um-ids/dailymed-annotations huggingface dataset:
1 INDICATIONS AND USAGE
Alendronate Sodium Tablets USP are a bisphosphonate indicated for:
Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2)
Treatment to increase bone mass in men with osteoporosis (1.3)
Treatment of glucocorticoid-induced osteoporosis (1.4)
Treatment of Paget's disease of bone (1.5)
Limitations of use:
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.6)
1.1 Treatment of Osteoporosis in Postmenopausal Women
Alendronate Sodium Tablets USP are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, Alendronate Sodium Tablets USP increase bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures) [see Clinical Studies (14.1)].
1.2 Prevention of Osteoporosis in Postmenopausal Women
Alendronate Sodium Tablets USP are indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2)].
1.3 Treatment to Increase Bone Mass in Men With Osteoporosis
Alendronate Sodium Tablets USP are indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)].
1.4 Treatment of Glucocorticoid-Induced Osteoporosis
Alendronate Sodium Tablets USP are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see Clinical Studies (14.4)].
1.5 Treatment of Paget's Disease of Bone
Alendronate Sodium Tablets USP are indicated for the treatment of Pagets disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease [see Clinical Studies (14.5)].
1.6 Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness of Alendronate Sodium Tablets USP for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of oxaprozin
tablets and other treatment options before deciding to use oxaprozin tablets.
Use the lowest effective dose for the shortest duration consistent with
individual patient treatment goals (see WARNINGS).
Oxaprozin tablets are indicated:
For relief of the signs and symptoms of osteoarthritis
For relief of the signs and symptoms of rheumatoid arthritis
For relief of the signs and symptoms of juvenile rheumatoid arthritis
1 INDICATIONSAND USAGE
Zoledronic acid injection is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis (1.1, 1.2) Treatment to increase bone mass in men with osteoporosis (1.3) Treatment and prevention of glucocorticoid-induced osteoporosis (1.4) Treatment of Pagets disease of bone in men and women (1.5) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.6)
1.1
Treatment of Osteoporosis in Postmenopausal Women
Zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, zoledronic acid injection reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, zoledronic acid injection reduces the incidence of new clinical fractures [see Clinical Studies (14.1)
].
1.2
Prevention of Osteoporosis in Postmenopausal Women
Zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.2)
].
1.3
Osteoporosis in Men
Zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)
].
1.4
Glucocorticoid-Induced Osteoporosis
Zoledronic acid injection is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months [see Clinical Studies (14.4)
].
1.5
Paget's Disease of Bone
Zoledronic acid injection is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Pagets disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see Clinical Studies (14.5)
].
1.6
Important Limitations of Use
The safety and effectiveness of zoledronic acid injection for the treatment of osteoporosis is based on clinical data of three years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
INDICATIONS & USAGE SECTION
Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].
Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
1 INDICATIONSAND USAGE
Famotidine tablets are indicated in adult and pediatric patients 40 kg andgreater 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 tablets is a histamine-2 (H2) 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.
1 INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).)
The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see CLINICAL STUDIES (14)].
Zolpidem tartrate extended-release tablet, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (1)
INDICATIONS AND USAGE
Lopressor HCT is indicated for the management of hypertension.
This fixed-combination drug is not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patient's needs, therapy with the fixed combination may be more convenient than with the separate components.
1 Indications and Usage
Succinylcholine chloride injection is indicated in adults and pediatric patients: as an adjunct to general anesthesia to facilitate tracheal intubation to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Succinylcholine chloride injection is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: as an adjunct to general anesthesia ( 1) to facilitate tracheal intubation ( 1) to provide skeletal muscle relaxation during surgery or mechanical ventilation. ( 1)
INDICATIONS AND USAGE
Anxiety Disorders
Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients:
Motor Tension(trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability);
Autonomic Hyperactivity(shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat');
Vigilance and Scanning(feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor.
Anxiety associated with depression is responsive to alprazolam tablets.
Panic Disorder
Alprazolam tablets are also indicated for the treatment of panic disorder, with or without agoraphobia.
Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see
CLINICAL STUDIES
).
Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
Demonstrations of the effectiveness of alprazolam tablets by systematic clinical study are limited to4 months duration for anxiety disorder and 4 to10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
INDICATIONS AND USAGE
CODRIX is indicated for the relief of mild to moderately severe pain.
1 INDICATIONS AND USAGE
Methylphenidate HCl Extended-Release Tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see
Clinical Studies (14)].
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go;" excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Methylphenidate HCl Extended-Release Tablets are a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65. (1)
1.1	Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
1.2	Need for Comprehensive Treatment Program
Methylphenidate HCl Extended-Release Tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.
INDICATIONS
AND
USAGE
Depression-Forthereliefofsymptomsofdepression.Endogenousdepressionismore likelytobeal
leviatedthanotherdepressivestates.Onetothreeweeks oftreatmentmay beneededbeforeoptimaltherapeuticeffectsareevident.
