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Altabax (Retapamulin) - Summary

 
 



ALTABAX SUMMARY

ALTABAX (retapamulin ointment), 1%

ALTABAX contains retapamulin, a semisynthetic pleuromutilin antibiotic.

ALTABAX is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies].

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ALTABAX and other antibacterial drugs, ALTABAX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.


See all Altabax indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Altabax (Retapamulin)

Efficacy and safety of retapamulin ointment as treatment of impetigo: randomized double-blind multicentre placebo-controlled trial. [2008.05]
BACKGROUND: Impetigo is a common skin infection, primarily caused by Staphylococcus aureus and mainly occurring in children. It is usually treated topically with antibiotics to achieve a quick cure and prevent spread of the infection. Worldwide, resistance rates of S. aureus against commonly used antibiotics are rising. Retapamulin belongs to a newly developed class of antibiotics for the treatment of uncomplicated skin infections. OBJECTIVES: Our aim was to compare the efficacy and safety of topical application of retapamulin ointment with topical placebo ointment in the treatment of primary impetigo... CONCLUSIONS: This study shows that topical retapamulin is effective and safe in the treatment of primary impetigo, offering a new treatment option.

Topical retapamulin ointment, 1%, versus sodium fusidate ointment, 2%, for impetigo: a randomized, observer-blinded, noninferiority study. [2007]
BACKGROUND: Retapamulin is a novel pleuromutilin antibacterial developed for topical use. OBJECTIVE: To compare the efficacy and safety of retapamulin ointment, 1% (twice daily for 5 days), with sodium fusidate ointment, 2% (3 times daily for 7 days), in impetigo... CONCLUSION: Retapamulin is a highly effective and convenient new treatment option for impetigo, with efficacy against isolates resistant to existing therapies. 2007 S. Karger AG, Basel

Topical retapamulin ointment (1%, wt/wt) twice daily for 5 days versus oral cephalexin twice daily for 10 days in the treatment of secondarily infected dermatitis: results of a randomized controlled trial. [2006.12]
BACKGROUND: New antibacterial agents with activity against pathogenic strains resistant to established antibiotics are needed to treat patients with secondarily infected dermatitis (SID). OBJECTIVE: We sought to determine the clinical safety and efficacy of topical retapamulin ointment 1% versus oral cephalexin for the treatment of SID... CONCLUSIONS: Retapamulin ointment 1% (bid) for 5 days was as effective as oral cephalexin (bid) for 10 days in treatment of patients with SID, and was well tolerated.

Retapamulin ointment twice daily for 5 days vs oral cephalexin twice daily for 10 days for empiric treatment of secondarily infected traumatic lesions of the skin. [2006.09]
INTRODUCTION: Retapamulin is a novel, topical antibacterial of the pleuromutilin class in development for the treatment of secondarily infected traumatic lesions of the skin... CONCLUSIONS: Retapamulin offers a novel, effective, and convenient topical treatment for secondarily infected traumatic lesions.

Retapamulin: what is the role of this topical antimicrobial in the treatment of bacterial infections in atopic dermatitis? [2010.01]
In atopic dermatitis (AD), the stratum corneum of patients appears to have alterations that predispose them to colonization and invasion by various bacteria, most notably Staphylococcus aureus (S...

more studies >>

Clinical Trials Related to Altabax (Retapamulin)

Twice Daily Altabax Application for the Treatment of Uncomplicated Soft Tissue Infection [Recruiting]
The purpose of this study is to document the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with bacterial infections, including impetigo, folliculitis, and minor soft tissue infections including secondarily infected eczema presumed to be caused by methicillin resistant Staph aureus. Male and female patients ages 9 months to 98 years will be recruited from a university based dermatology clinic. Upon enrollment, wound cultures will be collected, and then subjects will apply topical retapamulin twice daily for five days. The primary endpoint will be resolution of methicillin-resistant Staphylococcus aureus (MRSA) infection based on clinical presentation and physical exam, as well as bacteriological efficacy based on culture results. It is anticipated that approximately 75 patients will be enrolled, with expectation that approximately 50 of these patients will have MRSA infections.

Efficacy Study of Altabax to Clear Methicillin-Resistant Staphylococcus Aureus (MRSA) Nasal Colonization [Not yet recruiting]
The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal colonization. The hypothesis is that the prevalence of MRSA increases as a function of increasing clinical exposure and that the topical antibiotic Altabax is efficacious in clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane University medical students and residents and physicians of Tulane Medical Center and Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for the study. After giving informed consent, subjects will be swabbed to obtain specimens for culture and asked to complete a short survey to assess risk factors. Swabs will be used to directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive subjects will be offered a treatment protocol with the topical antibiotic Altabax (retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily for 5 days. After the 5-day treatment is complete, subjects will be retested for the presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all cultures will additionally undergo disk susceptibility testing for retapamulin, erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and 20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those subjects found to be MRSA positive, data from the follow-up cultures will be used to assess the efficacy of Altabax in clearing MRSA nasal colonization.

ALTARGO(Retapamulin) PMS(Post-marketing Surveillance) [Not yet recruiting]

Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis [Recruiting]
Skin infections may complicate the treatment of atopic dermatitis. The use of topical ointments has become very important to avoid the use of oral antibiotics. There is little supporting literature regarding the use of topical antibiotics in secondarily infected atopic dermatitis.

This study will investigate the safety and effectiveness of Altabax ointment use in treating secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus pyogenes.

Retapamulin for Reducing MRSA Nasal Carriage [Not yet recruiting]
The investigators will conduct a randomized placebo-controlled double-blinded study of nasal decolonization with retapamulin vs. placebo for the eradication of MRSA nasal carriage among adult carriers with low-level (MIC 8-256) and high-level mupirocin resistant (MIC >256) strains.

Objectives:

1. To determine the percent of intervention vs. control patients with successful MRSA nasal decolonization as determined by bilateral nares swabs following a 5-day twice-a-day regimen of retapamulin.

2. To determine the time to decolonization based upon interim and final bilateral nares swabs.

3. To determine the acceptability of retapamulin by surveying participants about their experience and adverse events experienced during this study.

The duration of participant follow-up is expected to last up to 6 weeks.

This study will evaluate the safety and effectiveness of Altabax (retapmulin) during decolonization of MRSA carriers with mupirocin-resistant strains, stratified by low-level and high-level resistance to mupirocin. Mupirocin resistance is increasingly common and there is no approved substitute topical agent for decolonization of the MRSA nasal reservoir.

more trials >>

Reports of Suspected Altabax (Retapamulin) Side Effects

Pruritus (5)Burning Sensation (4)Hypersensitivity (3)Drug Ineffective (3)Pain (3)Application Site Pain (3)Skin Exfoliation (2)Erythema (2)Dermatitis Contact (2)Blister (2)more >>


Page last updated: 2010-10-05

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