um-ids/dailymed-annotations huggingface dataset:
INDICATIONS AND USAGE
Hypertension
Irbesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Nephropathy in Type 2 Diabetic Patients
Irbesartan is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with
type 2 diabetes and hypertension. In this population, Irbesartan reduces the rate of progression of nephropathy as measured by the occurrence of doubling of
serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) (see
CLINICAL PHARMACOLOGY: Clinical Studies
).
1 INDICATIONS AND USAGE
Gabapentin is indicated for:
Management of postherpetic neuralgia in adults
Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
Gabapentin is indicated for: Postherpetic neuralgia in adults (1) Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy (1)
1 INDICATIONS AND USAGE
Anastrozole tablets are aromatase inhibitors indicated for:
Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer (1.1)
First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer (1.2)
Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets (1.3)
1.1 Adjuvant Treatment
Anastrozole tabletsare indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
1.2 First-Line Treatment
Anastrozole tablets are indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.
1.3 Second-Line Treatment
Anastrozole tablets are indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets.
INDICATIONS AND USAGE
Supplementation of the diet with ten essential vitamins.
Supplementation of the diet with fluoride for cariesprophylaxis.
M
ultivitamin with Fluoride 0.5 mg Chewable Tablets
provide 0.5 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water fluoridelevel is less than 0.3 ppm, and for children 6 years of ageand above where the drinking water contains 0.3 through0.6 ppm of fluoride.
Multivitamin with Fluoride
0.5
mg Chewable Tablets
supply significant amounts of Vitamins A, C, D, E,thiamine, riboflavin, niacin, vitamin B6, vitamin B12, andfolate to supplement the diet, and to help assure thatnutritional deficiencies of these vitamins will not develop.
Thus, in a single easy-to-use preparation, children obtainten essential vitamins and the important mineral, fluoride.The American Academy of Pediatrics recommends thatchildren up to age 16, in areas where drinking watercontains less than optimal levels of fluoride, receive dailyfluoride supplements.
Children using
Multivitamin with Fluoride
0
.
5
mg
Chewable Tablets regularly should receive semiannualdental examinations. The regular brushing of teeth andattention to good oral hygiene practices are also essential.Multivitamin with Fluoride Chewable Tablets is aprescription product for the clinical dietary management ofthe metabolic processes of caries prophylaxis and providessupplementation of the diet with ten essential vitamins.
1 INDICATIONS AND USAGE
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies
[see
Clinical Studies (14)]
.
The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
Zolpidem tartrate tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. (
1)
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.
INDICATIONS AND USAGE
Citalopram HBr is indicated for the treatment of depression.
The efficacy of citalopram HBr 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 in hospitalized depressed patients has not been adequately studied.
The efficacy of citalopram 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
1 INDICATIONS AND USAGE
Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated:
in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1)
in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2)
in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3)
as a single agent for the treatment of pancreatic cancer. (1.4)
1.1 Ovarian Cancer
Gemcitabine for Injection, USP in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
1.2 Breast Cancer
Gemcitabine for Injection, USP in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
1.3 Non-Small Cell Lung Cancer
Gemcitabine for Injection, USP in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
1.4 Pancreatic Cancer
Gemcitabine for Injection, USP is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine for Injection, USP is indicated for patients previously treated with fluorouracil.
1 INDICATIONS AND USAGE
Vancomycin hydrochloride capsule is a glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of: (1)
Clostridioide difficile -associated
diarrhea
Enterocolitis caused by Staphylococcus
aureus
(including methicillin resistant strains)
Limitations
of Use: (1) (5.1)
Parenteral administration of
vancomycin is not effective for the above infections; therefore, vancomycin
hydrochloride capsule must be given orally for these infections.
Orally administered vancomycin
hydrochloride capsules are not effective for other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsule and other antibacterial drugs, vancomycin hydrochloride capsule should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1)
Vancomycin Hydrochloride Capsules are indicated for the treatment of Clostridioides
difficil
e-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients less than 18 years of age.
Limitations of Use
.
Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections.
Orally administered vancomycin hydrochloride capsules are not effective for other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin 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.
1 INDICATIONS AND USAGE
Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.
Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older(1)
INDICATIONS AND USAGECyclobenzaprine hydrochloride tablets 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 hydrochloride tablets 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 hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
1 INDICATIONS AND USAGE
Celecoxib capsules are indicated
Celecoxib is a nonsteroidal anti-inflammatory drug indicated for:
Osteoarthritis (OA) (1.1)
Rheumatoid Arthritis (RA) (1.2)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3)
Ankylosing Spondylitis (AS) (1.4)
Acute Pain (AP) (1.5)
Primary Dysmenorrhea (PD) (1.6)
1.1 Osteoarthritis (OA)
For the management of the signs and symptoms of OA [see
Clinical Studies (14.1)
].
