Navigation Links
FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
Date:9/16/2009

WASHINGTON, Sept. 16 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA's authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Promethazine should neither be administered into an artery nor administered under the skin because of the risk of severe tissue injury, including gangrene, the boxed warning says. There is also a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue. As a result of these risks, the preferred route of administration is injecting the drug deep into the muscle.

A requested revision in the Dosage and Administration section of the label states that if health care professionals choose to administer promethazine intravenously, they should limit the drug's concentration and rate of administration and ensure a properly functioning intravenous line.

The companies that make promethazine are required to submit the requested safety label changes to the FDA within 30 days or provide a reason why they do not believe such changes are necessary. If they do not submit new language, or the FDA disagrees with the language proposed by the companies, the agency can order the label change as deemed appropriate to address the new safety information.

Promethazine was previously sold unde
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. To get college students to wash hands requires proper tools, attention-getting tactics
2. Getting College Students To Wash Hands, Halt Disease, Requires Giving Them Proper Tools and Spreading The Word In Ways That Get Attention, Say K-State Expert and Colleague
3. Eliminating polio requires global, coordinated effort -- Health Affairs article highlights risks, rewards of eradication
4. Neuroimaging suggests that truthfulness requires no act of will for honest people
5. THCA on 2009 Legislative Session: Seniors Medicaid-Financed Nursing Home Care Requires Substantially More Investment as Population Ages, Care Needs Grow
6. When Chest Pain Requires Quick Action in ER
7. Using tools requires that the brain is able to control movements
8. Getting Closer to Controlling Cancer Requires Funding More Laboratories and Commitment Beyond Two Years of New Stimulus, Weiner and Berg Assert in Denver Post Oped
9. Poison Prevention Requires Diligence
10. Recession-resistant Marketing Requires Innovative Steps
11. Stimulus Bill Requires Modification in U.S. Senate to Better Protect Seniors Ongoing Access to Quality Nursing Home Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/25/2015)... Caicos Islands, BWI (PRWEB) April 25, 2015 ... (PLS) has celebrated three months of successfully welcoming visitors ... January 5, 2015. , As part of a ... of Providenciales airport was completely redesigned to speed up ... up the process of getting out of the airport ...
(Date:4/25/2015)... On Friday, April 17, Interstate Batteries ... Best Implementation Award. This award is given to ... of RFID technology to improve its manufacturing, supply chain ... best demonstrates how RFID is delivering real value to ... Live! 2015 in San Diego, the RFID industries annual ...
(Date:4/24/2015)... As the nation recognizes the Month ... of these young men and women, the “Alaska – ... their Families” presents a special training session on Adverse ... a better understanding of the effect of childhood trauma ... – civilian and military – who provide services and ...
(Date:4/24/2015)... The 1975 have had an intense past two ... theaters, festivals and TV performances. Now that they’ve settled back ... Dirty Hit Records, to provide clean drinking water to those ... Cadence & Cause website, this four-piece has graciously donated ... signed photo card. Entries from this sweepstakes will ...
(Date:4/24/2015)... 2015 Anchor Health Administrators (Anchor), specialists ... today announced their exclusive agreement with LTC Solutions for ... Insurance distribution partner. , Anchor has more than 18 ... benefits for associations, and is currently the designated advocate ... Term Care Insurance member benefit. , “I am very ...
Breaking Medicine News(10 mins):Health News:The Tuscany on Grace Bay Celebrates Providenciales Airport Expansion With Summer Specials to Travelers! 2Health News:Seeonic’s Industry Leading Technology Powers Interstate Batteries to Winning Award 2Health News:Coalition Presents Resiliency Training to Raise Awareness during Month of the Military Child (#MOTMC2015) 2Health News:Internationally Recognized British Indie Rock Outfit The 1975 Partner with Cadence & Cause to Provide Clean Drinking Water to Those in Need 2
... In response to ... In Health (PIH) Stand with Haiti initiative. Buildium started the campaign with a $1,000 donation, ... ... ongoing needs in Haiti, Buildium today announced a fundraising campaign to benefit the Partners In ...
... , ... ... ... ...
... , ... ... , ... , , ...
... deal with physical pain, researchers say , THURSDAY, Feb. ... back pain may find relief through cognitive behavioral therapy, ... beliefs. , Chronic lower back pain is one of ... the British researchers report. And, it can be expensive ...
... , ... ... , , , ... ...
