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.
Published Studies Related to Altabax (Retapamulin)
The safety and efficacy of topical retapamulin ointment versus placebo ointment
in the treatment of secondarily infected traumatic lesions: a randomized,
double-blind superiority study. 
in the treatment of patients with secondarily infected traumatic lesions... CONCLUSION: Clinical success rates were higher with retapamulin versus placebo in
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. 
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.
Clinical Trials Related to Altabax (Retapamulin)
Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids Versus Low-Potency Corticosteroid Mono-therapy [Withdrawn]
This study is designed to determine whether the addition of topical Altabax (R) to a
treatment regimen of topical corticosteroid therapy speeds clearance of atopic dermatitis
and improves quality of life.
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 [Withdrawn]
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.
United States Pharmacovigilence Retapamulin-Prescribing [Completed]
Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical
antibiotics approved for human use. In the United States (US), retapamulin is approved for
the treatment of impetigo in persons nine or more months of age and was launched on 12 April
2007. This five-year study is designed to examine use of retapamulin in the pediatric
population less than nine months of age. We will conduct an annual assessment of
prescription sales claims for retapamulin using the Integrated Health Care Information
Services (IHCIS) National Managed Care Benchmarked Database. For each year of reporting, the
observed frequencies of the exposure, with or without same-day, co-prescribed sales claim of
mupirocin, will be identified. The study objectives are to determine the frequency of
retapamulin sales in a representative US population stratified by the designated age group
and to determine the frequency of same-day sale of the topical agent, mupirocin.
EU PV for Retapamulin-Prescribing [Completed]
Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical
antibiotics approved for human use. In the European Union (EU), retapamulin is approved for
the treatment of impetigo and secondarily-infected traumatic lesions in persons nine or more
months of age. This study is designed to examine retapamulin use in the pediatric
population less than nine months of age. We will conduct a five-year assessment of
prescriptions for retapamulin using the General Practice Research Database. For each year of
reporting, the observed frequencies of prescriptions of retapamulin, with or without
same-day co-prescriptions of topical mupirocin or fusidic acid, will be identified. The
five-year reporting period will include five years of distinct, non-overlapping,
non-cumulative prescription use of first exposure to retapamulin, with or without same-day
co-prescription of topical mupirocin or fusidic acid.
Reports of Suspected Altabax (Retapamulin) Side Effects
Burning Sensation (4),
Drug Ineffective (3),
Application Site Pain (3),
Skin Exfoliation (2),
Dermatitis Contact (2),
Blister (2), more >>
Page last updated: 2014-11-30