um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) should be used only to treat 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.
Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are combination penicillin-class antibacterials and beta-lactamase inhibitors indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
1.1 Lower Respiratory Tract Infections
caused by beta-lactamaseproducing isolates of Haemophilus influenzae and Moraxella catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.3 Sinusitis
caused by beta-lactamaseproducing isolates of H. influenzae and M. catarrhalis.
1.4 Skin and Skin Structure Infections
caused by beta-lactamaseproducing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species.
1.5 Urinary Tract Infections
caused by beta-lactamaseproducing isolates of E. coli, Klebsiella species, and Enterobacter species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, USP, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) should not be used.
INDICATIONS AND USAGE
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE for Oral Solution is indicated for bowel cleansing prior to colonoscopy.
1 INDICATIONS AND USAGE
Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications
[see
CLINICAL STUDIES (
14)]
.
Clonidine hydrochloride extended-release tablets are a centrally acting alpha
2-adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications.
(
1)
INDICATIONSAND USAGE
Doxepin Hydrochloride Capsules, USP are recommended for the treatment of:
Psychoneurotic patients with depression and/or anxiety.
Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).
Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.
The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry.
Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.
1 INDICATIONS AND USAGE
Alfuzosin hydrochloride extended-release tablets, USP, an alpha adrenergic antagonist, are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1)
Important Limitations of Use:
Alfuzosin hydrochloride extended-release tablets, USP are not indicated for treatment of hypertension. (1.1)
Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in pediatric population. (1.1, 8.4, 12.3)
Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
1.1 Important Limitations of Use
Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hypertension.
Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in pediatric population.
INDICATIONS AND USAGE
Cephalexin Capsules, USP is indicated for the treatment of the
following infections when caused by susceptible strains of the designated
microorganisms:
Respiratory tract infections caused by Streptococcus
pneumoniae and Streptococcus pyogenes
(Penicillin is the usual drug of choice in the treatment and prevention of
streptococcal infections, including the prophylaxis of rheumatic fever.
Cephalexin Capsules, USP is generally effective in the eradication of
streptococci from the nasopharynx; however, substantial data establishing the
efficacy of Cephalexin Capsules, USP in the subsequent prevention of rheumatic
fever are not available at present.)
Otitis media due to Streptococcus pneumoniae,
Haemophilus influenzae, Staphyloccus aureus,
Streptococcus pyogenes, and Moraxella
catarrhalis
Skin and skin structure infections caused by Staphylococcus aureusand/or Streptococcus pyogenes
Bone infections caused by Staphylococcus
aureusand/or Proteus mirabilis
Genitourinary tract infections, including acute prostatitis, caused by
Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae
NoteCulture and susceptibility tests should be
initiated prior to and during therapy. Renal function studies should be
performed when indicated.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cephalexin and other antibacterial drugs, Cephalexin 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
Fenofibrate tablets 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 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 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 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)]
.
1 INDICATIONS AND USAGE
Bortezomib for injection is a proteasome inhibitor indicated for:
treatment of adult patients with multiple myeloma (1.1)
treatment of adult patients with mantle cell lymphoma (1.2)
1.1	Multiple Myeloma
Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma.
1.2	Mantle Cell Lymphoma
Bortezomib for injection is indicated for the treatment of adult patients with mantle cell lymphoma.
INDICATIONS AND USAGE
Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Corneal Ulcers:
Pseudomonas aeruginosa
Serratia marcescens*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus (Viridans Group)*
Conjunctivitis:
Haemophilus influenzae
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
*Efficacy for this organism was studied in fewer than 10 infections.
1 INDICATIONS AND USAGE
Doxorubicin is an anthracycline topoisomerase II inhibitor indicated:
as a component of multiagent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer
(1.1).
for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma (1.2).
1.1 Adjuvant Breast Cancer
DOXOrubicin HCl Injection, USP is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer [see Clinical Studies (14.1)].