... drugs intended to halt growth of brain cancer stem cells ... conclude that blocking these cells may be somewhat effective, but ... the job done. One focus of attack is a ... shown is important for cancer stem cell growth. A new ...
Cached Medicine News:Health News:Buildium Announces Fundraising Campaign to Benefit Haiti Relief Efforts 2Health News:DNC Chairman Tim Kaine Applauds President, Members of Congress on Today's Bipartisan Summit 2Health News:DNC Chairman Tim Kaine Applauds President, Members of Congress on Today's Bipartisan Summit 3Health News:Clinton Bush Haiti Fund Awards International Medical Corps $500,000 for Emergency Medical Care and Long-Term Rebuilding 2Health News:Clinton Bush Haiti Fund Awards International Medical Corps $500,000 for Emergency Medical Care and Long-Term Rebuilding 3Health News:Chronic Back Pain Soothed by Cognitive Behavioral Therapy 2Health News:Chronic Back Pain Soothed by Cognitive Behavioral Therapy 3Health News:NSBA Implores Congress to Act on Health Care Reform 2Health News:NSBA Implores Congress to Act on Health Care Reform 3Health News:Notch-blocking drugs kill brain cancer stem cells, yet multiple therapies may be needed 2
(Date:4/24/2015)... April 24, 2015  Lannett Company, Inc. (NYSE: ... increased its five-year revolving credit facility to $120 million ... feature that will allow the company to increase borrowings ... million, subject to securing additional commitments from existing lenders ... credit facility remains December 18, 2018.   ...
(Date:4/24/2015)... Spain , April 24, 2015  Elekta has ... Monaco® treatment planning system , enabling European clinics ... supports major treatment techniques including advanced 3D planning, IMRT, ... system. Monaco ... as well improved workflow efficiency. Advancements in 3D planning ...
(Date:4/23/2015)...  Edwards Lifesciences Corporation (NYSE: EW ), the ... hemodynamic monitoring, today reported net income for the quarter ... diluted share.  Net income for the same period a ... share, and non-GAAP net income was $82.1 million, or ... the quarter ended March 31, 2015 increased 13.0 percent to ...
Breaking Medicine Technology:Lannett Expands Revolving Credit Facility To $120 Million 2Elekta CE marks for Monaco v5.10 treatment planning system 2Edwards Lifesciences Reports First Quarter Results 2Edwards Lifesciences Reports First Quarter Results 3Edwards Lifesciences Reports First Quarter Results 4Edwards Lifesciences Reports First Quarter Results 5Edwards Lifesciences Reports First Quarter Results 6Edwards Lifesciences Reports First Quarter Results 7Edwards Lifesciences Reports First Quarter Results 8Edwards Lifesciences Reports First Quarter Results 9Edwards Lifesciences Reports First Quarter Results 10Edwards Lifesciences Reports First Quarter Results 11Edwards Lifesciences Reports First Quarter Results 12Edwards Lifesciences Reports First Quarter Results 13Edwards Lifesciences Reports First Quarter Results 14Edwards Lifesciences Reports First Quarter Results 15Edwards Lifesciences Reports First Quarter Results 16
... 2 Results from studies related ... ) lead developmental product candidate, fidaxomicin, ... Annual Interscience Conference on Antimicrobial Agents and Chemotherapy ... and Exhibition Center in Boston on September 12-15, ...
... Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins... -- DALLAS, Texas, September 2, 2010 ... ... (typeof(lpUnit)==,undefined,) var lpUnit=,PRN,; --> ... function(data) { var s = ,; var first_result; // Results are keyed by longUrl, so we need ...
Cached Medicine Technology:Optimer Pharmaceuticals Announces Presentations of Additional Fidaxomicin Phase 3 Data at Upcoming ICAAC Annual Meeting 2Optimer Pharmaceuticals Announces Presentations of Additional Fidaxomicin Phase 3 Data at Upcoming ICAAC Annual Meeting 3Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies Now Available at ReportsandReports 2Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies Now Available at ReportsandReports 3Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies Now Available at ReportsandReports 4Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies Now Available at ReportsandReports 5Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies Now Available at ReportsandReports 6Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies Now Available at ReportsandReports 7Manufacturing of Biologics - Increasing Demand for Monoclonal Antibodies and Recombinant Proteins Drives Increases in Capacities and Innovative Production Technologies Now Available at ReportsandReports 8
Combination heat and moisture exchanger and bacterial/viral filters for Anesthesia and Respiratory applications....
HME w/bacterial viral filter w/CO2...
... The Portex® Thermovent® T helps provide protection to ... is small and extremely lightweight making it ideal ... With a high rate of heat and moisture ... retention., ,All HMEs and filters have ISO ...
... Thermovent® T helps provide protection to the exposed ... and extremely lightweight making it ideal for active ... high rate of heat and moisture recovery, it ... ,All HMEs and filters have ISO standard tapered ...
Medicine Products: