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Recent News and Articles on the Keywords: complicated skin + skin infections + merrem  Related to the article below (Last Update: 7/1/2008)

Ceftobiprole, a new anti-MRSA broad-spectrum antibiotic, receives ...
FOXBusiness -
About Complicated Skin Infections Complicated skin and soft tissue infections are among the most common infections in the hospital setting. ...
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Ad-Hoc-News (Pressemitteilung)
all 31 news articles »  SWF:BSLN - OTC:CMTX - BOM:500674
Ceftobiprole Approved in Canada for Treatment of Complicated Skin ...
DG News -
... of ceftobiprole medocaril for injection (ZEFTERA) for the treatment of complicated skin and soft tissue infections including diabetic foot infections. ...
New Data Show Preemptive Treatment May Significantly Reduce Skin ...
PharmiWeb.com (press release), UK - Jun 30, 2008
Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. ...
New Data Show Preemptive Treatment May Significantly Reduce Skin ...
WELT ONLINE, Germany - Jun 26, 2008
Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. ...AMGN

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Another related risk is that of skin disorders or granulomas. These occur when the body rejects foreign objects being inserted into the outer skin, ...
Targanta submits MAA for oritavancin for treatment of gram ...
RTT News, NY - Jun 9, 2008
... the treatment of complicated skin and soft tissue infections caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. ...TARG
Forest Laboratories Announces Positive Results From Phase III ...
RedOrbit, TX - Jun 19, 2008
"We are extremely pleased with the top-line results demonstrating ceftaroline's efficacy in treating complicated skin and skin structure infections, ...FRX
Zacks Equity Research Analyst Blog GSK Boosts Theravance, Near-Term
Zacks.com, IL - Jun 26, 2008
We expect the US launch of Theravance, Inc.?s (THRX) Telavancin, for the treatment of complicated skin infections, to occur by August, provided the company ...THRX
Babies' Irritated Skin Could Indicate Severe Diaper Rash
eMaxHealth.com, NC - Jun 18, 2008
"Barrier Therapeutics is committed to increasing the awareness of parents about skin conditions, including diaper rash with documented yeast infection," ...
Targanta Submits Marketing Authorization Application for Oritavancin
FOXBusiness - Jun 9, 2008
The MAA seeks approval of oritavancin for the treatment of complicated skin and soft tissue infections (cSSTI) caused by gram-positive bacteria, ...TARG
Source: Google News

Role of linezolid in the treatment of complicated skin and soft tissue infections -
WJ Peppard, JA Weigelt - Expert Rev. Anti Infect. Ther., 2006 - Future Drugs
... resistant strains) or Streptococcus pneumoniae (including MDR strains); complicated
skin and skin structure infections, including diabetic foot ...

… of Meropenem, Administered at 500 Milligrams Every 8 Hours, in Plasma and Cantharidin-Induced Skin … -
D Maglio, R Teng, PT Thyrum, CH Nightingale, DP … - Antimicrobial Agents and Chemotherapy, 2003 - aac.highwire.org
... approved for intra-abdominal infections and bacterial ... for lower respiratory tract,
skin and soft tissue, gynecologic, and complicated urinary tract ...

Safety of Newer Parenteral Antibiotics -
GE Stein - Clinical Infectious Diseases, 2005 - UChicago Press
... In a phase 2 clinical trial of patients with complicated skin or skin-structure
infections, 25 or 50 mg of tigecycline was infused over the ...

Diabetic foot infections and antibiotic therapy -
T Zgonis, GP Jolly, BJ Buren, P Blume - Clinics in Podiatric Medicine and Surgery, 2003 - Elsevier
... efficacy for moderate to severe complicated skin and skin ... as monotherapy for bacterial
skin and soft ... treatment of limb-threatening diabetic foot infections. ...

… , double-blind, randomized study of complicated skin and skin-structure infections in patients with … -
JM Embil, NE Soto, DA Melnick - Clinical Therapeutics, 2006 - Elsevier
... and folliculitis that are caused by 13-hemolytic streptococci and Staphylococcus
aureus, complicated skin and skin-structure infections (cSSSIs) are often ...

Diabetic foot infections
BA Cunha - Emerg Med, 1997 - emedicine.com
... Indicated for complicated skin and skin structure infections caused by E coli,
E faecalis (vancomycin-susceptible isolates only), S aureus ...