Childhood Enuresis-Maybeusefulas temporaryadjunctivetherapyinreducing enuresis in children aged 6 years and older, after possibleorganic causes havebeen excludedbyappropriatetests.Inpatients havingdaytimesymptoms of frequencyand urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. Theeffectiveness of treatment may decreasewith continued drug administration.
INDICATIONS AND USAGE
Fluconazole tablets, USP are indicated for the treatment of:
Vaginal candidiasis (vaginal yeast infections due to Candida).
Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets, USP were also effective for the treatment of Candida urinary tract infections, peritonitis and systemic Candida infections including candidemia, disseminated candidiasis and pneumonia.
Cryptococcal meningitis. Before prescribing fluconazole tablets, USP for AIDS patients with cryptococcal meningitis, please see
CLINICAL STUDIES
section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.
Prophylaxis. Fluconazole tablets, USP are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
INDICATION AND USAGE
Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to
intact skin.
Issued 2011-11 N-BB-CA-A-DB(2)BB89X404+2
TERUFLEX BLOOD BAG SYSTEM with Diversion Blood Sampling Arm
CPDA-1 SOLUTIONFor the collection of 450 mL and 500 mL of Whole Blood
FULL PRESCRIBING INFORMATION
*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 8, 9, 10, 12, 13, 14, 15 and 17].
1. INDICATIONS AND USAGE
1.1. Read these instructions carefully before use.1.2.
Rx ONLY1.3.
Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.1.4.
For the collection of 450 mL +/- 10% and 500 mL +/- 10% Whole Blood.1.5.
Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the whole blood unit.1.6.
For further processing, use standard component processing techniques.
Image of Figure Sealing with tape
Image of Fig. 1 (attach luer adapter to tube holder)
Image of Fig. 2a and Fig. 2b (DBSA)
Image of Fig. 3a and Fig. 3b (filling DBSA)
INDICATIONS AND USAGE
Metformin hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
1 INDICATIONS AND USAGE
QUZYTTIR is indicated for the treatment of acute urticaria in adults and children 6 months of age and older.
QUZYTTIR is a histamine-1 (H1) receptor antagonist indicated for the treatment of acute urticaria in adults and children 6 months of age and older (1)
Limitations of Use:
Not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function (1)
Limitations of use:
QUZYTTIR is not recommended in pediatric patients less than 6 years of age with impaired renal or hepatic function.
INDICATIONS AND USAGE
Whole blood; for use in blood collection.
1 INDICATIONS& USAGE
Tamsulosin Hydrochloride Capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [
see
Clinical Studies (14)
]. Tamsulosin Hydrochloride Capsules are not indicated for the treatment of hypertension.
Tamsulosin Hydrochloride Capsules is an alpha
1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia
(1)
Tamsulosin Hydrochloride Capsules
are not indicated for the treatment of hypertension
(1)
INDICATIONS AND USAGE
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin 50 mg/m .
1.
2
Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
2.
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.
3.
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 Oral Solution, USP is recommended even where the incidence of postoperative nausea and/or vomiting is low.
4.
INDICATIONS AND USAGE:
Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution is indicated to hasten onset of analgesia and reduce injection pain, by adjusting commercial preparations of Lidocaine w/ Epinephrine anesthetic solution to a more physiologic pH.
1 INDICATIONS AND USAGE
To reduce the development of drugresistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium 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 is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
Amoxicillin and clavulanate potassium is a combination penicillin-class antibacterial and betalactamase inhibitor indicated for treatment of the following:
Lower respiratory tract infections
((
1.1)
Acute bacterial otitis media
((
1.2)
Sinusitis
(1.3)
Skin and skin structure infections
(1.4)
Urinary tract infections
(1.5)
1.1Lower Respiratory Tract Infections
caused by betalactamaseproducing isolates of
Haemophilus
influenzae
and
Moraxella
catarrhalis.
1.2 Acute Bacterial Otitis Media
caused by betalactamaseproducing isolates of
H.
influenzae
and
M.
catarrhalis.
1.3 Sinusitis
caused by betalactamaseproducing isolates of
H.
influenzae
and
M.
catarrhalis.
1.4 Skin and Skin Structure Infections
caused by betalactamaseproducing isolates of
Staphylococcus aureus, Escherichia coli, and
Klebsiella
species
.
1.5 Urinary Tract Infections
caused by betalactamaseproducing isolates of
E. coli,
Klebsiella
species, and
Enterobacter
species.
1.6 Limitations of Use
When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used.
INDICATIONS AND USAGE
Isosorbide mononitrate extended-release tablets, USPare indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral ISMN is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
INDICATIONS AND USAGESumatriptan Succinate Tablets are indicated for the acute
treatment of migraine attacks with or without aura in adults.
Sumatriptan Succinate Tablets are not intended for the prophylactic therapy
of migraine or for use in the management of hemiplegic or basilar migraine (see
CONTRAINDICATIONS). Safety and effectiveness of Sumatriptan Succinate Tablets
have not been established for cluster headache, which is present in an older,
predominantly male population.