Refer to the “Also Known As” section to reference different products that include the same medication as Altabax.
Brand Name: Altabax
Generic Name: RETAPAMULIN
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: OINTMENT
Data Current As Of: 2019-09-30
indications & usage
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 (14)]. Safety in patients younger than 9 months has not been established.
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.
ALTABAX, a pleuromutilin antibacterial, is indicated for the topical treatment of impetigo due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes in patients aged 9 months or older. (1) Safety in patients younger than 9 months has not been established.
warnings & precautions
In the event of sensitization or severe local irritation from ALTABAX, usage should be discontinued, the ointment wiped off, and appropriate alternative therapy for the infection instituted [see Patient Counseling Information (17)].
not for systemic or mucosal use
ALTABAX is not intended for ingestion or for oral, intranasal, ophthalmic, or intravaginal use. The efficacy and safety of ALTABAX on mucosal surfaces have not been established. Epistaxis has been reported with the use of ALTABAX on nasal mucosa.
potential for microbial overgrowth
The use of antibiotics may promote the selection of nonsusceptible organisms. Should superinfection occur during therapy, appropriate measures should be taken.
Prescribing ALTABAX in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Coadministration of oral ketoconazole 200 mg twice daily increased retapamulin geometric mean AUC(0-24) and Cmax by 81% after topical application of retapamulin ointment, 1% on the abraded skin of healthy adult males. Due to low systemic exposure to retapamulin following topical application in adults and pediatric patients aged 2 years and older, dosage adjustments for retapamulin are unnecessary in these patients when coadministered with CYP3A4 inhibitors, such as ketoconazole. Based on in vitro P450 inhibition studies and the low systemic exposure observed following topical application of ALTABAX, retapamulin is unlikely to affect the metabolism of other P450 substrates.
Concomitant administration of retapamulin and CYP3A4 inhibitors, such as ketoconazole, has not been studied in pediatric patients. In pediatric subjects aged 2 to 24 months, systemic exposure of retapamulin was higher compared with subjects aged 2 years and older after topical application [see Pharmacokinetics (12.3)]. Based on the higher exposure of retapamulin, it is not recommended to coadminister ALTABAX with strong CYP3A4 inhibitors in patients younger than 24 months.
The effect of concurrent application of ALTABAX and other topical products to the same area of skin has not been studied.
patient counseling information
Patients using ALTABAX and/or their guardians should receive the following information 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 a 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. A 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 3 to 4 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 a registered trademark of Almirall, S.A.
Manufactured for: Almirall, LLC, Exton, PA 19341
© 2019 Almirall, LLC. All rights reserved.