1.2 Other Cancers
Doxorubicin is indicated for the treatment of
acute lymphoblastic leukemia
acute myeloblastic leukemia
Hodgkin lymphoma
non-Hodgkin lymphoma (NHL)
metastatic breast cancer
metastatic Wilms tumor
metastatic neuroblastoma
metastatic soft tissue sarcoma
metastatic bone sarcoma
metastatic ovarian carcinoma
metastatic transitional cell bladder carcinoma
metastatic thyroid carcinoma
metastatic gastric carcinoma
metastatic bronchogenic carcinoma
INDICATIONS & USAGE
Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
1 INDICATIONS AND USAGE
Minocycline hydrochloride is a tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1)
1.1 Indication
Minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.
1.2 Limitations of Use
Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release tablets has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see CLINICAL STUDIES (14)].
To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, minocycline hydrochloride extended-release tablets should be used only as indicated [see WARNINGS AND PRECAUTIONS (5.11)].
INDICATIONS AND USAGE
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system.
INDICATIONS
Methenamine hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate and other antibacterial drugs, methenamine hippurate tablets 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
Timolol GFS 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Timolol GFS is a beta-adrenergic receptor inhibitor indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma (1)
INDICATIONS AND USAGE
Desoximetasone Ointment, 0.25% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.
1.1 Prevention of Cardiovascular Disease in Adults
In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to:
Reduce the risk of myocardial infarction
Reduce the risk of stroke
Reduce the risk for revascularization procedures and angina
In adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to:
Reduce the risk of myocardial infarction
Reduce the risk of stroke
In adult patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to:
Reduce the risk of non-fatal myocardial infarction
Reduce the risk of fatal and non-fatal stroke
Reduce the risk for revascularization procedures
Reduce the risk of hospitalization for CHF
Reduce the risk of angina
1.2 Hyperlipidemia
Atorvastatin calcium tablets are indicated:
As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb);
As an adjunct to diet for the treatment of adult patients with elevated serum TG levels (Fredrickson Type IV);
For the treatment of adult patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet;
To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable;
As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) if after an adequate trial of diet therapy the following findings are present:
LDL-C remains
190 mg/dL or
LDL-C remains
160 mg/dL and:
there is a positive family history of premature cardiovascular disease or
two or more other CVD risk factors are present in the pediatric patient
1.3 Limitations of Use
Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).
Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.
Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.
Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.
1 INDICATIONS AND USAGE
North American Coral Snake Antivenin (Equine) is indicated only for the treatment of envenomation caused by bites of North American coral snakes - Micrurus (including the eastern and Texas varieties).
North American Coral Snake Antivenin (Equine) is a horse-derived antivenin indicated for the treatment of envenomation caused by North American coral snakes - Micrurus. (1)
1 INDICATIONS AND USAGE
Exemestane tablets are an aromatase inhibitor indicated for:
adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy (14.1).
treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy (14.2).
1.1 Adjuvant Treatment of Postmenopausal Women
Exemestane tablets are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1)].
1.2 Advanced Breast Cancer in Postmenopausal Women
Exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2)].
1 INDICATIONS & USAGE
Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated:
in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. (1.1)
for the treatment of chronic hepatitis B in adults and pediatric patients12 years and older. (1.2)
1.1 HIV-1 Infection
Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg.
1.2 Chronic Hepatitis B
Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 12 years of ageand older.
Pediatric use information is approved for Gilead Sciences, Inc.s VIREAD (tenofovir disoproxil fumarate) tablets. However, due to Gilead Sciences, Inc.s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
1 INDICATIONS AND USAGE
Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.
Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder.
Diclofenac sodium topical gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. (
1)
Diclofenac sodium topical gel was not evaluated for use on joints of the spine, hip, or shoulder.
(14.1)
INDICATIONSAND USAGE
Methocarbamol tablets, USP are 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 methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
1	INDICATIONS AND USAGE
MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1% / 2.5% is indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired.
MYDCOMBI is a combination of tropicamide, an anticholinergic, and phenylephrine hydrochloride, an alpha-1 adrenergic receptor agonist indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired (1)
1 INDICATIONS AND USAGE
PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for:
PROTONIX is a proton pump inhibitor (PPI) indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance of Healing of Erosive Esophagitis (1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (1.3)
1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
PROTONIX is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
1.2 Maintenance of Healing of Erosive Esophagitis
PROTONIX is indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.