Ertapenem-Associated Seizures in a Peritoneal Dialysis Patient -
AH Seto, JC Song, SS Guest - The Annals of Pharmacotherapy, 2005 - Harvey Whitney Books
... Ertapenem once daily versus piperacillin-tazobactam 4 times per day for treatment
of complicated skin and skin-structure infections in adults ...

FDA Approvals: Focalin XR, Merrem IV, Tramadol ODT
Y Waknine - medscape.com
... Meropenem Injection (Merrem IV) for Complicated Skin and Skin Structure
Infections. On May 25, the FDA approved a new indication ...

FDA Approvals: Focalin XR, Merrem IV, Tramadol ODT
CME Medscape, M Connect, C Care, G Surgery, M … - medscape.com
... Meropenem Injection (Merrem IV) for Complicated Skin and Skin Structure
Infections. On May 25, the FDA approved a new indication ...

Meropenem in the treatment of complicated skin and soft tissue infections -
DN Fish - Therapeutics and Clinical Risk Management, 2006 - pubmedcentral.nih.gov
... Complicated skin and soft tissue infections (cSSTIs) are those which involve abnormal
skin or wounds ... the most common nosocomial infection among surgical ...

Source: Google Scholar
 
 

FDA approves Merrem for complicated skin and skin structure infections

 
 
FDA ( Food and Drug Administration ) approved antibiotic Merrem i.v. ( Meropenem for injection ) to treat adults and children with complicated skin and skin structure infections ( cSSSI ).

Merrem, a broad-spectrum carbapenem injectable antibiotic, currently is indicated and approved for use in the United States as a single agent therapy for intra-abdominal infections and bacterial meningitis.

The approval is based on results from one of the largest studies conducted to date of hospitalized patients with cSSSI.
The study showed that Meropenem, administered 500 mg IV every 8 hours, is a well-tolerated and effective treatment for patients with cSSSI, including the elderly and patients with diabetes mellitus.

A Phase III, randomized, double-blind, multicenter clinical trial of 1,037 patients with complicated skin and skin structure infections compared the efficacy, safety and tolerability of Meropenem, given at 500 mg IV every 8 hours, and Imipenem-Cilastatin given at 500 mg IV every 8 hours.
The primary efficacy end point was clinical outcome at follow-up in the clinically evaluable and modified intent-to-treat ( MITT; patients who met eligibility criteria and received greater than or equal to 1 dose of study drug ) populations.

The success rates in the clinically evaluable patients at the follow-up visit were 86% in the Meropenem arm and 83 percent in Imipenem-Cilastatin arm and 73 percent ( Meropenem ) and 75 percent ( Imipenem-Cilastatin ) in the MITT population.
The frequency of adverse events and drug-related adverse events were similar between treatment groups.
The most common adverse events reported in both treatment groups were headache, nausea, constipation, diarrhea, anemia, pain, and pruritus.

Among clinically evaluable patients 65 years of age and over, 81 percent of patients treated with Meropenem had a satisfactory clinical response at follow-up, compared with 72 percent of patients treated with Imipenem-Cilastatin.
Similarly, in the clinically evaluable population, among those with diabetes mellitus, 86 percent of patients treated with Meropenem had a satisfactory clinical response at follow-up, compared with 72 percent of patients treated with Imipenem-Cilastatin.
Among patients with microbiologically-documented infection, Meropenem demonstrated an excellent success rate in patients infected with Gram-positive aerobes ( 88 percent versus 83 percent ), Gram-negative aerobes ( 80 percent versus 75 percent ), and anaerobic pathogens ( 84 percent versus 85 percent; Meropenem versus Imipenem-Cilastatin ).

The pivotal clinical trial was supported by a pharmacokinetic trial demonstrating that Meropenem administered at 500 mg IV every 8 hours achieves levels in interstitial skin fluid sufficient to treat the common pathogens associated with complicated skin infections.

There are approximately 1.5 million patients who annually receive broad- spectrum antibiotics in hospitals for cSSSI. Complicated skin and skin structure infections involve the skin and may involve deeper soft tissues, often requiring surgical intervention and antibiotic therapy. These infections include complicated cellulitis, complex abscesses, perirectal abscesses, and other skin infections requiring intravenous antimicrobials and hospitalization.

Meropenem is generally well tolerated and has a low incidence of adverse events.
Systemic adverse events reported with Meropenem are typical of those seen with other intravenous antibiotics and include diarrhea, nausea, vomiting, and headache. Serious and occasionally fatal hypersensitivity ( anaphylactic ) reactions have been reported in patients receiving therapy beta-lactams.

Source: AstraZeneca, 2005
 
 
 
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