Company:

GlaxoSmithKline

Antibacterial (pleuromutilin)

Retapamulin 1%; oint.

Topical treatment of impetigo due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes in patients ≥ 9 months of age.

Altabax contains retapamulin, a semisynthetic pleuromutilin antibiotic. Each gram of ointment contains 10mg of retapamulin in white petrolatum.

Retapamulin selectively inhibits bacterial protein synthesis by interacting at a site on the 50S subunit of the bacterial ribosome. By binding to this site, retapamulin inhibits peptidyl transfer, blocks P-site interactions, and prevents the normal formation of active 50S ribosomal subunits. Retapamulin has been shown to be active against Staphylococcus aureus (methicillin-susceptible isolates only) and Streptococcus pyogenes, both in vitro and in clinical trials.

Altabax is for external use only. It is not intended for ingestion or for oral, intranasal, ophthalmic, or intravaginal use. The treated area may be covered by a sterile bandage or gauze dressing, if desired. A bandage will protect the treated area and avoid accidental transfer of ointment to the eyes or other areas.

Systemic exposure following topical application of retapamulin through intact and abraded skin is low. The effect of concurrent application of retapamulin and other topical products to the same area of skin has not been studied.

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

The safety and efficacy of retapamulin was evaluated in a randomized, double-blind, placebo-controlled study involving 210 adults and children 9 months of age and older for the treatment of impetigo up to 100cm² in total area (up to 10 lesions) or a total body surface area not exceeding 2%. Patients with underlying skin disease or skin trauma, with clinical evidence of secondary infection were excluded from the study. One hundred and thirty-nine patients received treatment with retapamulin. The study showed that after five days of treatment, the rates of clinical success, defined as response to impetigo at end of therapy wherein no further antibacterial treatment was needed, were greater in the retapamulin group (85.6%) than in the placebo group (52.1%).

>9 months: not recommended. ≥9 months: apply thin layer to affected area (up to 100cm² in total area in adults or 2% total body surface area in children) twice daily for 5 days. May cover with bandage or gauze dressing. Reevaluate if no improvement in symptoms within 3–4 days after starting treatment.

Not for intraoral, intranasal, ophthalmic, or intravaginal use. Discontinue if irritation or sensitization occurs. Prolonged use may result in superinfection. Pregnancy (Cat.B). Nursing mothers.

Application site irritation.

Oint—5g, 10g, 15g

For more information call (888) 825-5249 or visit www.Altabax.com.

5/25/07