Altabax

ALTABAX- retapamulin ointment
Almirall, LLC

1 INDICATIONS AND 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.

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 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 (17)].

3 DOSAGE FORMS AND STRENGTHS

10 mg retapamulin per 1g of ointment in 15- and 30- gram tubes

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Local Irritation

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)].

5.2 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.

5.3 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.

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The safety profile of ALTABAX was assessed in 2,115 adult and pediatric subjects 9 months and older who used at least one dose from a 5-day, twice-a-day regimen of retapamulin ointment. Control groups included 819 adult and pediatric subjects who used at least one dose of the active control (oral cephalexin), 172 subjects who used an active topical comparator (not available in the US), and 71 subjects who used placebo.

Adverse events rated by investigators as drug-related occurred in 5.5% (116/2,115) of subjects treated with retapamulin ointment, 6.6% (54/819) of subjects receiving cephalexin, and 2.8% (2/71) of subjects receiving placebo. The most common drug-related adverse events (greater than or equal to 1% of subjects) were application site irritation (1.4%) in the retapamulin group, diarrhea (1.7%) in the cephalexin group, and application site pruritus (1.4%) and application site paresthesia (1.4%) in the placebo group.

Adults

The adverse events, regardless of attribution, reported in at least 1% of adults (aged 18 years and older) who received ALTABAX or comparator are presented in Table 1.

Table 1. Adverse Events Reported by ≥1% of Adult Subjects Treated with ALTABAX or Comparator in Phase 3 Clinical Trials
Adverse Event ALTABAXN = 1,527% CephalexinN = 698%
Headache 2.0 2.0
Application site irritation 1.6 <1.0
Diarrhea 1.4 2.3
Nausea 1.2 1.9
Nasopharyngitis 1.2 <1.0
Creatinine phosphokinase increased <1.0 1.0

Pediatrics

The adverse events, regardless of attribution, reported in at least 1% of pediatric subjects aged 9 months to 17 years who received ALTABAX are presented in Table 2.

Table 2. Adverse Events Reported by ≥1% in Pediatric Subjects Aged 9 Months to 17 Years Treated with ALTABAX in Phase 3 Clinical Trials
Adverse Event ALTABAXN = 588% CephalexinN = 121% PlaceboN = 64%
Application site pruritus 1.9 0 0
Diarrhea 1.7 5.0 0
Nasopharyngitis 1.5 1.7 0
Pruritus 1.5 1.0 1.6
Eczema 1.0 0 0
Headache 1.2 1.7 0
Pyrexia 1.2 <1.0 1.6

Other Adverse Events

Application site pain, erythema, and contact dermatitis were reported in less than 1% of subjects in clinical trials.

Page 1 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.