Navigation Links
Supplemental New Drug Application Submitted to FDA for NUCYNTA® ER (Tapentadol) Extended-Release Tablets for Diabetic Peripheral Neuropathic Pain
Date:10/31/2011

ccurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation.
  • Use NUCYNTA® ER with caution in patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve, such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression, or coma. In such patients, even usual therapeutic doses of NUCYNTA® ER may increase airway resistance and decrease respiratory drive to the point of apnea. Alternative non–mu-opioid agonist analgesics should be considered, and NUCYNTA® ER should be employed only under careful medical supervision at the lowest effective dose in such patients. If respiratory depression occurs, it should be treated as any mu-opioid agonist-induced respiratory depression.
  • Patients receiving other opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, centrally acting muscle relaxants, or other CNS depressants (including alcohol) concomitantly with NUCYNTA® ER may exhibit additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, coma, or death may result if these drugs are taken in combination with NUCYNTA® ER. When such combined therapy is contemplated, a dose reduction of one or both agents should be considered.
  • Opioid analgesics can raise cerebrospinal fluid pressure as a result of respiratory depression with carbon dioxide retention. Therefore, NUCYNTA® ER should not be used in patients who may be susceptible to the effects of raised cerebrospinal fluid pressure, such as those with evidence of head injury and increased intracranial pressure. Opioid analgesics may obscure the clinical
    '/>"/>

  • SOURCE Janssen Pharmaceuticals Research & Development
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

    Related medicine technology :