1.2 Rheumatoid Arthritis (RA)
For the management of the signs and symptoms of RA [see
Clinical Studies (14.2)
].
1.3 Juvenile Rheumatoid Arthritis (JRA)
For the management of the signs and symptoms of JRA in patients 2 years and older [see
Clinical Studies (14.3)
].
1.4 Ankylosing Spondylitis (AS)
For the management of the signs and symptoms of AS [see
Clinical Studies (14.4)
].
1.5 Acute Pain
For the management of acute pain in adults [see
Clinical Studies (14.5)
].
1.6 Primary Dysmenorrhea
For the management of primary dysmenorrhea [see
Clinical Studies (14.5)
].
1 INDICATIONS AND USAGE
Palonosetron hydrochloride injection is indicated in adults for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
acute nausea and vomiting associated with initial and repeat course of highly emetogenic cancer chemotherapy (HEC).
postoperativenauseaandvomiting (PONV) for up to 24 hoursfollowing surgery. Efficacybeyond24 hourshasnot beendemonstrated.
As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride is recommended even where the incidence of postoperative nausea and/or vomiting is low.
Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of:
acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.
Palonosetron hydrochloride injectionisaserotonin-3(5-HT
3) receptor antagonist indicated in:
Adults for prevention of:
acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).
(1)
acute nausea and vomiting associated with initial and repeat course of highly emetogenic cancer chemotherapy (HEC).
(1)
postoperativenauseaandvomiting (PONV) for up to 24 hoursfollowing surgery. Efficacybeyond24 hourshasnot beendemonstrated.
(1)
Pediatric patients aged 1 month to less than 17 years for prevention of:
acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy (HEC).(
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.
For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
1 INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below:
Lower Respiratory Tract Infections - caused by betalactamaseproducing isolates of
Haemophilus influenzae and
Moraxella catarrhalis.
Acute Bacterial Otitis Media - caused by betalactamaseproducing isolates of
H. influenzae and
M. catarrhalis.
Sinusitis - caused by betalactamaseproducing isolates of
H. influenzae and
M. catarrhalis.
Skin and Skin Structure Infections - caused by betalactamaseproducing isolates of
Staphylococcus aureus, Escherichia coli, and
Klebsiella species
.
Urinary Tract Infections - caused by betalactamaseproducing isolates of
E. coli, Klebsiella species
, and
Enterobacter species.
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used.
Usage
To reduce the development of drugresistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium 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.
Amoxicillin and clavulanate potassium tablets are a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: (
1)
Lower respiratory tract infections
Acute bacterial otitis media
Sinusitis
Skin and skin structure infections
Urinary tract infections
Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used. (
1)
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (
1)
1 INDICATIONS AND USAGE
RHOFADE (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.
Rhofade cream is an alpha1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. (1)
INDICATIONS AND USAGE
Phenazopyridine HCl is indicated for the symptomatic relief of pain,burning, urgency, frequency, and other discomforts arising fromirritation of the lower urinary tract mucosa caused by infection,trauma, surgery, endoscopic procedures, or the passage of soundsor catheters. The use of Phenazopyridine HCl for relief ofsymptoms should not delay definitive diagnosis and treatment ofcausative conditions. Because it provides only symptomatic relief,prompt appropriate treatment of the cause of pain must beinstituted and Phenazopyridine HCl should be discontinued whensymptoms are controlled. The analgesic action may reduce oreliminate the need for systemic analgesics or narcotics. It is,however, compatible with antibacterial therapy and can help torelieve pain and discomfort during the interval before antibacterialtherapy controls the infection. Treatment of a urinary tract infectionwith Phenazopyridine HCl should not exceed 2 days because thereis a lack of evidence that the combined administration ofPhenazopyridine HCl and an antibacterial provides greater benefitthan administration of the antibacterial alone after 2 days. (See
DOSAGE AND ADMINISTRATION section.)
INDICATIONS AND USAGE
Indium In 111 Chloride Sterile Solution is indicated for radiolabeling ProstaScint preparations used for in vivo diagnostic imaging procedures. It is also indicated for radiolabeling Zevalin preparations used for Radioimmunotherapy procedures. Please refer to the package insert for ProstaScint or Zevalin for information on the final drug product.
INDICATIONS AND USAGE
I. Vasospastic Angina
Nifedipine is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers.
II. Chronic Stable Angina
(Classical Effort-Associated Angina)
Nifedipine is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents.
In chronic stable angina (effort-associated angina), nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients are incomplete.
Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See
WARNINGS.)