ALTABAX retapamulin ointment
Physicians Total Care, Inc.
DESCRIPTION
ALTABAX contains retapamulin, semisynthetic pleuromutilin antibiotic. The chemical name of retapamulin is acetic acid, [[(3-exo)-8-methyl-8-azabicyclo[3.2.1]oct-3-yl]thio]-, (3aS ,4R ,5S ,6S ,8R ,9R ,9aR ,10R)-6-ethenyldecahydro-5-hydroxy-4,6,9,10-tetramethyl-1-oxo-3a,9-propano-3aH -cyclopentacycloocten-8-yl ester. Retapamulin, white to pale-yellow crystalline solid, has molecular formula of C30 H47 NO4 S, and molecular weight of 517.78.
Each gram of ointment for dermatological use contains 10 mg of retapamulin in white petrolatum.
ALTABAX is indicated for use in adults and pediatric patients aged 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 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies (14)].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ALTABAX and other antibacterial drugs, ALTABAX should
2 DOSAGE AND ADMINISTRATION
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 months or older) twice daily for days. The treated area may be covered with sterile bandage or gauze dressing if desired [see Patient Counseling info. (17)].
3 DOSAGE FORMS AND STRENGTHS
10 mg retapamulin/1g of ointment in 5, 10, 15, and 30 gram tubes
Pregnancy Category B
ALTABAX is an antibacterial agent
PATIENT COUNSELING info.
Patients using ALTABAX and/or their guardians should receive the following info. and instructions: Use ALTABAX as directed by the healthcare practitioner. As with any topical medication, patients and caregivers should wash their hands after application if the hands are not the area for treatment.
ALTABAX is for external use only. Do not swallow ALTABAX or use it in the eyes, on the mouth or lips, inside the nose, or inside the female genital area.
The treated area may be covered by sterile bandage or gauze dressing, if desired. This may also be helpful for infants and young children who accidentally touch or lick the lesion site. bandage will protect the treated area and avoid accidental transfer of ointment to the eyes or other areas.
Use the medication for the full time recommended by the healthcare practitioner, even though symptoms may have improved.
Notify the healthcare practitioner if there is no improvement in symptoms within to days after starting use of ALTABAX.
ALTABAX may cause reactions at the site of application of the ointment. Inform the healthcare practitioner if the area of application worsens in irritation, redness, itching, burning, swelling, blistering, or oozing.
ALTABAX is registered trademark of GlaxoSmithKline.
