AIDS. (1)
Nausea and vomiting associated with cancer chemotherapy in patients who have failed to
respond adequately to conventional antiemetic treatments. (1)