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Drug Criteria & Outcomes
Retapamulin (Altabax™) Formulary Evaluation
By Sarita Bhat, Pharm.D. Candidate, Auburn (AL) University
Brand Name (Manufacturer): Albatax™
Generic Name: Retapamulin
FDA Approved Indication:
Black Box Warnings:
|Bactroban® nasal ointment 1g||$6.07|
|Bactroban® 2% ointment 22g||$38.08|
|Mupirocin 2% ointment 22g||$10.30|
Potential for Medication Errors:
Clinical Trial Summary:
Parish LC, Jorizzo JL, Breton JJ, et al. Topical retapamulin ointment (1% wt/wt) twice daily for five days versus oral cephalexin twice daily for 10 days in the treatment of secondarily infected dermatitis: Results of a randomized controlled trial. J Am Acad Dermatol. 2006; 55: 1003-1013.
To determine clinical safety and efficacy of topical retapamulin ointment 1% versus oral cephalexin for the treatment of SID.
Study Design and Population:
5 randomized 2:1 retapamulin: cephalexin trials with 3 non-inferiority trials against oral cephalexin, 1 non-inferiority trial against topical fusidic acid ointment for impetigo treatment, and 1 superiority trial against placebo.
|Clinical success rates (%) with retapamulin:|
|9 mos - <2 yrs||50||93||95|
|2 - <6 yrs||95||89||88|
|6 - <13 yrs||98||90||95|
|13 - <18 yrs||93||100||94|
|18 - <65 yrs||90||91||91|
|Clinical success rates (%) with other drugs:|
|Age||Cephalexin for SITL||Fusidic Acid for Impetigo||Placebo for Impetigo|
|9 mos - <2 yrs||N/A||92||33|
|2 - <6 yrs||92||93||33|
|6 - <13 yrs||100||89||68|
|13 - <18 yrs||89||79||50|
|18 - <65 yrs||91||91||71|
Treatment with retapamulin ointment 1% was as effective as oral cephalexin as seen by 85.9% efficacy in the retapamulin group and 89.7% efficacy in the cephalexin group in the PPC population. This was a non-inferiority trial with 90% power to detect a greater than 10% difference in treatment, and the treatment difference was -3.8%, which is within 10%.
Clinical Trial Summary:
Rittenhouse S, Biswas S, Broskey J et al. Selection of Retapamulin, A Novel Pleuromutilin for Topical Use. Antimicrob Agents Ch. 2006; 50: 3882-3885.
This trial compared the in vitro activity of retapamulin to that of other commonly used topical antibiotics, showing MIC and MBC values for various antibiotics against several different strains of Staphylococcus and Streptococcus. MBC's were lower for retapamulin when directly compared with mupirocin against the same bacterial isolates in vitro. Retapamulin had the lowest MIC90 in most of the isolates studied. The authors concluded that retapamulin retains excellent in vitro activity against some isolates that are currently known to be resistant to commonly used antibiotics such as mupirocin, beta-lactams, macrolides, and quinolones, but they looked at very few isolates of these resistant strains.
Since the cost of retapamulin is much higher than that of generic mupirocin, it would be best to use Mupirocin when appropriate for impetigo and other skin infections caused by susceptible strains of Staphylococcus aureus and Streptococcus pyogenes. Retapamulin is not indicated for coverage of methicillin-resistant Staphylococcus aureus, and mupirocin is indicated for this purpose. Although the in vitro studies with retapamulin showed promise, the published clinical data has not proven that retapamulin is superior to the current treatment options available for gram-positive skin infections. It is recommended that retapamulin currently be restricted on the institutional formulary. Some institutions may want to classify the drug as non-formulary, where use is strongly discouraged. Alternatively, retapamulin could be classified as formulary status, but restricted to a small group of specialty physicians such as infectious disease and dermatology, where for unusual cases a specialty practitioner desires to use the new drug.