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.

A thin layer of ALTABAX should be applied to the affected area (up to 100 cm² in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) twice daily for 5 days. The treated area may be covered with a sterile bandage or gauze dressing if desired [see PATIENT COUNSELING INFORMATION ].

Dosage Forms and Strength

10 mg retapamulin/1g of ointment in 5, 10, and 15 gram tubes

Storage and Handling

ALTABAX is supplied in 5 gram, 10 gram, and 15 gram tubes.

NDC 0007-5180-05 (5 gram tube)

NDC 0007-5180-10 (10 gram tube)

NDC 0007-5180-22 (15 gram tube)

Store at 25°C (77°F) with excursions permitted to 15°-30°C (59°-86°F).

ALTABAX is a trademark of GlaxoSmithKline.
GlaxoSmithKline
Research Triangle Park, NC 27709
©2007, GlaxoSmithKline. All rights reserved.
FDA rev date: 4/13/2007

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