    1. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
    2. ORENCIA(R) (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
    3. FDA Accepts Wyeths Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
    4. Supplemental New Drug Application for PREZISTA(TM) Submitted to U.S. Food and Drug Administration
    5. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
    6. CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)
    7. Anesiva Announces FDA Approval of Supplemental New Drug Application to Expand Zingo(TM) Indication
    8. FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)
    9. Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder
    10. Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA
    11. Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:7/31/2015)... -- Semler Scientific, Inc. (Nasdaq: SMLR ), a company ... and physician groups, today reported financial results for the ... "In the second quarter of 2015, Semler reported continued ... quarter over quarter revenue growth of 8%, and quarter ... units of 18%," said Doug Murphy-Chutorian, M.D., chief executive ...
    (Date:7/31/2015)... According to a new market research report ... Dual-Energy X-ray Absorptiometry (DEXA), Skinfold Calipers, Air Displacement Plethysmography ... to 2019", published by MarketsandMarkets, the global Body Composition ... is estimated to grow to $1,425.7 Million by 2019, ... 2019. Browse 41 market data Tables ...
    (Date:7/30/2015)... International Inc. (NYSE: MTD ) today announced second ... , Sales in local currency increased 3% ... sales decreased 4% as currency reduced sales growth by ... diluted share as reported (EPS) were $2.73, compared with ... , an increase of 9% over the prior-year ...
    Breaking Medicine Technology:Semler Reports Second Quarter 2015 Financial Results 2Semler Reports Second Quarter 2015 Financial Results 3Semler Reports Second Quarter 2015 Financial Results 4Semler Reports Second Quarter 2015 Financial Results 5Semler Reports Second Quarter 2015 Financial Results 6Body Composition Analyzers Market Worth $1,425.7 Million by 2019 2Body Composition Analyzers Market Worth $1,425.7 Million by 2019 3Body Composition Analyzers Market Worth $1,425.7 Million by 2019 4Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 2Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 3Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 4Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 5Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 6Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 7Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 8Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 9Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 10Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 11Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 12Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 13Mettler-Toledo International Inc. Reports Second Quarter 2015 Results 14
    ... Omthera Pharmaceuticals, Inc., a privately-held emerging specialty ... and Chief Executive Officer, will present at the ... InterContinental Boston, in Boston, Massachusetts, on Wednesday, June ... About Omthera Pharmaceuticals, Inc.Founded in 2008, Omthera ...
    ... Alere Inc. (NYSE: ALR ) (the "Company") ... each of its consent solicitations commenced on May 31, ... the "Proposed Modifications") governing its 9.0% Senior Subordinated Notes ... due 2018 (the "8.625% Notes") and 7.875% Senior Notes ...
    Cached Medicine Technology:
    (Date:7/31/2015)... CA (PRWEB) , ... July 31, 2015 , ... ... by High Times magazine. What are the STASH awards? The Significant Technological ... made by the cannabis-cultivation community as well as tried-and-true products that have stood ...
    (Date:7/31/2015)... New York (PRWEB) , ... July 31, 2015 , ... ... strut their stuff, Super-Sod debuted their new type of sod called Leisure Time(TM) ... trademark application in process. , To commemorate introduction of this new type of sod, ...
    (Date:7/31/2015)... ... August 01, 2015 , ... Super Bowl 50 will emanate from Levi’s ... biggest day each year is the Super Bowl. In the two weeks that separate the ... the host venue. The 2016 Super Bowl game will mark the 50th time it has ...
    (Date:7/31/2015)... ... 2015 , ... Precision Aesthetics is New York’s only Thermage skin tightening pinnacle ... provider of Exilis non-surgical fat reduction in New York. Due to its unparalleled ... International clientele. Many patients travel to New York to get their non-surgical skin ...
    (Date:7/31/2015)... ... July 31, 2015 , ... Last week, the ... The store can be accessed by visiting http://www.curemeso.org/store . , “Our new ... The best part: whenever a product is purchased, the Meso Foundation receives a ...
    Breaking Medicine News(10 mins):Health News:The High Times S.T.A.S.H. Awards Are in, Guess Who Took Home the Prize for “Best Grow System” 2Health News:Super-Sod Introduces Leisure Time(TM) Zoysia Grass with an Adirondack Chair Promotion 2Health News:Cheap 2016 Super Bowl Tickets at Levi's Stadium: Ticket Down Slashes Ticket Prices on Super Bowl 50 Tickets in Santa Clara, CA at Levi's Stadium 2Health News:Mesothelioma Organization Launches New Store 2Health News:Mesothelioma Organization Launches New Store 3
    ... (July 13, 2010) Pitt County Memorial ... study demonstrating that universal surveillance for methicillin-resistant ... (HAIs) related to devices. Infection rates decreased ... percent for central line-associated bacteremias (CLA-BSI); and ...
    ... HealthDay Reporter , TUESDAY, July 13 (HealthDay News) -- ... on the best way to use two classes of hormone ... of breast tumor. After a systematic review of medical ... inhibitor -- a drug that reduces the amount of estrogen ...
    ... BOSTON (July 13, 2010) With current public health ... contamination, innovations that better predict disease outbreaks have vast ... online in advance of print on July 6 in ... describe their vision for the future of disease surveillance, ...
    ... HealthDay Reporter , MONDAY, July 12 (HealthDay News) ... to open blocked arteries are getting proven treatments in U.S. ... the results of a large-scale study. Data on more ... from January 2007 through June 2009 also showed that the ...
    ... Stockholm, Sweden: Men who enter adult life obese face a life-long ... In a study presented today (Tuesday) at the International ... conscripts starting at the age of 20 until up to the ... obese man was twice as likely to die as a man ...
    ... of the Society for the Study of Ingestive Behavior (SSIB), ... and drinking behavior, finds that that feelings of hunger have ... and taste of food in overweight than healthy weight individuals. ... overweight participants and found that the overweight participants had greater ...
    Cached Medicine News:Health News:Study shows universal surveillance for MRSA significantly decreased HAIs at PCMH 2Health News:Experts Issue New Guidelines on Breast Cancer Drugs 2Health News:Experts Issue New Guidelines on Breast Cancer Drugs 3Health News:Researchers envision better disease surveillance to improve public health 2Health News:Heart Attack Care Is Getting Better, Report Finds 2Health News:Heart Attack Care Is Getting Better, Report Finds 3Health News:Study finds lifelong doubling in death risk for men who are obese at age 20 years 2
    ... confirmed Atriums superior biocompatibility and strength ... hernia repair. These same studies indicate ... hernia mesh can result in a ... when Atrium first introduced thin wall ...
    ... Repair Company, we recognize that there are ... tissue in-growth between the prosthesis and the ... Like all the products in Bards complete ... clinically proven, versatile repair.,The Reconix Patch is ...
    ... In applications such as laparoscopic ... reconstruction, surgeons require a surgical biomaterial ... incorporation.,GORE MYCROMESH Biomaterial provides the answer ... soft tissue reconstructions. Made from strong, ...
    ... CompanySM is pleased to announce the latest ... Composix E/X mesh.,When Bard Composix mesh was ... ventral hernia repair prosthesis that combined two ... ePTFE, in one product. Bard Composix E/X ...
    Medicine Products: